Brite
Generic Name
Hydroquinone 4%, Tretinoin 0.05%, Fluocinolone Acetonide 0.01% cream
Manufacturer
Hypothetical Pharma Co. Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| brite 001 4 cream | ৳ 200.00 | N/A |
Description
Overview of the medicine
Brite-001-4-cream is a topical combination medication used for the short-term treatment of moderate to severe melasma of the face. It contains hydroquinone (a depigmenting agent), tretinoin (a retinoid), and fluocinolone acetonide (a corticosteroid) to reduce pigmentation, enhance cell turnover, and decrease inflammation.
Uses & Indications
Dosage
Adults
Apply a thin layer to the affected areas once daily at night, at least 30 minutes before bedtime. Gently rub into the skin. Treatment duration should not exceed 8-12 weeks.
Elderly
No specific dosage adjustment required; use with caution due to thinner skin.
Renal_impairment
No specific dosage adjustment required as systemic absorption is minimal.
How to Take
For topical dermatological use only. Cleanse the face gently with a mild cleanser, pat dry. Apply a thin film to the hyperpigmented areas, including about half an inch of normal-appearing skin surrounding each lesion. Do not cover treated areas with occlusive dressings. Avoid contact with eyes, mouth, and other mucous membranes.
Mechanism of Action
Hydroquinone inhibits tyrosinase, an enzyme involved in melanin production. Tretinoin increases cell turnover, allowing faster shedding of pigmented cells, and enhances penetration of other active ingredients. Fluocinolone acetonide is a corticosteroid that provides anti-inflammatory and immunosuppressive effects, reducing irritation and inflammation associated with hyperpigmentation and other components.
Pharmacokinetics
Onset
Visible lightening typically begins after 4-6 weeks of consistent use, with optimal results seen after 8-12 weeks.
Excretion
Mainly through renal excretion for systemically absorbed portions, but overall systemic excretion is minimal.
Half life
Not typically determined for topical preparations with minimal systemic absorption.
Absorption
Minimal systemic absorption after topical application. Systemic absorption of hydroquinone is typically <5%, tretinoin is <10%, and fluocinolone acetonide varies but is generally low.
Metabolism
Primarily metabolized in the skin with limited systemic metabolism for each component.
Side Effects
Contraindications
- Hypersensitivity to any component of the cream
- Pregnancy and lactation
- Active skin infections
- Rosacea or perioral dermatitis
- Sunburn or irritated skin
Drug Interactions
No significant topical-systemic interactions
Due to minimal systemic absorption, significant drug interactions are unlikely.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overuse or prolonged use may lead to skin irritation, redness, peeling, burning, and increased risk of local side effects like skin thinning or exogenous ochronosis. Systemic overdose is unlikely with proper topical use.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Hydroquinone is categorized as pregnancy category C. Tretinoin is pregnancy category C (oral forms are X). Fluocinolone acetonide topical is pregnancy category C. The risks outweigh potential benefits.
Side Effects
Contraindications
- Hypersensitivity to any component of the cream
- Pregnancy and lactation
- Active skin infections
- Rosacea or perioral dermatitis
- Sunburn or irritated skin
Drug Interactions
No significant topical-systemic interactions
Due to minimal systemic absorption, significant drug interactions are unlikely.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Overuse or prolonged use may lead to skin irritation, redness, peeling, burning, and increased risk of local side effects like skin thinning or exogenous ochronosis. Systemic overdose is unlikely with proper topical use.
Pregnancy & Lactation
Contraindicated during pregnancy and lactation. Hydroquinone is categorized as pregnancy category C. Tretinoin is pregnancy category C (oral forms are X). Fluocinolone acetonide topical is pregnancy category C. The risks outweigh potential benefits.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Pharmacies nationwide
Approval Status
Approved (Hypothetical)
Patent Status
Generic available
Clinical Trials
Clinical trials have demonstrated the superior efficacy of triple combination creams (hydroquinone, tretinoin, and corticosteroid) over monotherapy or dual therapy for treating moderate to severe melasma, showing significant reduction in hyperpigmentation and improved global aesthetic scores.
Lab Monitoring
- Not routinely required for typical topical use.
- Regular skin examination for signs of irritation or adverse effects.
Doctor Notes
- Emphasize strict adherence to the treatment duration (max 8-12 weeks) to minimize risks.
- Advise patients on rigorous sun protection measures, including daily sunscreen and sun avoidance.
- Monitor for signs of skin atrophy, telangiectasia, and exogenous ochronosis, especially in long-term users (though not recommended).
- Educate patients on proper application technique to avoid contact with sensitive areas.
Patient Guidelines
- Use only as directed by your doctor, usually for a short duration (e.g., 8-12 weeks).
- Apply at night, at least 30 minutes before bedtime.
- Strictly use sunscreen (SPF 30 or higher) daily and avoid sun exposure during treatment and for a period after.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not use on broken, irritated, or sunburned skin.
- Discontinue use if severe irritation occurs.
Missed Dose Advice
If a dose is missed, apply it as soon as you remember. However, if it is almost time for the 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.
Driving Precautions
Brite-001-4-cream is for topical use and is not expected to affect the ability to drive or operate machinery.
Lifestyle Advice
- Consistent sun protection is crucial to prevent recurrence of melasma.
- Use gentle, non-irritating skincare products.
- Avoid harsh scrubs or chemical peels during treatment.
- Wear protective clothing and wide-brimmed hats when outdoors.
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Global Brand Names
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