Epzicom (Abacavir Sulfate / Lamivudine) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

EPZICOM

No clinically significant changes to pharmacokinetic parameters were observed for abacavir or lamivudine when administered together.

Abacavir

Abacavir has no effect on the pharmacokinetic properties of ethanol. Ethanol decreases the elimination of abacavir causing an increase in overall exposure (see CLINICAL PHARMACOLOGY: Drug Interactions).

The addition of methadone has no clinically significant effect on the pharmacokinetic properties of abacavir. In a study of 11 HIV-infected patients receiving methadone-maintenance therapy (40 mg and 90 mg daily), with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased 22% (90% CI 6% to 42%). This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.

Lamivudine

Trimethoprim (TMP) 160 mg/sulfamethoxazole (SMX) 800 mg once daily has been shown to increase lamivudine exposure (AUC). No change in dose of either drug is recommended. The effect of higher doses of TMP/SMX on lamivudine pharmacokinetics has not been investigated (see CLINICAL PHARMACOLOGY).

Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of EPZICOM in combination with zalcitabine is not recommended.

See CLINICAL PHARMACOLOGY for additional drug interactions.

OVERDOSAGE

Abacavir

There is no known antidote for abacavir. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

Lamivudine

One case of an adult ingesting 6 grams of lamivudine was reported; there were no clinical signs or symptoms noted and hematologic tests remained normal. It is not known whether lamivudine can be removed by peritoneal dialysis or hemodialysis.

CONTRAINDICATIONS

EPZICOM Tablets are contraindicated in patients with previously demonstrated hypersensitivity to abacavir or to any other component of the product (see WARNINGS). Following a hypersensitivity reaction to abacavir, NEVER restart EPZICOM or any other abacavir-containing product. Fatal rechallenge reactions have been associated with readministration of abacavir to patients with a prior history of a hypersensitivity reaction to abacavir (see WARNINGS and PRECAUTIONS).

EPZICOM Tablets are contraindicated in patients with hepatic impairment (see CLINICAL PHARMACOLOGY).