VALACICLOVIR Film-coated tablet Ref.[7371] Active ingredients: Valaciclovir

Method of administration

Oral use.

The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.

Varicella zoster virus (VZV) infections – herpes zoster and ophthalmic zoster

Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster.

There are no data on treatment started more than 72 hours after onset of the zoster rash.

Immunocompetent Adults

The dose in immunocompetent patients is 1000 mg three times daily for seven days (3000 mg total daily dose). This dose should be reduced according to creatinine clearance (see renal impairment below).

Immunocompromised Adults

The dose in immunocompromised patients is 1000 mg three times daily for at least seven days (3000 mg total daily dose) and for 2 days following crusting of lesions. This dose should be reduced according to creatinine clearance (see renal impairment below).

In immunocompromised patients, antiviral treatment is suggested for patients presenting within one week of vesicle formation or at any time before full crusting of lesions.

Treatment of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years)

Immunocompetent Adults and Adolescents (≥12 years)

The dose is 500 mg of Valaciclovir to be taken twice daily (1000 mg total daily dose). This dose should be reduced according to creatinine clearance (see renal impairment below).

For recurrent episodes, treatment should be for three to five days. For initial episodes, which can be more severe, treatment may have to be extended to ten days. Dosing should begin as early as possible.

For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately upon appearance of the first signs or symptoms. Valaciclovir can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence.

Herpes labialis

For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents. The second dose should be taken about 12 h (no sooner than 6 h) after the first dose. This dose should be reduced according to creatinine clearance (see Renal impairment below). When using this dosing regimen, treatment should not exceed one day, since this has been shown not to provide additional clinical benefit. Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching or burning).

Immunocompromised Adults

For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at least 5 days, following assessment of the severity of the clinical condition and immunological status of the patient. For initial episodes, which can be more severe, treatment may have to be extended to ten days. Dosing should begin as early as possible. This dose should be reduced according to creatinine clearance (see Renal impairment below). For maximum clinical benefit, the treatment should be started within 48 hours. A strict monitoring of the evolution of lesions is advised.

Suppression of recurrences of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years)

Immunocompetent Adults and Adolescents (≥12 years)

The dose is 500 mg of Valaciclovir to be taken once daily. Some patients with very frequent recurrences (≥ 10/year in absence of therapy) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily). This dose should be reduced according to creatinine clearance (see Renal impairment below).Treatment should be re-evaluated after 6 to 12 months of therapy.

Immunocompromised Adults

The dose is 500 mg of Valaciclovir twice daily. This dose should be reduced according to creatinine clearance (see Renal impairment below). Treatment should be re-evaluated after 6 to 12 months of therapy.

Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years)

The dosage of Valaciclovir is 2000 mg four times a day, to be initiated as early as possible post-transplant.

This dose should be reduced according to creatinine clearance (see Renal impairment below).

The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients.

Special populations

Children

The efficacy of valaciclovir in children below the age of 12 years has not been evaluated.

Elderly

The possibility of renal impairment in the elderly must be considered and the dose should be adjusted accordingly (see Renal impairment below). Adequate hydration should be maintained.

Renal impairment

Caution is advised when administering Valaciclovir to patients with impaired renal function. Adequate hydration should be maintained. The dose of Valaciclovir should be reduced in patients with impaired renal function as shown in Table 1 below.

In patients on intermittent haemodialysis, the Valaciclovir dose should be administered after the haemodialysis has been performed. The creatinine clearance should be monitored frequently, especially during periods when renal function is changing rapidly e.g. immediately after renal transplantation or engraftment. The Valaciclovir dosage should be adjusted accordingly.

Hepatic impairment

Studies with a 1000 mg dose of valaciclovir in adult patients show that dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained). Pharmacokinetic data in adult patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dose adjustment; however, clinical experience is limited. For higher doses (4000 mg or more per day), see section 4.4.

Table 1. Dosage for renal impairment:

^a For patients on intermittent haemodialysis, the dose should be given after dialysis on dialysis days.
^b For HSV suppression in immunocompetent subjects with a history of ≥10 = recurrences/year, better results may be obtained with 250 mg twice daily.

Symptoms and Signs

Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of valaciclovir. Nausea and vomiting may also occur. Caution is required to prevent inadvertent overdosing. Many of the reported cases involved renally impaired and elderly patients receiving repeated overdoses, due to lack of appropriate dosage reduction.

Treatment

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.

3 years.

This medicinal product does not require any special storage condition.

Clear PVC/PVdC Aluminium foil blister or HDPE bottle with PP closure.

Pack sizes:

Blister: 7, 10, 21, 30, 42, 50, 90 & 112 tablets.

HDPE bottle: 30 & 500 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.