Schedule H

Oral

• Capsules: 10 mg, 25 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Severe Psoriasis (Pustular, Erythrodermic, or Extensive Plaque Psoriasis)

Adults:

Parameter Dose

Starting dose 25–30 mg orally once daily with food

Titration Adjust after 2–4 weeks based on clinical response and tolerability

Usual maintenance dose 25 mg once daily (may reduce to 10–25 mg/day for long-term maintenance)

Maximum dose 50 mg/day

Clinical notes: Often combined with topical therapies or phototherapy for synergistic effect. Avoid concurrent methotrexate due to additive hepatotoxicity. Response assessment typically at 8–12 weeks.

1. Disorders of Keratinisation (e.g., Congenital Ichthyosis, Darier's Disease)

Adults — Specialist dermatology use only:

Parameter Dose

Starting dose 10–25 mg orally once daily with food

Titration Adjust every 2–4 weeks based on skin response and tolerability

Usual maintenance dose Lowest effective dose (often 10 mg daily or alternate day)

Maximum dose 50 mg/day

Clinical notes: Chronic use requires specialist oversight due to cumulative toxicity risk. Long-term monitoring for skeletal and hepatic effects essential.

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Chemoprevention of non-melanoma skin cancer (high-risk patients, e.g., transplant recipients) 10–25 mg/day Long-term OFF-LABEL; Specialist only; Regular dermatological and hepatic monitoring required RCT/meta-analysis in transplant dermatology; not standard practice in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Severe Refractory Keratinisation Disorders (e.g., Lamellar Ichthyosis)

Age ≥12 years — Paediatric dermatologist supervision only:

Parameter Dose

Starting dose 0.5 mg/kg/day orally (may divide into two doses)

Titration Adjust every 2–4 weeks based on response and tolerability

Usual maintenance dose Lowest effective dose

Maximum dose 1 mg/kg/day (not exceeding 35 mg/day in most cases)

Safety monitoring:

• Growth parameters every 3–6 months

• Bone development assessment with prolonged use (consider skeletal radiography)

• Liver enzymes every 4–8 weeks initially, then every 3 months

• Fasting lipid profile every 3 months

Secondary Indications — Paediatrics (Off-label)

Indication Dose Notes Evidence Basis

Severe Refractory Pustular Psoriasis 0.3–0.5 mg/kg/day orally OFF-LABEL; Specialist only; Use only in severe, refractory cases Limited paediatric data; extrapolated from adult studies

Age restriction: Not recommended below 12 years of age except under strict paediatric dermatologist supervision with documented severe disease and no alternatives.

Severity Recommendation

Mild to moderate impairment No specific dose reduction; use with caution

Severe impairment Initiate at minimum effective dose (10 mg/day); monitor closely

Dialysis Not significantly removed by dialysis; use with caution

• Pregnancy or women planning pregnancy (highly teratogenic)

• Women of childbearing potential not using effective contraception

• Severe hepatic impairment

• Severe renal impairment (unmonitored)

• Chronic abnormally elevated lipid levels uncontrolled by treatment

• Concurrent use with methotrexate

• Concurrent use with tetracyclines (risk of pseudotumour cerebri)

• Hypersensitivity to acitretin, other retinoids, or excipients

• Blood donation during and for 3 years after treatment

• Diabetes mellitus (may impair glucose tolerance)

• Alcohol consumption (increases etretinate formation, prolongs teratogenic risk)

• History of depression or psychiatric disorders

• Pre-existing bone abnormalities or osteoporosis risk factors

• Pre-existing hyperlipidaemia

• Contact lens wearers (dry eye risk)

• History of pancreatitis

• Concurrent phototherapy (increased photosensitivity)

Parameter Recommendation

Risk category Category X — Absolutely contraindicated

Overall safety Highly teratogenic; causes severe fetal malformations (craniofacial, cardiac, CNS, thymic)

Contraception requirements Effective contraception mandatory: 1 month before, throughout treatment, and for 3 YEARS after discontinuation

Preferred alternatives Cyclosporine, biologics (certolizumab), or phototherapy in women of childbearing potential

What to monitor Pregnancy test before initiation, monthly during treatment, and periodically for 3 years post-treatment

Parameter Recommendation

Compatibility Contraindicated during breastfeeding

Drug levels in milk Low to moderate; however, due to long half-life and teratogenic potential, breastfeeding must be avoided

Preferred alternatives Phototherapy, topical therapies

Resumption of breastfeeding Only several weeks after complete drug discontinuation; consult specialist

• Starting dose: 10–25 mg/day (start at lower end)

• Titration: Slower titration preferred; assess response at 4-week intervals

• Extra risks: Increased susceptibility to mucocutaneous adverse effects; reduced hepatic and renal reserve; monitor lipid profile and LFTs more frequently; assess bone health if prolonged use anticipated

Drug/Class Interaction Recommendation

Methotrexate Additive hepatotoxicity; increased risk of liver damage Avoid combination

Tetracyclines (doxycycline, minocycline) Risk of pseudotumour cerebri (benign intracranial hypertension) Avoid combination

Alcohol Leads to re-esterification to etretinate (very long half-life >120 days); prolongs teratogenic risk Absolute avoidance during and 2 months after treatment

Vitamin A supplements Additive hypervitaminosis A toxicity Avoid concurrent use

Progestogen-only contraceptives (minipills) Reduced contraceptive efficacy Combine with barrier method; prefer combined oral contraceptives

Drug/Class Interaction Recommendation

Statins and fibrates May be required to manage acitretin-induced hyperlipidaemia Monitor lipids; adjust lipid-lowering therapy as needed

Phenytoin Potential altered metabolism; protein binding displacement Monitor phenytoin levels

Warfarin Potential effect on vitamin K metabolism Monitor INR closely

Glibenclamide May alter glucose tolerance Monitor blood glucose

Ciclosporin Increased ciclosporin levels reported Monitor ciclosporin levels if used concurrently

• Cheilitis (very common; dose-related)

• Dry skin and mucous membranes

• Skin peeling and pruritus

• Hair thinning or alopecia

• Nail fragility and changes

• Dry eyes, conjunctivitis

• Epistaxis

• Arthralgia, myalgia

• Elevated triglycerides and cholesterol

• Transient elevation of liver enzymes

• Hepatotoxicity — persistent LFT elevation requires dose reduction or discontinuation

• Pancreatitis — secondary to severe hypertriglyceridaemia; discontinue immediately

• Pseudotumour cerebri (benign intracranial hypertension) — especially with tetracyclines; requires immediate discontinuation

• Skeletal abnormalities with chronic use — hyperostosis, premature epiphyseal closure (paediatric), calcification of ligaments

• Severe depression, mood disturbances — monitor and discontinue if significant

• Teratogenicity — severe fetal malformations; effects persist for 3 years post-discontinuation

Phase Parameters

Baseline Pregnancy test (women of childbearing potential); LFTs; Fasting lipid profile; CBC; Renal function; Blood glucose (diabetics)

After initiation LFTs and fasting lipids every 2–4 weeks for first 2 months; Pregnancy test monthly (women)

Long-term LFTs and lipids every 3 months; Bone density assessment if treatment >6 months; Ophthalmological examination if visual symptoms; Growth monitoring in children; Monthly pregnancy tests throughout and for 3 years after stopping

• Acrotac® (Cipla)

• Novoret® (Sun Pharma)

• Acetin® (Dr. Reddy's)

• Sorvate® (Abbott)

• Tretiva-A® (Intas)

Note: Not included in NLEM; not under NPPA price control. Available in AIIMS Essential Medicines List for select dermatological indications.

• Pregnancy prevention is paramount — counsel all women of reproductive age extensively; document contraception counselling

• Absolute alcohol avoidance is critical — alcohol converts acitretin to etretinate (half-life >120 days), extending teratogenic risk for years

• Start with lowest effective dose to minimise mucocutaneous side effects; cheilitis is often the dose-limiting adverse effect

• Pre-existing hyperlipidaemia should be optimised before initiation; statins may be required during therapy

• Avoid concurrent tetracyclines (pseudotumour cerebri risk) and vitamin A supplements

• Combination with topical therapies or narrowband UVB phototherapy often allows lower acitretin doses with better efficacy

acitretin; psoriasis; retinoid; keratinisation disorders; ichthyosis; teratogenic; hepatotoxicity; hyperlipidaemia; dermatology; pregnancy-contraindicated; NLEM-excluded

RxIndia v1.0 — 27 Apr 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• AIIMS Dermatology drug list

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (Retinoid chapter)

• Indian Journal of Dermatology, Venereology and Leprology (retinoid guidelines)

• RCT/meta-analysis (for off-label chemoprevention in transplant patients — marked accordingly)