Crilomus
Generic Name
Tacrolimus 1 mg Capsule
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| crilomus 1 mg capsule | ৳ 50.00 | ৳ 500.00 |
Description
Overview of the medicine
Crilomus 1 mg capsule contains Tacrolimus, an immunosuppressant medication used to prevent organ rejection in transplant patients.
Uses & Indications
Dosage
Adults
Highly individualized, typically 0.075-0.3 mg/kg/day orally in two divided doses. Adjusted based on trough blood levels.
Elderly
Similar to adults, but cautious dosing and monitoring are advised due to potential for impaired renal or hepatic function.
Renal_impairment
No specific dosage adjustment for renal impairment, but careful monitoring of blood levels is essential.
How to Take
Orally, usually twice daily, preferably on an empty stomach 1 hour before or 2-3 hours after a meal. Swallow capsules whole.
Mechanism of Action
Tacrolimus acts as a calcineurin inhibitor, preventing T-lymphocyte activation and proliferation, thereby suppressing the immune response.
Pharmacokinetics
Onset
Not immediate, onset of immunosuppression usually occurs within days.
Excretion
Primarily excreted in feces, small amount in urine.
Half life
Approximately 12-18 hours (variable).
Absorption
Variable and incomplete oral absorption, influenced by food. Peak plasma concentrations reached in 1-3 hours.
Metabolism
Extensively metabolized in the liver (CYP3A4) and intestine.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole)
Drug Interactions
CYP3A4 Inducers (e.g., Rifampin, Phenytoin)
Decrease tacrolimus blood levels, reducing efficacy. Dose adjustment may be necessary.
Nephrotoxic agents (e.g., Aminoglycosides, NSAIDs)
Increased risk of nephrotoxicity.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin)
Increase tacrolimus blood levels, increasing risk of toxicity. Dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include renal dysfunction, neurotoxicity (tremor, headache), and gastrointestinal disturbances. Management is supportive, no specific antidote. Hemodialysis is not effective.
Pregnancy & Lactation
Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to excretion in breast milk.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole)
Drug Interactions
CYP3A4 Inducers (e.g., Rifampin, Phenytoin)
Decrease tacrolimus blood levels, reducing efficacy. Dose adjustment may be necessary.
Nephrotoxic agents (e.g., Aminoglycosides, NSAIDs)
Increased risk of nephrotoxicity.
CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin)
Increase tacrolimus blood levels, increasing risk of toxicity. Dose adjustment may be necessary.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms may include renal dysfunction, neurotoxicity (tremor, headache), and gastrointestinal disturbances. Management is supportive, no specific antidote. Hemodialysis is not effective.
Pregnancy & Lactation
Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to excretion in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials support its efficacy and safety in organ transplantation. Ongoing studies explore new indications and formulations.
Lab Monitoring
- Tacrolimus trough blood levels
- Kidney function tests (creatinine, BUN)
- Liver function tests (ALT, AST)
- Electrolytes (potassium, magnesium)
- Blood glucose
- Complete blood count
Doctor Notes
- Monitor tacrolimus trough levels closely, especially during initiation and dose adjustments.
- Assess renal and liver function regularly.
- Educate patients on the importance of adherence and signs of infection/rejection.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not change dose or stop medication without consulting your doctor.
- Report any unusual symptoms or side effects immediately.
Missed Dose Advice
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose.
Driving Precautions
May cause visual disturbances or neurological side effects (e.g., tremor, dizziness) that could impair ability to drive or operate machinery. Exercise caution.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid exposure to direct sunlight and use sunscreen.
- Avoid grapefruit and grapefruit juice.
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