Clindamycin Phosphate
A-s Medication Solutions
Human Prescription Drug
NDC 50090-5779Clindamycin Phosphate is a human prescription drug labeled by 'A-s Medication Solutions'. National Drug Code (NDC) number for Clindamycin Phosphate is 50090-5779. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Clindamycin Phosphate drug includes Clindamycin Phosphate - 11.9 mg/mL . The currest status of Clindamycin Phosphate drug is Active.
Drug Information:
| Drug NDC: | 50090-5779 |
| 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: | Clindamycin Phosphate |
| 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 Phosphate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | A-s Medication Solutions |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - 11.9 mg/mL
|
| 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: | ANDA |
| 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: | 01 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jan, 2026 |
| 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: | ANDA209846 |
| 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, 2024 |
| 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: | A-S Medication Solutions
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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]
Neuromuscular Blockade [PE]
|
| 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 |
|---|
| 50090-5779-0 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (50090-5779-0) / 60 mL in 1 BOTTLE, WITH APPLICATOR | 07 Oct, 2021 | 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:
Clindamycin phosphate clindamycin phosphate water propylene glycol isopropyl alcohol sodium hydroxide clindamycin phosphate clindamycin
Drug Interactions:
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.
Indications and Usage:
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 ).
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 s tool assay for c. difficile toxin may be helpful diagnos tically. when s ignificant diarrhea occurs, the drug should be discontinued. large bowel end oscopy should be considered to es tablish a definitive diagnosis in cases of severe diarrhea. a
Read more...ntiperistaltic 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 Precautions:
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.
Dosage and Administration:
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.
Contraindications:
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.
Adverse Reactions:
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 event treatment emergent adverse event solution n=553(%) burning 62 (11) itching 36 (7) burning/itching 60 (11) dryness 105 (19) erythema 86 (16) oiliness/oily skin 8 (1) peeling 61 (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
Read more... the use of topical formulations of clindamycin.
Adverse Reactions Table:
| Treatment Emergent Adverse Event | Solution n=553(%) |
| Burning | 62 (11) |
| Itching | 36 (7) |
| Burning/Itching | 60 (11) |
| Dryness | 105 (19) |
| Erythema | 86 (16) |
| Oiliness/Oily Skin | 8 (1) |
| Peeling | 61 (11) |
Drug Interactions:
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.
Use in Pregnancy:
Pregnancy teratogenic effects in 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.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients under the age of 12 have not been established.
Geriatric Use:
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.
Overdosage:
Overdosage topically applied clindamycin phosphate topical solution can be absorbed in sufficient amounts to produce systemic effects (see warnings ).
Description:
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). the structural formula represented below is 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 p
Clinical Pharmacology:
Clinical pharmacology mechanism of action the mechanism of action of clindamycin in treating acne vulgaris is unknown.
Pharmacokinetics:
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 (0â3 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.
How Supplied:
How supplied product: 50090-5779 ndc: 50090-5779-0 60 ml in a bottle, with applicator / 1 in a carton
Package Label Principal Display Panel:
Clindamycin phosphate label image