Aciclovir Sodium Naprod Life Sciences

Aciclovir is an antiviral drug active against herpes viruses. Aciclovir Sodium for intravenous infusion B.P. is a Sterile Powder and it is a formulation for intravenous administration.
Aciclovir sodium is a white, crystalline powder, and its solubility in water exceeding 100 mg/ml. Each 250 mg, 500 mg vial of Aciclovir sodium for intravenous infusion B.P. to be reconstituted with Sterilizes Water for intravenous infusion B.P. and further dilution in any appropriate intravenous solution must be performed before infusion.
Each vial contains: Aciclovir Sodium equivalent to Aciclovir B.P 250 mg/500 mg.

Pharmacology: Mechanism of Antiviral Effects: Aciclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against human herpes viruses including herpes simplex types 1 (HSV-1) and 2 (HSV-2), varicella-zoster virus (VZV), Epstein-Barr virus (EBV), and cytomegalovirus (CMV).

Aciclovir sodium for Intravenous Infusion B.P. is indicated for the treatment of initial and recurrent mucosal and cutaneous Herpes simplex (HSV-1 and HSV-2) and varicella-zoster (shingles) infections in immunocompromised patients. It is also indicated for herpes, simplex encephalitis in patients over 6 months of age and for severe initial clinical episodes of herpes genitalis in patients who are not immunocompromised.

Herpes Simplex Infections: Mucosal and Cutaneous Herpes Simplex (HSV-1 and HSV-2) Infections in Immunocompromised Patients: 5 mg/kg infused at a constant rate over 1 hour, every 8 hours (15 mg/kg/day) for 7 days in adult patients with normal renal function. In pediatric patients under 12 years of age, more accurate dosing can be attained by infusion 250 mg/m2 at a constant rate over 1 hour, every 8 hour, every 8 hour (750 mg/m2 day) for 7 days.
Herpes Simplex Encephalitis: 10 mg/kg infused at a constant rate over at least 1 hour, every 8 hours for 10 days. In pediatric patients between 6 months and 12 years of age more accurate dosing is achieved by infusion 500 mg/m2, at constant rate over at least 1 hour, every 8 hours for 10 days.
Varicella Zoster Infections: Zoster in Immunocompromised Patients: 10 mg/kg infused at a constant rate over 1 hour, every 8 hours, for 7 days in adult patients with normal renal function. In pediatrics under 12 years of age, plasma concentrations are attained by infusion 500 mg/m2 at a constant rate over at least 1 hour, every 8 hours for 7 days. Obese patients should be dosed at 10 mg/kg (Ideal Body Weight). A maximum dose eq. to 500 mg/m2 every 8 hours should not be exceeded for any patient.

Aciclovir sodium for Intravenous Infusion B.P. is contraindicated for patients who develop hypersensitivity to the drug.

Aciclovir sodium for Intravenous Infusion B.P. intended for slow intravenous infusion only. It should not be used by other routes: topically, intramuscular, orally, subcu-taneously, 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.

General: The recommended dosage, frequency, and length of treatment should not be exceeded. Administration of Aciclovir sodium Intravenous Infusion B.P. by intravenous infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first 2 hours following infusion, particular attention should be given to establishing sufficient urine flow during that period in order to prevent precipitation in renal tubules. Recommended urine output is >500 ml per gram of drug infused. In patients with encephalitis, the recommended hydration should be balanced by the risk of cerebral edema. When dosage adjustments are required, they should be based on estimated creatinine clearance. Approximately 1% of patients receiving intravenous Aciclovir have manifested eccephalopathic changes characterized by either lethargy, obtundation, tremors, confusion, hallucinations, agitation, seizures, or coma.

Use in Pregnancy: Pregnancy category C: There are no adequate and controlled studies in pregnancy women. Use during pregnancy only if the potential benefit out weighs the potential risk to fetus.
Use in Lactation: Caution should be exercised when Aciclovir sodium for Intravenous Infusion B.P. is administered to a nursing woman.

General: Fever, pain, and rarely, anaphylaxis.
Digestive: Elevated liver function tests, nausea.
Hemic and Lyphtic: Leukopenia, thrombocytopenia.
Nervous: Agitation, coma, confusion, convulsions, delirium, hallucinations, obtundation, psychosis.
Skin: Alopecia, erythema multiforme, pruritus, rash, Stevens-Johnson syndrome, toxi-cepidemal necrolysis, urticaria.
Urogenital: Elevated blood urea nitrogen, elevated creatinine, renal failure.

Co-administration of probenecid with Aciclovir has been shown to increase the mean half-life and the area under the concentrations-time curve. Urinary excretion and renal clearance were correspondingly reduced.

Store below 25°C.
Protected from light.
Do not refrigerate.

Antivirals

J05AB01 - aciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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