Valovir-500

Valovir-500

valaciclovir

Manufacturer:

Hetero Labs

Distributor:

Camber
Concise Prescribing Info
Contents
Valaciclovir HCl
Indications/Uses
Herpes zoster (shingles) & ophth zoster in immunocompetent adults. Herpes zoster in adults w/ mild or moderate immunosuppression. Treatment & suppression of HSV infections of the skin & mucous membranes in adults & adolescents & in immunocompromised adults including 1st-episode, recurrences, or suppression of recurrent genital herpes. Treatment & suppression of recurrent ocular HSV infections in immunocompetent adults & adolescents & in immunocompromised adults. Prophylaxis of CMV infection & disease following solid organ transplantation in adults & adolescents.
Dosage/Direction for Use
Herpes zoster & ophth zoster Immunocompetent adult 1,000 mg tid for 7 days. Immunocompromised adult 1,000 mg tid for at least 7 days & for 2 days following crusting of lesions. HSV Adult & adolescent ≥12 yr & immunocompetent adult & adolescent ≥12 yr 500 mg bid, 3-5 days for recurrent episodes or may be extended up to 10 days for initial episodes which can be more severe. Immunocompromised adult 1,000 mg bid for at least 5 days. May be extended up to 10 days for initial episodes which can be more severe. Herpes labialis (cold sores) Adult & adolescent 2,000 mg bid for 1 day. 2nd dose should be taken about 12 hr (no sooner than 6 hr) after the 1st dose. Treatment should not exceed 1 day. Suppression of recurrences of HSV infections Adult & adolescent ≥12 yr & immunocompetent adult & adolescent ≥12 yr 500 mg once daily. Patient w/ very frequent recurrences (≥10/yr in absence of therapy) 500 mg daily as divided dose (250 mg bid). Immunocompromised adult 500 mg bid. Prophylaxis of cytomegalovirus infection & disease Adult & adolescent ≥12 yr 2,000 mg qid, initiated as early as possible post-transplant for 90 days. Renal impairment Herpes zoster Immunocompetent & immunocompromised adult: CrCl ≥50 mL/min 1,000 mg tid, 30-49 mL/min 1,000 mg bid, 10-29 mL/min 1,000 mg once daily, 10 mL/min 500 mg once daily. HSV infections Immunocompetent adult & adolescent: CrCl ≥30 mL/min 500 mg bid, <30 mL/min 500 mg once daily. Immunocompromised adult: CrCl ≥30 mL/min 1,000 mg bid, <30 mL/min 1,000 mg once daily. Herpes labialis Immunocompetent adult & adolescent (alternative 1-day regimen): CrCl ≥50 mL/min 2,000 mg bid in 1 day, 30-49 mL/min 1,000 mg bid in 1 day, 10-29 mL/min 500 mg bid in 1 day, <10 mL/min 500 mg as a single dose. Suppression of HSV infections Immunocompetent adult & adolescent: CrCl ≥30 mL/min 500 mg once daily, <30 mL/min 250 mg once daily. Immunocompromised adult: ≥30 mL/min 500 mg bid, <30 mL/min 500 mg once daily. CMV prophylaxis in solid organ transplant recipient Adult & adolescent CrCl ≥75 mL/min 2,000 mg qid, 50-<75 mL/min 1,500 mg qid, 25-<50 mL/min 1,500 mg tid, 10-<25 mL/min 1,500 mg bid, <10 mL/min or on dialysis 1,500 mg once daily.
Administration
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Special Precautions
W/draw immediately if signs & symptoms suggestive of DRESS appear. Ensure adequate fluid intake in patients who are at risk of dehydration. Immunocompromised patients w/ complicated herpes zoster ie, those w/ visceral involvement, disseminated zoster, motor neuropathies, encephalitis & cerebrovascular complications, ophth zoster should be treated w/ IV antiviral therapy. Transplant patients at high risk of CMV disease (eg, donor CMV +ve/recipient CMV -ve or use of anti-thymocyte globulin induction therapy). Avoid intercourse when symptoms are present even if treatment has been initiated. Renal impairment. Use of higher doses (≥4,000 mg daily) in hepatic impairment & liver transplantation. Pregnancy & lactation. Elderly. Childn <12 yr.
Adverse Reactions
Headache. Nausea; dizziness; vomiting, diarrhoea; rashes including photosensitivity, pruritus.
Drug Interactions
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. May increase aciclovir plasma conc w/ medicinal products that compete or inhibit active tubular secretion (eg, tenofovir).
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
Valovir-500 FC tab 500 mg
Packing/Price
100's
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