Sonexa
Generic Name
Tacrolimus
Manufacturer
Various generic manufacturers (e.g., Incepta Pharmaceuticals Ltd.)
Country
Bangladesh (common for generic brands)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sonexa 6 mg injection | ৳ 36.00 | N/A |
Description
Overview of the medicine
Sonexa 6 mg Injection contains Tacrolimus, an immunosuppressant used to prevent and treat organ rejection in patients who have received a transplant (e.g., kidney, liver, heart). It helps to lower the body's immune response to the new organ.
Uses & Indications
Dosage
Adults
Initial intravenous dose is typically 0.01-0.05 mg/kg/day as a continuous infusion, adjusted based on individual patient response and tacrolimus blood trough levels. Usually converted to oral formulation as soon as possible.
Elderly
No specific dose adjustments are typically required for elderly patients, but close monitoring of renal function and tacrolimus blood levels is recommended.
Renal_impairment
No specific dose adjustment is needed for renal impairment, but careful monitoring of tacrolimus blood levels and renal function is crucial due to potential nephrotoxicity.
How to Take
Sonexa 6 mg Injection is for intravenous use only. It should be administered as a continuous intravenous infusion over 24 hours. It must be diluted prior to use with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a concentration between 0.005 mg/mL and 0.02 mg/mL. The patient should be switched to oral tacrolimus as soon as feasible.
Mechanism of Action
Tacrolimus is a calcineurin inhibitor. It acts by inhibiting the T-lymphocyte activation by binding to an intracellular protein, FKBP-12. The Tacrolimus-FKBP-12 complex then inhibits calcineurin, which normally dephosphorylates NFAT (Nuclear Factor of Activated T-cells). Inhibition of calcineurin prevents the transcription of cytokine genes, leading to reduced T-cell proliferation and thus immunosuppression.
Pharmacokinetics
Onset
Rapid when administered intravenously, typically within minutes of infusion start.
Excretion
Primarily excreted in the feces, with a minor amount excreted in the urine. Less than 1% is excreted as unchanged drug.
Half life
The elimination half-life is highly variable, ranging from approximately 12 to 36 hours in adult transplant patients, and can be prolonged in patients with hepatic impairment.
Absorption
Administered intravenously, tacrolimus injection has 100% bioavailability. Peak concentrations are achieved rapidly.
Metabolism
Extensively metabolized in the liver and intestine primarily by the cytochrome P450 3A4 (CYP3A4) isoenzyme.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation.
- Hypersensitivity to HCO-60 (polyoxyethylenated hydrogenated castor oil) in some IV formulations.
Drug Interactions
Potassium-sparing diuretics, ACE inhibitors, ARBs
Increased risk of hyperkalemia. Monitor potassium levels.
Nephrotoxic drugs (e.g., cyclosporine, aminoglycosides)
Increased risk of nephrotoxicity. Avoid concomitant use or monitor renal function closely.
CYP3A4 Inducers (e.g., rifampin, phenytoin, St. John's Wort)
Can decrease tacrolimus blood levels, reducing efficacy. Dose increase of tacrolimus may be necessary.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, diltiazem)
Can increase tacrolimus blood levels, increasing risk of toxicity. Dose reduction of tacrolimus may be necessary.
Storage
Store at room temperature (20-25°C), excursions permitted to 15-30°C. Protect from light. Do not refrigerate or freeze. Diluted solutions should be used within 24 hours.
Overdose
Limited information on tacrolimus overdose. Symptoms may include exaggerated side effects such as nephrotoxicity, neurotoxicity, and infections. Management is supportive, involving discontinuation of the drug, monitoring vital signs, electrolyte balance, and renal/hepatic function. Hemodialysis is not effective due to high protein binding and extensive metabolism.
Pregnancy & Lactation
Pregnancy Category C. Tacrolimus can cause fetal harm (e.g., renal dysfunction, hyperkalemia, neurological effects). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tacrolimus is excreted in breast milk and can cause serious adverse reactions in nursing infants. Breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to tacrolimus or any component of the formulation.
- Hypersensitivity to HCO-60 (polyoxyethylenated hydrogenated castor oil) in some IV formulations.
Drug Interactions
Potassium-sparing diuretics, ACE inhibitors, ARBs
Increased risk of hyperkalemia. Monitor potassium levels.
Nephrotoxic drugs (e.g., cyclosporine, aminoglycosides)
Increased risk of nephrotoxicity. Avoid concomitant use or monitor renal function closely.
CYP3A4 Inducers (e.g., rifampin, phenytoin, St. John's Wort)
Can decrease tacrolimus blood levels, reducing efficacy. Dose increase of tacrolimus may be necessary.
CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin, diltiazem)
Can increase tacrolimus blood levels, increasing risk of toxicity. Dose reduction of tacrolimus may be necessary.
Storage
Store at room temperature (20-25°C), excursions permitted to 15-30°C. Protect from light. Do not refrigerate or freeze. Diluted solutions should be used within 24 hours.
Overdose
Limited information on tacrolimus overdose. Symptoms may include exaggerated side effects such as nephrotoxicity, neurotoxicity, and infections. Management is supportive, involving discontinuation of the drug, monitoring vital signs, electrolyte balance, and renal/hepatic function. Hemodialysis is not effective due to high protein binding and extensive metabolism.
Pregnancy & Lactation
Pregnancy Category C. Tacrolimus can cause fetal harm (e.g., renal dysfunction, hyperkalemia, neurological effects). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tacrolimus is excreted in breast milk and can cause serious adverse reactions in nursing infants. Breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to the specific product packaging for exact expiry date.
Availability
Hospitals, Transplant Centers, Specialty Pharmacies
Approval Status
FDA Approved (for Tacrolimus)
Patent Status
Off-patent (compound), specific formulations may vary
WHO Essential Medicine
YesClinical Trials
Tacrolimus has undergone extensive clinical trials demonstrating its efficacy and safety in preventing and treating organ rejection across various transplant types (kidney, liver, heart, lung, pancreas). Studies have compared it with other immunosuppressants and evaluated its long-term outcomes, including patient and graft survival, and adverse event profiles.
Lab Monitoring
- Tacrolimus trough blood levels (regularly)
- Renal function (serum creatinine, BUN)
- Liver function tests (AST, ALT, bilirubin)
- Electrolytes (potassium, magnesium)
- Blood glucose levels
- Complete Blood Count (CBC)
- Blood pressure monitoring
Doctor Notes
- Tacrolimus is a critical immunosuppressant requiring strict adherence to dosing and meticulous monitoring of blood levels to balance efficacy and toxicity.
- Be vigilant for signs of infection, nephrotoxicity, neurotoxicity, and new-onset diabetes.
- Counsel patients on drug-drug and drug-food interactions, especially grapefruit.
- Consider pharmacogenomic testing (CYP3A5) to optimize initial dosing, particularly in specific ethnic populations.
Patient Guidelines
- Follow your doctor's instructions meticulously regarding dosing and administration.
- Do not stop or change your dose without consulting your transplant team.
- Attend all scheduled blood tests and follow-up appointments to monitor drug levels and potential side effects.
- Report any signs of infection (fever, chills, sore throat) or unusual symptoms immediately.
- Avoid grapefruit and grapefruit juice, as they can interact with tacrolimus.
Missed Dose Advice
As this is a hospital-administered injection crucial for immunosuppression, a missed dose should be immediately reported to the healthcare provider. Maintaining consistent blood levels is vital to prevent organ rejection.
Driving Precautions
Tacrolimus can cause neurological side effects such as tremors, headaches, and visual disturbances, which may impair your ability to drive or operate machinery. Exercise caution and assess your response to the medication before engaging in such activities.
Lifestyle Advice
- Maintain good personal hygiene to reduce the risk of infection.
- Avoid crowded places and contact with people who are sick, especially during the initial post-transplant period.
- Discuss any vaccinations with your doctor, as live vaccines are generally contraindicated.
- Protect your skin from sun exposure to reduce the risk of skin cancer.
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