Roaccutane
Generic Name
Isotretinoin
Manufacturer
F. Hoffmann-La Roche Ltd.
Country
Switzerland
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roaccutane 20 mg capsule | ৳ 113.20 | ৳ 1,132.00 |
Description
Overview of the medicine
Isotretinoin is a retinoid primarily used for the treatment of severe, recalcitrant nodular acne that has not responded to other therapies.
Uses & Indications
Dosage
Adults
Initial dose is usually 0.5 mg/kg/day, taken once or twice daily with food. Dose may be adjusted to 0.5-1 mg/kg/day based on response and tolerability. A typical course is 15-20 weeks.
Elderly
Safety and efficacy have not been established. Not typically recommended due to age-related skin changes and other medications. If used, extreme caution and lower starting doses are advised.
Renal_impairment
Start with a lower dose (e.g., 10 mg/day or 0.1 mg/kg/day) and adjust based on patient tolerance and clinical response.
How to Take
Take Roaccutane capsules with a meal, usually once or twice daily. Swallow the capsules whole; do not chew, crush, or suck them.
Mechanism of Action
It reduces sebaceous gland size and inhibits sebaceous gland activity, leading to a substantial reduction in sebum production. It also normalizes follicular keratinization and has anti-inflammatory properties, inhibiting the growth of Propionibacterium acnes.
Pharmacokinetics
Onset
Clinical improvement usually begins within 1-2 months of therapy initiation.
Excretion
Approximately equal amounts are excreted in the urine and feces.
Half life
Isotretinoin: 10-20 hours; its main active metabolite, 4-oxo-isotretinoin: 17-29 hours.
Absorption
Oral absorption is variable but significantly increased when taken with a high-fat meal.
Metabolism
Primarily hepatic metabolism via cytochrome P450 (CYP) enzymes, particularly CYP2C8, CYP2C9, CYP2B6, and CYP3A4. It undergoes isomerization to tretinoin and oxidation to 4-oxo-isotretinoin.
Side Effects
Contraindications
- Pregnancy, planning pregnancy, or women of childbearing potential not using effective contraception.
- Breastfeeding.
- Hepatic impairment.
- Severe hyperlipidemia.
- Hypervitaminosis A.
- Concomitant treatment with tetracyclines (due to risk of pseudotumor cerebri).
- Hypersensitivity to isotretinoin or any excipient.
Drug Interactions
Phenytoin
Isotretinoin may alter phenytoin protein binding, requiring monitoring.
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension). Concomitant use is contraindicated.
St. John's Wort
May reduce the efficacy of hormonal contraceptives, increasing the risk of pregnancy.
Vitamin A supplements
Increased risk of hypervitaminosis A. Avoid concomitant use.
Systemic corticosteroids
May exacerbate acne and potentially increase bone loss.
Topical keratolytics or exfoliants
Increased skin irritation and dryness; avoid concomitant use.
Storage
Store below 25°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are similar to those of hypervitaminosis A, including headache, nausea, vomiting, facial flushing, cheilitis, and abdominal pain. Management is supportive; discontinue the drug and manage symptoms symptomatically.
Pregnancy & Lactation
Isotretinoin is highly teratogenic and is strictly contraindicated in pregnancy due to the high risk of severe birth defects. It is also contraindicated during breastfeeding as it is likely excreted in human milk, posing a risk to the infant.
Side Effects
Contraindications
- Pregnancy, planning pregnancy, or women of childbearing potential not using effective contraception.
- Breastfeeding.
- Hepatic impairment.
- Severe hyperlipidemia.
- Hypervitaminosis A.
- Concomitant treatment with tetracyclines (due to risk of pseudotumor cerebri).
- Hypersensitivity to isotretinoin or any excipient.
Drug Interactions
Phenytoin
Isotretinoin may alter phenytoin protein binding, requiring monitoring.
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension). Concomitant use is contraindicated.
St. John's Wort
May reduce the efficacy of hormonal contraceptives, increasing the risk of pregnancy.
Vitamin A supplements
Increased risk of hypervitaminosis A. Avoid concomitant use.
Systemic corticosteroids
May exacerbate acne and potentially increase bone loss.
Topical keratolytics or exfoliants
Increased skin irritation and dryness; avoid concomitant use.
Storage
Store below 25°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are similar to those of hypervitaminosis A, including headache, nausea, vomiting, facial flushing, cheilitis, and abdominal pain. Management is supportive; discontinue the drug and manage symptoms symptomatically.
Pregnancy & Lactation
Isotretinoin is highly teratogenic and is strictly contraindicated in pregnancy due to the high risk of severe birth defects. It is also contraindicated during breastfeeding as it is likely excreted in human milk, posing a risk to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, as indicated on the packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of isotretinoin for severe nodular acne. Ongoing post-marketing surveillance and studies continue to refine understanding of its long-term effects and management.
Lab Monitoring
- Baseline and monthly lipid profile (triglycerides, cholesterol) monitoring.
- Baseline and monthly liver function tests (LFTs) monitoring.
- Baseline and monthly pregnancy tests for all females of childbearing potential.
- Complete blood count (CBC) to monitor for blood dyscrasias.
- Blood glucose monitoring, especially in patients with diabetes or risk factors.
Doctor Notes
- Ensure strict adherence to the iPLEDGE program or equivalent national pregnancy prevention guidelines for all female patients of reproductive potential.
- Thoroughly assess patient's mental health history and monitor for any psychiatric symptoms throughout treatment.
- Emphasize the importance of taking Roaccutane with food to ensure optimal absorption and efficacy.
- Regular laboratory monitoring (lipids, LFTs) is crucial to detect potential adverse effects early.
Patient Guidelines
- Strictly adhere to the pregnancy prevention program. Use two forms of effective contraception during and for one month after treatment.
- Do not donate blood during treatment and for at least one month after stopping the drug, to prevent exposure to pregnant women.
- Avoid sun exposure and use sunscreen and protective clothing due to increased photosensitivity.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after therapy due to increased skin fragility and scarring risk.
Missed Dose Advice
If you miss a dose, take 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 dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Roaccutane may cause night blindness or other visual disturbances, which can be permanent. Patients should exercise caution when driving or operating machinery, especially at night.
Lifestyle Advice
- Use moisturizers and lip balms frequently to combat skin and lip dryness.
- Lubricating eye drops may be helpful for dry eyes.
- Report any changes in mood, behavior, or thoughts of self-harm to your doctor immediately.
- Avoid alcohol consumption as it can increase the risk of liver side effects.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Roaccutane Brand
Other medicines available under the same brand name
