Schedule H

Oral, Intravenous

• Capsules: 50 mg, 100 mg

• Injection: 100 mg/vial (powder for reconstitution) — limited availability, not widely marketed

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acne Vulgaris (Inflammatory, Moderate to Severe)

Parameter Details

Starting dose 50–100 mg orally once daily

Titration May increase to twice daily based on response and tolerability

Usual maintenance dose 100 mg orally once or twice daily

Maximum dose 200 mg/day

Duration 6–12 weeks

Clinical Notes:

• Evaluate efficacy every 6–8 weeks

• Consider resistance or alternative agent if poor response

• Extended-release formulation reduces vestibular side effects (if available)

• Discontinue if no improvement after 12 weeks

1. Skin and Soft Tissue Infections (SSTIs) — Including Community-Acquired MRSA

Parameter Details

Starting dose 200 mg orally as initial dose (loading)

Titration Not applicable

Usual maintenance dose 100 mg orally every 12 hours

Maximum dose 200 mg/day

Duration 5–10 days depending on severity and clinical response

Clinical Notes:

• Preferred oral option for uncomplicated MRSA skin infections

• Culture confirmation recommended before initiation

• Not for empirical use in serious systemic infections

1. Respiratory Tract Infections (Including Atypical Pneumonia)

Parameter Details

Starting dose 200 mg orally or IV as initial dose

Titration Not applicable

Usual maintenance dose 100 mg orally or IV every 12 hours

Maximum dose 200 mg/day

Duration 7–14 days depending on clinical response

Clinical Notes:

• Use when atypical organisms suspected or confirmed (Mycoplasma pneumoniae, Chlamydia pneumoniae, Chlamydia psittaci)

• IV route reserved for patients unable to tolerate oral therapy

• Switch to oral therapy as soon as clinically feasible

1. Leprosy (Alternative Agent in Multi-Drug Therapy)

Parameter Details

Starting dose 100 mg orally once daily

Titration Not applicable

Usual maintenance dose 100 mg orally once daily

Maximum dose 100 mg/day

Duration Minimum 6 months; as per National Leprosy Eradication Programme (NLEP) guidelines

Clinical Notes:

• Used as alternative when dapsone or rifampicin not tolerated

• Always used in combination therapy (typically with clofazimine)

• Requires specialist guidance under public health programme

• Monitor for drug reactions and hepatotoxicity

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

Indication Dose Duration Notes Evidence Basis

Rheumatoid arthritis (disease-modifying effect) Starting: 100 mg orally once daily; Maintenance: 100 mg orally twice daily; Max: 200 mg/day Long-term OFF-LABEL; Specialist (Rheumatologist) only; Consider in patients refractory to conventional DMARDs Supported by RCTs (MIRA trial and others); used in Indian rheumatology practice

Rosacea (papulopustular) Starting: 50 mg orally once daily; Maintenance: 50–100 mg once daily; Max: 100 mg/day 8–12 weeks OFF-LABEL; Dermatologist supervision Indian dermatology specialist practice; supportive international data

Nocardiosis Starting: 100 mg orally twice daily; Max: 200 mg/day Months; based on clinical response OFF-LABEL; Specialist (ID) only; Combination therapy usual Case series and specialist practice

PAEDIATRIC DOSING (Specialist Only)

⚠️ Not recommended in children below 8 years of age due to risk of permanent tooth discoloration and enamel hypoplasia.

Primary Indications (Approved / Standard in India)

1. Acne Vulgaris (≥12 years)

Weight/Age Starting Dose Titration Maintenance Dose Maximum Dose Duration

≥12 years and ≥45 kg 50 mg orally once daily May increase to twice daily if tolerated 50–100 mg orally twice daily 200 mg/day 6–12 weeks

≥12 years and <45 kg 50 mg orally once daily Not applicable 50 mg orally once or twice daily 100 mg/day 6–12 weeks

1. Skin and Soft Tissue Infections / Respiratory Tract Infections (≥8 years)

Age/Weight Starting Dose Titration Maintenance Dose Maximum Dose Duration

≥8 years 4 mg/kg orally as initial loading dose (max 200 mg) Not applicable 2 mg/kg orally every 12 hours 200 mg/day 5–10 days

Clinical Notes:

• Culture confirmation recommended for MRSA infections

• Monitor for vestibular symptoms (dizziness, vertigo)

• Ensure adequate hydration and upright posture after dosing

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable. No routinely recommended off-label paediatric indications.

Safety Monitoring in Children:

• Monitor for vestibular symptoms (dizziness, vertigo, ataxia)

• Observe for signs of raised intracranial pressure (headache, visual disturbances, papilloedema)

• Periodic dental examination for prolonged courses

• Baseline and periodic LFTs if therapy exceeds 8 weeks

⚠️ Contraindicated in children <8 years unless life-threatening infection with no safer alternative exists, and under specialist supervision only.

50 mL/min No dose adjustment required

30–50 mL/min Use standard dose with caution; monitor for azotemia

<30 mL/min Use with caution; anti-anabolic effect may worsen azotemia; consider alternative agent

End-stage renal disease / Dialysis Avoid if possible; not significantly removed by dialysis; if essential, use reduced dose under specialist supervision

Note: Minocycline is less dependent on renal excretion compared to other tetracyclines, but anti-anabolic effects warrant caution in severe renal impairment.

• Known hypersensitivity to minocycline or any tetracycline antibiotic

• Children <8 years of age (except in life-threatening situations with no alternative)

• Pregnancy (especially 2nd and 3rd trimester)

• Lactation (systemic use)

• Concurrent use with isotretinoin or other systemic retinoids (risk of pseudotumor cerebri)

• Severe hepatic insufficiency

• History of intracranial hypertension or pseudotumor cerebri

• Pre-existing autoimmune conditions (may trigger drug-induced lupus, autoimmune hepatitis, or vasculitis)

• Prolonged use (>12 weeks) — increased risk of pigmentation abnormalities and autoimmune phenomena

• Concurrent hepatotoxic drugs — requires closer LFT monitoring

• Photosensitivity — counsel on sun protection (though less phototoxic than doxycycline)

• Vestibular disorders — minocycline has higher vestibular toxicity than other tetracyclines

• Myasthenia gravis — may exacerbate muscle weakness

• Renal impairment — risk of azotemia due to anti-anabolic effect

• Elderly patients — increased susceptibility to vestibular adverse effects

Parameter Details

Risk category Contraindicated (Category D equivalent)

Fetal risks Permanent tooth discoloration; enamel hypoplasia; inhibition of bone growth; hepatotoxicity (especially 2nd and 3rd trimester)

Preferred alternatives Beta-lactams (amoxicillin, cephalosporins); macrolides (azithromycin, erythromycin) depending on infection type

When it may be used Only in life-threatening infections where no safer alternative exists; requires specialist involvement and documented informed consent

Monitoring Serial fetal growth monitoring; maternal LFTs; neonatal examination for dental/skeletal abnormalities if inadvertent exposure

Parameter Details

Compatible with breastfeeding Not recommended for systemic use

Drug levels in milk Low to moderate; may cause adverse effects in infant

Preferred alternatives Amoxicillin, cephalosporins, erythromycin, or azithromycin depending on indication

Infant monitoring If exposure unavoidable: monitor for gastrointestinal upset, feeding difficulties, oral thrush, and weight gain

Parameter Recommendation

Starting dose 50–100 mg orally once daily

Titration Slow; increase cautiously based on tolerability

Extra risks Increased risk of vestibular side effects (dizziness, vertigo, falls); oesophageal irritation; hepatotoxicity; azotemia in those with reduced renal reserve

Monitoring Baseline and periodic renal function, LFTs; counsel on adequate hydration and upright posture for 30 minutes after dosing

Interacting Drug Effect Recommendation

Isotretinoin / Systemic retinoids Synergistic risk of pseudotumor cerebri (benign intracranial hypertension) Avoid combination absolutely

Warfarin Enhanced anticoagulant effect; bleeding risk Monitor INR closely; may need warfarin dose reduction

Methotrexate Increased methotrexate toxicity (displacement from protein binding) Monitor LFTs, CBC; consider avoiding combination or close specialist oversight

Penicillins Theoretical bacteriostatic-bactericidal antagonism Avoid combination in serious life-threatening infections

Live oral vaccines (Typhoid, Cholera) Reduced vaccine efficacy Avoid during active minocycline therapy; complete course before vaccination

Ergot alkaloids Increased risk of ergotism Avoid combination

Interacting Drug Effect Recommendation

Antacids (aluminium, magnesium, calcium) Chelation reduces minocycline absorption Separate administration by at least 2–3 hours

Iron supplements Reduced minocycline absorption Separate administration by at least 2–3 hours

Calcium and dairy products Reduced absorption Take minocycline 1 hour before or 2 hours after dairy/calcium

Oral contraceptives Potential reduced efficacy (especially with GI disturbance) Advise additional barrier contraception during treatment

Cyclosporine Possible increased nephrotoxicity Monitor renal function

Phenytoin, Carbamazepine, Barbiturates CYP enzyme induction may reduce minocycline half-life Monitor clinical efficacy; may need dose adjustment

Digoxin Increased digoxin levels in some patients (gut flora alteration) Monitor digoxin levels

• Dizziness and vertigo (dose-related; more common with 100 mg twice daily)

• Nausea and vomiting

• Abdominal discomfort

• Headache

• Photosensitivity (less than doxycycline)

• Skin and mucosal pigmentation (with prolonged use)

• Diarrhoea

Adverse Effect Clinical Significance

Drug-induced lupus-like syndrome Presents with arthralgia, myalgia, positive ANA; requires immediate discontinuation

Autoimmune hepatitis Elevated transaminases, jaundice; discontinue and refer for hepatology evaluation

Vasculitis Rare; may present with rash, fever, multi-organ involvement

Pseudotumor cerebri (benign intracranial hypertension) Headache, visual disturbances, papilloedema; discontinue immediately; avoid concurrent retinoids

Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN) Rare; life-threatening; requires immediate discontinuation and hospitalisation

Anaphylaxis / Angioedema Rare; emergency management required

Blue-grey pigmentation Skin, mucosa, teeth, nails, sclera; typically with prolonged use (>12 weeks); may be irreversible

Oesophageal ulceration More common if taken without adequate water or in supine position

⚠️ Immediate discontinuation required for suspected autoimmune reactions, SJS/TEN, pseudotumor cerebri, or severe hypersensitivity.

Phase Parameters

Baseline LFTs; renal function (urea, creatinine); CBC; pregnancy test in women of childbearing age

During therapy (short-term <8 weeks) Clinical monitoring for vestibular symptoms, rash, GI intolerance

During therapy (prolonged >8 weeks) Monthly LFTs; monitor for signs of autoimmune reactions (arthralgia, rash, fever); check for skin/mucosal pigmentation

Long-term Periodic dental examination if therapy extended; watch for pigmentation changes; neurological assessment for vestibular symptoms

Patient counselling Sun protection; adequate hydration; remain upright for 30 minutes after dosing

Single-agent formulations:

• Minoz® (Cipla)

• Minocin® (Pfizer)

• Minoface® (Dr. Reddy's)

• Minaret® (Sun Pharma)

• Cynomycin® (Alembic)

• Divaine® (Ranbaxy/Sun)

FDC with Isotretinoin: NOT RECOMMENDED due to risk of pseudotumor cerebri; avoid use.

• Not under NPPA fixed ceiling price as of 2024

• Available under some state government schemes at reduced cost

• Preferred tetracycline for acne: Better lipid solubility, superior tissue penetration, and less phototoxicity compared to doxycycline; however, higher vestibular side effect profile.

• Vestibular toxicity is distinctive: Dizziness and vertigo are more common with minocycline than other tetracyclines; avoid in patients with balance disorders or those operating machinery.

• Oesophagitis prevention: Counsel patients to take with a full glass of water and remain upright for at least 30 minutes after dosing.

• Limit duration: Avoid continuous use beyond 12 weeks unless clearly indicated and with regular monitoring for autoimmune phenomena and pigmentation.

• Pregnancy confirmation mandatory: Always confirm pregnancy status in reproductive-age females before initiating therapy.

• Autoimmune vigilance: Be alert for drug-induced lupus, hepatitis, or vasculitis during prolonged therapy; discontinue immediately if suspected.

Minocycline; tetracycline; acne vulgaris; MRSA; atypical pneumonia; leprosy; vestibular toxicity; drug-induced lupus; pigmentation; pregnancy-contraindicated; Schedule H India

RxIndia v1.0 — 05 May 2025

• CDSCO Approved Package Inserts

• Indian Pharmacopoeia / National Formulary of India (NFI) 2023

• API Textbook of Medicine

• IADVL Guidelines for Acne Management

• ICMR Essential Medicines Formulary

• National Leprosy Eradication Programme (NLEP) Guidelines

• IAP Guidelines (supportive for paediatric age restrictions)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian dermatology and rheumatology specialist practice (for off-label indications)

• RCTs: MIRA trial (for rheumatoid arthritis off-label use)