Schedule H

Oral, Intravenous (IV), Intramuscular (IM), Topical, Intravaginal

• Capsule: 150 mg, 300 mg (as hydrochloride)

• Injection: 150 mg/mL in 2 mL ampoule (300 mg), 4 mL ampoule (600 mg)

• Topical gel/solution/lotion: 1% (as phosphate)

• Vaginal cream: 2% (as phosphate)

• Vaginal suppository/ovule: 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Skin and Soft Tissue Infections (Cellulitis, Abscess, Wound Infection, Erysipelas)

Oral Route (Mild-Moderate Infections)

Step Dose Clinical Notes

Starting dose 150–300 mg every 6 hours Based on severity

Titration Not applicable Fixed dosing

Usual maintenance dose 150–300 mg every 6 hours Duration 7–10 days

Maximum dose 450 mg every 6 hours (1.8 g/day) For severe infections

Intravenous Route (Severe Infections)

Step Dose Clinical Notes

Starting dose 600 mg every 8 hours Administer over 20–30 minutes

Titration May increase to 900 mg every 8 hours if needed Based on clinical response

Usual maintenance dose 600–900 mg every 8 hours Switch to oral when clinically stable

Maximum dose 4.8 g/day in divided doses For life-threatening infections

Key points:

• Good coverage for Staphylococcus (including many CA-MRSA), Streptococcus, and anaerobes

• Alternative for beta-lactam allergic patients

• Excellent tissue penetration including bone

1. Anaerobic Infections (Intra-abdominal, Pelvic, Aspiration Pneumonia, Lung Abscess)

Intravenous Route

Step Dose Clinical Notes

Starting dose 600–900 mg every 8 hours Usually combined with gram-negative coverage

Titration Not applicable

Usual maintenance dose 600–900 mg every 8 hours Duration depends on source control and response

Maximum dose 4.8 g/day

Key points:

• Typically combined with aminoglycoside or fluoroquinolone for mixed aerobic-anaerobic infections

• Excellent for Bacteroides fragilis group

• Does NOT cover gram-negative aerobes — never use as monotherapy for intra-abdominal sepsis

1. Bone and Joint Infections (Osteomyelitis, Septic Arthritis)

Intravenous then Oral Route

Phase Dose Clinical Notes

IV phase 600–900 mg every 8 hours Minimum 2–4 weeks IV for osteomyelitis

Oral step-down 300–450 mg every 6 hours After clinical improvement

Total duration 4–6 weeks (septic arthritis) to 6–12 weeks (osteomyelitis) Based on source control and response

Maximum dose 4.8 g/day IV; 1.8 g/day oral

Key points:

• Excellent bone penetration — drug of choice for staphylococcal osteomyelitis when beta-lactams contraindicated

• Often combined with rifampicin for biofilm-associated infections

• IV-to-oral switch feasible due to excellent oral bioavailability (~90%)

1. Pelvic Inflammatory Disease (PID)

Intravenous Route (Inpatient Regimen)

Step Dose Clinical Notes

Starting dose Clindamycin 900 mg IV every 8 hours + Gentamicin 2 mg/kg loading then 1.5 mg/kg every 8 hours Standard combination regimen

Titration Not applicable

Usual maintenance dose Continue IV for minimum 48 hours after clinical improvement Then switch to oral

Oral step-down Clindamycin 450 mg every 6 hours OR Doxycycline 100 mg BD Complete 14 days total treatment

1. Acne Vulgaris (Topical)

Topical Route

Step Dose Clinical Notes

Starting dose Apply 1% gel/solution/lotion once daily Start with once daily to assess tolerance

Titration Increase to twice daily if tolerated

Usual maintenance dose Apply thin layer to affected areas twice daily After washing and drying face

Maximum dose Twice daily application Prolonged monotherapy not recommended

Key points:

• ALWAYS combine with benzoyl peroxide to reduce antibiotic resistance

• Fixed-dose combination products (clindamycin + benzoyl peroxide) preferred

• Limit duration to 12 weeks; reassess need if continuing

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Skin and Soft Tissue Infections / Anaerobic Infections

Oral Route — Weight-Based

Step Dose Clinical Notes

Starting dose 8–10 mg/kg/day in 3–4 divided doses For mild-moderate infections

Titration Increase to 16–20 mg/kg/day for moderate-severe Based on clinical response

Usual maintenance dose 10–20 mg/kg/day in 3–4 divided doses

Maximum dose 1.8 g/day (37.5 mg/kg/day)

Intravenous Route — Weight-Based

Step Dose Clinical Notes

Starting dose 15–20 mg/kg/day in 3–4 divided doses For moderate-severe infections

Titration Up to 40 mg/kg/day for severe/life-threatening

Usual maintenance dose 20–40 mg/kg/day in 3–4 divided doses

Maximum dose 40 mg/kg/day OR 4.8 g/day (whichever is lower) Maximum single dose: 600 mg oral, 900 mg IV

1. Bone and Joint Infections (Osteomyelitis, Septic Arthritis)

Route Dose Clinical Notes

IV (initial) 30–40 mg/kg/day in 3–4 divided doses Minimum 2–4 weeks IV for osteomyelitis

Oral (step-down) 30 mg/kg/day in 3–4 divided doses After clinical and inflammatory marker improvement

Total duration 4–6 weeks minimum Based on infection severity and response

1. Acne Vulgaris (≥12 years)

Formulation Dose Clinical Notes

Topical 1% gel/solution Apply thin layer to affected areas once or twice daily Combine with benzoyl peroxide

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Toxoplasmosis (with pyrimethamine + leucovorin) 20–30 mg/kg/day in 4 divided doses Based on infection severity OFF-LABEL; Paediatric ID specialist only

Malaria (with quinine) 10 mg/kg every 8 hours 7 days OFF-LABEL; Alternative to doxycycline in children <8 years

Safety monitoring:

• Monitor for diarrhoea (C. difficile risk)

• LFTs if prolonged use

• Watch for rash or allergic reactions

Minimum age: Not recommended below 1 month of age except under neonatologist/paediatric ID specialist supervision (concern for benzyl alcohol in some injectable formulations)

Notes:

• Clindamycin is primarily hepatically metabolised

• Not significantly removed by haemodialysis or peritoneal dialysis

• No supplemental dosing required after dialysis

Note: Clindamycin is primarily hepatically metabolised; half-life significantly prolonged in severe liver disease

• Known hypersensitivity to clindamycin or lincomycin

• History of Clostridioides difficile infection (CDI) or antibiotic-associated colitis with clindamycin

• Concurrent use with erythromycin or other macrolides (antagonistic at ribosomal level)

• History of gastrointestinal disease (ulcerative colitis, Crohn's disease, antibiotic-associated diarrhoea) — high risk of CDI

• Elderly patients — increased CDI risk; start at lower doses

• Atopic individuals — may have increased hypersensitivity risk

• Prolonged therapy — monitor for superinfection and hepatotoxicity

• Myasthenia gravis — may exacerbate muscle weakness

• Concurrent neuromuscular blocking agents — may potentiate blockade

• Neonates — injectable formulations may contain benzyl alcohol; use with caution

Parameter Recommendation

Safety category Generally considered safe (extensive experience); crosses placenta in low concentrations

Preferred alternatives Beta-lactams remain first-line when appropriate; clindamycin used when penicillin-allergic or anaerobic coverage needed

When it may be used Skin/soft tissue infections; PID; bacterial vaginosis; group B streptococcal prophylaxis in penicillin-allergic patients

Monitoring GI tolerance; signs of allergic reaction; LFTs if prolonged use

Notes:

• Vaginal clindamycin is acceptable in pregnancy for bacterial vaginosis

• Used for GBS prophylaxis in labour in penicillin-allergic patients (if isolate susceptible)

Parameter Recommendation

Compatibility Compatible with breastfeeding for short courses

Drug levels in milk Low (milk:plasma ratio 0.5–1.0; infant receives <2% of maternal dose)

Preferred alternatives Beta-lactams if appropriate; no need to avoid clindamycin when indicated

Infant monitoring Observe for diarrhoea, loose stools, oral thrush, rash; blood in stool (rare — discontinue if occurs)

Topical/Vaginal: No concern for breastfeeding — negligible systemic absorption

• Recommended starting dose: 150 mg every 6 hours (oral) or 600 mg every 8 hours (IV) — lower end of dosing range

• Titration: Slower; increase only if needed and tolerated

• Additional risks:

• Significantly increased risk of C. difficile infection — consider alternatives if available

• May have reduced hepatic function — monitor for accumulation

• Assess hydration status and renal function (though no renal adjustment needed)

• Monitor for diarrhoea closely — any diarrhoea warrants consideration of CDI testing

• Monitoring: Daily stool assessment; LFTs with prolonged use

Drug Interaction Management

Erythromycin / Azithromycin / Clarithromycin (macrolides) Antagonistic binding at 50S ribosomal subunit → reduced efficacy of both drugs AVOID combination — do not use together

Neuromuscular blocking agents (vecuronium, rocuronium, atracurium) Clindamycin potentiates neuromuscular blockade → prolonged paralysis Use with caution in anaesthesia; inform anaesthetist; may need reduced doses of NMBAs

Kaolin-pectin antidiarrhoeals Reduces GI absorption of oral clindamycin by ~90% Avoid concurrent oral administration; separate by 2 hours minimum

Live vaccines (BCG, oral typhoid) Theoretical reduced vaccine efficacy with systemic antibiotic use Avoid live vaccines during active infection/antibiotic treatment where possible

Drug Interaction Management

Rifampicin CYP3A4 induction may reduce clindamycin levels Monitor clinical efficacy; may need higher clindamycin doses

Warfarin May enhance anticoagulant effect (mechanism unclear) Monitor INR closely during concurrent use; adjust warfarin dose as needed

Cyclosporine / Tacrolimus Potential for altered immunosuppressant levels Monitor cyclosporine/tacrolimus levels

Chloramphenicol Potential antagonism at ribosomal binding site Avoid combination if possible

Systemic (Oral/IV):

• Diarrhoea (up to 20% — most common)

• Nausea and vomiting

• Abdominal pain/cramping

• Maculopapular rash

• Dysgeusia (metallic taste)

Topical:

• Skin dryness

• Erythema and peeling

• Burning/stinging sensation

• Oiliness

Vaginal:

• Vaginal irritation

• Vulvovaginal candidiasis

• Abnormal discharge

Reaction Action Required

Clostridioides difficile infection (CDI) / Pseudomembranous colitis Discontinue clindamycin immediately; send stool for C. difficile toxin; treat with oral vancomycin or fidaxomicin; supportive care; may require hospitalisation

Severe allergic reaction / Anaphylaxis Discontinue permanently; standard anaphylaxis management

Stevens-Johnson Syndrome / TEN (rare) Discontinue immediately; hospitalise; dermatology and burns unit involvement

DRESS syndrome Discontinue; supportive care; may require corticosteroids

Acute generalised exanthematous pustulosis (AGEP) Discontinue; supportive care

Hepatotoxicity (cholestatic hepatitis, elevated transaminases) Discontinue; monitor LFTs; hepatology referral if severe

Blood dyscrasias (neutropenia, agranulocytosis — rare) Discontinue; haematology referral

Note: CDI can occur up to 2 months after clindamycin use — warn patients about persistent diarrhoea

During treatment Daily assessment for diarrhoea (especially in hospitalised patients); GI symptoms

If diarrhoea develops Stool test for C. difficile toxin (PCR or EIA); consider discontinuation

Prolonged therapy (>2 weeks) LFTs weekly; CBC if concerned about bone marrow suppression

Post-treatment Counsel patient about delayed-onset CDI symptoms (up to 8 weeks)

Systemic (Oral/Injection):

• Dalacin C (Pfizer)

• Clindac (Alkem)

• Clinidac (Stadmed)

• Clincin (Aristo)

Topical:

• Clindac A (Alkem)

• Clindamycin Gel (various)

• Clindasol (Sun Pharma)

• Clinderm (Derma)

Vaginal:

• Clingen (Menarini)

• Clingyn (various)

• Dalacin V (Pfizer — limited availability)

Fixed-Dose Combinations (Topical):

NLEM status: Clindamycin injection 150 mg/mL is included in NLEM 2022 — ceiling price applicable under NPPA

Government supply: Available through public health facilities for serious infections

• C. difficile warning is real: Clindamycin has one of the highest associations with CDI among antibiotics — use judiciously; counsel patients that diarrhoea developing even weeks after stopping should prompt medical review

• Excellent oral bioavailability: ~90% bioavailability allows reliable IV-to-oral switch; don't prolong IV unnecessarily when patient can take oral

• Topical monotherapy promotes resistance: ALWAYS combine topical clindamycin with benzoyl peroxide for acne to reduce Cutibacterium acnes resistance — use fixed-dose combinations

• Penicillin-allergy alternative: Excellent option for skin/soft tissue and bone infections in penicillin-allergic patients, but verify need — many "penicillin allergies" are not true IgE-mediated reactions

• Does NOT cover gram-negatives: Never use clindamycin alone for mixed aerobic-anaerobic infections — always combine with gram-negative coverage (aminoglycoside, fluoroquinolone, or third-generation cephalosporin)

• Erythromycin antagonism: Do not combine with macrolides — they compete for the same ribosomal binding site and antagonise each other

clindamycin; lincosamide; anaerobic infections; skin infections; MRSA; acne; bacterial vaginosis; osteomyelitis; C. difficile risk; penicillin alternative; NLEM India

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• NLEM 2022 (National List of Essential Medicines)

• ICMR Treatment Guidelines for Antimicrobial Use

• AIIMS Antibiotic Policy

• IAP Infectious Diseases Chapter Guidelines (paediatric dosing)

• API Textbook of Medicine (11th Edition)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

• Harrison's Principles of Internal Medicine (21st Edition)