Soritin
Generic Name
Isotretinoin
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soritin 10 mg capsule | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Isotretinoin is a retinoid primarily used for severe recalcitrant nodular acne. It works by reducing the size and activity of sebaceous glands, thereby decreasing sebum production, and also has anti-inflammatory properties.
Uses & Indications
Dosage
Adults
Initially 0.5 mg/kg body weight daily, taken with food, usually for 15-20 weeks. Dose adjusted based on response and tolerability, up to a maximum of 1 mg/kg daily. Cumulative dose 120-150 mg/kg.
Elderly
Not typically recommended as acne is rare in this population. If used, caution is advised.
Renal_impairment
Initiate at a lower dose (e.g., 10 mg daily or 0.1 mg/kg/day) and titrate carefully due to limited data.
How to Take
Oral, with a full meal, usually once or twice daily.
Mechanism of Action
Isotretinoin reduces sebaceous gland size and activity, thereby inhibiting sebum production. It also normalizes follicular keratinization, preventing comedone formation, and possesses anti-inflammatory effects.
Pharmacokinetics
Onset
Clinical improvement often seen within 1-2 months of treatment initiation.
Excretion
Approximately equal amounts are excreted in the urine and feces.
Half life
Isotretinoin: 10-20 hours; 4-oxo-isotretinoin (active metabolite): 17-50 hours.
Absorption
Variable, improved when taken with food. Peak plasma concentrations are typically reached in 2-4 hours.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (primarily CYP2C8) to 4-oxo-isotretinoin (active) and other metabolites.
Side Effects
Contraindications
- Pregnancy and lactation
- Women of childbearing potential not using effective contraception
- Severe hepatic impairment
- Severe hyperlipidemia
- Hypersensitivity to isotretinoin or any excipient
- Concomitant use of tetracyclines
Drug Interactions
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension).
Vitamin A supplements
Increased risk of vitamin A toxicity (hypervitaminosis A).
Systemic corticosteroids
May exacerbate acne initially; use with caution.
Progestin-only oral contraceptives
May be less effective; two forms of contraception are required.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of acute overdose include headache, nausea, vomiting, facial flushing, cheilitis, abdominal pain, ataxia. Management is symptomatic and supportive.
Pregnancy & Lactation
Absolutely contraindicated in pregnancy due to severe teratogenic effects. Women of childbearing potential must use two forms of effective contraception for at least one month before, during, and one month after treatment. Contraindicated during lactation due to potential harm to the infant.
Side Effects
Contraindications
- Pregnancy and lactation
- Women of childbearing potential not using effective contraception
- Severe hepatic impairment
- Severe hyperlipidemia
- Hypersensitivity to isotretinoin or any excipient
- Concomitant use of tetracyclines
Drug Interactions
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension).
Vitamin A supplements
Increased risk of vitamin A toxicity (hypervitaminosis A).
Systemic corticosteroids
May exacerbate acne initially; use with caution.
Progestin-only oral contraceptives
May be less effective; two forms of contraception are required.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of acute overdose include headache, nausea, vomiting, facial flushing, cheilitis, abdominal pain, ataxia. Management is symptomatic and supportive.
Pregnancy & Lactation
Absolutely contraindicated in pregnancy due to severe teratogenic effects. Women of childbearing potential must use two forms of effective contraception for at least one month before, during, and one month after treatment. Contraindicated during lactation due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
DGDA Approved
Patent Status
Expired
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of isotretinoin for severe acne, leading to its widespread use despite significant side effect profiles.
Lab Monitoring
- Liver function tests (LFTs) before and periodically during treatment
- Lipid profile (triglycerides, cholesterol) before and periodically during treatment
- Pregnancy test for women of childbearing potential before and monthly during treatment
Doctor Notes
- Strict adherence to pregnancy prevention protocol (e.g., IPLEDGE) for all female patients of childbearing potential is critical.
- Regular monitoring of liver function and lipid profile is essential throughout the treatment course.
- Counsel patients on potential psychiatric side effects, including depression and suicidal ideation, and advise immediate reporting of any mood changes.
- Inform patients about the common mucocutaneous dryness and advise on supportive care (moisturizers, lip balms).
Patient Guidelines
- Do not donate blood during treatment and for one month after stopping treatment.
- Avoid waxing, dermabrasion, and laser skin treatments during and for at least 6 months after treatment.
- Use a broad-spectrum sunscreen and protective clothing when outdoors.
- Immediately report any changes in mood, vision, or severe abdominal pain.
Missed Dose Advice
Take the missed dose as soon as you remember, unless it's almost time for your next scheduled dose. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause night vision impairment, so caution is advised, especially when driving at night. Some patients may also experience dizziness.
Lifestyle Advice
- Use moisturizers and lip balms frequently to manage dryness.
- Avoid excessive sun exposure.
- Limit alcohol intake, especially if liver enzymes are elevated.
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