Tacromus
Generic Name
Tacrolimus 1 mg capsule
Manufacturer
Generic Pharmaceuticals
Country
Global / Various
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tacromus 1 mg capsule | ৳ 50.00 | ৳ 500.00 |
Description
Overview of the medicine
Tacrolimus is an immunosuppressant medication used to prevent rejection of transplanted organs (e.g., kidney, liver, heart). It works by decreasing the activity of the body's immune system.
Uses & Indications
Dosage
Adults
Initial dosage typically 0.05-0.2 mg/kg/day orally, administered in two divided doses (every 12 hours). Doses are adjusted based on whole blood trough concentrations and clinical response.
Elderly
Similar to adults, but close monitoring of renal and hepatic function is advised due to potential age-related decline in these functions.
Renal_impairment
No specific dose adjustment is generally required, but close monitoring of tacrolimus trough levels and renal function is essential due to potential for nephrotoxicity.
How to Take
Take orally, usually twice daily, on an empty stomach (at least 1 hour before or 2-3 hours after meals) to ensure consistent absorption. Swallow the capsule whole with water; do not chew or crush.
Mechanism of Action
Tacrolimus acts as a calcineurin inhibitor. It binds to the immunophilin FKBP-12, forming a complex that inhibits calcineurin. This inhibition prevents the dephosphorylation of NFAT (Nuclear Factor of Activated T-cells), thereby blocking the transcription of genes encoding various cytokines (e.g., IL-2, IL-3, IFN-gamma) and ultimately suppressing T-lymphocyte activation and proliferation.
Pharmacokinetics
Onset
Immunosuppressive effects begin within hours to days, but full therapeutic effect and steady-state levels require several days.
Excretion
Primarily excreted in feces (approximately 92%) via biliary excretion, with only a small amount (<1%) excreted in urine.
Half life
Terminal elimination half-life averages 12-24 hours, but can vary widely (e.g., 7-49 hours).
Absorption
Incomplete and variable oral absorption (typically 20-25%). Food, especially high-fat meals, can decrease absorption. Peak concentrations reached in 1-3 hours.
Metabolism
Extensively metabolized by the cytochrome P450 3A (CYP3A) enzyme system in the liver and intestinal wall. Significant first-pass metabolism.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation.
- Hypersensitivity to other macrolides (e.g., sirolimus).
Drug Interactions
Live vaccines
Avoid due to immunosuppression.
Potassium-sparing diuretics (e.g., spironolactone)
Increased risk of hyperkalemia.
Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B)
Increased risk of nephrotoxicity.
CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
Can significantly decrease tacrolimus blood levels, requiring dose increase and close monitoring.
CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, diltiazem, verapamil, protease inhibitors)
Can significantly increase tacrolimus blood levels, requiring dose reduction and close monitoring.
Storage
Store below 25°C to 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include severe nephrotoxicity, neurotoxicity, and gastrointestinal effects. Treatment is supportive and symptomatic; tacrolimus is not dialyzable. Monitor blood levels and manage specific toxicities.
Pregnancy & Lactation
Pregnancy Category C. Tacrolimus can cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation.
- Hypersensitivity to other macrolides (e.g., sirolimus).
Drug Interactions
Live vaccines
Avoid due to immunosuppression.
Potassium-sparing diuretics (e.g., spironolactone)
Increased risk of hyperkalemia.
Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B)
Increased risk of nephrotoxicity.
CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
Can significantly decrease tacrolimus blood levels, requiring dose increase and close monitoring.
CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, diltiazem, verapamil, protease inhibitors)
Can significantly increase tacrolimus blood levels, requiring dose reduction and close monitoring.
Storage
Store below 25°C to 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include severe nephrotoxicity, neurotoxicity, and gastrointestinal effects. Treatment is supportive and symptomatic; tacrolimus is not dialyzable. Monitor blood levels and manage specific toxicities.
Pregnancy & Lactation
Pregnancy Category C. Tacrolimus can cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; therefore, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the product packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of tacrolimus in preventing organ rejection across various solid organ transplant types. Ongoing research explores its use in new indications, long-term outcomes, and optimizing individualized therapy.
Lab Monitoring
- Tacrolimus whole blood trough levels (critical for dose adjustment).
- Renal function tests (serum creatinine, BUN).
- Liver function tests (ALT, AST, bilirubin).
- Electrolytes (potassium, magnesium, phosphorus).
- Blood glucose levels (risk of post-transplant diabetes mellitus).
- Blood pressure.
- Complete Blood Count (CBC).
Doctor Notes
- Therapeutic drug monitoring (TDM) of tacrolimus whole blood trough levels is crucial for safe and effective dosing.
- Individualize dosing based on patient response, tolerability, and blood concentrations.
- Be vigilant for drug interactions, especially with CYP3A4 inhibitors/inducers and nephrotoxic agents.
- Educate patients on the importance of consistent dosing and adherence to monitoring schedules.
Patient Guidelines
- Take your medication at the same time each day to maintain consistent blood levels.
- Do not change your dose or stop taking tacrolimus without consulting your doctor.
- Avoid grapefruit and grapefruit juice while on this medication.
- Report any new or worsening side effects immediately to your healthcare provider.
- Regular blood tests and doctor's appointments are crucial.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Tacrolimus may cause neurological symptoms such as tremor, headache, dizziness, or visual disturbances. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Protect yourself from direct sunlight and UV light due to increased risk of skin cancer; use sunscreen and protective clothing.
- Maintain good personal hygiene to reduce the risk of infections.
- Avoid live vaccines.
- Discuss all other medications, including over-the-counter drugs, herbal products, and supplements, with your doctor.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Tacromus Brand
Other medicines available under the same brand name
