Adult: 600-1,200 mg daily. Severe infections: 1,200-2,700 mg daily, may be increased up to 4,800 mg daily via IV in life-threatening situations. All doses are given in 2-4 equally divided doses. Max: 600 mg (single IM inj); 1,200 mg (single 1-hour IV infusion). IV doses must be infused over at least 10-60 minutes. Max infusion rate: 30 mg/min. For β-haemolytic streptococcal infections: Continue treatment for at least 10 days (to prevent subsequent risk of rheumatic fever or glomerulonephritis). Consideration must be given to local treatment guidelines. Child: ≥1 month 20-40 mg/kg daily divided into 3 or 4 equal doses. Max: 600 mg (single IM inj). IV doses must be infused over at least 10-60 minutes. Max infusion rate: 30 mg/min. For β-haemolytic streptococcal infections: Continue treatment for at least 10 days (to prevent subsequent risk of rheumatic fever or glomerulonephritis). Dosage and treatment recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Adult: As treatment: Moderately severe cases: 150-300 mg 6 hourly. Severe cases: 300-450 mg 6 hourly. For β-haemolytic streptococcal infections: Continue treatment for at least 10 days (to prevent subsequent risk of rheumatic fever or glomerulonephritis). Consideration must be given to local treatment guidelines. Child: As oral solution: Serious infections: 8-12 mg/kg daily. Severe infections: 13-16 mg/kg daily. More severe infections: 17-25 mg/kg daily. As oral cap: Serious infection: 8-16 mg/kg daily. More severe infections: 16-20 mg/kg daily. All doses are given in 3 or 4 equally divided doses. For β-haemolytic streptococcal infections: Continue treatment for at least 10 days (to prevent subsequent risk of rheumatic fever or glomerulonephritis). Dosage and treatment recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Topical/Cutaneous Acne vulgaris
Adult: As lotion or solution: Apply a thin film to the affected area(s) bid. As gel or foam: Apply a thin film to the affected area(s) once daily. Dosage recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Vaginal Bacterial vaginosis
Adult: As 2% cream: Apply 1 applicator full (approx 100 mg) intravaginally at bedtime for 3-7 days. As pessary or ovule: Insert 1 pessary or ovule (100 mg) at bedtime for 3 days. Dosage recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Administration
May be taken with or without food. Cap: Take w/ a full glass of water to avoid oesophageal irritation. Granules for oral soln: Dissolve in water & shake well before use.
Reconstitution
Oral solution: Reconstitute bottle labelled as 100 mL by adding 75 mL of water. Initially, add a large portion of the water and shake vigorously; then add the remainder and shake until the solution is uniform. IV infusion: Dilute with 50-100 mL of compatible diluent (e.g. dextrose 5% in water, NaCl 0.9%) to a final concentration not exceeding 18 mg/mL.
Incompatibility
Incompatible with alkaline preparations, drugs unstable at low pH, ampicillin, aminophylline, barbiturates, Ca gluconate, ceftriaxone, ciprofloxacin, idarubicin, Mg sulfate, phenytoin, and ranitidine.
Contraindications
Hypersensitivity. Topical or vaginal: History of inflammatory bowel disease, regional enteritis, or ulcerative or antibiotic-associated colitis.
Special Precautions
Patient with atopy, history of gastrointestinal disease (e.g. colitis). Not indicated for the treatment of meningitis. Renal and moderate to severe hepatic impairment. Neonates, children, and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Superinfection (particularly yeasts), acute kidney injury (including acute renal failure). Blood and lymphatic system disorders: Agranulocytosis, neutropenia, thrombocytopenia, leucopenia, eosinophilia. Cardiac disorders: Rarely, cardiopulmonary arrest (rapid IV inj). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dysgeusia. General disorders and administration site conditions: Pain and/or abscess at the inj site. Investigations: Abnormal LFTs. Nervous system disorders: Headache, dizziness. Renal and urinary disorders: UTI, glycosuria, proteinuria (vaginal). Reproductive system and breast disorders: Vulvovaginal candidiasis, pain, or disorder (vaginal). Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus; skin dryness or oiliness (topical). Vascular disorders: Thrombophlebitis (IV). Rarely, hypotension (rapid IV inj). Potentially Fatal:Clostridioides difficile-associated diarrhoea (CDAD), pseudomembranous colitis; severe cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor CBC, LFTs, renal function (periodically during prolonged treatment). Asses for changes in bowel frequency; signs of colitis and resolution of symptoms.
Overdosage
Symptoms: Dermatitis, nephrotoxicity, hepatotoxicity, haematological abnormalities, severe diarrhoea, pseudomembranous colitis. Rapid IV administration of large doses may cause ventricular dysrhythmias, hypotension, cardiac arrest. Management: Supportive treatment (e.g. respiratory and cardiac function).
Drug Interactions
May enhance the action of neuromuscular blocking agents. May increase coagulation tests (e.g. prothrombin time, INR) and risk of bleeding with vitamin K antagonists (e.g. warfarin, acenocoumarol, fluindione). Increased plasma concentrations with CYP3A4 and CYP3A5 inhibitors. Reduced plasma concentrations with CYP3A4 and CYP3A5 inducers.
Food Interaction
May reduce the rate of absorption with food (oral). Reduced plasma concentrations with St. John's wort.
Action
Description: Mechanism of Action: Clindamycin, a lincosamide antibiotic, inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, thereby preventing the peptide bond formation, ribosome assembly and translation process. Pharmacokinetics: Absorption: As clindamycin hydrochloride: Rapidly absorbed from the gastrointestinal tract. As clindamycin phosphate: Minimally absorbed from the skin and vagina. Reduced rate of absorption with food (oral). Bioavailability: Approx 90% (oral). Time to peak plasma concentration: Within 1 hour (oral); 1-3 hours (IM); approx 10-14 hours (vaginal cream); approx 5 hours (vaginal pessary). Distribution: Widely distributed in body fluids and tissues, including the bone; no significant levels in the CSF (even with inflamed meninges). Crosses the placenta and enters breast milk. Plasma protein binding: 94%. Metabolism: Metabolised in the liver by CYP3A4 and to a lesser extent by CYP3A5 to form clindamycin sulfoxide (major metabolite) and N-desmethylclindamycin (minor metabolite). Biologically inactive clindamycin phosphate (IV formulation) is rapidly converted to active clindamycin. Excretion: Via urine (approx 10% as active drug and metabolites); faeces (approx 4%). Elimination half-life: Approx 3 hours; 1.5-2.6 hours (vaginal cream); 11 hours (vaginal pessary).
Chemical Structure
Clindamycin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 446598, Clindamycin. https://pubchem.ncbi.nlm.nih.gov/compound/Clindamycin. Accessed Aug. 16, 2023.
Storage
Store between 20-25°C. Reconstituted oral solution: Do not refrigerate. Storage recommendations may vary among countries and individual products. Refer to specific product guidelines.
J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections. D10AF01 - clindamycin ; Belongs to the class of topical antiinfective preparations used in the treatment of acne. G01AA10 - clindamycin ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.
References
Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 02/05/2023.Anon. Clindamycin (Systemic) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/05/2023.Anon. Clindamycin (Systemic). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/05/2023.Anon. Clindamycin (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/05/2023.Anon. Clindamycin (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/05/2023.Anon. Clindamycin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/05/2023.Buckingham R (ed). Clindamycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2023.Cleocin Cream (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Cleocin Hydrochloride Capsule (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Cleocin Pediatric Granule, for Solution (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Cleocin Suppository (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Cleocin T Solution, Lotion, Gel (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Clindamycin 100 mg Pessaries (Aerona Clinical Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Clindamycin 150 mg/mL Solution for Injection or Infusion (Hameln Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Clindamycin 600 mg Capsules, Hard (Morningside Healthcare Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Clindamycin Aerosol, Foam (Medimetriks Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Clindamycin Phosphate Injection, Solution (Pharmacia & Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/05/2023.Dalacin C (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/05/2023.Dalacin C Capsules 75 mg or Clindamycin Hydrochloride Capsules 75 mg (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Dalacin Cream 2% (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Dalacin T Topical Lotion (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.Dalacin T Topical Solution (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.iNova Pharmaceuticals (New Zealand) Limited. Clindatech 10 mg/mL Topical Solution data sheet 04 January 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 02/05/2023.Joint Formulary Committee. Clindamycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/05/2023.Paediatric Formulary Committee. Clindamycin. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 02/05/2023.Pfizer New Zealand Ltd. Dalacin C 150 mg Capsules data sheet 20 January 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 02/05/2023.Pfizer New Zealand Ltd. Dalacin C 600 mg/4 mL Solution for Injection data sheet 20 January 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 02/05/2023.Topicil 1% Topical Solution (Schmidt Biomedtech Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/05/2023.Zindaclin 1% Gel (Canute Pharma [Ireland] Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/05/2023.
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