Schedule H

Oral, Intramuscular (IM), Intra-articular, Intralesional, Topical, Ophthalmic, Otic

• Tablet: 0.5 mg (as betamethasone)

• Injection: 4 mg/mL (as betamethasone sodium phosphate) in 1 mL ampoule

• Injection: 2 mL ampoule containing betamethasone sodium phosphate 2 mg/mL + betamethasone acetate 5 mg/mL (depot formulation)

• Topical cream/ointment: 0.025% (valerate), 0.05% (dipropionate, valerate)

• Topical lotion: 0.05%, 0.1%

• Eye/Ear drops: 0.1% (as sodium phosphate)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Antenatal Corticosteroid Therapy for Fetal Lung Maturity (Threatened Preterm Birth <34 Weeks)

Intramuscular Route

Step Dose Clinical Notes

Starting dose 12 mg IM First of two doses

Titration Not applicable Fixed regimen

Usual maintenance dose 12 mg IM repeated once after 24 hours Total course: 2 doses (24 mg)

Maximum dose 24 mg total per course Single course preferred; rescue course controversial

Key points:

• Standard of care for threatened preterm delivery between 24–34 weeks gestation

• Optimal benefit if delivery occurs >24 hours and <7 days after first dose

• Reduces neonatal RDS, IVH, NEC, and mortality

• Equally effective as dexamethasone; betamethasone may have slight neurodevelopmental advantage

• Included in MoHFW essential obstetric care protocols

1. Inflammatory Dermatoses (Eczema, Psoriasis, Contact Dermatitis, Lichen Simplex Chronicus)

Topical Route

Formulation Dose Clinical Notes

Betamethasone valerate 0.025% (Moderate potency) Apply thin layer once or twice daily Suitable for face, flexures with caution

Betamethasone valerate 0.1% / dipropionate 0.05% (Potent) Apply thin layer once or twice daily Avoid face, flexures, genitals

Betamethasone dipropionate 0.05% (Very potent with some vehicles) Apply once daily Limit to 2 weeks; avoid thin skin

Duration limits:

• Face/intertriginous areas: Maximum 5–7 days with moderate potency; avoid potent preparations

• Body/limbs: Maximum 2–4 weeks continuous use

• Scalp: Lotion/solution preferred; may use longer under supervision

Key points:

• Match potency to site and severity

• Avoid occlusive dressings unless specifically indicated

• Taper gradually after prolonged use to prevent rebound

1. Intra-articular/Intralesional Injection (Joint Inflammation, Bursitis, Tendinitis, Keloids)

Intra-articular/Intralesional Route

Site Dose Clinical Notes

Large joints (knee, hip, shoulder) 4–8 mg (1–2 mL of 4 mg/mL) Use depot formulation for sustained effect

Medium joints (elbow, wrist, ankle) 2–4 mg

Small joints (MCP, IP) 0.5–1 mg

Tendon sheaths/Bursae 1–4 mg Avoid injection into tendon substance

Keloids/Hypertrophic scars 0.5–2 mg per cm² Intralesional; may repeat every 4–6 weeks

Key points:

• Strict aseptic technique essential

• Maximum 3–4 injections per joint per year

• Allow minimum 3–4 weeks between injections to same site

• Avoid weight-bearing for 24–48 hours after large joint injection

1. Systemic Inflammatory/Allergic Conditions (Acute Severe Allergies, Asthma Exacerbation Unable to Take Oral)

Intramuscular Route

Step Dose Clinical Notes

Starting dose 4–8 mg IM as single dose For acute allergic reactions, severe urticaria

Titration Not applicable Single dose or short course

Usual maintenance dose Not recommended — switch to oral prednisolone for maintenance

Maximum dose 8 mg per dose; 12 mg/day Depot formulation provides 1–3 weeks effect

Key points:

• Not for long-term systemic use — prednisolone preferred

• IM depot injection useful when oral administration not feasible

• Consider oral corticosteroid switch as soon as possible

1. Ophthalmic/Otic Inflammatory Conditions

Eye Drops (0.1%)

• Post-operative inflammation: 1–2 drops every 4–6 hours; taper over 2–4 weeks

• Anterior uveitis: 1–2 drops every 1–2 hours initially; taper based on response

• Allergic conjunctivitis: 1–2 drops 2–4 times daily for 1–2 weeks

Ear Drops (0.1%)

• Otitis externa: 2–3 drops 3–4 times daily for 7–10 days

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Inflammatory Dermatoses (Eczema, Contact Dermatitis)

Topical Route — Age-Based

Age Formulation Application Duration

1–12 years Betamethasone valerate 0.025% (moderate potency) Thin layer once or twice daily Maximum 7–14 days

12 years May use 0.05% dipropionate on body/limbs Once or twice daily Maximum 2–3 weeks

Key points:

• Avoid potent preparations in children <12 years

• Never use on face, genitals, or flexures in children except under specialist guidance

• Higher surface area:volume ratio increases systemic absorption risk

• Monitor growth with prolonged or widespread use

1. Acute Asthma Exacerbation (When Oral Not Feasible)

Intramuscular Route — Weight-Based

Step Dose Clinical Notes

Starting dose 0.05–0.1 mg/kg IM (max 4–6 mg) Alternative to oral prednisolone in vomiting child

Titration Not applicable Single dose

Usual maintenance dose Switch to oral prednisolone

Maximum dose 6 mg single dose

1. Antenatal Corticosteroids (Administered to Mother)

Administer standard adult dosing (12 mg IM × 2 doses 24 hours apart) to pregnant mother for fetal benefit.

Secondary Indications — Paediatrics (Off-label)

Indication Dose Notes

Infantile Haemangioma (alternative to propranolol) Topical 0.05% or intralesional 0.5–1 mg OFF-LABEL; Paediatric dermatology specialist only; Evidence: Limited case series; propranolol preferred

Minimum age: Not recommended below 1 year of age for topical use except under paediatric dermatologist supervision. Systemic use in infants only under specialist care.

Safety monitoring:

• Growth velocity with prolonged use

• Signs of HPA axis suppression

• Skin atrophy with topical use

• Blood glucose if systemic

Notes:

• Corticosteroids are not significantly renally excreted

• Safe in haemodialysis and peritoneal dialysis patients

• Monitor for fluid retention in patients with concurrent renal disease

Note: Corticosteroids are hepatically metabolised; reduced clearance in severe liver disease

• Known hypersensitivity to betamethasone or any formulation component

• Systemic fungal infections (for systemic use)

• Cerebral malaria (high-dose systemic steroids worsen outcome)

• Intrathecal/epidural administration (not approved; neurotoxicity risk)

• Live vaccine administration (for patients on immunosuppressive systemic doses)

• Untreated serious bacterial, viral, or fungal infections (unless life-saving anti-inflammatory effect needed)

• Herpes simplex keratitis (for ophthalmic use)

• Fungal or viral skin infections at application site (for topical use)

• Diabetes mellitus — may worsen glycaemic control; monitor glucose

• Hypertension — sodium and fluid retention

• Congestive heart failure — may exacerbate fluid overload

• Peptic ulcer disease or history of GI bleeding

• Tuberculosis (latent or active) — may reactivate; screen before prolonged use

• Osteoporosis — increased fracture risk with prolonged use

• Glaucoma or family history — monitor IOP with ocular/prolonged systemic use

• Psychiatric history — may precipitate mood disorders, psychosis

• Immunocompromised patients — increased infection risk

• Myasthenia gravis — may worsen initially

• Children — growth suppression with prolonged topical or systemic use

• Hypothyroidism — enhanced steroid effect

• Recent intestinal anastomosis — impaired healing

Parameter Recommendation

Safety category Compatible when indicated; extensive safety data for antenatal use

Preferred alternatives Betamethasone IS the preferred agent for antenatal fetal lung maturity; for other indications, use lowest effective dose of any appropriate corticosteroid

When it may be used Antenatal corticosteroids (24–34 weeks threatened preterm birth); other inflammatory conditions when benefit outweighs risk

Monitoring Maternal: Blood glucose (especially in GDM); Fetal: Growth surveillance with repeated courses

Notes:

• Standard of care for fetal lung maturation in preterm birth

• Topical use: Prefer low-moderate potency; limit area and duration

• Repeated antenatal courses associated with reduced fetal growth — avoid unless clearly indicated

• Single course does not appear to affect long-term child development

Parameter Recommendation

Compatibility Compatible with breastfeeding for short-term systemic or topical use

Drug levels in milk Low (infant receives <1% of maternal weight-adjusted dose with usual systemic doses)

Preferred alternatives Not required — betamethasone is acceptable; for prolonged high-dose systemic use, consider prednisolone

Infant monitoring Observe for poor weight gain, feeding difficulties; signs of adrenal suppression with prolonged high-dose maternal use (rare)

Topical use: Compatible; avoid application to nipples/areola before breastfeeding

• Recommended starting dose: Use lowest effective dose for all routes

• Titration: Slower titration; more cautious approach

• Additional risks:

• Increased susceptibility to glucose intolerance and diabetes

• Higher risk of osteoporosis and fractures — consider bone protection

• Skin fragility with topical use — easier skin atrophy

• Fluid retention — may worsen hypertension and heart failure

• Increased infection risk

• Neuropsychiatric effects (confusion, delirium) more common

• Delayed wound healing

• Recommendation: Avoid prolonged systemic use unless strongly indicated; monitor closely

Drug Interaction Management

Live vaccines (BCG, MMR, varicella, oral polio, yellow fever) Reduced vaccine efficacy; risk of disseminated infection AVOID live vaccines during and for 1 month after immunosuppressive steroid doses

Rifampicin Potent CYP3A4 inducer → markedly reduced betamethasone levels (50–70% reduction) May need 2–3 fold increase in corticosteroid dose; consider alternative anti-TB regimen if possible

Phenytoin/Phenobarbital/Carbamazepine CYP3A4 induction → reduced corticosteroid effect May need increased corticosteroid dose; monitor clinical response

Fluoroquinolones (especially in elderly) Additive risk of tendon rupture Avoid combination if possible; if essential, warn patient about tendon symptoms

Cyclosporine Mutual inhibition of metabolism → increased levels of both drugs Monitor for toxicity of both; may need dose reduction

Ritonavir and other strong CYP3A4 inhibitors Markedly increased corticosteroid exposure → Cushing's syndrome, adrenal suppression AVOID combination with systemic betamethasone if possible; if essential, use lowest dose and monitor closely

Drug Interaction Management

NSAIDs Additive risk of GI ulceration and bleeding Use with caution; consider PPI prophylaxis

Potassium-wasting diuretics (furosemide, thiazides) Additive hypokalaemia Monitor potassium; supplement if needed

Insulin/Oral hypoglycaemics Corticosteroid-induced hyperglycaemia reduces efficacy Monitor glucose; may need to increase antidiabetic dose

Warfarin Variable effect on INR (usually increased) Monitor INR more frequently when starting/stopping steroids

Digoxin Hypokalaemia from steroids increases digoxin toxicity risk Monitor potassium and digoxin levels

Antihypertensives Corticosteroid-induced fluid retention may reduce efficacy Monitor BP; may need antihypertensive dose adjustment

Isoniazid Reduced isoniazid levels Monitor for TB treatment efficacy

Systemic (with prolonged use):

• Weight gain and fluid retention

• Hyperglycaemia

• Mood changes (euphoria, irritability, insomnia)

• Acne and hirsutism

• Increased appetite

• Easy bruising

• Muscle weakness

Topical:

• Skin thinning (atrophy)

• Telangiectasia

• Striae (stretch marks)

• Burning/stinging at application site

• Contact dermatitis (rare)

• Hypertrichosis

Ophthalmic:

• Burning/stinging

• Blurred vision (transient)

Reaction Action Required

Adrenal suppression/crisis (after sudden withdrawal) Do not stop abruptly after prolonged use; taper gradually; hydrocortisone replacement if crisis

Cushing's syndrome (iatrogenic) Taper and discontinue; may take months to resolve

Severe infections (masked presentation) High index of suspicion; investigate promptly; treat aggressively

Osteoporotic fractures Bone protection during prolonged use; DEXA monitoring

Avascular necrosis (hip, knee, shoulder) Discontinue if possible; orthopaedic referral

Posterior subcapsular cataract Ophthalmology referral; usually irreversible

Steroid-induced glaucoma Monitor IOP; ophthalmology referral

Psychosis/severe mood disturbance Reduce dose or discontinue; psychiatric evaluation

Perioral dermatitis / Steroid rosacea (topical) Discontinue topical steroid; treat with appropriate non-steroidal therapy

Steroid-induced diabetes Glucose monitoring; antidiabetic treatment as needed

Growth suppression (children) Monitor growth velocity; use lowest effective dose/duration

Short-term systemic use (<2 weeks) Blood pressure; glucose (in diabetics or high risk)

Long-term systemic use (>4 weeks) Blood pressure; glucose every 1–3 months; serum potassium; DEXA scan (baseline and annually if high-dose); ophthalmology review annually (cataract, glaucoma)

Topical use (prolonged/widespread) Skin examination for atrophy, striae; growth monitoring in children; morning cortisol if adrenal suppression suspected

Ophthalmic use (>2 weeks) Intraocular pressure; lens examination

Systemic (Oral/Injection):

• Betnesol (GSK/Glaxo) — tablets, injection

• Celestone (MSD — limited availability)

• Betamethasone IP (generic — multiple manufacturers)

Topical:

• Betnovate (GSK) — cream, ointment, lotion, scalp application

• Diprobate (Sun Pharma) — cream, ointment

• Betaderm (various manufacturers)

Ophthalmic/Otic:

• Betnesol-N (GSK) — eye/ear drops (with neomycin)

• Betamethasone eye drops (generic)

Common FDCs (Topical):

NLEM status: Betamethasone injection 4 mg/mL is included in NLEM 2022 (for antenatal use) — ceiling price applicable under NPPA

Government supply: Available through maternal health programmes for antenatal corticosteroid use

• Antenatal steroids save lives: Single course of betamethasone 12 mg IM × 2 doses (24 hours apart) significantly reduces neonatal morbidity and mortality in preterm birth — ensure availability in all obstetric units

• Match topical potency to site: Use mild-moderate potency for face, flexures, children; reserve potent preparations for thick skin (palms, soles) or severe disease elsewhere

• Avoid topical steroid combinations indiscriminately: FDCs with antifungals/antibiotics are grossly overused in India; use only when mixed infection confirmed

• Taper after prolonged use: Systemic corticosteroids for >2–3 weeks require gradual tapering to prevent adrenal crisis

• TB screening in India: Always screen for latent TB (Mantoux/IGRA) before initiating prolonged systemic corticosteroids in our high-burden setting

• Not interchangeable depot formulations: Betamethasone sodium phosphate is rapid-acting; acetate is depot — combination preparations provide both immediate and sustained effect

betamethasone; corticosteroid; antenatal steroids; fetal lung maturity; topical steroid; glucocorticoid; preterm birth; dermatology; intra-articular injection; 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)

• MoHFW Guidelines on Skilled Birth Attendance and Essential Obstetric Care

• FOGSI Good Clinical Practice Recommendations — Preterm Birth Management

• IADVL (Indian Association of Dermatologists, Venereologists and Leprologists) Guidelines on Topical Corticosteroids

• AIIMS Formulary

• API Textbook of Medicine (11th Edition)

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