Valaciclovir Actavis

Valaciclovir Actavis

valaciclovir

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Valaciclovir HCl
Indications/Uses
Treatment of herpes zoster (shingles) & ophth zoster in immunocompetent adults. Treatment of herpes zoster in adults w/ mild or moderate immunosuppression. Treatment & suppression of HSV infections of the skin & mucous membranes in immunocompetent adults & adolescents & in immunocompromised adults including treatment of 1st-episode of genital herpes; treatment of recurrences of genital herpes; suppression of recurrent genital herpes. Treatment & suppression of recurrent ocular HSV infections. Prophylaxis of cytomegalovirus (CMV) infection & disease following solid organ transplantation in adults & adolescents.
Dosage/Direction for Use
Herpes zoster & ophth zoster Immunocompetent adult 1,000 mg tds for 7 days. Immunocompromised adult 1,000 mg tds for at least 7 days & for 2 days following crusting of lesions. HSV infections Immunocompetent adult & adolescent ≥12 yr 500 mg bd for 10 days (initial episodes) or 3-5 days (recurrent episodes). Immunocompromised adult 1,000 mg bd for at least 5 days or 10 days (initial episodes). Herpes labialis (cold sore) Adult & adolescent Initially 2,000 mg bd for 1 day. 2nd dose to be taken 12 hr after 1st dose. Suppression of recurrences of HSV infections Immunocompetent adult & adolescent ≥12 yr 250 mg bd. Immunocompromised adult 500 mg bd. Prophylaxis of CMV infection & disease Adult & adolescent ≥12 yr 2,000 mg qds for 90 days but may need to be extended in high-risk patients. All doses to be reduced according to CrCl.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Contraindications
Hypersensitivity to valaciclovir or aciclovir.
Special Precautions
Ensure adequate fluid intake in patients at risk of dehydration, particularly the elderly. Patients w/ renal impairment; hepatic impairment & liver transplantation. Closely monitor clinical response particularly in immunocompromised patients, ocular HSV infection patients, & in CMV infections in transplant patients. Advise patient to avoid intercourse when symptoms are present even if treatment w/ an antiviral has been initiated. Pregnancy & lactation. Elderly.
Adverse Reactions
Headache. Nausea; dizziness; vomiting, diarrhoea; rashes including photosensitivity, pruritus.
Drug Interactions
Increased nephrotoxicity w/ other nephrotoxic medicinal products eg, aminoglycosides, organoplatinum compd, iodinated contrast media, MTX, pentamidine, foscarnet, ciclosporin & tacrolimus. Reduced renal clearance & increased AUC of aciclovir w/ cimetidine & probenecid. Increased aciclovir conc w/ other medicinal products that compete w/ or inhibit active tubular secretion (eg, tenofovir). Increased plasma AUCs of aciclovir & inactive metabolite of mycophenolate mofetil when co-administered.
MIMS Class
Antivirals
ATC Classification
J05AB11 - valaciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Valaciclovir Actavis FC tab 500 mg
Packing/Price
42's
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