BETADERM 0.1/GM TOPICAL OINTMENT 20G

Indications

Approved Uses

Relief of inflammatory and pruritic manifestations of corticosteroid‑responsive dermatoses (e.g., eczema/dermatitis including atopic and contact dermatitis, and psoriasis excluding widespread plaque psoriasis).

Dosage & Administration

Dosing by Condition

Apply a thin layer to affected areas once or twice daily; reduce frequency (e.g., once daily or less) as control is achieved; avoid prolonged continuous use, especially on face/flexures or under occlusion.

Initial Dose

Apply a thin layer to the affected area once or twice daily

Maintenance Dose

Apply once daily, or intermittently (once a day, twice a week) to prevent relapse.

Maximum Dose

Use should be limited to the least amount compatible with an effective therapeutic regimen, especially for long-term use. Maximum weekly dose recommendations for some forms are 50g.

Children's Dosage

Use with caution in children; apply sparingly once daily for the shortest duration possible; avoid use in children under 1 year; in children, the skin surface area to body mass ratio is higher, increasing risk of systemic absorption

Dose Adjustment Notes

No renal/hepatic dose adjustment is routinely required for topical betamethasone valerate; minimize systemic absorption by using the smallest amount for the shortest duration, avoiding large areas, prolonged use, face/flexures, and occlusion, and taper frequency once controlled.

How to Take

For topical use only: apply a thin layer to clean, dry affected skin and rub in gently; wash hands before and after use (unless treating the hands); avoid eyes, mouth and other mucous membranes; do not use under occlusive dressings/bandages unless directed by a prescriber.

Side Effects

Common Side Effects

Common local effects: burning/stinging, itching/irritation, dryness, erythema; with continued use: skin atrophy, striae, telangiectasia, folliculitis/acneiform eruptions, hypopigmentation, hypertrichosis, and secondary infection.

Side Effect Frequency

Frequency varies by reference; commonly reported local effects include burning/stinging, pruritus, irritation, and dryness; less common/uncommon include folliculitis, acneiform eruptions, hypopigmentation, hypertrichosis; rare/very rare include skin atrophy, striae, telangiectasia, allergic contact dermatitis, and systemic effects (HPA-axis suppression/Cushingoid features) with prolonged/large-area/occlusive use.

Safety & Warnings

Contraindications

Contraindicated: hypersensitivity to betamethasone valerate/excipients; untreated cutaneous infections (bacterial, fungal, viral) and primary viral lesions (e.g., herpes simplex, varicella); rosacea; acne vulgaris; perioral dermatitis; pruritus ani/genital pruritus; use in infants <1 year is generally avoided (not a strict contraindication in all references).

Warnings & Precautions

External use only; avoid eyes/mucosa and periocular use; avoid prolonged use, large areas, broken skin, and occlusion unless directed; do not use on face/intertriginous areas for extended periods; monitor for infection and stop/add antimicrobials if infection occurs; use lowest effective potency/shortest duration and taper after prolonged use; caution in diabetes and in children due to higher absorption.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant interactions are uncommon, but additive systemic corticosteroid effects can occur with concurrent systemic/topical steroids; occlusive dressings markedly increase absorption; strong CYP3A4 inhibitors (e.g., ritonavir/cobicistat, itraconazole) may increase systemic steroid effects if absorption is substantial.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Use with caution in children; apply sparingly once daily for the shortest duration possible; avoid use in children under 1 year; in children, the skin surface area to body mass ratio is higher, increasing risk of systemic absorption

Elderly

Use with caution; elderly patients have thinner, more fragile skin with increased risk of atrophy and systemic absorption; use minimum effective dose and duration

Kidney Impairment

No routine dose adjustment for topical use; use caution in severe renal impairment only if significant systemic absorption is expected (large areas/prolonged/occlusion).

Storage & Patient Advice

Missed Dose

Apply when remembered; if it is close to the next scheduled application, skip the missed dose and resume the regular schedule; do not apply extra to make up for a missed dose.

Overdose

Acute topical overdose is unlikely; chronic excessive use can cause local atrophy/striae and systemic hypercortisolism (HPA-axis suppression/Cushingoid features). Management: stop or taper depending on duration, treat symptoms, and consider adrenal function assessment if prolonged/high-dose exposure; accidental ingestion warrants medical assessment/supportive care.

Patient Counseling

Use only as prescribed: apply a thin layer to affected skin once or twice daily; wash hands after use (unless treating hands); avoid eyes/mucosa and broken skin unless directed; do not cover with airtight dressings/diapers unless instructed; use the smallest amount for the shortest time and stop/taper when controlled; seek medical advice if no improvement in ~1-2 weeks, if worsening, or if signs of infection occur; avoid prolonged use on face, groin, or skin folds.

Monitoring Requirements

Monitor clinical response and local adverse effects (atrophy, striae, telangiectasia, acne/folliculitis, hypopigmentation) and signs of secondary infection; if prolonged use, large surface area, pediatric use, or occlusion, consider monitoring for HPA-axis suppression (e.g., symptoms and/or cortisol testing if clinically indicated).

Pharmacology

Mechanism of Action

A topical glucocorticoid that binds intracellular glucocorticoid receptors to alter gene transcription, inducing anti‑inflammatory proteins (e.g., lipocortins inhibiting phospholipase A2) and suppressing pro‑inflammatory cytokines, leading to reduced inflammation, pruritus, and vasoconstriction.

Duration of Effect

Not precisely defined; clinical effect is maintained with regular once‑ or twice‑daily application rather than a single-dose duration claim.

Half-Life

Not well-defined for topical betamethasone valerate; if systemically absorbed, betamethasone has a plasma half-life of ~5-6 hours (biologic effect duration is longer).

Bioavailability

Percutaneous absorption is variable and generally low through intact skin, but increases with inflammation/broken skin, application to thin skin (e.g., face/groin), large surface area, prolonged use, and occlusion.

Metabolism

Betamethasone valerate is hydrolyzed in the skin to active betamethasone; any absorbed drug is primarily metabolized in the liver.

Excretion

After systemic absorption, corticosteroids are mainly metabolized and then excreted in urine (renal) as metabolites; a smaller fraction may be excreted in bile/feces.

Protein Binding

Systemically absorbed betamethasone is bound to plasma proteins (albumin and corticosteroid-binding globulin) to a moderate degree; a precise % is not consistently specified for this topical product.

Product Information

Available Dosage Forms

Ointment (this product: BETADERM betamethasone valerate 0.1% topical ointment, 20 g tube).

Composition per Dose

Each gram of ointment: 1 mg betamethasone (as betamethasone valerate 1.22 mg) equivalent to 0.1% w/w betamethasone valerate

Generic Availability

Yes

Skin Condition

Eczema, Psoriasis, Dermatitis

Steroid Potency

Potent

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