VALOVIR

VALACYCLOVIR

Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).

Herpes simplex & Varicella-zoster virus infections

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis. Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by- Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids Stimulating hepatobilliary secretion Protecting hepatocytes against bile acid-induced apoptosis Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Adult Dosage: Cold Sores: 2 grams every 12 hours for 1 day Genital Herpes: Initial episode: 1 gram twice daily for 10 days Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients: 1 gram once daily Alternate dose in patients with < 9 recurrences/year: 500 mg once daily HIV-infected patients: 500 mg twice daily Reduction of transmission: 500 mg once daily Herpes Zoster: 1 gram 3 times daily for 7 days Pediatric Dosage: Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily

No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.

Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.

The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).

Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women. Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.

Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients

Store in cool & dry place, away from children.