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Presentation

\nSimplovir 200 tablet: Each tablet contains Aciclovir BP 200 mg. \n \nSimplovir 400 tablet: Each tablet contains Aciclovir BP 400 mg. \n \nSimplovir 250 IV: Each vial contains lyophilized powder of Aciclovir Sodium equivalent to Aciclovir BP 250 mg. \n \nSimplovir 500 IV: Each vial contains lyophilized powder of Aciclovir Sodium equivalent to Aciclovir BP 500 mg. \n \nSimplovir 1 gm IV: Each vial contains lyophilized powder of Aciclovir Sodium equivalent to Aciclovir BP 1 gm. \n \n

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Description

\nSimplovir 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. \n \n

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Indications

\n? Herpes Zoster \n \n? Genital Herpes \n \n? Chickenpox \n \n? Herpes Simplex Infections \n \n? Herpes Simplex Encephalitis \n \n

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Dosage & Administration

\nThe 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. \n \nSimplovir Tablet \n? Acute Herpes Zoster: \n800 mg every 4 hours, 5 times daily for 7 to 10 days. \n? Genital Herpes: \nInitial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days. \n \nChronic suppressive therapy for recurrent disease: 400 mg 2 times daily for up to 12 months. \nIntermittent therapy: 200 mg every 4 hours, 5 times daily for 5 days. \n? Chickenpox: \nChildren (2 years of age and older): 20 mg/kg/dose 4 times daily (80 mg/kg/day) for 5 days. \nAdults and Children (>40 kg): 800 mg 4 times daily for 5 days. \n \nSimplovir IV \nThe required dose of Aciclovir IV should be administered by slow intravenous infusion over a one-hour period. \n? Herpes Simplex (HSV-1 and HSV-2) Infections: \nAdults and Adolescents (?12 years): 5 mg/kg, 8 hourly for 7 days. \nPediatrics (<12 years): 10 mg/kg 8 hourly for 7 days. \n? Severe Initial Herpes Genitalis: \nAdults and Adolescents (?12 years): 5 mg/kg 8 hourly for 5 days. \n? Herpes Simplex Encephalitis: \nAdults and Adolescents (?12 years): 10 mg/kg 8 hourly for 10 days. \nPediatrics (3 months to 12 years of age): 20 mg/kg 8 hourly for 10 days. \n? Neonatal Herpes Simplex (Birth to 3 months): \n10 mg/kg 8 hourly for 10 days. \n? Varicella Zoster: \nAdults and Adolescents (?12 years): 10 mg/kg 8 hourly for 7 days. \nPediatrics (<12 years): 20 mg/kg 8 hourly for 7 days. \n \nDose adjustment of Tablet for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2): \nFor Cr Cl= > 25 : 800 mg 4 hourly 5 times daily \nFor Cr Cl = 10 to 25 : 200 mg 4 hourly 5 times daily or 400 mg 12 hourly or 800 mg 8 hourly \nFor Cr Cl = 0 to 10 : 200 mg 12 hourly or 400 mg 12 hourly or 800 mg 12 hourly \nDose adjustment of IV for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2): \nFor Cr Cl = > 50 : 100% of recommended dose, 8 hourly \nFor Cr Cl = 25 to 50 : 100% of recommended dose, 12 hourly \nFor Cr Cl = 10 to 25 : 100% of recommended dose, 24 hourly \nFor Cr Cl = 0 to 10 : 50% of recommended dose, 24 hourly \nCaution: Rapid or bolus intravenous injection must be avoided. Intramuscular or subcutaneous injection must be avoided. \nReconstitution procedure of IV infusion \nVial 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. \nThe 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. \nCompatible infusion fluids \nSodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v) \nSodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP \nSodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion BP \nHartmann\\\'s Solution \n \n

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Side Effects

\nRash, gastro-intestinal disturbances, rises in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decreases in hematological indices, headache, neurological reactions, fatigue. \n \n

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Precautions

\nAciclovir should be administered with caution in patient with renal impairment and doses should be adjusted according to creatinine clearance. \n \n

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Use in Pregnancy & Lactation

\nPregnancy category B & caution should be exercised when it is administered to a lactating mother. \n \n

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Drug Interaction

\nProbenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity. \n \n

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Storage

\nKeep in a cool & dry place away from light. Keep drugs out of the reach of children. \n \n

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Commercial Pack

\nSimplovir 200 mg tablet: Each box contains 3 blister strips of 10 tablets. \nSimplovir 400 mg tablet: Each box contains 2 blister strips of 10 tablets. \nSimplovir 250 IV: Each box contains 1 vial of 250 mg Aciclovir lyophilized powder, 1 bottle of 50 ml of 0.9% Sodium Chloride solution, 1 disposable syringe & 1 infusion set. \n \n