Reduction of Transmission: Valcivir is indicated for the reduction of transmission of genital herpes in immunocompetent adults.

Herpes Zoster: Valcivir is indicated for the treatment of herpes zoster (shingles) in immunocompetent adults.

Pediatric Patients:

Cold Sores (Herpes Labialis): Valcivir is indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age.

Chickenpox: Valaciclovir is indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age. Based on efficacy data from clinical studies with oral acyclovir, treatment with Valcivir should be initiated within 24 hours after the onset of rash.

 

Advantages:

• High efficiency against Herpes simplex virus (HSV) and chickenpox virus (HHV)
• Significantly reduces the risk of transmitting genital herpes
• Reduces asymptomatic virus spread
• More effective and significantly reduces the accuracy and severity of pain than acyclovir with herpes zoster
• Provides high oral bioavailability, up to 60-70%
• Convenient dosage regimen
• Favorable Safety Profile
• Considered safe for mother and baby during pregnancy (no adverse effects to the fetus or newborn have been reported to date)
• Low risk of medicine interaction

 

Contraindications: Valcivir is contraindicated in patients known to be hyper sensitive to valaciclovir, acyclovir or any components of formulations of Valcivir.  

Dosage and administration:  

Treatment of herpes zoster: The dosage is 1000 mg of Valcivir to be taken three times daily for seven days.

Treatment of herpes simplex infections: The dosage is 500 mg of Valcivir to be taken twice daily.

For recurrent episodes, treatment should be for three or five days.

For initial episodes, which can be more severe, treatment may have to be extended from five 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 after the first signs or symptoms appear. Valcivir can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence. Alternatively, for herpes labialis (cold sores), Valcivir 2 g twice daily for one day is effective treatment. The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose. 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).

Prevention (suppression) of recurrence of herpes simplex infections:

In immunocompetent, 500 mg of Valcivir to be taken once daily. Some patients with very frequent recurrences (e.g. 10 or more per year) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily).

For immunocompromised patients the dose is 500 mg twice daily.

Reduction of transmission of genital herpes:

In immunocompetent heterosexual adults with 9 or fewer recurrences per year, 500 mg of Valcivir to be taken once daily by the infected partner. There are no data on the reduction of transmission in the other patient populations.

Prophylaxis of cytomegalovirus infection (CMV) and disease: The dosage of Valcivir in adults and adolescents (from 12 year of age) is 2 g four times a day, to be initiated as early as possible posttransplant. This dose should be reduced according to creatinine clearance. The duration of treatment will usually be 90 days, but may need to be extended in high risk patients. Children There are no data available on the use of valaciclovir in children. 

Side effects/Precaution: Common side effects: headache and nausea.

Packing: Carton box containing 2 transparent (AL/PVC) blisters, each of 10 tablets and an inner leaflet.

Storage: Store in a dry place at temperature not exceeding 30°C. Keep out of reach of children.

Shelf life: 36 months

Manufacturer: Eva Pharma for Pharmaceuticals & Medical Appliances 176 El-Sadat str., Kafr El-Gabal, El-Haram, Giza, Egypt

See also:  http://www.evapharma.com/