|Therapeutic Class:||Therapeutic Group: Anti Viral|
|Manufacturer:||Acme Laboratories Limited.|
|Last Updated:||2020-11-20 18:15:00|
Acivir Tablet contains Acyclovir (Oral). Acivir uses:
• Herpes Zoster
• Genital Herpes
• Herpes Simplex Infections
• Herpes Simplex Encephalitis
Acivir Tablet contains Acyclovir (Oral) 400 mg. Acivir doses:
The total daily dosage of Aciclovir should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogens, renal function and body-weight.
• Acute Herpes Zoster:
800 mg every 4 hours, 5 times daily for 7 to 10 days.
• Genital Herpes:
Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.
Chronic suppressive therapy for recurrent disease: 400 mg 2 times daily for up to 12 months.
Intermittent therapy: 200 mg every 4 hours, 5 times daily for 5 days.
Children (2 years of age and older): 20 mg/kg/dose 4 times daily (80 mg/kg/day) for 5 days.
Adults and Children (>40 kg): 800 mg 4 times daily for 5 days.
The required dose of Aciclovir IV should be administered by slow intravenous infusion over a one-hour period.
• Herpes Simplex (HSV-1 and HSV-2) Infections:
Adults and Adolescents (≥12 years): 5 mg/kg, 8 hourly for 7 days.
Pediatrics (<12 years): 10 mg/kg 8 hourly for 7 days.
• Severe Initial Herpes Genitalis:
Adults and Adolescents (≥12 years): 5 mg/kg 8 hourly for 5 days.
• Herpes Simplex Encephalitis:
Adults and Adolescents (≥12 years): 10 mg/kg 8 hourly for 10 days.
Pediatrics (3 months to 12 years of age): 20 mg/kg 8 hourly for 10 days.
• Neonatal Herpes Simplex (Birth to 3 months):
10 mg/kg 8 hourly for 10 days.
• Varicella Zoster:
Adults and Adolescents (≥12 years): 10 mg/kg 8 hourly for 7 days.
Pediatrics (<12 years): 20 mg/kg 8 hourly for 7 days.
Dose adjustment of Tablet for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2):
For Cr Cl= > 25 : 800 mg 4 hourly 5 times daily
For Cr Cl = 10 to 25 : 200 mg 4 hourly 5 times daily or 400 mg 12 hourly or 800 mg 8 hourly
For Cr Cl = 0 to 10 : 200 mg 12 hourly or 400 mg 12 hourly or 800 mg 12 hourly
Dose adjustment of IV for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2):
For Cr Cl = > 50 : 100% of recommended dose, 8 hourly
For Cr Cl = 25 to 50 : 100% of recommended dose, 12 hourly
For Cr Cl = 10 to 25 : 100% of recommended dose, 24 hourly
For Cr Cl = 0 to 10 : 50% of recommended dose, 24 hourly
Caution: Rapid or bolus intravenous injection must be avoided. Intramuscular or subcutaneous injection must be avoided.
Reconstitution procedure of IV infusion
Vial containing 250 mg Aciclovir will be reconstituted with 50 ml infusion solution and vial containing 500 mg Aciclovir will be reconstituted with 100 ml infusion solution. Besides, Vial containing 1 gm Aciclovir will be reconstituted with 250 ml infusion solution. 10 ml of the infusion solution will be added to the vial containing 250 mg, 500 mg and 1 gm Aciclovir. Shake well and transfer the required amount of solution to the infusion container. The final concentration of Aciclovir will be not more than 5 mg/ml.
The reconstituted solution should be used within 12 hours. Refrigeration of reconstituted solution may result in the formation of a precipitate which will re-dissolve at room temperature.
Compatible infusion fluids
Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP
Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion BP
Rash, gastro-intestinal disturbances, rises in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decreases in hematological indices, headache, neurological reactions, fatigue.
Aciclovir is the brand name of Aciclovir, a synthetic purine nucleoside with inhibitory activity against herpes simplex virus(HSV-1 & HSV-2) and varicella-zoster virus (VZV). The activity of Aciclovir is highly selective due to its affinity for the enzyme thymidine kinase encoded by HSV and VZV. This viral enzyme converts Aciclovir into Aciclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate and finally triphosphate by a number of cellular enzymes. In vitro, Aciclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) Competitive inhibition of viral DNA polymerase, 2) Incorporation into and termination of the growing viral DNA chain and 3) Inactivation of the viral DNA polymerase.
Aciclovir should be administered with caution in patient with renal impairment and doses should be adjusted according to creatinine clearance.
Concomitant administration of probenecid and acyclovir has reportedly increased the mean plasma half-life and decreased urinary excretion and renal clearance of acyclovir. Amphotericin B has been shown to potentiate the antiviral effect of acyclovir against pseudorabies virus in vitro when both drugs are added to the culture medium. Ketoconazole and acyclovir have shown dose-dependent, synergistic, antiviral activity against herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in in-vitro replication studies.
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in nursing mothers: Acyclovir should be administered to a nursing mother with caution and only when indicated. Geriatric Use: No overall differences in safety are observed between older and younger subjects.
Acyclovir is contraindicated in patients known to be hypersensitive to acyclovir. For the patients with severe renal impairment, a reduction of the doses is recommended.
HSV infections in children over 2 years should be given adult doses and children below 2 years should be given half of the adult dose.
Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.
Keep in a cool & dry place away from light. Keep drugs out of the reach of children.
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