Amtrac-1 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Warnings Special Precautions Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tacrolimus

Indications/Uses

Prevent or manage rejection in patients receiving organ transplants.

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Dosage/Direction for Use

Adult Rejection prophylaxis for kidney transplant patients Initially 0.2 mg/kg/day every 12 hr in 2 divided doses. Liver transplant patients Initially 0.1-0.15 mg/kg/day every 12 hr. Heart transplant patients Initially 0.075 mg/kg/day every 12 hr in 2 divided doses. Doses as high as 0.3 mg/kg/day administered every 12 hr in 2 divided doses may be appropriate. Childn (for organ transplant) Rejection reversal liver transplant Initially 0.15-0.2 mg/kg/day divided every 12 hr. Heart transplant Initially 0.1-0.3 mg/kg/day divided every 12 hr. Kidney transplant Initially 0.2-0.3 mg/kg/day divided every 12 hr.

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Administration

Should be taken on an empty stomach: Take at least 1 hr before or 2-3 hr after meals. Consume immediately once removed from blister.

Contraindications

Hypersensitivity.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Amtrac-1 detailed prescribing information

Special Precautions

Increased risk of lymphoma & other malignancies, particularly of the skin due to immunosuppression. Increased susceptibility to bacterial, viral, fungal, & protozoal infections, including opportunistic infections. Mild or moderate HTN. Avoid K-sparing diuretics. Hepatic & renal impairment. Pregnancy & lactation.

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Adverse Reactions

Infection, tremor, headache, HTN, abnormal renal function, insomnia, nausea, hypomagnesemia, UTI, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, anemia. Kidney transplant: Constipation, diarrhea, headache, abdominal pain. Liver transplant: Paresthesia, fever, hyperglycemia. Heart transplant: DM, CMV infection, hyperglycemia, leukopenia, bronchitis, pericardial effusion, hyperlipemia.

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Drug Interactions

Drugs associated w/ renal dysfunctions eg, aminoglycosides, amphotericin B & cisplatin. Additive/synergistic nephrotoxicity w/ cyclosporine.

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Storage

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Description

View Amtrac-1 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Immunosuppressants

ATC Classification

L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.

Regulatory Classification

Presentation/Packing

Form

Amtrac-1 cap 1 mg

Packing/Price

10's

Amtrac-1

tacrolimus

Manufacturer:

AMN Life Science

Distributor:

Multicare