NDC 73473-302 Clindamycin Phosphate

Clindamycin Phosphate

NDC Product Information

Clindamycin Phosphate with NDC 73473-302 is a a human prescription drug product labeled by Solaris Pharma Corporation. The generic name of Clindamycin Phosphate is clindamycin phosphate. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clindamycin Phosphate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Lincosamide Antibacterial - [EPC] (Established Pharmacologic Class)
  • Lincosamides - [CS]
  • Neuromuscular Blockade - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Solaris Pharma Corporation
Labeler Code: 73473
FDA Application Number: ANDA212842 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-14-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Clindamycin Phosphate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Clindamycin phosphate gel USP, 1%, a topical antibiotic, contains clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 981, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. Chemically, clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chlorosubstitution of the 7 (R)-hydroxyl group of the parent antibiotic, lincomycin, and has the structural formula represented below: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-a-D-galacto-octopyranoside 2-(dihydrogen phosphate).

Clinical Pharmacology

Pharmacokinetics: In an open-label, parallel group study of 24 patients with acne vulgaris, once-daily topical administration of approximately 3 to 12 grams/day of clindamycin phosphate for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/mL.Following multiple applications of clindamycin phosphate less than 0.04% of the total dose was excreted in the urine.Microbiology: Although clindamycin phosphate is inactive in vitro, rapid in vitro hydrolysis converts this compound to clindamycin, which has antibacterial activity. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. In vitro studies indicated that clindamycin inhibited all tested Propionibacterium acnes cultures at a minimum inhibitory concentration (MIC) of 0.4 mcg/mL. Cross-resistance has been demonstrated between clindamycin and erythromycin.

Clinical Studies

In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used clindamycin phosphate gel, 1% once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, clindamycin phosphate applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:*P<0.05   Lesions  Clindamycin Phosphate  QD N=162    Vehicle Gel QD N=82  Inflammatory  51%  40%*  Noninflammatory  25%  12%*  Total  38%  27%* There was a trend in the investigator's global assessment of the results, which favored clindamycin phosphate QD over the vehicle QD. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to clindamycin phosphate. There was no signal for contact sensitization in the clinical trials under normal use conditions.

Indications And Usage

Clindamycin phosphate gel, 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 gel, 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.

Precautions

General: Clindamycin phosphate 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.Carcinogenesis, Mutagenesis, Impairment of Fertility:The carcinogenicity of a 1% clindamycin phosphate gel similar to clindamycin phosphate was evaluated by daily application to mice for 2 years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 mL of clindamycin phosphate 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 clindamycin phosphate 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: 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 clindamycin is excreted in human milk following use of clindamycin phosphate. 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 in children under the age of 12 have not been established.Geriatric Use:The clinical study with clindamycin phosphate did not include sufficient numbers of patients aged 65 and over to determine if they respond differently than younger patients.

Adverse Reactions

In the one well-controlled clinical study comparing clindamycin phosphate and its vehicle, the incidence of skin and appendages adverse events occurring in ≥1% of the patients in either group is presented below:                                                                                     Number (%) of Patients  Body System/Adverse Event  Clindamycin Phosphate  QD N=168  Vehicle Gel QD N=84  Skin and appendages disorders        Dermatitis  0 (0.0)  1 (1.2)  Dermatitis contact  0 (0.0)  1 (1.2)  Dermatitis fungal  0 (0.0)  1 (1.2)  Folliculitis  0 (0.0)  1 (1.2)  Photosensitivity reaction  0 (0.0)  1 (1.2)  Pruritus  1 (0.6)  1 (1.2)  Rash erythematous  0 (0.0)  0 (0.0)  Skin dry  0 (0.0)  0 (0.0)  Peeling  1 (0.6)  0 (0.0) 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.To report SUSPECTED ADVERSE REACTIONS, contact Solaris Pharma Corporation at 1-833-919-0527 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied clindamycin phosphate may be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Dosage And Administration

Apply a thin film of clindamycin phosphate gel USP, 1% once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.Keep container tightly closed.

How Supplied

Clindamycin phosphate gel USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size:75 mL bottle - NDC 73473-302-75Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not store in direct sunlight. Manufactured for: Solaris Pharma Corporation Bridgewater, NJ 08807,USARevised 08/2021

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