Spotless-4
Generic Name
Hydroquinone, Tretinoin, Fluocinolone Acetonide Cream
Manufacturer
Dermacare Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| spotless 4 cream | ৳ 50.00 | N/A |
Description
Overview of the medicine
Spotless-4 Cream is a combination topical medication containing hydroquinone, tretinoin, and fluocinolone acetonide. It is primarily used for the short-term treatment of moderate to severe melasma of the face, by reducing hyperpigmentation, promoting skin cell turnover, and decreasing inflammation.
Uses & Indications
Dosage
Adults
Apply a thin layer to the affected areas once daily, usually at night, for a duration of up to 8-12 weeks, as directed by a physician.
Elderly
Similar to adult dosage, but with caution due to potentially thinner and more fragile skin. Physician supervision is recommended.
Renal_impairment
No specific dosage adjustment is generally required for topical use, as systemic absorption is minimal.
How to Take
Apply a thin film evenly to the hyperpigmented areas of the face, including about 0.5 inches of normal-appearing skin surrounding the lesions. Apply once daily at night, at least 30 minutes before bedtime. Gently wash your face with a mild cleanser and pat dry before application. Do not use occlusive dressings. Avoid contact with eyes, mouth, and mucous membranes. Wash hands immediately after application.
Mechanism of Action
Hydroquinone inhibits tyrosinase, an enzyme involved in melanin synthesis. Tretinoin increases cell turnover, facilitating the shedding of pigmented keratinocytes and enhancing hydroquinone penetration. Fluocinolone Acetonide is a potent corticosteroid that reduces inflammation and irritation, and has mild depigmenting effects.
Pharmacokinetics
Onset
Visible improvement typically seen within 4-6 weeks, with significant results usually appearing after 2-3 months of consistent use.
Excretion
Minimal systemic excretion. Absorbed components are generally excreted via urine and feces after metabolism.
Half life
Not well-characterized for topical application due to minimal systemic exposure. Components are primarily metabolized locally in the skin.
Absorption
Minimal systemic absorption occurs with topical application; however, some components can be absorbed. The extent of absorption depends on the skin condition and area of application.
Metabolism
Primarily metabolized locally in the skin. Minimal systemic metabolism for hydroquinone and tretinoin, while fluocinolone acetonide can undergo hepatic metabolism if systemically absorbed.
Side Effects
Contraindications
- Hypersensitivity to any component of the cream
- Pregnancy and lactation
- Children under 12 years of age
- Severely irritated or eczematous skin
- Broken or abraded skin
Drug Interactions
Photosensitizing drugs
Increased risk of photosensitivity with other photosensitizing agents.
Other topical preparations
Avoid concurrent use of other potentially irritating topical products, especially those containing sulfur, resorcinol, or salicylic acid. Products containing benzoyl peroxide or hydrogen peroxide may inactivate hydroquinone.
Storage
Store below 25°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Excessive application may lead to pronounced irritation, redness, scaling, and discomfort. Systemic overdose is unlikely with proper topical use but possible with extensive application over large areas. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation due to the potential teratogenic effects of tretinoin and potential systemic absorption of hydroquinone and corticosteroids. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to any component of the cream
- Pregnancy and lactation
- Children under 12 years of age
- Severely irritated or eczematous skin
- Broken or abraded skin
Drug Interactions
Photosensitizing drugs
Increased risk of photosensitivity with other photosensitizing agents.
Other topical preparations
Avoid concurrent use of other potentially irritating topical products, especially those containing sulfur, resorcinol, or salicylic acid. Products containing benzoyl peroxide or hydrogen peroxide may inactivate hydroquinone.
Storage
Store below 25°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Excessive application may lead to pronounced irritation, redness, scaling, and discomfort. Systemic overdose is unlikely with proper topical use but possible with extensive application over large areas. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation due to the potential teratogenic effects of tretinoin and potential systemic absorption of hydroquinone and corticosteroids. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, depending on specific formulation.
Availability
Pharmacies and drugstores
Approval Status
Approved (for component combination)
Patent Status
Off-patent for active ingredients, brand specific formulations may be patented
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of triple combination creams (hydroquinone, tretinoin, corticosteroid) in the treatment of moderate to severe facial melasma.
Lab Monitoring
- No specific laboratory monitoring is typically required for routine topical use.
Doctor Notes
- Emphasize the importance of strict sun protection before, during, and after treatment.
- Limit the duration of use to minimize risks of adverse effects like ochronosis and skin atrophy.
- Educate patients on proper application technique and potential side effects, including irritation management.
- Consider a treatment holiday or step-down therapy after the initial treatment period.
Patient Guidelines
- Use only as directed by your physician.
- Apply a broad-spectrum sunscreen with SPF 30 or higher daily, and use protective clothing when outdoors.
- Avoid excessive sun exposure, tanning beds, and sunlamps.
- Avoid contact with eyes, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on broken, eczematous, or severely irritated skin.
- Report any severe irritation, burning, or unusual skin changes to your doctor.
Missed Dose Advice
If you miss a dose, apply it as soon as you remember, unless it is almost time for your next dose. In that case, 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
Spotless-4 Cream is for topical use and is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Maintain strict sun protection practices.
- Avoid harsh skin products (e.g., abrasive soaps, strong cleansers, chemical peels) that may increase irritation.
- Use gentle, non-comedogenic moisturizers to counteract dryness.
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