Topibet-CL
Generic Name
Clobetasol Propionate + Neomycin Sulfate
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| topibet cl 01 1 ointment | ৳ 35.00 | N/A |
Description
Overview of the medicine
Topibet-CL Ointment is a combination medication containing Clobetasol Propionate, a potent corticosteroid, and Neomycin Sulfate, an aminoglycoside antibiotic. It is used to treat various inflammatory and itchy skin conditions where bacterial infection is present or likely.
Uses & Indications
Dosage
Adults
Apply a thin layer to the affected skin area once or twice daily. Do not use for more than 2 weeks continuously without medical advice. Total weekly dose should not exceed 50g.
Elderly
Use with caution due to potential for increased systemic absorption and thinner skin. Dosage similar to adults, but monitor for adverse effects.
Renal_impairment
Use with caution. Although systemic absorption is limited, prolonged or extensive use could lead to systemic effects. Consult a physician.
How to Take
For external use only. Apply a thin film to the affected skin area and rub in gently. Wash hands thoroughly before and after application. Avoid contact with eyes, mouth, and mucous membranes. Do not cover the treated area with occlusive dressings unless advised by a doctor.
Mechanism of Action
Clobetasol Propionate is a highly potent corticosteroid that suppresses the inflammatory response through various mechanisms, including inhibition of prostaglandin and leukotriene synthesis. 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 and antipruritic effects of clobetasol may be noticed within hours to a few days. Antibacterial effects of neomycin are onset within hours.
Excretion
Clobetasol and its metabolites are primarily excreted by the kidneys, and to a lesser extent, via bile. Unabsorbed neomycin is excreted unchanged in faeces; absorbed neomycin is rapidly excreted by the kidneys.
Half life
Systemic half-life of absorbed clobetasol is approximately 3-5 hours. Neomycin's half-life is short when systemically absorbed.
Absorption
Clobetasol Propionate can be absorbed systemically, especially with prolonged use, application over large surface areas, or under occlusive dressings. Neomycin absorption through intact skin is minimal but can be increased if the skin is damaged or inflamed.
Metabolism
Clobetasol is primarily metabolized in the liver. Neomycin is poorly metabolized.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate, Neomycin Sulfate, or any component of the formulation.
- Viral skin infections (e.g., herpes simplex, varicella), fungal infections (unless specifically treated by the combination), tuberculosis of the skin, acne vulgaris, rosacea, perioral dermatitis, perianal and genital pruritus.
- Do not use on children under 1 year of age.
Drug Interactions
No significant topical interactions known.
Systemic absorption of corticosteroids can interact with other systemic medications (e.g., CYP3A4 inhibitors like Ritonavir, Itraconazole may increase systemic exposure), but this is rare with proper topical use.
Storage
Store below 25°C, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Topical overdose is unlikely to produce acute systemic effects. Chronic overdose or misuse can lead to systemic effects of corticosteroid excess (e.g., HPA axis suppression) and increased risk of local side effects. Discontinue use and manage symptoms symptomatically.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings. Limited data on excretion in breast milk; use with caution in nursing mothers, avoiding application to the breast area.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate, Neomycin Sulfate, or any component of the formulation.
- Viral skin infections (e.g., herpes simplex, varicella), fungal infections (unless specifically treated by the combination), tuberculosis of the skin, acne vulgaris, rosacea, perioral dermatitis, perianal and genital pruritus.
- Do not use on children under 1 year of age.
Drug Interactions
No significant topical interactions known.
Systemic absorption of corticosteroids can interact with other systemic medications (e.g., CYP3A4 inhibitors like Ritonavir, Itraconazole may increase systemic exposure), but this is rare with proper topical use.
Storage
Store below 25°C, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Topical overdose is unlikely to produce acute systemic effects. Chronic overdose or misuse can lead to systemic effects of corticosteroid excess (e.g., HPA axis suppression) and increased risk of local side effects. Discontinue use and manage symptoms symptomatically.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings. Limited data on excretion in breast milk; use with caution in nursing mothers, avoiding application to the breast area.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Pharmacies, drugstores
Approval Status
Approved by DGDA/FDA
Patent Status
Off-patent (for generic combination)
Clinical Trials
Clinical trials for Clobetasol Propionate and Neomycin Sulfate combination have established its efficacy and safety for indicated conditions.
Lab Monitoring
- If used extensively or for prolonged periods, monitor for signs of HPA axis suppression (e.g., plasma cortisol levels).
Doctor Notes
- Educate patients on proper application technique and duration limits to prevent systemic absorption and local side effects.
- Monitor for signs of secondary infection or worsening of the condition, indicating need for reassessment.
- Advise against use on facial areas, intertriginous areas, or under occlusion for prolonged periods without careful supervision.
Patient Guidelines
- Use only as directed by your doctor.
- Do not use on the face, groin, or underarms unless specifically instructed by your doctor.
- Do not use for longer than the prescribed duration to avoid side effects.
- Do not use for children without medical supervision.
- Avoid contact with eyes.
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 resume your regular dosing schedule. Do not apply extra medicine to make up for a missed dose.
Driving Precautions
Topical application is unlikely to affect ability to drive or operate machinery.
Lifestyle Advice
- Keep the affected area clean and dry.
- Avoid irritants that may worsen the skin condition.
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