Tacrobell (1mg) 50 Capsules

Tacrolimus, the active ingredient in Tacrolimus Capsules, exerts its immunosuppressive effects primarily by inhibiting the production and activation of T lymphocytes. It selectively binds to the intracellular protein, FK-binding protein 12 (FKBP12), creating a complex that then inhibits calcineurin, a calcium-dependent phosphatase enzyme. This inhibition prevents the dephosphorylation of the transcription factor NF-AT (nuclear factor of activated T-cells), which is essential for the transcription of several genes involved in T-cell activation, such as interleukin-2 (IL-2). By blocking the signal transduction pathway at the level of calcineurin, Tacrolimus suppresses the production of IL-2 and other cytokines, thereby inhibiting T-cell activation and proliferation. This mechanism is crucial in preventing the rejection of transplanted organs by modulating the immune response.

Immunosuppressant.

Capsule

The following are the uses of Tacrolimus Capsule:

• Used for preventing organ rejection after a liver, kidney, or heart transplant.
• Used for treating severe atopic dermatitis (a type of eczema) in adults and children when other treatments have not worked well.
• Used for preventing rejection in kidney transplant patients when other medications are not suitable.
• Used for treating graft-versus-host disease (a complication after bone marrow transplant).
• Used for managing rheumatoid arthritis when other treatments have not been effective.
• Used for controlling severe asthma in specific cases where standard therapies are insufficient.
• Used for treating ulcerative colitis, an inflammatory bowel disease, when other medications are not tolerated.

In the case of an overdose of Tacrolimus Capsules, it is important to recognize the signs and take prompt action. Symptoms may include nausea, vomiting, severe diarrhea, and potential kidney damage. If an overdose is suspected, seek medical advice immediately. Do not induce vomiting unless instructed by a healthcare professional, as this can worsen the situation. Prompt medical intervention is vital to manage the overdose and minimize potential harm to the patient.

In the case of a missed dose of Tacrolimus Capsule, it is important to take the medication as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. If you miss multiple doses, contact your healthcare professional for advice, as they may recommend adjusting your dosage or provide specific instructions to ensure you receive the correct amount of medication.

To take Tacrolimus Capsule, swallow the capsule whole with a full glass of water, preferably at the same time each day, following the dosage instructions provided by your healthcare professional, and avoid opening, crushing, or chewing the capsule for optimal absorption.

Here are the conditions and situations when Tacrolimus Capsule should not be taken:

• Do not take if you are allergic to Tacrolimus or any of the excipients in the capsule.
• Contraindicated in patients with a known hypersensitivity to macrolide antibiotics.
• Should not be used in patients with a history of liver disease or impaired liver function.
• Not recommended for individuals with a current or recent history of kidney disease.
• Avoid using if you have a gastrointestinal obstruction or severe gastrointestinal conditions.
• Do not take this medication if you have a history of prolonged QT interval or are taking other medications that can prolong the QT interval.
• Contraindicated in patients with a history of systemic fungal infections.
• Should not be used in patients with a history of severe skin reactions or allergies to similar medications.
• Not suitable for individuals with a history of lymphoma or other malignancies.

The side effects of Tacrolimus Capsule may include:

• Tremors or shaking
• Headache
• Nausea and vomiting
• Diarrhea
• High blood pressure (hypertension)
• Kidney problems
• Increased hair growth
• Skin rash or itching

Following are the precautions and warnings for Tacrolimus Capsule:

• Tacrolimus Capsules should be used with caution in patients with a history of liver or kidney disease as it can affect the metabolism and elimination of the drug.
• Regular monitoring of blood levels of tacrolimus is essential to ensure the appropriate dosage and to avoid potential toxicity.
• Patients should be closely monitored for signs of infection as Tacrolimus Capsules can weaken the immune system, making them more susceptible to infections.
• Avoid the use of live vaccines in patients receiving Tacrolimus Capsules as it may interfere with the immune response to the vaccine.
• This medication may cause high blood pressure, and blood pressure should be monitored regularly during treatment.
• Caution is advised in patients with diabetes as Tacrolimus Capsules can affect blood sugar levels.
• Do not consume grapefruit or grapefruit juice while taking Tacrolimus Capsules as it can affect the absorption and metabolism of the drug.
• Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as Tacrolimus Capsules may have potential risks for the fetus or infant.

Following are the drug interactions for Tacrolimus Capsule:

• Avoid combining with strong CYP3A4 inhibitors like ketoconazole or clarithromycin, as it can significantly increase Tacrolimus blood levels, leading to toxicity.
• Grapefruit juice and other CYP3A4 inhibitors should be used cautiously as they may elevate Tacrolimus concentrations.
• Concomitant use with CYP3A4 inducers such as rifampin can decrease Tacrolimus levels, potentially reducing its effectiveness.
• Tacrolimus may increase the risk of nephrotoxicity when used with other nephrotoxic drugs like aminoglycosides or amphotericin B.
• Monitoring is necessary when used with other immunosuppressants like mycophenolate mofetil, as it may increase the risk of infection and other side effects.
• The risk of myopathy and rhabdomyolysis may increase when combined with statins, especially those metabolized by CYP3A4.
• Caution is advised with drugs that prolong the QT interval, as Tacrolimus may also affect cardiac repolarization.

Following are the food interactions for Tacrolimus Capsule:

• Avoid grapefruit and grapefruit juice as they can increase Tacrolimus blood levels, leading to potential toxicity.
• Alcohol consumption should be limited or avoided as it may affect liver function and increase the risk of side effects.
• High-fat meals can increase Tacrolimus absorption, potentially leading to elevated blood levels and increased side effects.
• Garlic supplements may decrease Tacrolimus blood levels, requiring monitoring and possible dosage adjustments.
• Vitamin C supplements can reduce Tacrolimus absorption, which might lower its effectiveness.
• Live or live-attenuated vaccines may not be as effective when taking Tacrolimus, and could potentially lead to infections.
• Herbal supplements like St. John's Wort can significantly decrease Tacrolimus levels, necessitating close monitoring.
• Always consult your healthcare provider about specific dietary restrictions and interactions.

Tacrolimus Capsules should be stored in a secure and designated area, away from direct sunlight, moisture, and extreme temperatures. Maintain a consistent room temperature environment for storage, ideally between 68°F and 77°F (20°C and 25°C). Keep the capsules in their original packaging, tightly sealed, to ensure their integrity and protect them from exposure to air and humidity. It is crucial not to store the medication in the bathroom or kitchen, as these areas may expose it to heat and moisture. Always check the expiration date, and never use the capsules beyond this date. When disposing of unused or expired Tacrolimus Capsules, do not flush them down the toilet or pour them into a drain. Instead, follow local guidelines or consult a pharmacist for safe disposal methods to protect the environment and prevent misuse. Keep the medication out of the reach of children and pets to prevent accidental ingestion.

Following are the quick tips for Tacrolimus Capsule:

• Swallow the capsule whole with a full glass of water; do not crush, chew, or break it.
• Take Tacrolimus Capsule at the same time each day to maintain consistent blood levels.
• Avoid grapefruit and grapefruit juice as they can affect the absorption of the medicine.
• Regular blood tests are necessary to monitor tacrolimus levels and kidney function.
• Inform your doctor about all medications you are taking to prevent potential drug interactions.
• Avoid live vaccines during treatment without consulting your doctor.
• Contact your doctor immediately if you experience any signs of infection or unusual bleeding.