Xolitra
Generic Name
Azathioprine
Manufacturer
XYZ Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xolitra 05 mg tablet | ৳ 5.02 | ৳ 50.20 |
Description
Overview of the medicine
Azathioprine is an immunosuppressive drug used to prevent organ rejection after transplantation and to treat various autoimmune diseases.
Uses & Indications
Dosage
Adults
Dosage is highly individualized based on the condition being treated, patient response, and hematological parameters. Typically, 1 to 3 mg/kg/day, adjusted based on clinical response and tolerability. A 5 mg tablet would be used for precise dose adjustments, for very low-weight patients, or when higher doses require multiple tablets.
Elderly
Elderly patients may require reduced doses and careful monitoring due to potential decreased renal and hepatic function.
Renal_impairment
Dose reduction is necessary in patients with impaired renal function to avoid accumulation and toxicity.
How to Take
Administer orally, with or without food, but consistently at the same time each day to maintain steady drug levels.
Mechanism of Action
Azathioprine is a purine analogue that acts as an antimetabolite. It interferes with nucleic acid synthesis, thereby inhibiting the proliferation of rapidly dividing cells, especially lymphocytes, to suppress the immune response.
Pharmacokinetics
Onset
Immunosuppressive effects may take several weeks to months to become fully apparent.
Excretion
Primarily excreted in the urine, mainly as metabolites.
Half life
The plasma half-life of azathioprine is short (3-5 hours), but its active metabolites have longer and more sustained effects.
Absorption
Well absorbed orally, with bioavailability ranging from 40% to 70%. Peak plasma concentrations of azathioprine occur within 1-2 hours.
Metabolism
Extensively metabolized in the liver to 6-mercaptopurine (6-MP), which is then further metabolized by various enzymes, including thiopurine methyltransferase (TPMT) and xanthine oxidase.
Side Effects
Contraindications
- Hypersensitivity to azathioprine or any component of the formulation
- Severe infection
- Pancreatitis
- Pregnancy (relative contraindication, benefits must outweigh risks)
Drug Interactions
Warfarin
May alter anticoagulant effects, requiring closer INR monitoring.
Allopurinol
Significantly increases azathioprine levels; azathioprine dose must be reduced to 25% of the original dose.
Live vaccines
Concurrent use is contraindicated due to the risk of severe infection in immunosuppressed patients.
ACE inhibitors (e.g., Captopril)
Increased risk of hematologic toxicity, particularly leukopenia.
Aminosalicylates (e.g., Mesalazine)
May inhibit TPMT, increasing the risk of myelosuppression.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe myelosuppression, liver dysfunction, and increased susceptibility to infections. Management is supportive, involving frequent monitoring of blood counts and liver function, and appropriate treatment of infections.
Pregnancy & Lactation
Azathioprine is Category D in pregnancy. It should be avoided during pregnancy and lactation unless the potential benefits outweigh the risks. Women of childbearing potential should use effective contraception.
Side Effects
Contraindications
- Hypersensitivity to azathioprine or any component of the formulation
- Severe infection
- Pancreatitis
- Pregnancy (relative contraindication, benefits must outweigh risks)
Drug Interactions
Warfarin
May alter anticoagulant effects, requiring closer INR monitoring.
Allopurinol
Significantly increases azathioprine levels; azathioprine dose must be reduced to 25% of the original dose.
Live vaccines
Concurrent use is contraindicated due to the risk of severe infection in immunosuppressed patients.
ACE inhibitors (e.g., Captopril)
Increased risk of hematologic toxicity, particularly leukopenia.
Aminosalicylates (e.g., Mesalazine)
May inhibit TPMT, increasing the risk of myelosuppression.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe myelosuppression, liver dysfunction, and increased susceptibility to infections. Management is supportive, involving frequent monitoring of blood counts and liver function, and appropriate treatment of infections.
Pregnancy & Lactation
Azathioprine is Category D in pregnancy. It should be avoided during pregnancy and lactation unless the potential benefits outweigh the risks. Women of childbearing potential should use effective contraception.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date, check specific packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Ongoing clinical trials explore new indications for azathioprine, combination therapies, and long-term safety profiles in various patient populations and autoimmune conditions.
Lab Monitoring
- Complete Blood Count (CBC) with differential: Weekly or bi-weekly initially, then monthly, to monitor for myelosuppression.
- Liver Function Tests (LFTs): Regularly to monitor for hepatotoxicity.
- TPMT enzyme activity: Recommended before initiation of therapy to guide dosing and reduce toxicity risk.
Doctor Notes
- Strictly monitor CBC and LFTs, especially during the initial months of therapy and after any dose adjustments.
- Consider TPMT genotyping/phenotyping prior to initiation to minimize toxicity risk.
- Educate patients on the signs of infection, myelosuppression, and malignancy, emphasizing the importance of sun protection and adherence to follow-up appointments.
- Adjust dosage cautiously in patients with renal or hepatic impairment.
Patient Guidelines
- Report any signs of infection (fever, chills, sore throat), unusual bleeding or bruising, yellowing of skin/eyes, or severe abdominal pain immediately to your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor.
- Avoid exposure to sick people and practice good hygiene to reduce infection risk.
- Use sun protection (sunscreen, protective clothing) as azathioprine can increase the risk of skin cancer.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Azathioprine generally does not impair the ability to drive or operate machinery. However, if you experience side effects like dizziness or extreme fatigue, avoid these activities.
Lifestyle Advice
- Maintain a healthy diet and lifestyle. Avoid live vaccines. Limit alcohol intake.
- Regular follow-up with your doctor is crucial for monitoring and dose adjustment.
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