Tacroren 0.5 mg 10 Capsules

Prescription status:

Prescription required

Manufacturer Name:

La Renon Healthcare Pvt Ltd

Drug classification:

Immunosuppressants

What is this used for:

• After organ transplant to reduce the activity of the patient's immune system
• Atopic dermatitis

When to not take this medicine:

• Hypersensitivity/Known Allergy to tacrolimus.

How should I take the medicine?

Take this medicine with an adequate amount of water as directed by the physician. Do not take this medicine in small or larger amounts than recommended.

How this medicine works:

This medicine helps in the treatment atopic dermatitis (skin becomes itchy and turns red)

Side effects

• Opportunistic infection (Common)
• Diabetes mellitus (Common)
• Headache (Common)
• Hyperglycemia (Common)
• Hyperkalemia (Common)
• Mental status changes (Common)
• Nephrotoxicity (Common)
• Blurred vision (Less common)
• chest pain (Less common)
• increased sensitivity to pain (Less common)
• muscle cramps (Less common)
• numbness or pain in the legs (Less common)
• ringing in the ears (Less common)
• Sweating (Less common)
• Enlarged heart (Rare)
• Flushing of the face or neck (Rare)
• Weight loss (Rare)

Pregnancy warning: 

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant the use of the drug in pregnant women despite potential risks.

Lactation warning:

Use of this medicine is not recommended for lactating and breastfeeding mothers unless absolutely necessary. Inform your doctor about the use of either medicine. All the risks and benefits should be discussed with the doctor before taking this medicine.

Renal dose adjustments:

Usually, while using this medicine, it may not require any renal dose adjustments as the dosage form is topical and it is used only on the affected area. In case, any unusual signs are observed it is good to inform your doctor immediately.

Hepatic dose adjustments:

Usually, while using this medicine, it may not require any hepatic dose adjustments as the dosage form is topical and it is used only on the affected area. In case, any unusual signs are observed it is good to inform your doctor immediately.

Drug interactions:

• Cyclosporine-Major

Inform your doctor about the use of either medicines. When these medicines are taken together it can cause serious side effects on your kidneys. Call your doctor if your experience fever, chills, body aches, flu symptoms, and severe pain in your upper stomach spreading to your back. Appropriate dose adjustments or suitable alternate medicine may be considered based on the condition.

• Ritonavir-Major

Inform your doctor about the use of either medicines. When these medicines are taken together it may increase the risk of serious side effects such as infections, lymphoma and other cancers, diabetes, kidney problems, nervous system disorders (mental status changes, seizures, visual disturbances, tremors, abnormal sensations such as burning, pricking, tingling or numbness), high blood pressure, heart problems. Inform the doctor, appropriate dose adjustments or suitable alternate medicine may be considered based on the condition.

• Apixaban-Moderate

Inform your doctor about the use of either medicines. When these medicines are taken together

Tacrolimus may increase the blood levels of apixaban, which may result in a higher risk of bleeding complications.  Inform the doctor, appropriate dose adjustments or suitable alternate medicine may be considered based on the condition.

• Trimethoprim-Moderate

Inform your doctor about the use of either medicines. When these medicines are taken together It may increase the risk of kidney and/or nerve damage. Inform the doctor, appropriate dose adjustments or suitable alternate medicine may be considered based on the condition.

• Insulin glargine-Moderate

Inform your doctor about the use of either medicines. When these medicines are taken together Tacrolimus may interfere with blood glucose control and reduce the effectiveness of insulin glargine and other diabetic medications. Monitor your blood sugar levels closely. Inform the doctor, appropriate dose adjustments or suitable alternate medicine may be considered based on the condition.

Alcohol interactions:

Consumption of alcohol is not recommended while receiving/taking this medicine as it may cause interactions and lead to serious adverse effects and may worsen the health condition.

Food interactions:

N/A

Expert Advice:

1. This medicine may be taken before or after food, according to the doctors advice.
2. This medicine is not recommended to use in patients below 2 years of age and it is indicated to use in children between 2 to 15 years of age.
3. This medicine is not recommended for long term use.
4. It is recommended to discuss with your doctor before using this medicine in patients with a known history of a weak immune system.
5. During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.

Missed dose instructions:

Take this medicine as soon as you remember. However, if it is almost time for your next dose skip the dose and go back to your regular dosing schedule. Do not double dose to make up for the missed dose.

Overdose Instructions:

Seek emergency treatment or contact your physician in case if you experience any unusual signs and symptoms during the treatment with this medicine.

Storage Instructions:

Store the medicine in a cool and dry place. Keep the medicine away from the reach of the children

Reference:

1. Adoport 0.5 mg Hard Capsules - Summary of Product Characteristics (SmPC) - (emc) [Internet]. Medicines.org.uk. 2020 [cited 19 November 2020]. Available from: https://www.medicines.org.uk/emc/product/585/smpc#CONTRAINDICATIONS
2. Tacrolimus [Internet]. Pubchem.ncbi.nlm.nih.gov. 2020 [cited 19 November 2020]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/tacrolimus

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Keep away from direct sunlight

Store in a dry place