Clindagel
Clindamycin
Bausch Health Us, Llc
Human Prescription Drug
NDC 16781-462Clindagel also known as Clindamycin is a human prescription drug labeled by 'Bausch Health Us, Llc'. National Drug Code (NDC) number for Clindagel is 16781-462. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Clindagel drug includes Clindamycin Phosphate - 1 g/10mL . The currest status of Clindagel drug is Active.
Drug Information:
| Drug NDC: | 16781-462 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Clindagel |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Clindamycin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bausch Health Us, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CLINDAMYCIN PHOSPHATE - 1 g/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 25 Nov, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA050782 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bausch Health US, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309332
351330
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | EH6D7113I8
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Decreased Sebaceous Gland Activity [PE]
Lincosamide Antibacterial [EPC]
Lincosamides [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 16781-462-06 | 6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE | 01 Jul, 2015 | N/A | No |
| 16781-462-75 | 1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE | 25 Nov, 2013 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Clindagel clindamycin clindamycin phosphate clindamycin methylparaben polyethylene glycol 400 propylene glycol sodium hydroxide water carbomer homopolymer type a (allyl pentaerythritol crosslinked)
Indications and Usage:
Clinical studies in one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used clindagel (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, clindagel 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: lesions clindagel qd n=162 vehicle gel qd n=82 inflammatory 51% 40% p<0.05 noninflammatory 25% 12% total 38% 27% there was a trend in the investigatorâs global assessment of the results, which favored clindagel 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 clindagel. there was no signal for contact sensitization in the clinical trials under normal use conditions.
Warnings:
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. antiper
Read more...istaltic 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.
Dosage and Administration:
Dosage and administration apply a thin film of clindagel once daily to the skin where acne lesions appear. use enough to cover the entire affected area lightly. keep container tightly closed.
Contraindications:
Contraindications clindagel 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.
Adverse Reactions:
Adverse reactions in the one well-controlled clinical study comparing clindagel and its vehicle, the incidence of skin and appendages adverse events occurring in â¥1% of the patients in either group is presented in the following table: number (%) of patients body system/adverse event clindagel 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 ). abd
Read more...ominal 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 bausch health us, llc at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Adverse Reactions Table:
| Number (%) of Patients |
|---|
| Body System/Adverse Event | CLINDAGEL 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) |
Overdosage:
Overdosage topically applied clindagel may be absorbed in sufficient amounts to produce systemic effects (see warnings ).
Description:
Description clindagel (clindamycin phosphate) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, usp, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, 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 -α-d- galacto -octopyranoside 2-(dihydrogen phosphate). clindagel-01
Clinical Pharmacology:
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 clindagel for 5 days resulted in peak plasma clindamycin concentrations that were less than 5.5 ng/ml. following multiple applications of c lindagel 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.
How Supplied:
How supplied clindagel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following size: 75 ml bottle - ndc 16781-462-75 store 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. retain in carton until contents are used. distributed by: bausch health us, llc bridgewater, nj 08807 usa manufactured by: bausch health companies inc. laval, quebec h7l 4a8, canada clindagel is a trademark of bausch health companies inc. or its affiliates. © 2020 bausch health companies inc. or its affiliates 9706100 rev. 01/20
Package Label Principal Display Panel:
Package/label display panel carton - clindagel ndc 16781-462-75 rx only clindagel ® (clindamycin phosphate) topical gel equivalent to 1% clindamycin topical gel 1% for topical use only 75 ml ortho dermatologics carton