Alaclov 500mg

Viscous Eye Drop
Valacyclovir
ACI Pharmaceuticals

Other Strength:

Alternative:
- Valovir 500mg
- Revira 500mg
- Zostiva 500mg



Alaclov
Description
Alaclovis a preparationofValaciclovirwhichis anantiviralagent. Itis a prodrug, converted by esterasesto the active drug Aciclovir, as well as the amino acid valine, via hepaticfirst-pass metabolism.

Indications
Alaclov is indicated fortreatment of -
Herpes zoster (Shingles)Initial and suppression of recurrent herpes simplex infectionsof skin & mucous membraneincluding initial and recurrent genital herpesReduction oftransmission of genital herpesPrevention of cytomegalovirus disease following organ transplantationCold sores (Herpes labialisor fever blisters)

Dosageand administration

Adult
Herpes zoster:1gm threetimes daily for 7 days.Herpes simplex: -First episode, 500mg twice daily for 5 days, longer if new lesions appear during treatmentor if healing incomplete (1gmtwice daily for 10 days for genital herpes in immunocompromised or HIV positive patients).-Recurrent infection, 500mg twice daily for 5 days (1gm twice daily for 5 to 10 days for genital herpes in immunocompromised or HIV positive patients).-Herpes simplex, suppression, 500mg daily in1 to 2 divided doses (in immunocompromised or HIV positive patients, 500mg twice daily).Reduction of transmission of genital herpes, 500mg once daily to be taken by the infected partner.Prevention of cytomegalovirus disease following renal transplantation (preferably starting within 72 hours of transplantation), 2gm fourtimes daily usually for 90 days.

Children

Children12to 18 years of age
Herpes zoster: In immunocompromisedpatients, 1gm threetimes daily for 7 days.Herpes simplex:-First episode, 500mg twice daily for 5 days (longer if new lesions appear during treatment or if healing incomplete)-Recurrent infection, 500mg twice daily for 5 days-Suppression of Herpes simplex, 500mg daily in 1 to 2 divided doses (in immunocompromised or HIV positive patients, 500mg twice daily)Prevention of cytomegalovirus disease following renal transplantation (preferably starting within 72 hours of transplantation):2gm fourtimes daily usually for 90 days.Cold Sores (Herpeslabialis): The recommended doseis 2 gmtwice daily for 1 day taken 12 hours apart.

Children02to 18 yearsof age
Chickenpox: The recommended dosage forchickenpox in immunocompetent pediatric patientis 20 mg/kg administered threetimes daily for 5 days. The total dose should not exceed 1 gm threetimes daily.

Therapy should be initiated at the earliest symptom.

Patients with Renal Impairment
Dosage recommendations for adult patients with reduced renal function are given below.

IndicationsNormal DosageRegimen(CreatinineClearance≥ 50 mL/min)Creatinine Clearance (mL/min)30-4910-29< 10Herpes zoster1 gmevery 8 hours1 gmevery 12 hours1 gmevery 24 hours500 mg every 24 hoursGenital herpes: Initial episode1 gmevery 12 hoursNo reduction1 gmevery 24 hours 500 mg every 24 hoursGenital herpes:Recurrent episode500 mg every 12 hoursNo reduction500 mg every 24hours500 mg every 24hoursImmunocompetent patients 1 gmevery 24 hoursNo reduction500 mg every 24hours500 mg every 24hoursAlternate dose for immunocompetent patients with ≤ 9 recurrences/year 500 mg every 24 hoursNo reduction500 mg every 48hours500 mg every 48hoursHIV-infected patients500 mg every 12 hoursNo reduction500 mg every 24 hours500 mg every 24 hoursCold sores (Herpes labialis)Do not exceed 1 day of treatment.Two 2 gmdoses taken 12 hours apartTwo 1 gmdoses taken 12 hours apart Two 500 mg doses taken 12 hours apart500 mg single dose

Data are not available for the use of valaciclovirin pediatric patients with acreatinine clearance<50 mL/min/1.73 m².

Pregnancy and lactation
Valaciclovir is in pregnancy category B. Itshould be used during pregnancy & lactation only if the potential benefit justifies the risk.

Side-effects
Valacicloviris generally well tolerated.The common side effects are nausea, vomiting, fatigue, headache, dizziness, stomach pain, agitation, hallucinations, confusion, speech problems, unsteady movement, vision changes, seizures, loss of consciousness & fever.

Contraindications
Valacicloviris contraindicated in patients with clinically significant hypersensitivity reactionto Valaciclovir, Aciclovir, or any component of the formulation.

Precautions
Dosage reduction should be recommended when administering Valaciclovir to patients with renal impairment. The safety & efficacy of Valaciclovir have not been established in immuno
compromised patients other than for the suppression of genital herpes in HIV infected patients. Caution should be taken in patients with hepatic impairment &blood disorders.

Overdose
Acute renal failure & neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness & coma, have been reported in patients receiving overdoses of Valaciclovir. Caution is required to prevent inadvertent overdosing. Haemodialysis significantly enhances the removal of Aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.

Drug interactions
No clinically significant drug-drug interactions withValaciclovir are known. No dosage adjustment is recommended when valaciclovir is co-administered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal functions.

Pharmaceutical precautions
Store at room temperature, away from light and moisture. Keep all medicines away from children and pets.

Presentation
Alaclov10tablet: Each tablet contains Valaciclovir 500mg

Package quantities
Alaclov 10 tablet: Carton of 10 tablets in Alu-PVC blister

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