Schedule H

Oral

• Capsules: 250 mg, 500 mg

• Powder for oral suspension: 125 mg/5 mL, 250 mg/5 mL

• Injection: NOT AVAILABLE in India

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

⮞ Skin and Soft Tissue Infections (MSSA)

(Furuncles, carbuncles, cellulitis, impetigo, wound infections)

Parameter Recommendation

Starting dose 250 mg orally every 6 hours

Titration Increase to 500 mg every 6 hours for moderate-severe infections

Usual maintenance dose 250–500 mg every 6 hours

Maximum dose 2 g/day

Key Clinical Notes:

• Administer on empty stomach (1 hour before or 2 hours after meals)

• Duration: 7–14 days depending on severity and clinical response

• Confirm MSSA susceptibility when culture results available

⮞ Osteomyelitis (MSSA)

Oral step-down therapy after initial IV phase

Parameter Recommendation

Starting dose 500 mg orally every 6 hours

Titration Not applicable

Usual maintenance dose 500 mg every 6 hours

Maximum dose 2 g/day

Key Clinical Notes:

• Typically follows initial IV therapy with cloxacillin or other antistaphylococcal agent

• Total treatment duration: 4–6 weeks

• Specialist supervision required for transition from IV to oral therapy

• Monitor inflammatory markers (ESR, CRP) for response

⮞ Septic Arthritis (MSSA)

Oral step-down phase

Parameter Recommendation

Starting dose 500 mg orally every 6 hours

Titration Not applicable

Usual maintenance dose 500 mg every 6 hours

Maximum dose 2 g/day

Key Clinical Notes:

• Initiate with IV antistaphylococcal therapy; oral step-down after clinical stabilisation

• Total treatment duration: 3–4 weeks

• Specialist-supervised transition to oral phase

• Monitor joint swelling and inflammatory markers

⮞ Respiratory Tract Infections (Empirical MSSA Coverage)

(Staphylococcal pneumonia, bronchitis with suspected MSSA)

Parameter Recommendation

Starting dose 250 mg orally every 6 hours

Titration Increase to 500 mg every 6 hours based on severity

Usual maintenance dose 250–500 mg every 6 hours

Maximum dose 2 g/day

Key Clinical Notes:

• Duration: 7–10 days

• Consider culture and sensitivity before initiating if feasible

• Not first-line for community-acquired pneumonia

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Prophylaxis for recurrent SSTI (MSSA) 250–500 mg orally twice daily Up to 1 month OFF-LABEL; Based on Indian dermatology practice; Specialist supervision recommended; Not universally accepted

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

⮞ Skin and Soft Tissue Infections (MSSA)

Age/Weight Range Dose Frequency Maximum

<1 month Not recommended — —

1 month – 12 years 12.5–25 mg/kg/day Divided into 4 doses (every 6 hours) Adult dose

12 years Adult dosing applies Every 6 hours 2 g/day

Key Clinical Notes:

• Starting dose: 12.5 mg/kg/day for mild infections

• Titration: Increase to 25 mg/kg/day for moderate-severe infections

• Administer on empty stomach (1–2 hours before or after meals)

• Duration: 7–14 days depending on severity

Safety Monitoring:

• Monitor for GI tolerance (nausea, diarrhoea)

• Watch for skin rash or signs of hypersensitivity

• LFTs if therapy exceeds 2 weeks

Secondary Indications — Paediatrics (Off-label, if any)

Indication Dose Duration Notes

Osteomyelitis (MSSA) — Oral step-down 50–100 mg/kg/day divided every 6 hours 4–6 weeks total (after IV phase) OFF-LABEL; Specialist only; Based on AIIMS paediatric infectious disease protocols and IAP guidelines

Age Restriction Statement:

Not recommended in neonates (<1 month) due to limited safety data. Use in infants under specialist supervision only.

• Known hypersensitivity to penicillins or any beta-lactam antibiotic

• History of anaphylaxis or immediate-type allergic reaction to beta-lactams

• Prior cholestatic jaundice or hepatic dysfunction attributed to dicloxacillin use

• History of allergic diathesis (asthma, eczema, urticaria, hay fever)

• Cephalosporin allergy (approximately 5–10% cross-reactivity risk)

• Pre-existing hepatic dysfunction — monitor LFTs with prolonged use

• History of gastrointestinal disease, particularly antibiotic-associated colitis

• Risk of superinfection with prolonged therapy

• Clostridioides difficile-associated diarrhoea (CDAD) — though low risk

Parameter Information

Risk category Considered safe during pregnancy (beta-lactam class)

Safety statement No evidence of teratogenicity; extensive clinical experience

Preferred alternatives Amoxicillin-clavulanate for mild infections if MSSA not confirmed

When to use When indicated for confirmed or suspected MSSA infection

Monitoring Monitor maternal liver function if therapy exceeds 2 weeks

Parameter Information

Compatibility Compatible with breastfeeding

Drug level in milk Low

Preferred alternatives None required; dicloxacillin is acceptable

Infant monitoring Watch for loose stools, oral thrush, or skin rash

• Starting dose: Lower end of range preferred (250 mg every 6 hours) in frail patients

• Titration: Increase gradually based on clinical response and tolerance

• Additional considerations:

• Assess baseline renal function before initiation

• Higher susceptibility to GI adverse effects

• Monitor for hepatic dysfunction with prolonged use

• Consider polypharmacy and potential drug interactions

Interacting Drug Effect Management

Methotrexate Reduced renal clearance of methotrexate leading to increased toxicity (myelosuppression, mucositis) Avoid combination if possible; if essential, monitor methotrexate levels and toxicity closely

Warfarin May increase INR due to alteration of gut flora affecting vitamin K synthesis Monitor INR more frequently; adjust warfarin dose as needed

Probenecid Increases serum levels of dicloxacillin by competing for renal tubular secretion Avoid combination unless intentional for dose enhancement; consider dose reduction of dicloxacillin

Interacting Drug Effect Management

Oral contraceptives Theoretical risk of reduced contraceptive efficacy Advise additional barrier contraceptive method during therapy

Tetracyclines Possible antagonism (bacteriostatic vs bactericidal) reducing dicloxacillin efficacy Avoid co-administration if possible

Oral typhoid vaccine (Ty21a) May reduce vaccine immunogenicity Avoid during dicloxacillin therapy; complete antibiotic course before vaccination

Aminoglycosides Potential in vitro inactivation if mixed If used together, administer separately

• Nausea and vomiting

• Diarrhoea

• Abdominal cramps

• Maculopapular rash

• Urticaria

• Metallic or bitter taste

• Oral candidiasis (with prolonged use)

Adverse Effect Clinical Notes

Cholestatic hepatitis May occur during or after therapy; presents with jaundice, pruritus, elevated bilirubin and ALP; requires immediate discontinuation

Anaphylaxis / Angioedema Immediate hypersensitivity; discontinue drug; emergency management required

Pseudomembranous colitis Suspect with unexplained diarrhoea; discontinue and treat appropriately

Neutropenia / Eosinophilia Rare; associated with prolonged therapy; monitor CBC

Stevens-Johnson Syndrome Rare; discontinue immediately and refer for specialist care

Interstitial nephritis Rare; fever, rash, eosinophilia with renal dysfunction

Phase Parameters

Baseline LFTs (if pre-existing liver disease or prolonged therapy planned); allergy history; renal function

During therapy (<2 weeks) Clinical response; signs of hypersensitivity; GI tolerance

Prolonged therapy (>2 weeks) LFTs weekly; CBC; monitor for skin eruptions

Post-therapy Monitor for delayed hepatotoxicity (can occur after stopping)

• Diclocin (Alembic)

• Dyclo (Abbott)

• Diclox Kid (Macleods) — Paediatric suspension

• Diclocare

• Staflox

• Multiple generic preparations available

Note: Not included in NLEM; not NPPA price-controlled; variable pricing in private sector.

1. Empty stomach dosing is critical: Food significantly reduces oral bioavailability — always administer 1 hour before or 2 hours after meals.

1. Superior oral absorption: Dicloxacillin is acid-stable with more reliable oral absorption compared to cloxacillin, making it the preferred oral antistaphylococcal penicillin.

1. Narrow spectrum — use appropriately: Effective only against MSSA; has no activity against MRSA, Gram-negative organisms, or enterococci.

1. Ideal for oral step-down therapy: Excellent choice for completing treatment of bone/joint infections after initial IV therapy.

1. Hepatotoxicity surveillance: Monitor LFTs if therapy exceeds 2 weeks; cholestatic jaundice may have delayed presentation even after stopping drug.

1. No parenteral form in India: For severe infections requiring IV therapy, use cloxacillin instead; dicloxacillin is for oral treatment only.

Dicloxacillin; antibiotic; beta-lactam; penicillinase-resistant penicillin; MSSA; staphylococcal infection; skin infection; SSTI; oral step-down; hepatic monitoring; pregnancy-safe; paediatric-appropriate

RxIndia v1.0 — 10 Jan 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Paediatric Infectious Disease Protocols

• IAP Paediatric Drug Formulary

• Harrison's Principles of Internal Medicine

• ICMR Antimicrobial Use Guidelines

• Goodman & Gilman's: The Pharmacological Basis of Therapeutics