Acyclovir Sodium 1000 mg/20mL
Acyclovir Sodium · INJECTION, SOLUTION · AuroMedics Pharma LLC
Acyclovir Sodium is an antiviral medication given by injection into the vein to treat serious herpes infections, including herpes simplex virus and varicella-zoster virus infections. This medication works by slowing the growth and spread of the virus in your body.
Key Facts
- Brand Name
- Acyclovir Sodium
- Generic Name
- Acyclovir Sodium
- NDC Code (Product)
55150-155- Manufacturer
- AuroMedics Pharma LLC
- Strength
- 1000 mg/20mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203701
- Marketing Start
- 10/11/2013
Recall History
Zydus Pharmaceuticals (USA) Inc
Crystallization: customer complaints for crystallization in finished product.
Eugia US LLC
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Zydus Pharmaceuticals (USA) Inc
Crystallization: customer complaints for crystallization in finished product.
AuroMedics Pharma LLC
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Herpes Simplex Infections in Immunocompromised Patients Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis Acyclovir Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients. Herpes Simplex Encephalitis Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Sodium Injection is indicated for the treatment of neonatal herpes infections. Varicella-Zoster Infections in Immunocompromised Patients Acyclovir Sodium Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.
Dosage & Administration
DOSAGE AND ADMINISTRATION CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS ). INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS ). Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient. Dosage HERPES SIMPLEX INFECTIONS MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 AND HSV-2) INFECTIONS IN IMMUNOCOMPROMISED PATIENTS Adults and Adolescents (12 years of age and older) 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days. Pediatrics (Under 12 years of age) 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days. SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS Adults and Adolescents (12 years of age and older) 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days. HERPES SIMPLEX ENCEPHALITIS Adults and Adolescents (12 years of age and older) 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days. Pediatrics (3 months to 12 years of age) 20 mg/kg infused at a constant rate over 1 hour, every 8 hours for…
Warnings
WARNINGS Acyclovir Sodium 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.
Contraindications
CONTRAINDICATIONS Acyclovir Sodium Injection is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Drug Interactions
Drug Interactions See CLINICAL PHARMACOLOGY, Pharmacokinetics .
Adverse Reactions
ADVERSE REACTIONS The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at approximately 5 mg/kg (250 mg/m 2 ) 3 times daily, and approximately 300 patients who received approximately 10 mg/kg (500 mg/m 2 ) 3 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 adv…
Frequently Asked Questions
What is Acyclovir Sodium used for?
Acyclovir Sodium is an antiviral medication given by injection into the vein to treat serious herpes infections, including herpes simplex virus and varicella-zoster virus infections. This medication works by slowing the growth and spread of the virus in your body.
Is Acyclovir Sodium a controlled substance?
Acyclovir Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Acyclovir Sodium?
The generic name for Acyclovir Sodium is Acyclovir Sodium. There are no other listed brand versions of Acyclovir Sodium.
What is the NDC code for Acyclovir Sodium 1000 mg/20mL?
The NDC (National Drug Code) for Acyclovir Sodium 1000 mg/20mL is 55150-155, listed by AuroMedics Pharma LLC.
Other Acyclovir Sodium Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)