FDA label 4e677f4b-0520-4874-ba0d-72479918d782

WARNINGS Acyclovir for injection is intended for intravenous infusion only, and should not be administered topically, intramuscularly, orally, subcutaneously, or in the eye. Intravenous infusions must be given over a period of at least 1 hour to reduce the risk of renal tubular damage (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS : Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

ADVERSE REACTIONS The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at ~ 5 mg/kg (250 mg/m 2 ) three times daily, and approximately 300 patients who received ~ 10 mg/kg (500 mg/m 2 ) three times daily. The most frequent adverse reactions reported during administration of acyclovir were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine or 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% to 2% of patients. The following hematologic abnormalities occurred at a frequency of less than 1%: anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia. In addition, anorexia and hematuria were observed. Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir for injection in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. General Anaphylaxis, angioedema, fatigue, fever, headache, pain, peripheral edema. Digestive Abdominal pain, diarrhea, gastrointestinal distress, nausea. Cardiovascular Hypotension. Hemic and Lymphatic Disseminated intravascular coagulation, hemolysis, leukocytolastic vasculitis, leukopenia, lymphadenopathy. Hepatobiliary Tract and Pancreas Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Musculoskeletal Myalgia. Nervous Aggressive behavior, agitation, ataxia, coma, confusion, delirium, dizziness, dysarthria, encephalopathy, hallucinations, obtundation, paresthesia, psychosis, seizure, somnolence, tremor. These symptoms may be marked, particularly in older adults (see PRECAUTIONS ). Skin Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Severe local inflammatory reactions including tissue necrosis, have occurred following infusion of acyclovir into extravascular tissues. Special Senses Visual abnormalities Urogenital Renal failure, elevated blood urea nitrogen, elevated creatinine (see WARNINGS ).