Product Elements:
Clindamycin phosphate clindamycin phosphate clindamycin phosphate clindamycin isopropyl alcohol propylene glycol water clindamycin phosphate clindamycin phosphate clindamycin phosphate clindamycin cetostearyl alcohol glycerin isostearyl alcohol methylparaben sodium lauroyl sarcosinate stearic acid water clindamycin phosphate clindamycin phosphate clindamycin phosphate clindamycin allantoin carbomer homopolymer type b (allyl pentaerythritol crosslinked) methylparaben polyethylene glycol 400 propylene glycol sodium hydroxide water
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, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are 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 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. antiperi
Read more...staltic 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. cholestyramine or colestipol resins 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 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 products should be prescribed with caution in atopic individuals.
Dosage and Administration:
Dosage and administration apply a thin film of clindamycin phosphate topical solution, clindamycin phosphate topical lotion, clindamycin phosphate topical gel, or use a clindamycin phosphate topical solution pledget for the application of clindamycin phosphate twice daily to affected area. more than one pledget may be used. each pledget should be used only once and then be discarded. lotion: shake well immediately before using. pledget: remove pledget from foil just before use. do not use if the seal is broken. discard after single use. keep all liquid dosage forms in containers tightly closed.
Contraindications:
Contraindications clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are 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 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 events treatment emergent adverse event solution n=553(%) gel n=148(%) lotion n=160(%) burning 62 (11) 15 (10) 17 (11) itching 36 ( 7) 15 (10) 17 (11) burning/itching 60 (11) not recorded ( â ) ( â ) dryness 105 (19) 34 (23) 29 (18) erythema 86 (16) 10 ( 7) 22 (14) oiliness/oily skin 8 ( 1) 26 (18) 12 of 126 subjects (10) peeling 61 (11) ( â ) 11 ( 7) 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 (
Read more...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.
Adverse Reactions Table:
Number of Patients Reporting Events| Treatment Emergent Adverse Event | Solution n=553(%) | Gel n=148(%) | Lotion n=160(%) |
|---|
| Burning | 62 (11) | 15 (10) | 17 (11) |
| Itching | 36 ( 7) | 15 (10) | 17 (11) |
| Burning/Itching | 60 (11) | not recorded ( – ) | ( – ) |
| Dryness | 105 (19) | 34 (23) | 29 (18) |
| Erythema | 86 (16) | 10 ( 7) | 22 (14) |
| Oiliness/Oily Skin | 8 ( 1) | 26 (18) | 12of 126 subjects (10) |
| Peeling | 61 (11) | ( – ) | 11 ( 7) |
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 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Overdosage:
Overdosage topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects. (see warnings ).
Description:
Description clindamycin phosphate topical solution and clindamycin phosphate topical lotion contain clindamycin phosphate, usp, at a concentration equivalent to 10 mg clindamycin per milliliter. clindamycin phosphate topical gel contains clindamycin phosphate, usp, at a concentration equivalent to 10 mg clindamycin per gram. each clindamycin phosphate topical solution pledget applicator contains approximately 1 ml of topical solution. 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, and water. the gel contains allantoin, carbomer 934p, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. the lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate se (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified 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). chemical structure
Clinical Pharmacology:
Clinical pharmacology mechanism of action the 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 (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. microbiology clindamycin inhibits bacterial protein synthesis by binding to the 23s rna of the 50s subunit of the ribosome. clindamycin is bacteriostatic. antimicrobial activity clindamycin is active in vitro against most isolates of propionibacterium acnes; however, the clinical significance is unknown. resistance resistance to clindamycin is most often caused by modification of specific bases of the 23s r
Read more...ibosomal 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.
Mechanism of Action:
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 clindamycin phosphate topical solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 ml applicator bottleândc 59762-3728-1 60 ml applicator bottleândc 59762-3728-2 carton of 60 single-use pledget applicatorsândc 59762-3728-3 clindamycin phosphate topical gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 30 gram tubeândc 59762-3743-1 60 gram tubeândc 59762-3743-2 clindamycin phosphate topical lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 ml plastic squeeze bottleândc 59762-3744-1 store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp]. protect from freezing.
Package Label Principal Display Panel:
Principal display panel - 60 ml bottle label - solution ndc 59762-3728-2 60 ml greenstone ® brand clindamycin phosphate topical solution, usp 1%* solution for topical use only rx only principal display panel - 60 ml bottle label - solution
Principal display panel - 60 ml bottle carton - solution ndc 59762-3728-2 60 ml greenstone ® brand clindamycin phosphate topical solution, usp 1%* solution for topical use only rx only principal display panel - 60 ml bottle carton - solution
Principal display panel - pledget packet ndc 59762-3728-3 1 pledget greenstone ® brand clindamycin phosphate topical solution, usp 1%* pledget for topical use only rx only principal display panel - pledget packet
Principal display panel - 60 pledget packet carton ndc 59762-3728-3 60 pledgets greenstone ® brand clindamycin phosphate topical solution, usp 1%* pledget for topical use only rx only principal display panel - 60 pledget packet carton
Principal display panel - 60 ml bottle label - lotion ndc 59762-3744-1 60 ml greenstone ® brand clindamycin phosphate topical lotion 1%* for topical use only rx only principal display panel - 60 ml bottle label - lotion
Principal display panel - 60 ml bottle carton - lotion ndc 59762-3744-1 60 ml greenstone ® brand clindamycin phosphate topical lotion 1%* for topical use only rx only principal display panel - 60 ml bottle carton - lotion
Principal display panel - 60 gram tube label ndc 59762-3743-2 60 gram greenstone ® brand clindamycin phosphate topical gel 1%* for topical use only rx only store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp]. protect from freezing. for external use only. avoid contact with eyes. see crimp of tube for expiration date and lot number. dosage and use: see accompanying prescribing information. *each gram contains clindamycin phosphate equivalent to 10 mg (1%) of clindamycin. also contains allantoin, carbomer 934p, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. g distributed by: greenstone llc, peapack, nj 07977 principal display panel - 60 gram tube label
Principal display panel - 60 gram tube carton ndc 59762-3743-2 60 gram greenstone ® brand clindamycin phosphate topical gel 1%* for topical use only rx only principal display panel - 60 gram tube carton