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Zovirax Side Effects, and Drug Interactions - Acyclovir (Injectable)

Zovirax Side Effects, and Drug Interactions - Acyclovir (Injectable)

SIDE EFFECTS

The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at 300 patients who received daily.

The most frequent adverse reactions reported during acyclovir administration were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine of BUN in 5% to 10% (the higher incidence occurred usually following rapid (less than 10 minutes) intravenous infusion). Nausea and/or vomiting occurred in approximately 7% of the patients (the majority occurring in nonhospitalized patients who received 10 mg/kg). Itching, rash or hives occurred in approximately 2% of patients. Elevation of transaminases occurred in 1-2% of patients.

Approximately 1% of patients receiving intravenous acyclovir have manifested encephalopathic changes characterized by either lethargy, obtundation, tremors, confusion, hallucinations, agitation, seizures or coma see PRECAUTIONS.

Adverse reactions which occurred at a frequency of less than 1% and which were probably or possibly related to intravenous acyclovir administration were: anemia, anuria, hematuria, hypotension, edema, anorexia, lightheadedness, thirst, headache, diaphoresis, fever, neutropenia, thrombocytopenia, abnormal urinalysis (characterized by an increase in formed elements in urine sediment) and pain on urination.

Other reactions have been reported with a frequency of less than 1% in patients receiving acyclovir, but a causal relationship between acyclovir and the reaction could not be determined. These include pulmonary edema with cardiac tamponade, abdominal pain, chest pain, thrombocytosis, leukocytosis, neutrophilia, ischemia of digits, hypokalemia, purpura fulminans, pressure on urination, hemoglobinemia and rigors.

Observed During Clinical Practice

Based on clinical practice experience in patients treated with acyclovir sterile powder in the U.S., spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as proof of underlaying disease process. Voluntary reports of adverse events which have been received since market introduction include:

    General: fever, pain, and rarely, anaphylaxis

    Digestive: elevated liver function tests, nausea

    Hemic and Lymphatic: leukopenia

    Nervous: agitation, coma, confusion, convulsions, hallucinations, obtundation, psychosis

    Skin: rash

    Urogenital: elevated blood urea nitrogen, elevated creatinine, renal failure

DRUG INTERACTIONS

Co-administration of probenecid with acyclovir has been shown to increase the mean half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.36 The clinical effects of this combination have not been studied.

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