Nyclobate
Generic Name
Clobetasol Propionate 0.05% topical spray
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nyclobate 005 spray | ৳ 450.00 | N/A |
Description
Overview of the medicine
Nyclobate 0.05% Spray contains Clobetasol Propionate, a very potent topical corticosteroid indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.
Uses & Indications
Dosage
Adults
Apply a thin layer to the affected skin area twice daily, usually for up to 2 weeks. Do not use for more than 50g per week.
Elderly
Use with caution, similar dosage as adults but monitor for side effects, especially skin atrophy.
Renal_impairment
No specific dosage adjustment required for topical use, but systemic absorption should be minimized.
How to Take
For external use only. Spray directly onto the affected skin area from a distance of 10-15 cm until adequately covered. Rub gently if directed by physician. Wash hands after application. Avoid contact with eyes, face, and mucous membranes.
Mechanism of Action
Clobetasol Propionate is a corticosteroid that primarily acts by binding to glucocorticoid receptors. This binding leads to the inhibition of phospholipase A2, thereby blocking the release of arachidonic acid, a precursor to prostaglandins and leukotrienes. This results in potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
Pharmacokinetics
Onset
Within hours to days for noticeable effect.
Excretion
Primarily renal, with some biliary excretion.
Half life
Not well-established for topical application due to variable systemic absorption; systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Absorption
Percutaneous absorption varies depending on the integrity of the epidermal barrier, vehicle, and occlusion. Absorption is increased on inflamed or damaged skin and with occlusive dressings. Systemic absorption can occur.
Metabolism
Primarily hepatic, similar to other corticosteroids.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate or any component
- Rosacea
- Perioral dermatitis
- Acne vulgaris
- Perianal and genital pruritus
- Primary cutaneous viral infections (e.g., herpes simplex, varicella)
- Fungal or bacterial infections (untreated)
Drug Interactions
CYP3A4 Inhibitors
Coadministration with CYP3A4 inhibitors (e.g., ritonavir, itraconazole) may increase systemic exposure to Clobetasol Propionate and potentially increase adverse effects. Use with caution.
Other topical products
Avoid concurrent use of other potent topical corticosteroids on the same area to prevent cumulative effects and increased absorption.
Storage
Store below 30°C. Protect from direct sunlight and heat. Do not refrigerate or freeze. Keep out of reach of children. Pressurized container: may burst if heated.
Overdose
Acute overdose is unlikely. Chronic overdose or misuse can lead to systemic effects such as Cushing's syndrome, hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Treatment is symptomatic and supportive, including gradual withdrawal of the drug.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use with caution in nursing mothers, as it is unknown if topical corticosteroids are excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Clobetasol Propionate or any component
- Rosacea
- Perioral dermatitis
- Acne vulgaris
- Perianal and genital pruritus
- Primary cutaneous viral infections (e.g., herpes simplex, varicella)
- Fungal or bacterial infections (untreated)
Drug Interactions
CYP3A4 Inhibitors
Coadministration with CYP3A4 inhibitors (e.g., ritonavir, itraconazole) may increase systemic exposure to Clobetasol Propionate and potentially increase adverse effects. Use with caution.
Other topical products
Avoid concurrent use of other potent topical corticosteroids on the same area to prevent cumulative effects and increased absorption.
Storage
Store below 30°C. Protect from direct sunlight and heat. Do not refrigerate or freeze. Keep out of reach of children. Pressurized container: may burst if heated.
Overdose
Acute overdose is unlikely. Chronic overdose or misuse can lead to systemic effects such as Cushing's syndrome, hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Treatment is symptomatic and supportive, including gradual withdrawal of the drug.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use with caution in nursing mothers, as it is unknown if topical corticosteroids are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date, check specific product label.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
Clinical Trials
Numerous clinical trials have established the efficacy and safety of Clobetasol Propionate in various corticosteroid-responsive dermatoses. Specific trials for spray formulations focus on comparative efficacy and patient compliance.
Lab Monitoring
- HPA axis suppression tests (e.g., ACTH stimulation test) if prolonged use or extensive application is suspected
- Blood glucose monitoring in diabetics (rarely indicated for topical use)
Doctor Notes
- Prescribe for shortest effective duration.
- Educate patients on proper application technique and potential side effects.
- Monitor for signs of skin atrophy or systemic absorption.
- Avoid use on large body areas or under occlusion without careful consideration.
Patient Guidelines
- Use exactly as prescribed by your doctor.
- Do not use for longer than the prescribed period (usually 2 weeks).
- Avoid applying to the face, groin, or underarms unless specifically directed by a doctor.
- Wash hands before and after applying the spray.
- Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor.
Missed Dose Advice
If a dose is missed, apply it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not apply a double dose.
Driving Precautions
Nyclobate 0.05% Spray is not expected to affect the ability to drive or operate machinery, as systemic absorption is minimal with proper topical use.
Lifestyle Advice
- Maintain good skin hygiene.
- Avoid irritants that can worsen skin conditions.
- Moisturize regularly (on untreated areas or after the corticosteroid has absorbed) to help manage dry skin.
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