NDC 10135-691 Clindamycin Phosphate

Clindamycin Phosphate

NDC Product Code 10135-691

NDC 10135-691-61

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 60 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Clindamycin Phosphate with NDC 10135-691 is a a human prescription drug product labeled by Marlex Pharmaceuticals Inc. The generic name of Clindamycin Phosphate is clindamycin phosphate. The product's dosage form is solution and is administered via topical form.

Labeler Name: Marlex Pharmaceuticals Inc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

  • CLINDAMYCIN PHOSPHATE 11.9 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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.
  • 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]

Product Labeler Information

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

Labeler Name: Marlex Pharmaceuticals Inc
Labeler Code: 10135
FDA Application Number: ANDA209846 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: 03-01-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

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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 Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter.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 solution contains isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide, and water. The structural formula is 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-α-D- galacto-octopyranoside 2-(dihydrogen phosphate).

Clinical Pharmacology

Mechanism of ActionThe mechanism of action of clindamycin in treating acne vulgaris is unknown.

Pharmacokinetics

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as  clindamycin.Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Microbiology

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.Antimicrobial ActivityClindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.ResistanceResistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

Indications And Usage

Clindamycin Phosphate Topical Solution USP, 1% is indicated 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 Topical Solution USP, 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 s tool 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. Vancomycin has been found to be effective in the treatment of antibiotic- associated pseudomembranous colitis produced by Clostridium difficile. The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Choles tyramine or coles tipol res ins bind vancomycin in vitro. If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

General

Clindamycin Phosphate Topical Solution USP, 1% contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.Clindamycin Phosphate Topical Solution USP, 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.

Pregnancy

Teratogenic effectsIn clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Nursing Mothers

It is not known whether clindamycin is excreted in human breast milk following use of Clindamycin Phosphate Topical Solution. Clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 µg/mL following systemic use. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric Use

Clinical studies for Clindamycin Phosphate Topical Solution did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients.

Adverse Reactions

In 18 clinical studies of various formulations of Clindamycin Phosphate Topical Solution using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].Number of Patients Reporting EventTreatment Emergent Adverse EventSolution n=553(%)Burning62 (11)Itching36 (7)Burning/Itching60 (11)Dryness105 (19)Erythema86 (16)Oiliness/Oily Skin8 (1)Peeling61 (11)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, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

Overdosage

Topically applied Clindamycin Phosphate Topical Solution can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Dosage And Administration

Apply a thin film of Clindamycin Phosphate Topical Solution USP, 1% twice daily to affected area. Keep all liquid dosage forms in containers tightly closed.

How Supplied

Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:60 mL applicator bottle – NDC – 10135-0691-61
     
Store at controlled room temperature 20 to 25 °C (68 to 77 °F) [see USP]. Protect from freezing.Rx onlyTo report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720Rev. 02/20 GH

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