Aristobet-N
Generic Name
Betamethasone Valerate and Neomycin Sulfate Cream
Manufacturer
Aristopharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| aristobet n 01 05 cream | ৳ 28.00 | N/A |
Description
Overview of the medicine
Aristobet-N cream 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 such as eczema, dermatitis, and psoriasis where bacterial infection is present or likely.
Uses & Indications
Dosage
Adults
Apply a thin film to the affected skin area 2-3 times daily until improvement occurs, then reduce frequency to once daily or less. Treatment should not exceed 7 days without medical review.
Elderly
No specific dosage adjustment is generally required, but use with caution due to potential for skin thinning and increased systemic absorption, especially with co-morbidities.
Renal_impairment
Use with caution. Although systemic absorption is minimal, prolonged use or application to large areas/damaged skin might lead to increased systemic levels of neomycin, which is primarily renally excreted. Monitor renal function if concerns arise.
How to Take
For external use only. Apply a thin layer of cream to the affected skin area and gently rub it in. Do not apply to open wounds, eyes, mouth, or mucous membranes. Wash hands before and after application. Do not cover the treated area with occlusive dressings unless specifically advised by a doctor.
Mechanism of Action
Betamethasone Valerate acts as a potent corticosteroid, suppressing inflammatory and allergic responses by inhibiting the release of inflammatory mediators. Neomycin Sulfate is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, leading to bacterial cell death.
Pharmacokinetics
Onset
Anti-inflammatory effects typically begin within a few hours. Antibacterial effects develop as susceptible bacteria are killed over time.
Excretion
Systemically absorbed Betamethasone and its metabolites are mainly excreted via the kidneys. Unabsorbed Neomycin is excreted unchanged in the feces.
Half life
Not well-established for topical application due to minimal systemic absorption; systemically absorbed corticosteroids are metabolized and excreted relatively quickly.
Absorption
Systemic absorption of Betamethasone is minimal when applied topically, but can increase with occlusive dressings, prolonged use, or on damaged skin. Neomycin absorption is also minimal from intact skin but increases significantly from damaged or inflamed skin.
Metabolism
Absorbed Betamethasone is primarily metabolized in the liver to inactive metabolites. Neomycin, if absorbed, is not significantly metabolized in the body.
Side Effects
Contraindications
- Hypersensitivity to betamethasone, neomycin, other corticosteroids, aminoglycosides, or any excipients.
- Viral infections of the skin (e.g., herpes simplex, varicella).
- Fungal or yeast infections of the skin.
- Tuberculosis of the skin.
- Acne vulgaris, rosacea, perioral dermatitis.
- Ulcerated lesions or significant skin atrophy.
Drug Interactions
Systemic Aminoglycosides
Although systemic absorption of neomycin from topical application is usually low, concurrent use with systemic aminoglycosides may theoretically increase the risk of ototoxicity and nephrotoxicity, especially on large or damaged skin areas.
Systemic Corticosteroids
Concurrent use of other systemic or topical corticosteroids may increase the risk of systemic side effects.
Curariform Muscle Relaxants
Systemically absorbed neomycin can enhance the effect of curariform muscle relaxants.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Topical overdose is unlikely to cause acute systemic effects. However, prolonged or excessive use, especially on large skin areas or under occlusive dressings, may lead to systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) or neomycin-induced ototoxicity and nephrotoxicity. Treatment is symptomatic and supportive. Discontinue the cream gradually if systemic effects occur.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus or infant. Corticosteroids can be absorbed systemically, and neomycin has potential for ototoxicity. Consult a doctor before use.
Side Effects
Contraindications
- Hypersensitivity to betamethasone, neomycin, other corticosteroids, aminoglycosides, or any excipients.
- Viral infections of the skin (e.g., herpes simplex, varicella).
- Fungal or yeast infections of the skin.
- Tuberculosis of the skin.
- Acne vulgaris, rosacea, perioral dermatitis.
- Ulcerated lesions or significant skin atrophy.
Drug Interactions
Systemic Aminoglycosides
Although systemic absorption of neomycin from topical application is usually low, concurrent use with systemic aminoglycosides may theoretically increase the risk of ototoxicity and nephrotoxicity, especially on large or damaged skin areas.
Systemic Corticosteroids
Concurrent use of other systemic or topical corticosteroids may increase the risk of systemic side effects.
Curariform Muscle Relaxants
Systemically absorbed neomycin can enhance the effect of curariform muscle relaxants.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Topical overdose is unlikely to cause acute systemic effects. However, prolonged or excessive use, especially on large skin areas or under occlusive dressings, may lead to systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) or neomycin-induced ototoxicity and nephrotoxicity. Treatment is symptomatic and supportive. Discontinue the cream gradually if systemic effects occur.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy and lactation only if the potential benefit justifies the potential risk to the fetus or infant. Corticosteroids can be absorbed systemically, and neomycin has potential for ototoxicity. Consult a doctor before use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired
Clinical Trials
Extensive clinical trial data exist for Betamethasone and Neomycin individually and in combination for various inflammatory dermatoses with secondary infection. Specific trials for Aristobet-N would typically focus on bioequivalence and local tolerability for regulatory approval.
Lab Monitoring
- Routine lab monitoring is not typically required for short-term, localized topical use. For extensive or prolonged use, especially in children or patients with renal impairment, monitor for signs of systemic corticosteroid absorption (e.g., plasma cortisol levels) or neomycin toxicity (e.g., renal function, audiometry).
Doctor Notes
- Emphasize short-term use (max 7 days) to minimize local and systemic side effects, especially in sensitive areas like the face or in children.
- Advise against occlusive dressings due to increased absorption risks.
- Consider alternative antifungal or antiviral agents if infection type is not bacterial.
- Monitor for signs of secondary infection or worsening of the condition if used inappropriately.
Patient Guidelines
- Use this cream exactly as prescribed by your doctor and do not use it for longer than advised.
- Do not apply to the face, groin, underarms, or to large skin areas unless specifically directed by your doctor.
- Avoid contact with eyes, and if contact occurs, rinse thoroughly with water.
- Do not use occlusive dressings (e.g., bandages, tight clothing) over the treated area unless instructed by your doctor, as this can increase absorption.
- Inform your doctor if your condition does not improve within 7 days or if it worsens.
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 schedule. Do not apply a double dose to make up for a missed one.
Driving Precautions
Aristobet-N cream is a topical medication and is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain good skin hygiene. Avoid scratching the affected area to prevent further irritation and infection. Wear loose-fitting clothing to allow skin to breathe.
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