Indications

– Treatment of acute Herpes zoster (shingles) infections. Herpes zoster infections of the eyes, lungs in adults and genitals.
– Hemorrhagic chickenpox, chickenpox in immunosuppressed patients, chickenpox in neonates.

Present

Blister of 5 tablets. Box of 7 blisters.

Composition

Aciclovir ………………………………………………………800mg
Excipients s.q. for…………………………….…1 tablet
(Lactose, Corn starch, Povidone, Ethanol 96%, Sodium starch glycolate, Magnesium stearate, Microcrystalline cellulose).

Pharmacology

– Aciclovir is a synthetic purine nucleoside analogue (acycloguanosine) and is selectively active against HSV type 1 and VZV.
– HSV type 1 appears to be the most susceptible, then type 2, followed by VZV. EBV and CMV are also susceptible to Aciclovir to a lesser extent.
– Aciclovir is considered the drug of choice for the treatment of HSV encephalitis, the mortality rate may be reduced from 70% to 20% in patients receiving Aciclovir. For HSV– 2 encephalitis, the milder, Aciclovir is also appeared to be effective.

Pharmacokinetics

Bioavailability of an oral dose of Aciclovir is about 20% (15% – 30%). Food does not affect the absorption of the drug.
Aciclovir is widely distributed in the body tissues and fluids such as brain, kidney, lung, intestine, liver, lymphs, muscles, uterus, vaginal mucosa and secretion, tear, humor, semen, CSF. A small amount of Aciclovir is metabolized in the liver, the majority (30% – 90% of a dose) is excreted unchanged in the urine.

Contra-Indications

Hypersensitivity to any ingredient of the medicine.

Side effect

– Short– term administration: nausea, vomiting.
– Long– term administration (1 year): nausea, vomiting, diarrhea, bellyache, rash, headache.
Discontinue the medicine and inform your doctor about side– effects when using this medicine.

Precaution

– Elderly people.
– Renal dysfunction: adjusting dosing interval according to creatinine clearance.
– The risk of renal dysfunction is increased if Aciclovir is coadministered with other nephrotoxic drugs.
– Caution should be exercised when it is given to drivers or operators of machinery.
PREGNANCY AND LACTATION:
Caution should be exercised when it is given to pregnant women and nursing mothers.

Interaction

– Probenecid (Uricosuric antigout agent) may reduce urinary excretion and renal clearance of Aciclovir that may result in increased half– life of the latter.
– Coadministration of Zidovudine and Aciclovir may lead to lethargy and drowsiness.
– Amphotericin B and Ketoconazole may increase antiviral activity of Aciclovir.
– Interferon may increase in vitro antiviral activity of Aciclovir.
OVERDOSAGE & MANAGEMENT:
– Symptoms: elevation in serum creatinine concentration, renal failure, aggressive behaviour, agitation, tremors, seizures, palpitation, hypertension, dysuria, Aciclovir crystals may precipitate in the renal tubules if renal concentration exceeding 2.5mg/ml.
– Management: discontinue the medication and water and electrolyte replacement is instituted. If acute renal failure and anuria occur, use of hemodialysis should be considered until renal function is restored.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

Taken this medicine after meals.
– As prescribed by the physicians.
– Recommended dosage:
* Treatment of chickenpox and Herpes zoster infections: Adults: 1 tablet, 5 times daily x 7 days.
Children > 6 years: 1 tablet, 4 times daily x 5 days.
Children 2 – 6 years: ½ tablet, 4 times daily x 5 days.
* Renal dysfunction: increasing dosing interval according to creatinine clearance.
+ Creatinine clearance 10 – 25ml/min: every 8 hrs.
+ Creatinine clearance < 10ml/min: every 12 hrs.