Medicine Information

Betason-N

Name: Betason-N
Brand: Betason-N
Rating: 4.5 (117 reviews)

OintmentBetamethasone 0.1% w/w + Neomycin 0.5% w/wTopical Corticosteroid with AntibioticATC: D07BC01

Generic Name

Betamethasone Valerate + Neomycin Sulfate

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
betason n 01 05 ointment	৳ 18.00	N/A

Description

Overview of the medicine

Betason-N ointment is a combination topical medication containing a potent corticosteroid (Betamethasone Valerate) and an aminoglycoside antibiotic (Neomycin Sulfate). It is used to treat inflammatory skin conditions like eczema and dermatitis where bacterial infection is present or likely.

Uses & Indications

Eczema (atopic, infantile, discoid)

Psoriasis (excluding widespread plaque psoriasis)

Neurodermatitis

Seborrhoeic dermatitis

Contact sensitivity reactions

Lichen simplex chronicus

Where secondary bacterial infection is present or likely in these conditions.

Dosage

Adults

Apply a thin film to the affected skin area once or twice daily. Do not exceed 7 days of continuous treatment without medical review. Do not apply to large areas of skin.

Elderly

No specific dosage adjustment required, but caution is advised due to potential for thinner skin and increased absorption.

Renal_impairment

No specific dosage adjustment for topical use; however, prolonged use over large areas in patients with renal impairment should be avoided due to potential for systemic neomycin absorption.

How to Take

For external use only. Wash hands before and after application. Apply a thin layer to the affected area and rub gently. Avoid contact with eyes, mouth, and other mucous membranes. Do not cover the treated area with occlusive dressings unless advised by a doctor.

Mechanism of Action

Betamethasone, a corticosteroid, acts by inhibiting the release of mediators involved in inflammatory and allergic responses. Neomycin, an aminoglycoside antibiotic, inhibits bacterial protein synthesis by irreversibly binding to the 30S ribosomal subunit, leading to bacterial cell death.

Pharmacokinetics

Onset

Anti-inflammatory and antibiotic effects typically observed within hours to days of topical application.

Excretion

Primarily excreted renally if systemically absorbed; most topical drug remains at the site of application or is shed with skin cells.

Half life

Not well established for topical use due to minimal systemic absorption. Systemically absorbed Betamethasone has a biological half-life of 36-54 hours; Neomycin's half-life is around 2-3 hours systemically.

Absorption

Minimal systemic absorption through intact skin; absorption increases with skin damage, occlusion, or application to large areas. Neomycin absorption is also minimal but can be significant if applied to large areas of compromised skin.

Metabolism

Systemically absorbed Betamethasone is extensively metabolized in the liver; Neomycin is minimally metabolized.

Side Effects

Contraindications

Hypersensitivity to Betamethasone, Neomycin, or any component of the formulation.
Primary cutaneous viral infections (e.g., herpes simplex, varicella).
Primary bacterial infections (e.g., impetigo) without a corticosteroid indication.
Primary fungal infections.
Acne vulgaris, rosacea, perioral dermatitis.
Application to the ear canal if eardrum is perforated (due to neomycin ototoxicity risk).
Infections caused by neomycin-resistant organisms.

Drug Interactions

Systemic Aminoglycosides (e.g., Gentamicin, Amikacin)

Although systemic absorption of topical neomycin is minimal, caution is advised if patients are receiving concurrent systemic aminoglycosides due to potential for additive ototoxicity or nephrotoxicity, especially with large-area application or impaired skin barrier.

Storage

Store below 25°C in a dry place, protected from light. Do not freeze. Keep out of reach of children.

Overdose

Topical overdose is unlikely to cause acute systemic effects. Chronic overdose or misuse (e.g., applying to large areas, prolonged use, under occlusion) may lead to systemic corticosteroid effects (e.g., HPA axis suppression, Cushing's syndrome) or systemic neomycin effects (ototoxicity, nephrotoxicity).

Pregnancy & Lactation

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts or prolonged use. Lactation: Use with caution. Do not apply to the breast area to avoid accidental ingestion by the infant. Consult a doctor before use.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

5 gm tube10 gm tube15 gm tube

Shelf Life

Usually 24-36 months from the date of manufacture, specific to manufacturer.

Availability

Pharmacies, drugstores

Approval Status

Approved by DGDA (Bangladesh Drug Administration)

Patent Status

Generic available, likely off-patent

Clinical Trials

Numerous clinical trials have established the efficacy and safety of topical corticosteroids and topical aminoglycosides, both individually and in combination, for various dermatological conditions with secondary infection.

Lab Monitoring

No routine lab monitoring required for short-term topical use. For prolonged or extensive use, especially in children, monitoring for HPA axis suppression (e.g., plasma cortisol levels) may be considered. Renal function and audiometry may be considered if significant systemic neomycin absorption is suspected.

Doctor Notes

Advise patients on appropriate application technique and duration.
Emphasize not to exceed the prescribed duration, especially on the face or in children.
Be aware of potential for systemic absorption, particularly with large surface areas, prolonged use, or occlusive dressings.
Monitor for signs of secondary infection or worsening of condition.

Patient Guidelines

Use exactly as prescribed by your doctor.
Do not use for longer than the prescribed duration (usually not more than 7 days for this combination).
Avoid applying to the face, groin, or underarms unless specifically directed by your doctor.
Do not use on open wounds or broken skin.
Inform your doctor if your condition does not improve or worsens after a few days.

Missed Dose Advice

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.