Soritec
Generic Name
Acitretin
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| soritec 25 mg capsule | ৳ 85.26 | ৳ 852.60 |
Description
Overview of the medicine
Soritec (Acitretin) is an oral retinoid used for the treatment of severe psoriasis and other keratinization disorders. It works by normalizing cell growth and differentiation in the skin.
Uses & Indications
Dosage
Adults
Initial dose: 25 mg once daily. May be increased to 25-50 mg daily, up to a maximum of 75 mg daily for severe cases. Treatment duration depends on the condition, often 6-9 months or more.
Elderly
No specific dosage adjustment for elderly patients, but careful monitoring is recommended due to potential hepatic/renal impairment.
Renal_impairment
Use with caution. Dosage reduction may be necessary. Not recommended in severe renal impairment.
How to Take
Take orally, once daily, preferably with a main meal or milk to enhance absorption. Swallow the capsule whole with water.
Mechanism of Action
Acitretin is a retinoid that binds to and activates nuclear retinoic acid receptors (RARs) and retinoid X receptors (RXRs), which are transcription factors regulating gene expression. This leads to normalized cell growth and differentiation of keratinocytes, reducing the abnormal proliferation and inflammation seen in psoriasis and other disorders of keratinization.
Pharmacokinetics
Onset
Therapeutic effects typically seen after 2-4 weeks, maximum effect after 4-6 months.
Excretion
Excreted primarily via bile (feces) and urine. Due to the formation of etretinate, it can remain in the body for years.
Half life
Acitretin has a half-life of about 50 hours, but its active metabolite, etretinate, has a much longer half-life (around 120 days). This is critical for its long retention in the body.
Absorption
Well absorbed from the gastrointestinal tract, especially when taken with food. Peak plasma concentrations are reached within 2-5 hours.
Metabolism
Primarily metabolized in the liver to its active metabolite, 13-cis-acitretin (etretinate), and other inactive metabolites.
Side Effects
Contraindications
- Pregnancy (highly teratogenic and causes severe birth defects)
- Women of childbearing potential not using effective contraception (must avoid pregnancy for at least 3 years after stopping treatment)
- Severe hepatic or renal impairment
- Hypersensitivity to retinoids or any excipients
- Concomitant use with methotrexate or tetracyclines
Drug Interactions
Alcohol
Increases formation of etretinate, which has a very long half-life, extending teratogenic risk.
Phenytoin
May reduce protein binding of phenytoin.
Methotrexate
Increased risk of hepatotoxicity.
Tetracyclines
Increased risk of intracranial hypertension.
Vitamin A and other retinoids
Increased risk of hypervitaminosis A symptoms.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose resemble hypervitaminosis A (e.g., headache, nausea, vomiting, dizziness, dry skin, fatigue). Treatment involves immediate discontinuation of the drug and symptomatic supportive care. There is no specific antidote.
Pregnancy & Lactation
Contraindicated in pregnancy due to severe teratogenicity. Women of childbearing potential must use two reliable forms of contraception for at least 1 month before, during, and for 3 years after treatment. Breastfeeding is not recommended as acitretin is excreted in breast milk.
Side Effects
Contraindications
- Pregnancy (highly teratogenic and causes severe birth defects)
- Women of childbearing potential not using effective contraception (must avoid pregnancy for at least 3 years after stopping treatment)
- Severe hepatic or renal impairment
- Hypersensitivity to retinoids or any excipients
- Concomitant use with methotrexate or tetracyclines
Drug Interactions
Alcohol
Increases formation of etretinate, which has a very long half-life, extending teratogenic risk.
Phenytoin
May reduce protein binding of phenytoin.
Methotrexate
Increased risk of hepatotoxicity.
Tetracyclines
Increased risk of intracranial hypertension.
Vitamin A and other retinoids
Increased risk of hypervitaminosis A symptoms.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose resemble hypervitaminosis A (e.g., headache, nausea, vomiting, dizziness, dry skin, fatigue). Treatment involves immediate discontinuation of the drug and symptomatic supportive care. There is no specific antidote.
Pregnancy & Lactation
Contraindicated in pregnancy due to severe teratogenicity. Women of childbearing potential must use two reliable forms of contraception for at least 1 month before, during, and for 3 years after treatment. Breastfeeding is not recommended as acitretin is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
FDA approved (US), DGDA approved (Bangladesh)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have established the efficacy and safety of acitretin for severe psoriasis and keratinization disorders, particularly focusing on its teratogenic effects and long-term safety profile.
Lab Monitoring
- Liver function tests (baseline, then monthly for first few months, then every 3 months)
- Lipid profile (cholesterol, triglycerides - baseline, then monthly for first few months, then every 3 months)
- Pregnancy tests (monthly for women of childbearing potential during treatment and for 3 years after)
Doctor Notes
- Emphasize strict contraception for women of childbearing age for 3 years post-treatment.
- Monitor liver function tests and lipid profiles regularly.
- Advise patients on severe teratogenic risks and the importance of avoiding alcohol.
- Start with a low dose and gradually increase if tolerated, especially in elderly patients.
Patient Guidelines
- Do not donate blood during treatment and for at least 3 years after stopping Acitretin, as it can harm a pregnant recipient.
- Avoid excessive exposure to sunlight and artificial UV light (sunlamps, tanning beds) as Acitretin can increase photosensitivity. Use sunscreen and protective clothing.
- Do not take Vitamin A supplements without consulting your doctor.
- Women of childbearing potential must use highly effective contraception and receive counseling on the severe teratogenic risks.
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
May cause impaired night vision or visual disturbances, especially during the initial treatment period. Exercise caution when driving or operating machinery, particularly at night. If vision problems occur, avoid driving.
Lifestyle Advice
- Maintain good skin hydration using moisturizers.
- Use lip balm regularly for dry lips.
- Avoid alcohol consumption during and for 2 months after treatment.
- Wear contact lenses with caution, as dry eyes may occur.
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