CLINDAMYCIN PHOSPHATE FOAM, 1%

CLINDAMYCIN PHOSPHATE - clindamycin phosphate aerosol, foam 
Perrigo New York Inc

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CLINDAMYCIN PHOSPHATE FOAM, 1%

Rx Only

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DESCRIPTION

Clindamycin Phosphate Foam, 1% contains clindamycin phosphate, USP, a topical antibiotic for topical dermatologic use. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chloro-substitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin.

The chemical name for clindamycin phosphate is methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate), with the empirical formula C18H34CIN2O8PS, a molecular weight of 504.97. The following is the chemical structure:

Clindamycin Chemical Structure Image

Clindamycin Chemical Structure Image

Clindamycin Phosphate Foam, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

CLINICAL PHARMACOLOGY

Pharmacokinetics

In an open label, parallel group study in 24 patients with acne vulgaris, 12 patients (3 male and 9 female) applied 4 grams of clindamycin phosphate foam, 1%, once-daily for five days, and 12 patients (7 male and 5 female) applied 4 grams of clindamycin phosphate topical gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for clindamycin phosphate foam than for clindamycin phosphate topical gel.

Following multiple applications of clindamycin phosphate foam, 1% less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

Microbiology

The clindamycin component has been shown to have in vitro activity against Propionibacterium acnes, an organism which is associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product. Cross-resistance between clindamycin and erythromycin has been demonstrated.

CLINICAL STUDIES

In one multicenter, randomized, double-blind, vehicle-controlled clinical trial patients with mild to moderate acne vulgaris used clindamycin phosphate foam, 1% or the vehicle foam once daily for twelve weeks. Treatment response, defined as the proportion of patients clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:

Efficacy
Parameters
Clindamycin Phosphate Foam, 1%Vehicle Foam
n=386n=127
*
P< 0.05
Treatment response (ISGA)31%18%*
Percent reduction in lesion counts
Inflammatory Lesions49%35%*
Noninflammatory Lesions38%27%*
Total Lesions43%31%*

INDICATIONS AND USAGE

Clindamycin Phosphate Foam, 1% is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)

CONTRAINDICATIONS

Clindamycin Phosphate Foam, 1% is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

WARNINGS

Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. Antiperistaltic agents, such as opiates and diphenoxylate with atropine, may prolong and/or worsen the condition.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Avoid contact of clindamycin phosphate foam with eyes. If contact occurs, rinse eyes thoroughly with water.

PRECAUTIONS

General

Clindamycin Phosphate Foam, 1% should be prescribed with caution in atopic individuals.

Drug Interactions

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Carinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of a 1% clindamycin phosphate gel similar to clindamycin phosphate foam was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 to 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of clindamycin phosphate foam, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.

A 1% clindamycin phosphate gel similar to clinamycin phosphate foam caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight.

Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

Pregnancy

Teratogenic effects

Pregnancy Category B

Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride. These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from clindamycin phosphate based on a mg/m2 comparison. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clinamycin is excreted in human milk following use of Clindamycin Phosphate Foam, 1%. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of clindamycin phosphate foam in children under the age of 12 have not been studied.

Geriatric Use

The clinical study with clindamycin phosphate foam did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.

ADVERSE REACTIONS

The incidence of adverse events occurring in ≥ 1% of the patients in clinical studies comparing clindamycin phosphate foam and its vehicle is presented below:

Selected Adverse Events Occurring in ≥ 1% of Subjects

Adverse EventNumber (%) of Subjects
Clindamycin Phosphate Foam, 1%
N = 439
Vehicle Foam
N = 154
Headache12 (3%)1 (1%)
Application site burning27 (6%)14 (9%)
Application site pruritus5 (1%)5 (3%)
Application site dryness4 (1%)5 (3%)
Application site reaction, not otherwise specified3 (1%)4 (3%)

In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to clindamycin phosphate foam, 1%.

Orally and parenterally administered clindamycin has been associated with severe colitis, which may end fatally.

Cases of diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS). Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin.

OVERDOSAGE

Topically applied Clindamycin Phosphate Foam, 1% may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

DOSAGE AND ADMINISTRATION

Apply Clindamycin Phosphate Foam, 1% once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.

To Use Clindamycin Phosphate Foam, 1%:
 
  • 1.Do not dispense Clindamycin Phosphate Foam, 1% directly onto your hands or face, because the foam will begin to melt on contact with warm skin.
To Use Image

To Use Image

  • 2.Remove the clear cap.
  • 3.Hold the can at an upright angle and then press firmly to dispense. Dispense an amount directly into the cap or onto a cool surface. Dispense an amount of Clindamycin Phosphate Foam that will cover the affected area(s). If the can seems warm or the foam seems runny, run the can under cold water.
  • 4.Pick up small amounts of Clindamycin Phosphate Foam, 1% with your fingertips and gently massage into the affected areas until the foam disappears.
Throw away any of the unused medicine that you dispensed out of the can.
 
Avoid contact of Clindamycin Phosphate Foam, 1% with eyes. If contact occurs, rinse eyes thoroughly with water.

HOW SUPPLIED

Clindamycin Phosphate Foam, 1%, containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available as follows:

100 gram can (NDC 45802-660-33)
50 gram can (NDC 45802-660-32)

STORAGE AND HANDLING

Store at 20 – 25°C (68 – 77°F) [see USP Controlled Room Temperature].

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C).

Keep out of reach of children.

MADE IN ISRAEL

MANUFACTURED BY
PERRIGO
YERUHAM 80500, ISRAEL

DISTRIBUTED BY
PERRIGO®
ALLEGAN, MI 49010

Rev. 05/09
: 4T500 RC J1

Principal Display Panel - 50 g Carton

Clindamycin Phosphate Foam, 1%

Rx Only

Clindamycin Phosphate Foam, 1% 50 g Carton

Clindamycin Phosphate Foam, 1% 50 g Carton

Principal Display Panel - 50 g Label

Clindamycin Phosphate Foam, 1%

Rx Only

Clindamycin Phosphate Foam, 1% 50 g Label

Clindamycin Phosphate Foam, 1% 50 g Label


CLINDAMYCIN PHOSPHATE 
clindamycin phosphate   aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)45802-660
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
145802-660-321 CAN In 1 CARTONcontains a CAN
150 g In 1 CANThis package is contained within the CARTON (45802-660-32)
245802-660-331 CAN In 1 CARTONcontains a CAN
2100 g In 1 CANThis package is contained within the CARTON (45802-660-33)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09078511/02/200901/11/2010

Labeler - Perrigo New York Inc (078846912)
Revised: 09/2009Perrigo New York Inc