Cyclostad

Cyclostad

aciclovir

Manufacturer:

Stada

Distributor:

Croma Medic
Full Prescribing Info
Contents
Aciclovir.
Description
Each tablet contains: 200 mg Aciclovir.
Indications/Uses
For herpes simplex virus infection, genital herpes of the skin and mucus membrane in particular (primary and frequently recurring genital herpes). Also for adults with severe form of very frequently recurring genital herpes simplex virus infection.
Dosage/Direction for Use
Adults: Treatment of Herpes Infections: 200 mg should be taken 5 times daily at approximately 4-hours intervals, omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections, it may have to be extended.
In severely immunocompromised patients (eg, after bone marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 400 mg.
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.
Suppression of Herpes Simplex Infections in Immunocompetent Patients: 200 mg should be taken 4 times daily at approximately 6-hours interval. Many patients may be conveniently managed on a regimen of 400 mg taken twice daily at approximately 12-hours intervals. Dosage titration down to 200 mg taken 3 times daily at approximately 8-hours intervals or even twice daily at approximately 12-hours intervals may prove effective. Some patients may experience breakthrough infections on total daily doses of 800 mg. Therapy should be interrupted periodically at intervals of 6-12 months in order to observe possible changes in natural history of the disease.
Prophylaxis of Herpes Simplex Infections in Immunocompromised Patients: 200 mg should be taken 4 times daily at approximately 6-hours intervals. In severely immunocompromised patients (eg, after bone marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 400 mg 4 times daily at approximately 6-hours intervals. The duration of prophylactic administration is determined by the duration of the period at risk.
Treatment of Varicella and Herpes Zoster Infections: 800 mg should be taken 5 times daily at approximately 4-hours intervals, omitting the night time doses. Treatment should continue for 7-10 days.
Dosage in Renal Impairment: Patients with kidney function impairment, which is particularly prevalent in elderly patients, may need a lower aciclovir dose than previously indicated. Dosage should be adjusted accordingly.
Children: For Treatment of Herpes Simplex Infections and for Prophylaxis of Herpes Simplex Infections in Immune-compromised: Children 2 years and over should be given adult dosages and children <2 years should be given ½ of the adult dose. (See table.)

Click on icon to see table/diagram/image

For Treatment of Varicella Infections: Children >6 years: 800 mg 4 times daily; 2-6 years: 400 mg 4 times daily; <2 years: 200 mg 4 times daily. Dosing may be more accurately calculated as 20 mg Aciclovir//kg body weight (not to exceed 800 mg) 4 times daily. Treatment should continue for 5 days. No specific data are available on the suppression of herpes simplex infections and treatment of herpes zoster infections in immunocompetent children.
Overdosage
Aciclovir is only partly absorbed in the gastrointestinal tract. It is unlikely that serious toxic effects would occur of a dose of up to 5 g were taken on a single occasion. No data are available on the consequences of ingestion of higher doses.
Treatment: Ingestion of doses of aciclovir tablets in excess of 5 g warrants close observation of the patient. Aciclovir is dialysable by hemodialysis.
Contraindications
Hypersensitivity to aciclovir.
Special Precautions
Use in pregnancy & lactation: Limited data are available on the use of aciclovir during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Following oral administration of 200 mg 5 times daily, aciclovir has been detected in breast milk at concentrations ranging from 0.6-1.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosage of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
Use In Pregnancy & Lactation
Limited data are available on the use of aciclovir during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Following oral administration of 200 mg 5 times daily, aciclovir has been detected in breast milk at concentrations ranging from 0.6-4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosage of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman.
Side Effects
To date, aciclovir has occasionally been associated with the following side effects: Skin rashes, disappearing upon discontinuation of the product; gastrointestinal symptoms including nausea, vomiting, diarrhea and abdominal pain. There have been occasional reports of neurological side effects, mainly dizziness, confusion, hallucinations and drowsiness. These side effects disappear upon discontinuation of the product and are typically seen in patients with impaired kidney function or other conditions predisposing to this sort of adverse reactions. Moreover, there have been isolated reports of depersonalization experiences disappearing upon discontinuation of the product. Transient convulsions and psychoses have been observed.
There have been rare reports of transient laboratory adverse effects relating to liver and kidney function as well as the blood (bilirubin, liver enzyme, serum urea nitrogen and/or serum creatinine elevations, and/or slight reduction in hematological parameters). There have also been rare reports of headache, exhaustion, insomnia or fatigue.
There were rare reports of difficulty in breathing and with occasional incidence of hair loss associated with Aciclovir.
Drug Interactions
Probenecid increases the mean half-life and area under the plasma concentration-time curve of systemically administered aciclovir. Other drugs affecting renal physiology could potentially influence the pharmacokinetics of aciclovir. However, clinical experience has not identified other interactions with aciclovir.
Storage
Store at temperatures not exceeding 25°C. Keep dry.
MIMS Class
ATC Classification
J05AB01 - aciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Tab 200 mg x 25's.
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