COMPOSITION :
Virpes® Caplet 400 mg, each caplet contains : Aciclovir 400 mg.
DESCRIPTIONS :
Virpes® contains Aciclovir as active ingredients is available in 400 mg caplet.
INDICATIONS :
- For the treatment of Herpes simplex virus infections of the skin and mucous membrane, including initial and recurrent genital herpes.
- For the suppression (prevention of recurrences) of recurrent Herpes simplex infections in immune-competent patients.
- For the prophylaxis of Herpes simplex infections in immune-compromised patients.
- For the treatment of Varicella (Chickenpox) and Herpes zoster (Shingles) infections.
DOSAGE AND ADMINISTRATION :
Adults
- For treatment of Herpes simplex infections :
200 mg Aciclovir should be taken five times daily at approximately four-hourly intervals omitting the night time dose.
Treatment should continue for five days but in severe initial infections may have to be extended.
In severely immune-compromised patients (e.g., after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg or alternatively, intravenous dosing could be considered.
Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear.
- For suppression of Herpes simplex infections :
In immune-competent patients, 200 mg Aciclovir should be taken four times daily at approximately six-hourly intervals.
Many patients may conveniently managed on a regimen of 400 mg Aciclovir taken twice daily at approximately twelve-hourly intervals.
Dosage titration down to 200 mg taken thrice daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective.
Some patients may experience break-through infections on total daily doses of 800 mg Aciclovir.
Therapy should be interrupted periodically at intervals of six to twelve months in order to observe possible changes in the natural history of the disease.
- For prophylaxis of Herpes simplex infections :
In immune-compromised patients, 200 mg Aciclovir should be taken four times daily at approximately six-hourly intervals.
In severe immune-compromised patients (e.g., after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg or, alternatively, intravenous dosing could be considered.
The duration of prophylactic administration is determined by the duration of the period at risk.
- For treatment of Varicella and Herpes zoster infections :
800 mg Aciclovir should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days.
In severe immune-compromised patients (e.g., after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing.
Dosing should begin as early as possible after the start of an infection. Treatment yields better if initiated as soon as possible after onset of the rash.
Children
- For treatment and prophylaxis of Herpes simplex infections :
In the immune-compromised, children aged two years and over should be given adult dosages and children below the age of two years should be given half the adult dose.
- For treatment of Varicella infections :
Children over the age of six years can be given 800 mg Aciclovir four times daily and children between the ages of two and six years can be given 400 mg Aciclovir four times daily. Children below the age of two years can be given 200 mg Aciclovir four times daily. Dosing may be more accurately calculated as 20 mg Aciclovir/kgBW (not exceed 800 mg) four times daily.
Treatment should continue for five days.
No specific data are available on the suppression of Herpes simplex infections or the treatment of Herpes zoster infections in immune-competent children.
Elderly
The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Renal impairment). Adequate hydration of elderly patients taking high level oral doses of Aciclovir should be maintained.
Renal impairment
- Caution is advised when administering Aciclovir oral formulations to patients with impaired renal function. Adequate hydration should be maintained.
- In the treatment and prophylaxis of Herpes simplex infections in patients with impaired renal function, the recommended oral doses will not lead to accumulation of Aciclovir above levels that have been established safe by intravenous infusion. However, for patients with severe renal impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200 mg twice daily at approximately twelve-hourly intervals is recommended.
- In the treatment of Varicella and Herpes zoster infections, it is recommended to adjust the dosage to 800 mg twice daily, at approximately twelve-hourly intervals, for patients with severe renal impairment (creatinine clearance less than 10ml/minute) and to 800 mg three times daily, at intervals of approximately eight hours, for patients with moderate renal impairment (creatinine clearance in the range 10 to 25 ml/minute)
OVERDOSAGE :
Aciclovir is only partly absorbed in the gastrointestinal tract. Patient have ingested overdosage of up to 20 g Aciclovir on a single occasion, usually without toxic effects. Accidental, repeated overdosage of oral Aciclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion). It is unlikely that serious toxic effects would occur if a dose of up to 5 g were taken on a single occasion. No data are available on the consequences of the ingestion of higher doses.
Management :
Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of Aciclovir from the blood and may therefore be considered a management option in the event of symptomatic overdose.
CONTRAINDICATIONS :
Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir or Valaciclovir.
WARNINGS AND PRECAUTIONS :
Use in patient with renal impairment and in elderly patients :
Aciclovir is eliminated by renal clearence; therefore the dose must be reduced in patient with renal impairment (see DOSAGE AND ADMINISTRATION). Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see ADVERSE REACTIONS).
Hydration status : Carer should be taken to maintain adequate hydration in patients receiving high oral doses of Aciclovir.
Pregnancy
A post-marketing Aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Aciclovir. The birth defects described amongst Aciclovir exposed subject have not shown any uniqueness or consistent pattern to suggest a common cause.
The use of Aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks.
Lactation
Following oral administration of 200 mg Aciclovir five times a day, Aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to Aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if Aciclovir is to be administered to a nursing woman.
Effects on ability to drive and use machines
The clinical status of the patient and the adverse event profile of Aciclovir should be borne in mild when considering the patients ability to drive or operate machinery. There have been no studies to investigate the effect of Aciclovir on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.
PRESENTATION :
Virpes® Caplet 400 mg Box, 10 strips @ 10 caplets Reg. No. : DKL9702325104B1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
