Soritec
Generic Name
Acitretin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soritec 10 mg capsule | ৳ 45.14 | ৳ 451.40 |
Description
Overview of the medicine
Acitretin is a retinoid medication, a derivative of vitamin A, used for severe forms of psoriasis and other keratinization disorders that are resistant to conventional therapies.
Uses & Indications
Dosage
Adults
Initial dose 25-50 mg daily, usually for 2-4 weeks. Maintenance dose typically 25-50 mg daily, adjusted based on response and tolerability. Maximum 75 mg/day.
Elderly
No specific dosage adjustment recommended, but caution should be exercised due to potential comorbidities and reduced organ function.
Renal_impairment
Use with caution. Dose reduction may be necessary in severe renal impairment. Regular monitoring is advised.
How to Take
Take orally, preferably with a main meal or milk to enhance absorption. Swallow the capsule whole with water. Do not chew or crush.
Mechanism of Action
Acitretin acts by normalizing the growth and differentiation of epidermal cells. It binds to retinoid receptors (RARs and RXRs) to modulate gene expression, thereby reducing hyperproliferation and inflammation in psoriatic skin.
Pharmacokinetics
Onset
Therapeutic effects may take several weeks or even months to become apparent.
Excretion
Approximately equal amounts are excreted via the renal and biliary routes.
Half life
Parent drug: approximately 50 hours; active metabolite (etretinate): approximately 120 days. The long half-life of etretinate is clinically significant.
Absorption
Well absorbed orally, especially when taken with food. Peak plasma concentrations are reached within 2-5 hours.
Metabolism
Extensively metabolized in the liver to various metabolites, including the active metabolite etretinate, and 13-cis-acitretin.
Side Effects
Contraindications
- Pregnancy and women of childbearing potential (unless highly effective contraception is used for at least one month before, during, and for 3 years after treatment)
- Severe hepatic or renal impairment
- Hypersensitivity to acitretin or other retinoids
- Concomitant use with methotrexate
- Concomitant use with tetracyclines
- Concomitant use with Vitamin A supplements
Drug Interactions
Alcohol
May increase the formation of etretinate, a metabolite with a very long half-life. Patients must avoid alcohol during and for 2 months after treatment.
Phenytoin
Acitretin may reduce protein binding of phenytoin.
Methotrexate
Increased risk of hepatotoxicity.
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension).
Vitamin A supplements
Increased risk of hypervitaminosis A.
Oral contraceptives (progesterone-only)
Acitretin may reduce the efficacy of progesterone-only oral contraceptives.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include headache, nausea, vomiting, dizziness, abdominal pain, pruritus, and dry skin/mucous membranes. Treatment is supportive; there is no specific antidote. Discontinue the drug and manage symptoms.
Pregnancy & Lactation
Acitretin is classified as Pregnancy Category X. It is highly teratogenic and absolutely contraindicated in pregnancy and in women of childbearing potential unless strict contraception measures are followed. Avoid breastfeeding during treatment and for a period after, as acitretin and its metabolites are excreted in human milk.
Side Effects
Contraindications
- Pregnancy and women of childbearing potential (unless highly effective contraception is used for at least one month before, during, and for 3 years after treatment)
- Severe hepatic or renal impairment
- Hypersensitivity to acitretin or other retinoids
- Concomitant use with methotrexate
- Concomitant use with tetracyclines
- Concomitant use with Vitamin A supplements
Drug Interactions
Alcohol
May increase the formation of etretinate, a metabolite with a very long half-life. Patients must avoid alcohol during and for 2 months after treatment.
Phenytoin
Acitretin may reduce protein binding of phenytoin.
Methotrexate
Increased risk of hepatotoxicity.
Tetracyclines
Increased risk of pseudotumor cerebri (benign intracranial hypertension).
Vitamin A supplements
Increased risk of hypervitaminosis A.
Oral contraceptives (progesterone-only)
Acitretin may reduce the efficacy of progesterone-only oral contraceptives.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include headache, nausea, vomiting, dizziness, abdominal pain, pruritus, and dry skin/mucous membranes. Treatment is supportive; there is no specific antidote. Discontinue the drug and manage symptoms.
Pregnancy & Lactation
Acitretin is classified as Pregnancy Category X. It is highly teratogenic and absolutely contraindicated in pregnancy and in women of childbearing potential unless strict contraception measures are followed. Avoid breastfeeding during treatment and for a period after, as acitretin and its metabolites are excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check specific packaging for details.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Acitretin has undergone numerous clinical trials demonstrating its efficacy and safety in the treatment of severe psoriasis and other keratinization disorders. Studies focus on dose-response, long-term safety, and comparison with other antipsoriatic agents.
Lab Monitoring
- Liver function tests (baseline and monthly or as clinically indicated)
- Lipid profile (cholesterol, triglycerides - baseline and monthly or as clinically indicated)
- Blood glucose (especially in diabetic patients, baseline and periodic monitoring)
- Complete Blood Count (CBC) periodically
Doctor Notes
- Crucial to counsel all female patients of childbearing potential on the absolute necessity of strict contraception (dual method) for the stipulated period.
- Emphasize the alcohol restriction due to the risk of etretinate formation.
- Regularly monitor liver function tests, lipid profiles, and assess for any signs of musculoskeletal pain or vision changes.
- Acitretin is a second-line agent for severe psoriasis, reserved for cases unresponsive to other therapies or where other therapies are contraindicated.
Patient Guidelines
- For women of childbearing potential, use two reliable forms of contraception (one highly effective and a barrier method) for at least 1 month before, during, and for 3 years after stopping treatment.
- Avoid alcohol consumption during and for 2 months after treatment due to increased risk of etretinate formation.
- Do not donate blood during treatment and for 3 years after stopping treatment.
- Avoid excessive sun exposure and use sunscreen due to increased photosensitivity.
- Report any vision changes, severe headache, nausea, vomiting, or mood changes to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Acitretin may impair night vision, especially during the initial months of therapy. Exercise caution when driving or operating machinery at night or in low-light conditions.
Lifestyle Advice
- Maintain good skin hydration with moisturizers, use lip balm regularly, and consider artificial tears for dry eyes. Avoid vigorous physical activity if experiencing muscle or joint pain.
- Maintain a balanced diet to manage lipid levels.
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