No information provided.
Topically applied Clindamycin Palmitate Hydrochloride(Pediatric) can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).
Clindamycin Palmitate Hydrochloride(Pediatric) Foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis).
Clindamycin Palmitate Hydrochloride(Pediatric) Topical Solution, Clindamycin Palmitate Hydrochloride(Pediatric) Topical Gel and Clindamycin Palmitate Hydrochloride(Pediatric) 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.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with Clindamycin Palmitate Hydrochloride(Pediatric) Foam.
The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing Clindamycin Palmitate Hydrochloride(Pediatric) Foam and its vehicle is presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects
| Adverse Reactions | Number (%) of Subjects | |
| Clindamycin Palmitate Hydrochloride(Pediatric) Foam N = 439 | Vehicle Foam N = 154 | |
| Headache | 12 (3%) | 1 (1%) |
| Application site burning | 27 (6%) | 14 (9%) |
| Application site pruritus | 5 (1%) | 5 (3%) |
| Application site dryness | 4 (1%) | 5 (3%) |
| Application site reaction, not otherwise specified | 3 (1%) | 4 (3%) |
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to Clindamycin Palmitate Hydrochloride(Pediatric) Foam.
Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of Clindamycin Palmitate Hydrochloride(Pediatric) Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorrhagic diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.
In 18 clinical studies of various formulations of Clindamycin Palmitate Hydrochloride(Pediatric) using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events.
Number of Patients Reporting Events
| Treatment Emergent | Solution | Gel | Lotion |
| Adverse Event | n=553(%) | n=148(%) | n=160(%) |
| Burning | 62 (11) | 15 (10) | 17 (11) |
| Itching | 36 ( 7) | 15 (10) | 17 (11) |
| Burning/Itching | 60 (11) | # ( – ) | # ( – ) |
| Dryness | 105 (19) | 34 (23) | 29 (18) |
| Erythema | 86 (16) | 10 ( 7) | 22 (14) |
| Oiliness/Oily Skin | 8 ( 1) | 26 (18) | 12* (10) |
| Peeling | 61 (11) | # ( – ) | 11 ( 7) |
| # not recorded * of 126 subjects |
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.
Clindamycin Palmitate Hydrochloride(Pediatric) Foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.
Clindamycin Palmitate Hydrochloride(Pediatric) Topical Solution, Clindamycin Palmitate Hydrochloride(Pediatric) Topical Gel and Clindamycin Palmitate Hydrochloride(Pediatric) 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).
Pharmacodynamics of Clindamycin Palmitate Hydrochloride(Pediatric) Foam is unknown.
In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of Clindamycin Palmitate Hydrochloride(Pediatric) Foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for Clindamycin Palmitate Hydrochloride(Pediatric) Foam than for the clindamycin gel, 1%.
Following multiple applications of Clindamycin Palmitate Hydrochloride(Pediatric) Foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.
Included as part of the PRECAUTIONS section.
PRECAUTIONS ColitisSystemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, Clindamycin Palmitate Hydrochloride(Pediatric) Foam should be discontinued.
Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.
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. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
IrritationClindamycin Palmitate Hydrochloride(Pediatric) Foam can cause irritation. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, clindamycin should be discontinued.
Avoid contact of Clindamycin Palmitate Hydrochloride(Pediatric) Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water.
Clindamycin Palmitate Hydrochloride(Pediatric) Foam should be prescribed with caution in atopic individuals.
Patient Counseling InformationSee FDA-Approved patient labeling (PATIENT INFORMATION).
Instructions for UseClindamycin Palmitate Hydrochloride(Pediatric) Foam may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.
ColitisIn the event a patient treated with Clindamycin Palmitate Hydrochloride(Pediatric) Foam experiences severe diarrhea or gastrointestinal discomfort, Clindamycin Palmitate Hydrochloride(Pediatric) Foam should be discontinued and a physician should be contacted.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of FertilityThe carcinogenicity of a 1.2% clindamycin phosphate gel similar to Clindamycin Palmitate Hydrochloride(Pediatric) Foam was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Clindamycin Palmitate Hydrochloride(Pediatric) Foam, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.
A 1.2% clindamycin phosphate gel similar to Clindamycin Palmitate Hydrochloride(Pediatric) Foam 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.
Use In Specific Populations PregnancyPregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with Clindamycin Palmitate Hydrochloride(Pediatric) Foam. Clindamycin Palmitate Hydrochloride(Pediatric) Foam should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus.
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 Palmitate Hydrochloride(Pediatric) Foam based on a mg/m² comparison.
Nursing MothersIt is not known whether clindamycin is excreted in human milk following use of Clindamycin Palmitate Hydrochloride(Pediatric) Foam. 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.
If used during lactation and Clindamycin Palmitate Hydrochloride(Pediatric) Foam is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
Pediatric UseSafety and effectiveness of Clindamycin Palmitate Hydrochloride(Pediatric) Foam in children under the age of 12 have not been studied.
Geriatric UseThe clinical study with Clindamycin Palmitate Hydrochloride(Pediatric) Foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.
WARNINGSOrally 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. 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.
PRECAUTIONS GeneralClindamycin Palmitate Hydrochloride(Pediatric) 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 Palmitate Hydrochloride(Pediatric) should be prescribed with caution in atopic individuals.
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 MothersIt is not known whether clindamycin is excreted in human milk following use of Clindamycin Palmitate Hydrochloride(Pediatric). However, orally and parenterally administered clindamycin has been reported to appear in breast milk. 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 UseSafety and effectiveness in pediatric patients under the age of 12 have not been established.
Geriatric UseClinical studies for Clindamycin Palmitate Hydrochloride(Pediatric) 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.
Clindamycin Palmitate Hydrochloride(Pediatric) Foam is for topical use only, and not for oral, ophthalmic, or intravaginal use.
Apply Clindamycin Palmitate Hydrochloride(Pediatric) Foam once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.
If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued.
The contents of Clindamycin Palmitate Hydrochloride(Pediatric) Foam are flammable; avoid fire, flame and/or smoking during and immediately following application.
Apply a thin film of Clindamycin Palmitate Hydrochloride(Pediatric) Topical Solution, Clindamycin Palmitate Hydrochloride(Pediatric) Topical Lotion, Clindamycin Palmitate Hydrochloride(Pediatric) Topical Gel, or use a Clindamycin Palmitate Hydrochloride(Pediatric) Topical Solution pledget for the application of Clindamycin Palmitate Hydrochloride(Pediatric) 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.
