Uses of Revira 1: - Herpes labialis - Genital herpes infection - Herpes zoster Genital herpes, Herpes zoster, Herpes labialis, CMV infections Hypersensitvity to valaciclovir, aciclovir.

Herpes simplex & Varicella-zoster virus infections

Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.

How to use Valacyclovir: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Valacyclovir may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. May be taken w/ meals to reduce GI discomfort. Adult Dose: Oral Herpes zoster (shingles) Adult: 1 g tid for 7 days. Immunocompromised patients: Continue treatment for a further 2 days after crusting of lesions. Herpes simplex infections of skin and mucous membranes; Genital herpes Adult: 500 mg bid for 3-5 days for recurrent episodes or up to 10 days for initial episodes. Immunocompromised patients: 1 g bid for at least 5 days for recurrent episodes or up to 10 days for initial episodes. Prophylaxis of cytomegaloviral infections in immunocompromised patients Adult: 2 g 4 times daily, begin as soon as possible post-transplant and usually continued for 90 days. Herpes labialis Adult: 2 g 12 hrly for 1 day. Suppression of recurrent herpes simplex Adult: 500 mg daily as a single or in 2 divided doses. Immunocompromised patients: 500 mg bid. Treatment is re-evaluated after 6-12 mth of therapy. Child Dose: Herpes simplex infections of skin and mucous membranes; Genital herpes Child: >12 yr: 500 mg bid for 3-5 days for recurrent episodes or up to 10 days for initial episodes. Immunocompromised patients: 1 g bid for at least 5 days for recurrent episodes or up to 10 days for initial episodes. Prophylaxis of cytomegaloviral infections in immunocompromised patients Child: >12 yr: 2 g 4 times daily, begin as soon as possible post-transplant and usually continued for 90 days. Herpes labialis Child: >12 yr: 2 g 12 hrly for 1 day. Suppression of recurrent herpes simplex Adult: Child: >12 yr: 500 mg daily as a single or in 2 divided doses. Immunocompromised patients: 500 mg bid. Treatment is re-evaluated after 6-12 mth of therapy. Chickenpox <2 years: Safety and efficacy not established >2 years: 20 mg/kg PO q8hr for 5 days; not to exceed 1 g PO q8hr Renal Dose: Herpes labialis CrCl 30-49 mL/min: 1 g PO q12hr for 1 day CrCl 10-29 mL/min: 500 mg PO q12hr for 1 day CrCl <10 mL/min: 500 mg PO once Herpes zoster CrCl 30-49 mL/min: 1 g PO q12hr CrCl 10-29 mL/min: 1 g/day PO CrCl <10 mL/min: 500 mg/day PO Genital herpes (initial episode) CrCl 10-29 mL/min: 1 g/day PO CrCl <10 mL/min: 500 mg/day PO qDay Genital herpes (recurrent episodes)(suppressive therapy, immunocompetent patients) CrCl <29 mL/min: 500 mg/day PO

Increased risk of renal failure w/ nephrotoxic drugs (e.g. aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus). Probenecid and cimetidine may increase peak plasma concentrations and AUC of aciclovir.

Hypersensitvity to valaciclovir, aciclovir.

Common - Headache - Nausea - Abdominal pain >10% Headache (14-35%),Neutropenia (<18%),Elevated aspartate transaminase (AST) (2-16%),Nasopharyngitis (<16%),Nausea (6-15%),Elevated alanine transaminase (ALT) (<14%),Abdominal pain (2-11%) 1-10% Dysmenorrhea (1-8%),Depression (<7%),Arthralgia (<1-6%),Vomiting (<1-6%),Dizziness (2-4%),Rash (<8%),Rhinorrhea (<2%),Thrombocytopenia (<3%),Leukopenia (<1%) <1% Agitation,Aggression,Alopecia,Confusion,Erythema multiforme,Hypertension,Tachycardia,Tremor,Visual disturbances Potentially Fatal: Hepatitis; renal failure; blood dyscrasias; thrombotic thrombocytopenic purpura-hemolytic uremic syndrome.

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.

Precaution: Patient at risk of dehydration. Renal impairment. Pregnancy and lactation. Patient Counselling Avoid sexual intercourse when symptoms of genital herpes are present. Monitoring Parameters Monitor renal, hepatic and haematological functions. Lactation: Drug excreted in breast milk; use with caution

Store in cool & dry place, away from children.

Herpes simplex & Varicella-zoster virus infections

Valaciclovir is the L-valine ester of aciclovir. A prodrug, it is rapidly converted to aciclovir by intestinal and hepatic metabolism. Aciclovir inhibits DNA synthesis and viral replication and has antiviral activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella-zoster virus.

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.