Capsaicin/Menthol/Methyl Salicylate Lotion

Pronunciation: kap-SAY-sin/MEN-thol/METH-il sa-LIS-i-late
Generic Name: Capsaicin/Menthol/Methyl Salicylate
Brand Name: Dendracin Neurodendraxcin

Capsaicin/Menthol/Methyl Salicylate Lotion is used for:

Temporary relief of minor aches and muscle pain associated with arthritis, simple backaches, strains, and muscle soreness and stiffness. It may also be used for other conditions as determined by your doctor.

Capsaicin/Menthol/Methyl Salicylate Lotion is a topical analgesic. Exactly how it works is not known. It is thought to decrease the amount of a certain substance (substance P) that transmits pain in the body.

Do NOT use Capsaicin/Menthol/Methyl Salicylate Lotion if:

• you are allergic to any ingredient in Capsaicin/Menthol/Methyl Salicylate Lotion, sulfonamides (eg, sulfamethoxazole), para-aminobenzoic acid (PABA), aspirin, or soy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Capsaicin/Menthol/Methyl Salicylate Lotion:

Some medical conditions may interact with Capsaicin/Menthol/Methyl Salicylate Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an open wound or damaged, broken, or irritated skin

Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Capsaicin/Menthol/Methyl Salicylate Lotion

This may not be a complete list of all interactions that may occur. Ask your health care provider if Capsaicin/Menthol/Methyl Salicylate Lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Capsaicin/Menthol/Methyl Salicylate Lotion:

Use Capsaicin/Menthol/Methyl Salicylate Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Before the first use of Capsaicin/Menthol/Methyl Salicylate Lotion, rub a small amount onto your skin to check for sensitivity.


• Shake before each use. Apply just enough medicine to cover the affected area. Gently massage the medicine into skin until it disappears.


• Wash your hands with soap and water immediately after using Capsaicin/Menthol/Methyl Salicylate Lotion unless your hands are part of the treated area.


• If you are using Capsaicin/Menthol/Methyl Salicylate Lotion on your hands, allow 30 minutes for the medicine to absorb before washing. During this time, avoid touching damaged or irritated skin, contact lenses, or your eyes, nose, mouth, or other mucous membranes. Wash your hands after 30 minutes.


• Do not apply to wounds or damaged, broken (open), or irritated skin.


• Do not bandage or wrap the affected area.


• Do not use Capsaicin/Menthol/Methyl Salicylate Lotion with a heating pad.


• Do not expose the treated area to heat or direct sunlight. Warm or hot water or sunlight may increase burning or itching. Do not use Capsaicin/Menthol/Methyl Salicylate Lotion immediately after bathing, swimming, using a hot tub, sunbathing, or exposure to heat.


• If you miss a dose of Capsaicin/Menthol/Methyl Salicylate Lotion, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Capsaicin/Menthol/Methyl Salicylate Lotion.

Important safety information:

• For external use only. Avoid contact with the eyes, nose, mouth, or genitals. If Capsaicin/Menthol/Methyl Salicylate Lotion gets into your eyes, rinse immediately with cool water.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not use large amounts of Capsaicin/Menthol/Methyl Salicylate Lotion without checking with your doctor.


• Do not inhale any residue from Capsaicin/Menthol/Methyl Salicylate Lotion after it has dried. Coughing, sneezing, or throat or respiratory irritation may occur.


• Capsaicin/Menthol/Methyl Salicylate Lotion may be harmful if swallowed. If you may have taken Capsaicin/Menthol/Methyl Salicylate Lotion by mouth, contact your local poison control center or emergency room right away.


• Capsaicin/Menthol/Methyl Salicylate Lotion may stain clothes or bedding. Allow Capsaicin/Menthol/Methyl Salicylate Lotion to dry before you come in contact with clothing or any other surface.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• If your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop using this product and contact your health care provider.


• If redness is present or if irritation develops, check with your doctor before using any more of Capsaicin/Menthol/Methyl Salicylate Lotion.


• If severe burning or itching occurs, remove this product by thoroughly washing the area with soap and cold water.


• Capsaicin/Menthol/Methyl Salicylate Lotion should not be used in CHILDREN younger than 12 years old without checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Capsaicin/Menthol/Methyl Salicylate Lotion while you are pregnant. It is not known if Capsaicin/Menthol/Methyl Salicylate Lotion is found in breast milk. If you are or will be breast-feeding while you use Capsaicin/Menthol/Methyl Salicylate Lotion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Capsaicin/Menthol/Methyl Salicylate Lotion:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary burning or stinging at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation, redness, blistering, or severe or persistent burning at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Capsaicin/Menthol/Methyl Salicylate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Capsaicin/Menthol/Methyl Salicylate Lotion may be harmful if swallowed.

Proper storage of Capsaicin/Menthol/Methyl Salicylate Lotion:

Store Capsaicin/Menthol/Methyl Salicylate Lotion at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Close cap tightly after use. Do not store in the bathroom. Keep Capsaicin/Menthol/Methyl Salicylate Lotion out of the reach of children and away from pets.

General information:

• If you have any questions about Capsaicin/Menthol/Methyl Salicylate Lotion, please talk with your doctor, pharmacist, or other health care provider.


• Capsaicin/Menthol/Methyl Salicylate Lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Capsaicin/Menthol/Methyl Salicylate Lotion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Capsaicin/Menthol/Methyl Salicylate resources

• Capsaicin/Menthol/Methyl Salicylate Side Effects (in more detail)
• Capsaicin/Menthol/Methyl Salicylate Support Group
• 0 Reviews · Be the first to review/rate this drug

Clobex Shampoo

clobetasol propionate

Dosage Form: shampoo
FULL PRESCRIBING INFORMATION

INDICATIONS AND USAGE

Clobex Shampoo is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in patients 18 years of age and older.  Treatment should be limited to 4 consecutive weeks of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.  There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.

DOSAGE AND ADMINISTRATION

Clobex Shampoo should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clobex Shampoo.

Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.  The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.  Clobex Shampoo should not be used with occlusive dressings unless directed by a physician.

DOSAGE FORMS AND STRENGTHS

Shampoo: 0.05%

CONTRAINDICATIONS

Use of Clobex Shampoo is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

WARNINGS AND PRECAUTIONS

HYPOTHALAMIC-PITUITARY-ADRENAL (HPA) AXIS FUNCTION

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.  Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which increase systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings or use on occluded areas. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.  If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

The effect of Clobex Shampoo on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age.  In this study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with Clobex Shampoo applied once daily for 15 minutes to a dry scalp before lathering and rinsing.

If irritation develops, Clobex Shampoo should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clobex Shampoo should be discontinued until the infection has been adequately controlled.  Although Clobex Shampoo is intended for the topical treatment of moderate to severe scalp psoriasis, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Clobex Shampoo should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.

Treatment should be limited to 4 consecutive weeks.  As with other corticosteroids, therapy should be discontinued when control is achieved.

ADVERSE REACTIONS

In clinical trials with Clobex Shampoo, the following adverse reactions have been reported: burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.

The table below summarizes selected adverse events that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.

Summary of Selected Adverse Events ≥ 1% by Body System

Body System	Clobetasol	Vehicle
	Propionate Shampoo	Shampoo
	N=558	N=127
Skin and Appendages	49 (8.8%)	28 (22.0%)
Discomfort Skin	26 (4.7%)	16 (12.6%)
Pruritus	3 (0.5%)	9 (7.1%)
Body As A Whole	33 (5.9%)	12 (9.4%)
Headache	10 (1.8%)	1 (0.8%)

The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

  Laboratory Tests

The cortrosyn stimulation test may be helpful in evaluating patients for HPA axis suppression.

  Teratogenic Effects

Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

A teratogenicity study of clobetasol propionate in rats using the dermal route resulted in dose related maternal toxicity and fetal effects from 0.05 to 0.5 mg/kg/day. These doses are approximately 0.1 to 1.0 times, respectively, the maximum human topical dose of clobetasol propionate from Clobex Shampoo.  Abnormalities seen included low fetal weights, umbilical herniation, cleft palate, reduced skeletal ossification other skeletal abnormalities.

Clobetasol propionate administered to rats subcutaneously at a dose of 0.1 mg/kg from day 17 of gestation to day 21 postpartum was associated with prolongation of gestation, decreased number of offspring, increased perinatal mortality of offspring, delayed eye opening and delayed hair appearance in surviving offspring. Some increase in offspring perinatal mortality was also observed at a dose of 0.05 mg/kg. Doses of 0.05 and 0.1 mg/kg are approximately 0.1 and 0.2 fold the maximum human topical dose of clobetasol propionate from Clobex Shampoo.

USE IN SPECIFIC POPULATIONS

  Pregnancy

Teratogenic Effects: Pregnancy C:  There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobex Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

  Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quanitities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobex Shampoo is administered to a nursing woman.

  Pediatric Use

The effect of Clobex Shampoo on HPA axis suppression was evaluated in one study in adolescents 12 to 17 years of age. In this study, 5 of 12 evaluable subjects developed suppression of their HPA axis following 4 weeks of treatment with Clobex Shampoo applied once daily for 15 minutes to a dry scalp before lathering and rinsing. Only one of the five subjects who had suppression was tested for recovery of HPA axis, and this subject recovered after 2 weeks.

No studies have been performed in patients under the age of 12. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical cortico-steroids in infants and children.  Therefore, use is not recommended in patients under the age of 18.  Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

  Geriatric Use

Clinical studies of Clobetasol Propionate Shampoo did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

DESCRIPTION

Clobex Shampoo contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna- 1, 4-diene-3, 20-dione 17-propionate.

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

Each mL of Clobex Shampoo contains clobetasol propionate, 0.05%, in a shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, Clobex Shampoo has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

  Mechanism of Action

The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear.

  Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion. Topical corticosteroids can be absorbed from normal intact skin, while inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Due to the fact that circulating levels of corticosteroids are usually below the limit of detection following application, there are no human data regarding the pharmacokinetics of topical cortico-steroids. In such cases pharmacodynamic end points, including both hypothalamic-pituitary-adrenal (HPA) axis testing and topical vasoconstriction, are used as surrogates in the assessments of systemic exposure and relative potency, respectively.

Clobex Shampoo is in the super-high range of potency in vasoconstrictor studies.

NONCLINICAL TOXICOLOGY

  Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate did not produce any increase in chromosomal aberrations in Chinese hamster ovary cells in vitro in the presence or absence of metabolic activation. Clobetasol propionate was also negative in the micronucleus test in mice after oral administration.  Studies of the effect of Clobex Shampoo on fertility have not been conducted.

CLINICAL STUDIES

The safety and efficacy of Clobex Shampoo has been evaluated in two clinical trials involving 290 patients with moderate to severe scalp psoriasis. In both trials, patients were treated with either Clobex Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in the table below.

	CLOBEX® Shampoo		CLOBEX® Shampoo Vehicle
	n(%)		n(%)
	Study A	Study B	Study A	Study B
1 Success rate defined as the proportion of patients with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician’s Global Severity Scale for scalp psoriasis.
2 At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available).
3 Patients with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale.
Total Number of Patients	95	99	47	49
Success Rate1-at Endpoint2	40 (42.1%)	28 (28.3%)	1 (2.1%)	5 (10.2%)
Subjects with Scalp Psoriasis
	17 (17.9%)	12 (12.1%)	3 (6.4%)	1 (2.0%)
Parameter Clear (None) at Endpoint	21 (22.1%)	15 (15.2%)	0 (0%)	2 (4.1%)
	35 (36.8%)	34 (34.3%)	5 (10.6%)	5 (10.2%)
Erythema3 Scaling3 Plaque Thickening3

Clinical studies of Clobetasol Propionate Shampoo did not include sufficient numbers of non-Caucasian patients to determine whether they respond differently than Caucasian patients with regards to efficacy and safety.

HOW SUPPLIED

Clobex Shampoo is supplied in 4 fl.oz. (118 mL) bottles.  NDC 0299-3847-04

STORAGE AND HANDLING

Keep it tightly closed.  Store it at controlled room temperature 68˚F to 77˚F (20˚C-25˚C).

INFORMATION FOR PATIENTS

Patients using topical corticosteroids should received the following information and instructions:

Use of Clobex Shampoo in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression.

This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.

This medication should not be used for any disorder other than that for which it was prescribed.

The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician.

Patients should report any signs of local or systemic adverse reactions to their physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

Patients should wash their hands after applying the medication and they should inform their physician(s) that they are using Clobex Shampoo if surgery is contemplated.

Patients should not use more than 50 g (50 mL or 1.75 fl. oz.) per week of Clobex Shampoo.

PACKAGE LABEL

Rx Only

NDC 0299-3847-04

Clobex®

(clobetasol propionate)

SHAMPOO

0.05%

4 FL OZ

(118 mL)

GALDERMA

For External Use Only.

Not for Ophthalmic Use.

Usual dosage: Apply a thin film to affected areas of the scalp once daily; apply on dry scalp and leave in place for 15 minutes before lathering and rinsing. Do not apply CLOBEX® (clobetasol propionate) Shampoo, 0.05% to the face, underarms or groin, and avoid contact with eyes and lips. Do not use for longer than 4 weeks. See package insert for complete prescribing information.

Each mL contains: Active ingredient: clobetasol propionate, 0.05%.

Excipients: alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.

Storage: Keep tightly closed. Store at controlled room temperature 68°F to 77°F (20°C-25°C).

US Patent Pending

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texax 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

310147-0509

CLOBEX   clobetasol propionate  shampoo

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0299-3847 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clobetasol propionate (Clobetasol) Clobetasol 0.05 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength alcohol   citric acid   Water   sodium citrate   sodium laureth sulfate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0299-3847-04 118 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021644	03/01/2004

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Operations
DPT Laboratories, Ltd.		832224526	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Galderma Production Canada Inc		251676961	MANUFACTURE

Revised: 09/2010Galderma Laboratories, L.P.

More Clobex Shampoo resources

• Clobex Shampoo Side Effects (in more detail)
• Clobex Shampoo Use in Pregnancy & Breastfeeding
• Clobex Shampoo Drug Interactions
• Clobex Shampoo Support Group
• 16 Reviews for Clobex - Add your own review/rating

Compare Clobex Shampoo with other medications

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Calcarb

Generic Name: calcium carbonate (KAL see um KAR boe nate)

Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra

What is Calcarb (calcium carbonate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Calcarb (calcium carbonate)?

Do not take calcium carbonate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium carbonate works best if you take it with food.

What should I discuss with my healthcare provider before taking Calcarb (calcium carbonate)?

To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:

• 
  

  a history of kidney stones; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium carbonate if you are pregnant. Talk to your doctor before taking calcium carbonate if you are breast-feeding a baby.

How should I take Calcarb (calcium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium carbonate works best if you take it with food. Swallow the calcium carbonate tablet or capsule with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Calcarb (calcium carbonate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Calcarb (calcium carbonate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  decreased appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs can affect Calcarb (calcium carbonate)?

Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids or other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


• 
  

  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium carbonate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calcarb resources

• Calcarb Side Effects (in more detail)
• Calcarb Use in Pregnancy & Breastfeeding
• Calcarb Drug Interactions
• Calcarb Support Group
• 0 Reviews for Calcarb - Add your own review/rating

• Calcium Carbonate MedFacts Consumer Leaflet (Wolters Kluwer)


• Titralac Consumer Overview


• Titralac MedFacts Consumer Leaflet (Wolters Kluwer)


• Tums Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Calcarb with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Hypocalcemia
• Indigestion
• Osteopenia
• Osteoporosis
• Stomach Ulcer

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium carbonate.

See also: Calcarb side effects (in more detail)

Chlorpheniramine/Codeine Liquid

Pronunciation: KLOR-fen-IR-a-meen/KOE-deen
Generic Name: Chlorpheniramine/Codeine
Brand Name: Examples include Notuss-AC and Z-Tuss AC

Chlorpheniramine/Codeine Liquid is used for:

Relieving runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Codeine Liquid is an antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Chlorpheniramine/Codeine Liquid if:

• you are allergic to any ingredient in Chlorpheniramine/Codeine Liquid or any other codeine- or morphine-related medicine (eg, oxycodone)


• you have severe high blood pressure, severe heart blood vessel disease, angle-closure glaucoma, or peptic ulcers


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Chlorpheniramine/Codeine Liquid:

Some medical conditions may interact with Chlorpheniramine/Codeine Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart blood vessel problems, irregular heartbeat, or any other heart problems (eg, cor pulmonale)


• if you have a history of high blood pressure; diabetes; liver or kidney problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or bowels; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you are dehydrated; have very poor health; have a history of constipation; stomach problems (eg, ulcers); bowel problems (eg, chronic inflammation or ulceration of the bowel); or gallbladder problems (eg, gallstones); or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior


• if you are taking medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with Chlorpheniramine/Codeine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur


• Cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), sodium oxybate (GHB ), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Chlorpheniramine/Codeine Liquid's side effects


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Chlorpheniramine/Codeine Liquid's effectiveness


• Narcotic pain medicines (eg, hydrocodone) because the risk of their side effects may be increased by Chlorpheniramine/Codeine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Codeine Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Chlorpheniramine/Codeine Liquid:

Use Chlorpheniramine/Codeine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorpheniramine/Codeine Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Chlorpheniramine/Codeine Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlorpheniramine/Codeine Liquid.

Important safety information:

• Chlorpheniramine/Codeine Liquid may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Codeine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Chlorpheniramine/Codeine Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Chlorpheniramine/Codeine Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not use Chlorpheniramine/Codeine Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Chlorpheniramine/Codeine Liquid has chlorpheniramine in it. Before you start any new medicine, check the label to see if it has chlorpheniramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your cough or other symptoms do not get better within 1 week, or if they come back, or if you also have fever, rash, or persistent headache, check with your doctor.


• Chlorpheniramine/Codeine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Chlorpheniramine/Codeine Liquid for a few days before the tests.


• Chlorpheniramine/Codeine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Chlorpheniramine/Codeine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Chlorpheniramine/Codeine Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Chlorpheniramine/Codeine Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.


• Caution is advised when using Chlorpheniramine/Codeine Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Chlorpheniramine/Codeine Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlorpheniramine/Codeine Liquid while you are pregnant. It is not known if Chlorpheniramine/Codeine Liquid is found in breast milk. Do not breast-feed while taking Chlorpheniramine/Codeine Liquid.

When used for long periods of time or at high doses, Chlorpheniramine/Codeine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Chlorpheniramine/Codeine Liquid stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Chlorpheniramine/Codeine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Chlorpheniramine/Codeine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of Chlorpheniramine/Codeine Liquid:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; thickening of mucus secretions; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Chlorpheniramine/Codeine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; chest pain; cold or clammy skin; confusion; difficult or very slow breathing; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Chlorpheniramine/Codeine Liquid:

Store Chlorpheniramine/Codeine Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Codeine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Chlorpheniramine/Codeine Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Chlorpheniramine/Codeine Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Chlorpheniramine/Codeine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlorpheniramine/Codeine resources

• Chlorpheniramine/Codeine Side Effects (in more detail)
• Chlorpheniramine/Codeine Use in Pregnancy & Breastfeeding
• Chlorpheniramine/Codeine Drug Interactions
• Chlorpheniramine/Codeine Support Group
• 0 Reviews for Chlorpheniramine/Codeine - Add your own review/rating

Compare Chlorpheniramine/Codeine with other medications

• Cough and Nasal Congestion
• Hay Fever

Cerubidine

Pronunciation: daw-noe-ROO-bi-sin
Generic Name: Daunorubicin
Brand Name: Cerubidine

Cerubidine can cause tissue damage if it is injected by a route other than through the vein. Notify your doctor immediately if redness, pain, and swelling occur at or around the injection site. Cerubidine may cause heart problems, including heart failure, or bone marrow depression, making it hard to fight off infection. Notify your doctor immediately if you develop chest pain, an irregular heartbeat, trouble breathing, swelling of the hands or feet, easy bruising or bleeding, or signs of infection, such as fever, unusual fatigue, or persistent sore throat. Tell your doctor if you have liver or kidney problems before starting treatment with Cerubidine. You may require smaller doses.

Cerubidine is used for:

Treating certain types of cancer. It may be used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Cerubidine is a cytotoxic agent. It works by preventing the cancer cell from reproducing, which results in death of the cancer cell.

Do NOT use Cerubidine if:

• you are allergic to any ingredient in Cerubidine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cerubidine:

Some medical conditions may interact with Cerubidine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bone marrow depression, heart disease, gout, or liver or kidney problems, or if you have taken Cerubidine before

Some MEDICINES MAY INTERACT with Cerubidine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain medicines that act upon the liver (eg, methotrexate) or cyclosporine because the actions and side effects of Cerubidine may be increased


• Trastuzumab because the risk of heart problems may be increased


• Hydantoins (eg, phenytoin) because the effectiveness may be decreased and the risk of seizures may be increased by Cerubidine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cerubidine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cerubidine:

Use Cerubidine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cerubidine is usually administered as an injection at your doctor's office, hospital, or clinic.


• If Cerubidine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Cerubidine, contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Cerubidine.

Important safety information:

• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• If you get Cerubidine on your skin, wash thoroughly with soap and water.


• Cerubidine may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• Cerubidine may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Cerubidine causes the urine to turn red. This is harmless and not a cause for concern.


• Check with your doctor before having vaccinations while you are using Cerubidine.


• LAB TESTS, including blood cell counts; heart, liver, and kidney function tests; and uric acid levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cerubidine with caution in CHILDREN because they may be more sensitive to its effects, such as heart problems.


• PREGNANCY and BREAST-FEEDING: Cerubidine may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Cerubidine during pregnancy. It is unknown if Cerubidine is excreted in breast milk. Do not breast-feed while taking Cerubidine.

Possible side effects of Cerubidine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; hair loss; loss of appetite; mouth pain; nausea; sore throat; stomach pain; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the stools; chest pain; chills; cough or sore throat; excessive bleeding; fever; flushing; irregular heartbeat; pain, redness, or swelling at the injection site; shortness of breath; sores on the mouth or lips; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cerubidine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cerubidine:

Cerubidine is usually handled and stored by a health care provider. If you are using Cerubidine at home, store Cerubidine as directed by your pharmacist or health care provider. Keep Cerubidine out of the reach of children and away from pets.

General information:

• If you have any questions about Cerubidine, please talk with your doctor, pharmacist, or other health care provider.


• Cerubidine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cerubidine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cerubidine resources

• Cerubidine Side Effects (in more detail)
• Cerubidine Use in Pregnancy & Breastfeeding
• Cerubidine Drug Interactions
• Cerubidine Support Group
• 0 Reviews for Cerubidine - Add your own review/rating

• Cerubidine Prescribing Information (FDA)


• Cerubidine Advanced Consumer (Micromedex) - Includes Dosage Information


• Cerubidine Concise Consumer Information (Cerner Multum)


• Daunorubicin Prescribing Information (FDA)


• daunorubicin citrate Monograph (AHFS DI)

Compare Cerubidine with other medications

• Acute Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Acute Nonlymphocytic Leukemia

cetirizine and pseudoephedrine

Generic Name: cetirizine and pseudoephedrine (se TIR i zeen and SOO doe e FED rin)

Brand names: All Day Allergy-D, ZyrTEC-D, Goodsense Cetirizine D-12 Hour

What is cetirizine and pseudoephedrine?

Cetirizine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of cetirizine and pseudoephedrine is used to treat cold or allergy symptoms such as nasal and sinus congestion, sneezing, itching, watery eyes, or runny nose.

Cetirizine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cetirizine and pseudoephedrine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You should not use cetirizine and pseudoephedrine if you are allergic to either drug, or if you have narrow-angle glaucoma, severe high blood pressure (hypertension), severe coronary artery disease, if you are unable to urinate, or if you are allergic to hydralazine (Atarax, Vistaril).

Do not use any other over-the-counter cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine.

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

What should I discuss with my healthcare provider before taking cetirizine and pseudoephedrine?

Do not use cetirizine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious side effects can occur if you take pseudoephedrine before the MAO inhibitor has cleared from your body. You should not use cetirizine and pseudoephedrine if you are allergic to either drug, or if you have:

• 
  

  narrow-angle glaucoma;

  
  


• 
  

  severe high blood pressure (hypertension);

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are allergic to hydralazine (Atarax, Vistaril).

  
  

Ask a doctor or pharmacist about using cetirizine and pseudoephedrine if you have:

• 
  

  heart disease, coronary artery disease, high blood pressure, or heart rhythm disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  glaucoma;

  
  


• 
  

  kidney or liver disease;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

FDA pregnancy category C. It is not known whether cetirizine and pseudoephedrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cetirizine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from cetirizine and pseudoephedrine.

How should I take cetirizine and pseudoephedrine?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take one tablet every 12 hours, unless your doctor tells you otherwise. You may take this medication with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the medicine to be released at one time. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store cetirizine and pseudoephedrine at room temperature away from moisture and heat.

See also: Cetirizine and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, headache, nausea, vomiting, sweating, anxiety, drowsiness, increased thirst, fast or pounding heartbeats, trouble sleeping, or problems with urination.

What should I avoid while taking cetirizine and pseudoephedrine?

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with pseudoephedrine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold medication without first asking your doctor or pharmacist. Pseudoephedrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this drug. Read the label of any other medicine you are using to see if it contains pseudoephedrine. Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Cetirizine and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);

  
  


• 
  

  severe restless feeling, hyperactivity;

  
  


• 
  

  extreme feeling of fear or confusion;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  problems with vision; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  problems with concentration; or

  
  


• 
  

  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cetirizine and pseudoephedrine Dosing Information

Usual Adult Dose for Allergic Rhinitis:

1 tablet (5 mg-120 mg) orally twice daily.

Usual Pediatric Dose for Allergic Rhinitis:

12 years or older:

1 tablet (5 mg-120 mg) orally twice daily.

What other drugs will affect cetirizine and pseudoephedrine?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Before taking this medication, tell your doctor if you are also using any of the following drugs:

• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  blood pressure medication, especially methyldopa (Aldomet), mecamylamine (Inversine), or reserpine; or

  
  


• 
  

  diet pills, stimulants, or ADHD medications.

  
  

This list is not complete and there may be other drugs that can interact with cetirizine and pseudoephedrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More cetirizine and pseudoephedrine resources

• Cetirizine and pseudoephedrine Side Effects (in more detail)
• Cetirizine and pseudoephedrine Dosage
• Cetirizine and pseudoephedrine Use in Pregnancy & Breastfeeding
• Cetirizine and pseudoephedrine Drug Interactions
• Cetirizine and pseudoephedrine Support Group
• 3 Reviews for Cetirizine and pseudoephedrine - Add your own review/rating

Compare cetirizine and pseudoephedrine with other medications

• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about cetirizine and pseudoephedrine.

See also: cetirizine and pseudoephedrine side effects (in more detail)

Cefzil

Generic Name: Cefprozil
Class: Second Generation Cephalosporins
Chemical Name: (6R, 7R) - 7 - [(R) - 2 - amino - 2 - (p - hydroxyphenyl)acetamido] - 8 - oxo - 3 - propenyl - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylic acid monohydrate
CAS Number: 92665-29-7

Introduction

Antibacterial; β-lactam antibiotic; second generation cephalosporin.^{1 a}

Uses for Cefzil

Acute Otitis Media (AOM)

Treatment of AOM caused by S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).^{1 3 4 12 21 30 36 37 43 44 45 62 80 81}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).¹ Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.^{1 80 81}

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{48 49 50 59 76} oral cephalosporins and oral macrolides considered alternatives.^{48 49 50 59 76} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{48 50}

Respiratory Tract Infections

Treatment of acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).^{1 34 65 80 81}

Treatment of secondary bacterial infections of acute bronchitis caused by susceptible S. pneumoniae, H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).^{1 16 38 80 81}

Treatment of acute bacterial exacerbation of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae (including β-lactamase producing strains), or M. catarrhalis (including β-lactamase producing strains).^{1 16 38 80 81}

Treatment of mild to moderate community-acquired pneumonia† (CAP).²⁰ If an oral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.²⁰

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains) or S. pyogenes.^{1 10 35 63 80 81}

Also has been used for treatment of uncomplicated skin and skin structure infections caused by S. epidermidis†, S. saprophyticus†, group B or G streptococci†, E. coli†, or K. pneumoniae†.^{10 35}

Cefzil Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.^{1 80 81}

Dosage

Available as cefprozil monohydrate; dosage expressed as anhydrous cefprozil.^{1 80 81}

Pediatric Patients

Acute Otitis Media (AOM)

Oral

Children 6 months to 12 years of age: 15 mg/kg every 12 hours for 10 days.^{1 80 81}

Pharyngitis or Tonsillitis

Oral

Children 2–12 years of age: 7.5 mg/kg every 12 hours for 10 days.^{1 80 81}

Children ≥13 years of age: 500 mg once daily for 10 days.^{1 80 81}

Respiratory Tract Infections

Acute Sinusitis

Oral

Children 6 months to 12 years of age: 7.5 mg/kg every 12 hours for 10 days.^{1 80 81} For moderate to severe infections, 15 mg/kg every 12 hours for 10 days.^{1 80 81}

Children ≥13 years of age: 250 mg every 12 hours for 10 days.^{1 80 81} For moderate to severe infections, 500 mg every 12 hours for 10 days.^{1 80 81}

Secondary Bacterial Infections of Acute Bronchitis

Oral

Children ≥13 years of age: 500 mg every 12 hours for 10 days.^{1 80 81}

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥13 years of age: 500 mg every 12 hours for 10 days.^{1 80 81}

Skin and Skin Structure Infections

Oral

Children 2–12 years of age: 20 mg/kg once every 24 hours for 10 days.^{1 80 81}

Children ≥13 years of age: 250 or 500 mg every 12 hours for 10 days or 500 mg once daily for 10 days.^{1 80 81}

Adults

Pharyngitis or Tonsillitis

Oral

500 mg once daily for 10 days.^{1 80 81}

Respiratory Tract Infections

Acute Sinusitis

Oral

250 mg every 12 hours for 10 days.^{1 80 81} For moderate to severe infections, 500 mg every 12 hours for 10 days.^{1 80 81}

Secondary Bacterial Infections of Acute Bronchitis

Oral

500 mg every 12 hours for 10 days.^{1 80 81}

Acute Exacerbations of Chronic Bronchitis

Oral

500 mg every 12 hours for 10 days.^{1 80 81}

Skin and Skin Structure Infections

Oral

250 or 500 mg every 12 hours for 10 days or 500 mg once daily for 10 days.^{1 80 81}

Special Populations

Hepatic Impairment

No dosage adjustments required.^{1 80 81}

Renal Impairment

No dosage adjustments required in patients with Cl_cr ≥30 mL/minute.^{1 7 80 81}

Patients with Cl_cr <30 mL/minute: administer 50% of the usual dose using the usual dosing intervals.^{1 80 81}

Hemodialysis patients: administer cefprozil doses after dialysis sessions.^{1 80 81}

Geriatric Patients

No dosage adjustments required except those related to renal impairment.^{1 80 81} Cautious dosage selection because of age-related decreases in renal function.^{1 80 81} See Renal Impairment under Dosage and Administration.

Cautions for Cefzil

Contraindications

• 
  

  Known allergy to cefprozil or other cephalosporins.^{1 80 81}

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi with prolonged use.^{1 80 81} Careful observation of the patient is essential.^{1 80 81} Institute appropriate therapy if superinfection occurs.^{1 80 81}

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{1 80 81} C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefprozil, and may range in severity from mild diarrhea to fatal colitis.¹ Hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.^{1 80 81} Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.¹

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.¹ Some mild cases may respond to discontinuance alone.^{1 69 70 71 72 73} Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.^{1 69 70 71 72}

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (anaphylaxis,¹ serum-sickness-like reactions,^{1 14} erythema,^{9 12} Stevens-Johnson syndrome^{1 14} ) have been reported.¹

If a hypersensitivity reaction occurs, discontinue cefprozil immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.¹

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.¹ Cautious use recommended in patients with a history of hypersensitivity to penicillins:¹ avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction ^a and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefprozil and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^{1 80 81}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{1 80 81} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{1 80 81}

Phenylketonuria

Oral suspensions containing 125 or 250 mg of cefprozil/5 mL contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 28 mg of phenylalanine/5 mL.^{1 3 81}

Other commercially available preparations do not contain aspartame;¹ these other preparations should be used in individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine.¹

History of GI Disease

Cephalosporins should be used with caution in patients with a history of GI disease, particularly colitis.^{1 80 81} (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

Coombs' Test Results

Positive direct Coombs’ test results reported with some cephalosporins.^{1 a} This may interfere with certain hematologic studies or transfusion cross-matching procedures.^a May also cause positive Coombs’ tests in neonates whose mothers received a cephalosporin prior to delivery.^a

Specific Populations

Pregnancy

Category B.^{1 80 81}

Lactation

Distributed into milk; use with caution.^{1 80 81}

Pediatric Use

Safety and efficacy not established in infants <6 months of age for the treatment of AOM or acute sinusitis.^{1 80 81}

Safety and efficacy not established in children <2 years of age for the treatment of pharyngitis or tonsillitis or for uncomplicated skin and skin structure infections.^{1 80 81}

Geriatric Use

Safety and efficacy in those ≥65 years of age similar to that in younger adults, but possibility exists of greater sensitivity to the drug in some geriatric patients.^{1 80 81}

Cefprozil is substantially eliminated by kidneys and risk of toxicity may be greater in patients with impaired renal function.^{1 80 81} Assess renal function periodically since geriatric patients are more likely to have renal impairment.^{1 80 81}

Hepatic Impairment

Half-life only slightly prolonged.¹ No dosage adjustments required.¹

Renal Impairment

Decreased clearance.^{1 80 81}

Use with caution in those with known or suspected renal impairment.^{1 80 81} Monitor closely and assess renal function prior to and during therapy.^{1 80 81}

Reduce dosage in those with Cl_cr <30 mL/minute.^{1 80 81} See Renal Impairment under Dosage and Administration.

Common Adverse Effects

Diarrhea, nausea, vomiting, rash, genital pruritus or vaginitis, dizziness.^{1 9}

Interactions for Cefzil

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Aminoglycosides	Nephrotoxicity has been reported when aminoglycosides used concomitantly with some cephalosporins1
Antacids	Study using capsules (not commercially available) indicate bioavailability not affected when given 5 minutes after an antacid1
Diuretics		Caution if used concomitantly with potent diuretics since such drugs may adversely affect renal function1
Probenecid	Increased cefprozil AUC1
Tests for glucose	Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1 False-negative reaction possible in blood glucose tests using ferricyanide	Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1

Cefzil Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract.¹ Bioavailability is 90–95% in fasting adults;^{1 21 24} peak plasma concentrations attained within 1.5 hours.^{1 61}

Tablets and oral suspension are bioequivalent under fasting conditions.¹

Food

Food does not affect absorption or peak plasma concentrations, but time to peak plasma concentrations may be prolonged by 15–45 minutes.¹ Not considered clinically important.¹

Distribution

Extent

Distributed into various body tissues and fluids including blister fluid,^{21 22} middle ear fluid,²⁶ and tonsillar and adenoidal tissue.^{21 27}

Distributed into milk in low concentrations.^{1 5}

Plasma Protein Binding

35–45%.^{1 23}

Elimination

Metabolism

Not appreciably metabolized.^{21 22 23 24 28}

Elimination Route

Eliminated principally in urine by glomerular filtration and tubular secretion.^{21 22 23 24 28}

54–70% of a single dose eliminated unchanged in urine within 24 hours.^{1 21 22 23 24 28}

Half-life

Adults with normal renal function: 1–1.4 hours.^{1 21 22 23 28}

Children 6 months to 12 years of age: 0.94–2.1 hours.^{1 13 21}

Special Populations

In geriatric patients, clearance decreased and AUC increased.¹

Plasma half-life increased slightly in patients with hepatic impairment (about 2 hours).^{1 21}

Prolonged plasma half-life (up to 5.2–5.9 hours) in patients with renal impairment.^{1 7}

Stability

Storage

Oral

Tablets

15–30°C.^{1 80}

For Suspension

15–25°C.^{1 81} After reconstitution, store in a refrigerator and discard after 14 days.^{1 81}

Actions and SpectrumActions

• 
  

  Second generation cephalosporin active against some aerobic gram-negative bacteria that generally are resistant to first generation cephalosporins, but has a narrower spectrum of activity than third generation cephalosporins.^{1 3 11}

  
  


• 
  

  Usually bactericidal.^{1 a}

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^{1 a}

  
  


• 
  

  In vitro spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some anaerobic bacteria.¹ Inactive against fungi and viruses.^a

  
  


• 
  

  Gram-positive aerobes: active in vitro and in clinical infections against Staphylococcus aureus (including β-lactamase-producing strains), Streptococcus pneumoniae, and S. pyogenes (group A β-hemolytic streptococci).¹ Also active in vitro against Enterococcus durans, E. faecalis, Listeria monocytogenes, Staphylococcus epidermidis, S. saprophyticus, S. warneri, Streptococcus agalactiae (group B streptococci), and groups C, D, F, and G streptococci.¹ E. faecium and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.¹

  
  


• 
  

  Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains).^{1 21 a} Also active in vitro against Citrobacter diversus, Escherichia coli, Klebsiella pneumonia, Neisseria gonorrhoeae, (including β-lactamase-producing strains), Proteus mirabilis, Salmonella, Shigella, and Vibrio.¹ Inactive against most strains of Acinetobacter, Enterobacter, Morganella morganii, P. vulgaris, Providencia, Pseudomonas, and Serratia.¹

  
  


• 
  

  Anaerobes: active in vitro against Prevotella melaninogenicus, Clostridium difficile, C. perfringens, Fusobacterium, Peptostreptococcus, and Propionibacterium acnes.¹ Most strains of Bacteroides fragilis are resistant.¹

  
  


• 
  

  Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant staphylococci) should be considered resistant to cefprozil, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.¹⁹ In addition, β-lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenzae should be considered resistant to cefprozil despite the fact that results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.¹⁹

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including cefprozil) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).^{1 80 81}

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.^{1 80 81}

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefprozil or other antibacterials in the future.^{1 80 81}

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.¹ Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.¹

  
  


• 
  

  Advise individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine that cefprozil oral suspensions contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine.^{1 81}

  
  


• 
  

  Importance of notifying clinician of persistent or worsening symptoms of infection.^{1 80 81}

  
  


• 
  

  Importance of informing clinician if history includes allergy or sensitivity to cephalosporins or penicillins.^{1 80 81 a}

  
  


• 
  

  Importance of discontinuing cefprozil and informing clinician if an allergic or hypersensitivity reaction occurs.^{1 80 81 a}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 80 81 a}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cefprozil

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	125 mg (of anhydrous cefprozil) per 5 mL*	Cefprozil for Suspension
			Cefzil	Bristol-Myers Squibb
		250 mg (of anhydrous cefprozil) per 5 mL*	Cefprozil for Suspension
			Cefzil	Bristol-Myers Squibb
	Tablets, film-coated	250 mg (of anhydrous cefprozil)*	Cefprozil Film-coated Tablets
			Cefzil	Bristol-Myers Squibb
		500 mg (of anhydrous cefprozil)*	Cefprozil Film-coated Tablets
			Cefzil	Bristol-Myers Squibb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cefzil 250MG/5ML Suspension (B-M SQUIBB U.S. (PRIMARY CARE)): 100/$73.99 or 300/$212.97

Cefzil 250MG/5ML Suspension (B-M SQUIBB U.S. (PRIMARY CARE)): 50/$45.99 or 150/$115.97

Cefzil 250MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 20/$109.99 or 60/$305.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions December 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Myers Squibb. Cefzil (cefprozil) tablets and for oral suspension prescribing information. Princeton, NJ; 2007 Mar.

2. Bristol-Myers Squibb US Pharmaceutical Division, Princeton, NJ: Personal communication.

3. Anon. Cefprozil. Med Lett Drugs Ther. 1992; 34:63-4. [PubMed 1608347]

4. Arguedas AG, Zaleska M, Stutman HR et al. Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion. Pediatr Infect Dis J. 1991; 10:375-80. [PubMed 1906160]

5. Shyu WC, Shah VR, Campbell DA et al. Excretion of cefprozil into human breast milk. Antimicrob Agents Chemother. 1992; 36:938-41. [IDIS 296690] [PubMed 1510416]

6. Barriere SL. Pharmacology and pharmacokinetics of cefprozil. Clin Infect Dis. 1992; 14(Suppl 2):S184-8. [IDIS 297195] [PubMed 1617036]

7. Shyu WC, Pittman KA, Wilber RB et al. Pharmacokinetics of cefprozil in healthy subjects and patients with renal impairment. J Clin Pharmacol. 1991; 31:362-71. [IDIS 281527] [PubMed 2037710]

8. Christenson JC, Swenson E, Gooch WM III et al. Comparative efficacy and safety of cefprozil (BMY-28100) and cefaclor in the treatment of acute group A beta-hemolytic streptococcal pharyngitis. Antimicrob Agents Chemother. 1991; 35:1127-30. [IDIS 283443] [PubMed 1929253]

9. Wilber RB, Doyle CA, Durham SJ et al. Safety profile of cefprozil. Clin Infect Dis. 1992; 14(Suppl 2):S264-71. [IDIS 297204] [PubMed 1617047]

10. Parish LC, Doyle CA, Durham SJ et al. Cefprozil versus cefaclor in the treatment of mild to moderate skin and skin-structure infections. Clin Ther. 1992; 14:458-69. [PubMed 1638587]

11. Christenson JC, Gooch WM, Herrod JN et al. Comparative efficacy and safety of cefprozil and cefaclor in the treatment of acute uncomplicated urinary tract infections. J Antimicrob Chemother. 1991; 28:581-6. [PubMed 1761453]

12. Gehanno P, Berche P, Boucot I et al. Comparative efficacy and safety of cefprozil and amoxycillin/clavulanate in the treatment of acute otitis media in children. J Antimicrob Chemother. 1994; 33:1209-18. [IDIS 332237] [PubMed 7928814]

13. Saez-Llorens X, Shyu WC, Shelton S et al. Pharmacokinetics of cefprozil in infants and children. Antimicrob Agents Chemother. 1990; 34:2152-5. [IDIS 273722] [PubMed 2073105]

14. Lowery N, Kearns GL, Young RA et al. Serum sickness-like reactions associated with cefprozil therapy. J Pediatr. 1994; 125:325-8. [IDIS 335503] [PubMed 8040786]

15. Milatovic D, Adam D, Hamilton H et al. Cefprozil versus penicillin V in treatment of streptococcal tonsillopharyngitis. Antimicrob Agents Chemother. 1993; 37:1620-3. [IDIS 318765] [PubMed 8215273]

16. Bonnet JP, Ginsberg D, Nolen TM et al. Cefprozil vs. cefuroxime axetil in mild to moderate lower respiratory tract infections: a focus on bronchitis. Infect Med. 1992; (Suppl E):1-9.

17. SmithKline & French. Ancef (cefazolin sodium) prescribing information. Philadelphia, PA; 2001 Oct.

19. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; sixteenth informational supplement. CLSI document M100-S16. Wayne, PA; 2006.

20. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007; 44 Suppl 2:S27-72. [PubMed 17278083]

21. Wiseman LR, Benfield P. Cefprozil: a review of its antibacterial activity, pharmacokinetic properties, and therapeutic potential. Drugs. 1993; 45:295-317. [PubMed 7681376]

22. Barbhaiya RH, Shukla UA, Gleason CR et al. Phase I study of multiple-dose cefprozil and comparison with cefaclor. Antimicrob Agents Chemother. 1990; 34:1198-1203. [IDIS 267825] [PubMed 2393281]

23. Barbhaiya RH, Shukla WA, Gleason CR et al. Comparison of cefprozil and cefaclor pharmacokinetics and tissue penetration. Antimicrob Agents Chemother. 1990; 34:1204-9. [IDIS 267826] [PubMed 2393282]

24. Shyu WC, Shah VR, Campbell DA et al. Oral absolute bioavailability and intravenous dose-proportionality of cefprozil in humans. J Clin Pharmacol. 1992; 32:798-803. [IDIS 303254] [PubMed 1430299]

25. Shyu WC, Wilber RB, Pittman KA et al. Effect of antacid on the bioavailability of cefprozil. Antimicrob Agents Chemother. 1992; 36:962-5. [IDIS 296691] [PubMed 1510420]

26. Shyu WC, Haddad J, Reilly J et al. Penetration of cefprozil in middle ear fluid of patients with otitis media. Antimicrob Agents Chemother. 1994; 38:2210-1. [IDIS 335753] [PubMed 7811050]

27. Shyu WC, Reilly J, Campbell DA et al. Penetration of cefprozil into tonsillar and adenoidal tissues. Antimicrob Agents Chemother. 1993; 37:1180-3. [IDIS 314544] [PubMed 8517711]

28. Lode H, Muller C, Borner K et al. Multiple-dose pharmacokinetics of cefprozil and its impact on intestinal flora of volunteers. Antimicrob Agents Chemother. 1992; 36:144-9. [IDIS 289790] [PubMed 1590680]

29. Thornsberry C. Review of the in vitro antibacterial activity of cefprozil, a new oral cephalosporin. Clin Infect Dis. 1992; 14(Suppl 2):S189-94. [IDIS 297196] [PubMed 1617037]

30. Stutman HR, Arguedas AG. Comparison of cefprozil and other antibiotic regimens in the treatment of acute otitis media. Clin Infect Dis. 1992; 14(Suppl 2):S204-8. [IDIS 297198] [PubMed 1617039]

31. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin Pract. 1995; 4(Suppl 2):S88-94.

32. Brook I, Foote PA. Effect of penicillin or cefprozil therapy on tonsillar flora. J Antimicrob Chemother. 1997; 40:725-8. [IDIS 398251] [PubMed 9421324]

33. McCarty JM, Renteria A. Treatment of pharyngitis and tonsillitis with cefprozil: review of three multicenter trials. Clin Infect Dis. 1992; 14(Suppl 2):S224-30. [IDIS 297200] [PubMed 1617042]

34. van den Wijngaart W, Verbrugh H, Theopold HM et al. A noncomparative study of cefprozil at two dose levels in the treatment of acute uncomplicated bacterial sinusitis. Clin Ther. 1992; 14:306-13. [PubMed 1611651]

35. Nolen TM. Clinical trials of cefprozil for treatment of skin and skin-structure infections: review. Clin Infect Dis. 1992; 14(Suppl 2):S255-63. [IDIS 297203] [PubMed 1617046]

36. Blumer JL, Forti WP, Summerhouse TL. Comparison of the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil in the treatment of children with acute otitis media. Clin Ther. 1996; 18:811-20. [IDIS 376625] [PubMed 8930425]

37. Kafetzis DA. Multi-investigator evaluation of the efficacy and safety of cefprozil, amoxicillin-clavulanate, cefixime and cefaclor in the treatment of acute otitis media. Eur J Clin Microbiol Infect Dis. 1994; 13:857-65. [PubMed 7889960]

38. Ball P. Efficacy and safety of cefprozil versus other beta-lactam antibiotics in the treatment of lower respiratory tract infections. Eur J Clin Microbiol Infect Dis. 1994; 13:851-6. [PubMed 7889959]

39. McCarty JM. Comparative efficacy and safety of cefprozil versus penicillin, cefaclor and erythromycin in the treatment of streptococcal pharyngitis and tonsillitis. Eur J Clin Microbiol Infect Dis. 1994; 13:846-50. [PubMed 7889958]

40. Wise R. Comparative microbiological activity and pharmacokinetics of cefprozil. Eur J Clin Microbiol Infect Dis. 1994; 13:839-45. [PubMed 7889957]

41. Shyu WC, Shah VR, Campbell DA et al. Oral absolute bioavailability and intravenous dose-proportionality of cefprozil in humans. J Clin Pharmacol. 1992; 32:798-803. [IDIS 303254] [PubMed 1430299]

42. Standaert BB, Finney K, Taylor MT et al. Comparison between cefprozil and penicillin to eradicate pharyngeal colonization of group A beta-hemolytic streptococci. Pediatr Infect Dis J. 1998; 17:39-43. [IDIS 400305] [PubMed 9469393]

43. Pichichero ME, McLinn S, Aronovitz G et al. Cefprozil treatment of persistent and recurrent acute otitis media. Pediatr Infect Dis J. 1997; 16:471-8. [IDIS 386693] [PubMed 9154539]

44. Kozyrskyj AL, Hildes-Ripstein GE, Longstaffe SEA et al. Treatment of acute otitis media with a shortened course of antibiotics: a meta-analysis. JAMA. 1998; 279:1736-42. [IDIS 409347] [PubMed 9624028]

45. Kafetzis DA, Astra H, Mitropoulos L. Five-day versus ten-day treatment of acute otitis media with cefprozil. Eur J Clin Microbiol Infect Dis. 1997; 16:283-6. [PubMed 9177961]

46. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Safety. 1994; 10:318-27. [PubMed 8018304]

47. Thompson JW, Jacobs RF. Adverse effects of newer cephalosporins: an update. Drug Safety. 1993; 9:132-42. [PubMed 8397890]

48. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:755.

49. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:18-26.

50. Bisno AL, Gerber MA, Gwaltney JM et al. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Clin Infect Dis. 2002; 35:113-25. [IDIS 484228] [PubMed 12087516]

51. Klein JO. Management of streptococcal pharyngitis. Pediatr Infect Dis J. 1994; 13:572-5. [IDIS 331902] [PubMed 8078757]

52. Pichichero ME, Cohen R. Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis. Pediatr Infect Dis J. 1997; 16:680-95. [IDIS 390075] [PubMed 9239773]

53. Tack KJ, Henry DC, Gooch WM et al et al. Five-day cefdinir treatment for streptococcal pharyngitis. Antimicrob Agents Chemother. 1998; 42:1073-5. [IDIS 404900] [PubMed 9593129]

54. Pichichero ME. Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? Pediatr Infect Dis. 1993; 12:268-74.

55. Dajani AS, Kessler SL, Mendelson R et al. Cefpodoxime proxetil vs. penicillin V in pediatric streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J. 1993; 12:275-9. [PubMed 8483620]

56. Aujard Y, Boucot I, Brahimi N et al. Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. Pediatr Infect Dis J. 1995; 14:295-300. [IDIS 345876] [PubMed 7603811]

57. Mehra S, Van Moerkerke M, Welck J et al. Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children. Pediatr Infect Dis J. 1998; 17:452-7. [IDIS 408830] [PubMed 9655533]

58. Milatovic D. Evaluation of cefadroxil, penicillin and erythromycin in the treatment of streptococcal tonsillopharyngitis. Pediatr Infect Dis J. 1991; 10:S61-3. [PubMed 1945599]

59. Dajani A, Taubert K, Ferrieri P et al et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics. 1995; 96:758-64. [IDIS 355409] [PubMed 7567345]

60. Reviewers’ comments (personal observations).

61. Bristol-Myers Squibb, Plainsboro, NJ. Personal communication.

62. Aronovitz G. Treatment of upper and lower respiratory tract infections: clinical trials with cefprozil. J Pediatr Infect Dis J. 1998; 17:S83-8.

63. Nolen T, Conetta BJ, Durham SJ et al. Safety and efficacy of cefprozil vs. cefaclor in the treatment of mild to moderate skin and skin structure infections. Infect Med.