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The extended-release tacrolimus formulation Astagraf XL is not indicated for use in liver transplant recipients due to an increased 12-month mortality rate in female patients who received Astagraf XL compared with immediate-release capsules Prograf in a randomized, clinical trial.
The safety and efficacy of extended-release capsules Astagraf XL have not been established in pediatric patients less than 16 years of age. The safety and efficacy of extended-release tablets Envarsus XR have not been established in pediatric patients. The long-term effect of tacrolimus on the developing immune system in infants and children is not known.
Adjust dose, as needed, based on tacrolimus trough whole blood concentrations. The initial dose of tacrolimus should be administered no sooner than 6 hours after transplantation. NOTE: In patients unable to take oral tacrolimus, therapy may be initiated with tacrolimus injection. Continue continuous IV infusion only until the patient can tolerate oral administration. Give the first oral dose 8-12 hours after the IV infusion is stopped.
Protease Inhibitors Most protease inhibitors inhibit CYP3A enzymes and may increase tacrolimus whole blood concentrations. Monitoring of tacrolimus whole blood concentrations and tacrolimus-associated adverse reactions, and appropriate adjustments in the dosing regimen of tacrolimus are recommended when tacrolimus and protease inhibitors e. Azoles: Voriconazole, posaconazole, itraconazole, ketoconazole, fluconazole and clotrimazole inhibit CYP3A metabolism of tacrolimus and increase tacrolimus whole blood concentrations.
When initiating therapy with voriconazole or posaconazole in patients already receiving tacrolimus, it is recommended that the tacrolimus dose be initially reduced to one-third of the original dose and the subsequent tacrolimus doses be adjusted based on the tacrolimus whole blood concentrations. Caspofungin is an inducer of CYP3A and decreases whole blood concentrations of tacrolimus.
Calcium Channel Blockers Verapamil, diltiazem, nifedipine, and nicardipine inhibit CYP3A metabolism of tacrolimus and may increase tacrolimus whole blood concentrations.
Monitoring of whole blood concentrations and appropriate dosage adjustments of tacrolimus are recommended when these calcium channel blocking drugs and tacrolimus are used concomitantly. Antibacterials Erythromycin, clarithromycin, troleandomycin and chloramphenicol inhibit CYP3A metabolism of tacrolimus and may increase tacrolimus whole blood concentrations.
Monitoring of blood concentrations and appropriate dosage adjustments of tacrolimus are recommended when these drugs and tacrolimus are used concomitantly. Monitoring of whole blood concentrations and appropriate dosage adjustments of tacrolimus are recommended when these antimycobacterial drugs and tacrolimus are used concomitantly.
Anticonvulsants Phenytoin, carbamazepine and phenobarbital induce CYP3A enzymes and may decrease tacrolimus whole blood concentrations. Monitoring of whole blood concentrations and appropriate dosage adjustments of tacrolimus are recommended when these drugs and tacrolimus are used concomitantly. Concomitant administration of phenytoin with tacrolimus may also increase phenytoin plasma concentrations. Thus, frequent monitoring phenytoin plasma concentrations and adjusting the phenytoin dose as needed are recommended when tacrolimus and phenytoin are administered concomitantly.
Monitoring of whole blood concentrations and appropriate dosage adjustments of tacrolimus are recommended when St.
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Your may have some of these side effects while on Tacrolimus. Check with your doctor if you continue to have any of these side effects and they do not go away:What are precautionary measures I should take while taking Tacrolimus. Tacrolimus weakens your immune system, which increases chances of getting an infection. Make sure to cover your skin while outside. You should also use sunscreen with an SPF of 30 or higher to prevent sunburn.
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ExcretionFollowing intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
In rats, tacrolimus caused toxic effects to the nervous system and the eyes. Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus. Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
In rats, female reproductive function including birth was impaired at toxic dosages and the offspring showed reduced birth weights, viability and growth. Tubing, syringes and other equipment used to prepare or administer a suspension of Prograf capsule contents should not contain PVC. Store in the original package in order to protect from moisture.
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Closely monitor renal function and adjust telavancin doses based on calculated creatinine clearance.
Do not take this medication if you are allergic to tacrolimus or any ingredients of the medication.
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The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Infections Difficulty in sleeping insomnia Shaking, usually of the hands tremor Headache High blood pressure hypertension Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain Skin reactions such as rash, itch, acne, sweating, hair loss Raised blood sugar level hyperglycaemia Raised cholesterol level hypercholesterolaemia Disturbances in the normal levels of chemical components electrolytes in the blood, eg raised potassium, decreased sodium, magnesium, calcium Disturbances in the normal levels of blood cells in the blood Shortness of breath dyspnoea Appetite and weight changes Pain in the muscles or joints Visual disturbances Anxiety and agitation Confusion Depression Dizziness Pins and needles or numb sensations Seizures Heart problems such as abnormal heart beats, enlargement of the heart, heart failure Kidney problems such as decreased ki dney function or kidney failure Liver problems such as jaundice, hepatitis, liver failure Ulceration or bleeding in the gut Bleeding Abnormal blood clots in the blood vessels thromboembolism The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines.
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When a person has a liver, kidney, or heart transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too.
Anagrelide: Torsades de pointes TdP and ventricular tachycardia have been reported during post-marketing use of anagrelide.