Roaccutane
Generic Name
Isotretinoin
Manufacturer
Roche
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roaccutane 10 mg capsule | ৳ 97.35 | ৳ 973.52 |
Description
Overview of the medicine
Isotretinoin is a retinoid that works by decreasing facial oil (sebum) production, reducing the size of oil glands, and preventing hardening of the skin. It is used to treat severe nodular acne that has not responded to other treatments.
Uses & Indications
Dosage
Adults
Initial dose 0.5 mg/kg/day, typically taken once or twice daily. Increased to 1 mg/kg/day if necessary, for 15-20 weeks. Cumulative dose range 120-150 mg/kg per course.
Elderly
Not routinely used in elderly patients for acne. If used, consider lower doses due to potential decreased organ function.
Renal_impairment
Initial dose of 10 mg/day or 0.1 mg/kg/day, gradually increased to 0.5 mg/kg/day.
How to Take
Orally, preferably with a meal, once or twice daily. Swallow capsules whole, do not chew or crush.
Mechanism of Action
Reduces sebaceous gland size and sebum production, inhibits Propionibacterium acnes growth indirectly, and normalizes follicular keratinization.
Pharmacokinetics
Onset
Initial effects seen within 2-4 weeks, full effect may take longer (months).
Excretion
Approximately equal amounts excreted in urine and feces.
Half life
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin (active metabolite): 17-30 hours.
Absorption
Variable and increased with food. Peak plasma concentrations reached 2-4 hours after administration.
Metabolism
Primarily hepatic, mainly by CYP2C8, to its active metabolite 4-oxo-isotretinoin.
Side Effects
Contraindications
- Pregnancy (absolute contraindication), women of childbearing potential unless strict conditions are met (e.g., iPLEDGE program in US).
- Lactation.
- Hepatic impairment.
- Severe hyperlipidaemia.
- Hypervitaminosis A.
- Concomitant tetracycline therapy.
- Hypersensitivity to isotretinoin or any excipients.
Drug Interactions
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension). Avoid concomitant use.
Vitamin A supplements
Increased risk of hypervitaminosis A. Avoid concomitant use.
Topical keratolytics or exfoliants
May increase local irritation. Avoid concomitant use.
Storage
Store below 25°C, in a dry place, protected from light. Keep out of reach of children.
Overdose
Symptoms of acute overdose include headache, nausea, vomiting, facial flushing, cheilosis, abdominal pain, dizziness. Management is symptomatic and supportive.
Pregnancy & Lactation
Absolutely contraindicated in pregnancy due to severe teratogenic effects. Women of childbearing potential must use two effective forms of contraception starting one month before treatment, during treatment, and for one month after treatment. Contraindicated during breastfeeding.
Side Effects
Contraindications
- Pregnancy (absolute contraindication), women of childbearing potential unless strict conditions are met (e.g., iPLEDGE program in US).
- Lactation.
- Hepatic impairment.
- Severe hyperlipidaemia.
- Hypervitaminosis A.
- Concomitant tetracycline therapy.
- Hypersensitivity to isotretinoin or any excipients.
Drug Interactions
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension). Avoid concomitant use.
Vitamin A supplements
Increased risk of hypervitaminosis A. Avoid concomitant use.
Topical keratolytics or exfoliants
May increase local irritation. Avoid concomitant use.
Storage
Store below 25°C, in a dry place, protected from light. Keep out of reach of children.
Overdose
Symptoms of acute overdose include headache, nausea, vomiting, facial flushing, cheilosis, abdominal pain, dizziness. Management is symptomatic and supportive.
Pregnancy & Lactation
Absolutely contraindicated in pregnancy due to severe teratogenic effects. Women of childbearing potential must use two effective forms of contraception starting one month before treatment, during treatment, and for one month after treatment. Contraindicated during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Expired
Clinical Trials
Extensively studied in clinical trials for severe acne, demonstrating significant efficacy but also significant adverse effect profile, particularly teratogenicity.
Lab Monitoring
- Before treatment: Pregnancy test (for women), lipid profile, liver function tests.
- During treatment: Monthly pregnancy tests, lipid profile, liver function tests every 4-8 weeks.
Doctor Notes
- Strict adherence to pregnancy prevention program is paramount.
- Monitor for psychiatric symptoms and elevated liver enzymes/lipids.
- Educate patients thoroughly on potential side effects and precautions.
Patient Guidelines
- Do not get pregnant during treatment and for one month after stopping.
- Use two forms of effective contraception.
- Do not donate blood during treatment and for one month after stopping.
- Avoid excessive sun exposure and use sunscreen.
- Do not use waxing, dermabrasion, or laser skin treatments during and for at least 6 months after treatment.
- Report any mood changes, depression, or suicidal thoughts immediately to your doctor.
- Moisturize skin and lips regularly.
Missed Dose Advice
If a dose is missed, skip the missed dose and continue with the next scheduled dose. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause decreased night vision which can be permanent in some cases. Exercise caution when driving or operating machinery, especially at night. Rarely, visual disturbances or dizziness may occur.
Lifestyle Advice
- Maintain good hydration.
- Use mild, non-irritating skin care products.
- Avoid alcohol.
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