pharmacopeia
GET
/api/v1/drug/clindamycin
2D structure
(2S,4R)-N-[(1S,2S)-2-chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide
SMILES CCC[C@@H]1C[C@H](N(C1)C)C(=O)N[C@@H]([C@@H]2[C@@H]([C@@H]([C@H]([C@H](O2)SC)O)O)O)[C@H](C)Cl
InChIKey KDLRVYVGXIQJDK-AWPVFWJPSA-N

Mechanism of action

Sourced from openFDA

The mechanism of action of clindamycin in treating acne vulgaris is unknown.

Protein Synthesis

Indications

Sourced from openFDA
  • Clindamycin phosphate topical lotion 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 ).ICD-10: L70.0

Contraindications

Sourced from openFDA
  • Clindamycin phosphate topical lotion 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.contraindicated

Dosage & administration

Sourced from openFDA

Apply a thin film of clindamycin phosphate topical lotion twice daily to affected area. Lotion: Shake well immediately before using. Keep all liquid dosage forms in containers tightly closed.

Warnings & precautions

Sourced from openFDA

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. 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.

Adverse reactions

Sourced from openFDA

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) # ( – ) # ( – ) 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. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

Sourced from openFDA

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.

Pharmacokinetics

Sourced from openFDA
Metabolism
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.

Overdosage

Sourced from openFDA

Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).

Approval history

Sourced from openFDA
  • Feb 22, 1970NDANDA050162Pfizer
  • Oct 2, 1972NDANDA050441Pfizer
  • Jan 7, 1987NDANDA050615Pfizer
  • May 31, 1989NDANDA050600Pfizer
  • Aug 11, 1992NDANDA050680Pfizer
  • Aug 13, 1999NDANDA050767Pfizer
  • Nov 27, 2000NDANDA050782Bausch
  • Nov 30, 2004NDANDA050793Padagis Us

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 0781-3289-09)Active
    Sponsor: Sandoz Inc. · Reason: Demand increase for the drug
    Updated
  • Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 72572-074-24)Active
    Sponsor: Sandoz Inc.
    Updated
  • Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 0781-3290-09)Active
    Sponsor: Sandoz Inc.
    Updated
  • Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 72572-076-24)Active
    Sponsor: Sandoz Inc.
    Updated
  • Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 6 mg/1 mL (NDC 0781-3288-09)Active
    Sponsor: Sandoz Inc.
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
37,188 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,1348.4%
  2. 2Drug Hypersensitivity3,0488.2%
  3. 3Diarrhoea2,4996.7%
  4. 4Rash2,2926.2%
  5. 5Nausea2,1915.9%
  6. 6Pain1,9855.3%
  7. 7Off Label Use1,8304.9%
  8. 8Fatigue1,7054.6%
  9. 9Dyspnoea1,5714.2%
  10. 10Acute Kidney Injury1,5334.1%
  11. 11Pyrexia1,4884.0%
  12. 12Chronic Kidney Disease1,4473.9%
  13. 13Headache1,3183.5%
  14. 14Pruritus1,3183.5%
  15. 15Vomiting1,2913.5%

Literature

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Recent PubMed references pinned to Clindamycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 334 ClinicalTrials.gov registrations naming Clindamycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Clindamycin work?
The mechanism of action of clindamycin in treating acne vulgaris is unknown.
What is Clindamycin used for?
According to FDA labeling, Clindamycin carries indications including: Clindamycin phosphate topical lotion 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 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Clindamycin?
Clindamycin is classified as Antibiotics, Antiinfectives for treatment of acne, Lincosamides, Lincosamide Antibacterial, Protein Synthesis Inhibitors, Decreased Protein Synthesis, Decreased Sebaceous Gland Activity, Neuromuscular Blockade.
What are the brand names for Clindamycin?
Clindamycin is marketed under brand names including ANTIROBE, Acanya, Cabtreo, Cleocin, Cleocin-T, Clinda-Guard, ClindaCure, Clindacin.
What are the contraindications for Clindamycin?
Clindamycin labeling lists contraindications including: Clindamycin phosphate topical lotion 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.. Always consult the full prescribing information and a clinician.
Note. Data for clindamycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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