COMPOSITIONS :
| Valaciclovir HCl Dihydrate Film coated caplet 500 mg, each film coated caplet contains : Valaciclovir HCl dihydrate equivalent to Valaciclovir base 500 mg |
DESCRIPTIONS :
Valaciclovir HCl Dihydrate containing Valaciclovir HCl dihydrate (equivalent to Valaciclovir base) is available as 500 mg film coated caplet.
INDICATIONS :
Valaciclovir HCl Dihydrate Film coated caplet are indicated for :
- Treatment of herpes zoster (shingles).
- Treatment of herpes simplex infections of the skin and mucous membranes including initial and recurrent genital herpes.
DOSAGE AND ADMINISTRATIONS :
- Treatment of herpes zoster :
Adults : 1000 mg, to be taken 3 times daily for 7 days.
- Treatment of herpes simplex :
Adults : 500 mg, to be taken twice daily.
For recurrent episodes, treatment should be for 5 days. For initial episodes which can be more severe, treatment may have to be extended to 10 days. Dosing should begin as early as possible. For recurrent episodes which of herpes simplex, this should ideally be during the prodromal period or immediately the first signs or symptoms appear.
- Children :
No data are available.
- Elderly :
Dosage modification is not required unless renal function is significantly impaired.
- Renal impairment :
The dosage Valaciclovir should be modified as follows in patients with significantly impaired renal function.
The dosage of Valaciclovir should be reduced in patient with significantly impaired renal function as shown in the table below :
| Creatinine clearance (ml/minute) | Valaciclovir dose | |
| Herpes zoster | Herpes simplex | |
| 15 – 30 | 1000 mg twice daily | No modification required |
| < 15 | 1000 mg once daily | 500 mg once daily |
In patients on haemodialysis, the dosage recommended for patient with a creatinine clearance of < 15 ml/minute should be used, but this should be administered after the haemodialysis has been performed.
- Hepatic impairment :
Dose modification is not required in patients with mild or moderate cirrhosis.
OVERDOSAGE :
Symptoms : There are at present no data available on overdosage with Valaciclovir. A dose equivalent to the Aciclovir exposure from approximately 15 g Valaciclovir has been inadvertently administered as a single IV dose of Aciclovir (up to 80 mg/kg) without adverse effects.
Treatment : In the event of a symptomatic overdose occuring, Aciclovir is removable by haemodialysis.
CONTRAINDICATIONS :
Patients known to be hipersensitive to Valaciclovir, Aciclovir or any components of formulation.
WARNINGS AND PRECAUTIONS :
- Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly.
- Aciclovir is eliminated by renal clearance, therefore the dose of Valaciclovir must be reduced in patients with renal impairment.
- Elderly patients are likely to have reduced renal function and therefore the need for dose reduction.
- Caution should therefore be exercised when administering high doses of Valaciclovir to these patients.
- Should be used with caution for pregnant and lactating women.
DRUG INTERACTIONS :
- Cimetidine and Probenecid increase the AUC of Aciclovir by reducing its renal clearance. However no dosage adjustment is necessary because of the wide therapeutic index of Aciclovir.
- Other drugs which affect renal physiology could affect plasma levels of Aciclovir.
ADVERSE REACTIONS :
- Blood and lymphatic system disorders :
Very rare : Leucopenia, thrombocytopenia.
- Immune system disorders :
Very rare : Anaphylaxis.
- Psychiatric and nervous system disorders :
Rare : Dizziness, confusion, hallucinations, decreased consciousness.
Very rare : Agitation, tremor, ataxia, dysarthria, psychotic symptoms, convulsions, encephalopathy, coma.
- Gastrointestinal disorders :
Rare : Abdominal discomfort, vomiting, diarrhea.
- Skin and subcutaneous tissue disorders :
Rare : Pruritus.
Very rare : Urticaria, angioedema.
- Renal and urinary disorders :
Rare : Renal impairment.
Very rare : Acute renal failure, renal pain.
- Others : Renal insufficiency, microangiopathic hemolytic anemia and thrombocytopenia in severely immunocompromised patients, particularly those with advanced HIV disease, receiving high doses (8 g daily) of Valaciclovir for prolonged periods in clinical trials.
PRESENTATION :
Valaciclovir HCl Dihydrate Film coated caplet 500 mg Box, 3 blisters @ 10 film coated caplets
Reg. No. GKL1202346509A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia