Simplovir(Aciclovir)

Therapeutic Group: Anti Viral

Presentation

Simplovir 200 tablet: Each tablet contains Aciclovir BP 200

mg.

Simplovir 400 tablet: Each tablet contains Aciclovir BP 400

mg.

Simplovir 250 IV: Each vial contains lyophilized powder of Aciclovir Sodium equivalent to Aciclovir BP 250 mg.

Simplovir 500 IV: Each vial contains lyophilized powder of

Aciclovir Sodium equivalent to Aciclovir BP 500 mg.

Simplovir 1 gm IV: Each vial contains lyophilized powder of

Aciclovir Sodium equivalent to Aciclovir BP 1 gm.

Simplovir Suspension: Each 5 ml suspension contains

Aciclovir BP 200 mg.

Description

Simplovir 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.

Indications

● Herpes Zoster

● Genital Herpes

● Chickenpox

● Herpes Simplex Infections

● Herpes Simplex Encephalitis

Dosage & Administration

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.

Simplovir Tablet & Oral Suspension:
● Acute Herpes Zoster: 800 mg or 20 ml suspension every 4 hours, 5 times daily for 7 to 10 days.
● Genital Herpes: Initial Genital Herpes: 200 mg or 5 ml
suspension every 4 hours, 5 times daily for 10 days.
Chronic suppressive therapy for recurrent disease: 400 mg
or 10 ml suspension 2 times daily for up to 12 months.
Intermittent therapy: 200 mg or 5 ml suspension every 4 hours, 5 times daily for 5 days.
● Chickenpox: 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 or 20 ml suspension 4
times daily for 5 days.
Simplovir IV:
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.

Side Effects

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.

Precautions

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

Use in Pregnancy & Lactation

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

Drug Interaction

Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.

Storage

Do not store above 300 °C. Keep out of the reach of children.

Commercial Pack

Simplovir 200 mg tablet: Each box contains 3 blister strips of 10 tablets.
Simplovir 400 mg tablet: Each box contains 2 blister strips of 10 tablets.
Simplovir 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.
Simplovir 500 IV: Each box contains 1 vial of 500 mg
Aciclovir lyophilized powder, 1 bottle of 100 ml of 0.9%
Sodium Chloride solution, 1 disposable syringe & 1 infusion
set.
Simplovir 1 gm IV: Each box contains 1 vial of 1 gm Aciclovir
lyophilized powder, 1 bottle of 250 ml of 0.9% Sodium
Chloride solution, 1 disposable syringe & 1 infusion set.
Simplovir Suspension: Each box contains 70 ml suspension
in PET bottle and a measuring cup.