Vilerm

Vilerm

aciclovir

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Acyclovir (Inj: Na)
Indications/Uses
Varicella (chickenpox); herpes zoster (shingles) infections. Prophylaxis of CMV infection in bone marrow transplant recipients. Tab: HSV infections of skin & mucous membrane including initial & recurrent episodes of genital herpes. Prophylaxis & prevention of recurrent herpes simplex infections in immunocompetent patient. Inj: Herpes simplex infections in adult & neonate. Prophylaxis of herpes simplex infections in immunocompromised patients.
Dosage/Direction for Use
Tab Adult Varicella (chickenpox) 800 mg orally 4 times daily for 5 days. Herpes zoster (shingles) 800 mg 5 times daily (usually every 4 hr while awake) for 7-10 days. Herpes simplex infections 200 mg 5 times daily (usually every 4 hr while awake) for 5-10 days. May increase dose to 400 mg 5 times daily (usually every 4 hr while awake) for 7-14 days in severe infections. Genital herpes simplex infections initial episodes 200 mg 5 times daily (usually every 4 hr while awake) for 10 days. Episodic treatment of recurrent genital herpes simplex Initiate at earliest prodromal sign or symptom. 200 mg 5 times daily (usually every 4 hr while awake) for 5 days. Chronic suppressive therapy of recurrent episodes 400 mg bid for up to 12 mth. Interrupt therapy every 6-12 mth. May reduce dose to 400-600 mg daily. Chronic suppressive & maintenance prophylaxis of herpes simplex 200 mg qid or 400 mg bid. 400 mg tid for 7-14 days or may switch to IV therapy in severe HIV-infected patients. Severely immunocompromised patients Varicella (chickenpox) 800 mg orally 5 times daily for 5-7 days. Herpes zoster (shingles) 800 mg 5 times daily for 7-10 days. Herpes simplex infections 400 mg 5 times daily (usually every 4 hr while awake) for 7-14 days. Episodic treatment of recurrent genital herpes simplex Initiate at earliest prodromal sign or symptom. 400 mg tid for 5-14 days. Chronic suppressive therapy of recurrent episodes 400 mg bid, continued indefinitely regardless of CD4 count in patients w/ severe recurrences of genital herpes or who want to minimize frequency of recurrences or 400-800 mg bid-tid. Prophylaxis of CMV infection in bone marrow transplant patients 800 mg qid for 6 mth (from 1-7 mth post-transplant) after up to 1 mth of IV therapy. Childn Varicella (chickenpox) 20 mg/kg qid (80 mg/kg daily) for 5 days in childn ≥2 yr. 800 mg qid for 5 days in childn ≥2 yr weighing >40 kg. Treatment in immunocompromised patient 20 mg/kg tid for 7-14 days. Max: 400 mg. Suppressive therapy in immunocompromised patient 20 mg/kg bid. Max: 800 mg. Reassess after 12 mth. Prophylaxis of CMV infection in childn >2 yr who have undergone bone marrow transplant Use adult dose. Renal impairment w/ CrCl 10-25 mL/min/1.73 m2 Usual dose regimen of 800 mg every 4 hr 5 times daily: 800 mg every 8 hr, CrCl 0-10 mL/min/1.73 m2 Usual dose regimen of 800 mg every 4 hr 5 times daily: 800 mg every 12 hr. Usual dose regimen of 200 mg every 4 hr 5 times daily or 400 mg every 12 hr: 200 mg every 12 hr. Immunocompromised patient w/ renal impairment: CrCl 50-80 mL/min/1.73 m2 200-800 mg every 6-8 hr, 25-50 mL/min/1.73 m2 200-800 mg every 8-12 hr, 10-25 mL/min/1.73 m2 200-800 mg every 12-24 hr, <10 mL/min/1.73 m2 200-400 mg every 24 hr. IV infusion Chickenpox, shingles Adult 5 mg/kg every 8 hr. 10 mg/kg every 8 hr in immunocompromised patients. Childn <12 yr 250 mg/m2 every 8 hr. 500 mg/m2 every 8 hr in immunocompromised patients. Herpes simplex infections Adult 5 mg/kg every 8 hr. Childn between 3 mth & 12 yr 250 mg/m2 every 8 hr (750 mg/m2 daily). Neonate to childn 3 mth 10 mg/kg every 8 hr. Herpes simplex encephalitis Adult 10 mg/kg every 8 hr. Childn between 3 mth & 12 yr 500 mg/m2 every 8 hr. Prophylaxis of herpes simplex infection in immunocompromised patients Adult 5 mg/kg every 8 hr. Childn <12 yr 500 mg/m2 every 8 hr. Prophylaxis of CMV infection in bone marrow transplant recipient Adult & childn >2 yr 500 mg/m2 tid (every 8 hr) 5 days before up to 30 days after transplant. Renal impairment w/ CrCl 25-50 mL/min/1.73 m2 Usual dose given every 12 hr, 10-25 mL/min/1.73 m2 Usual dose given every 24 hr, 0-10 mL/min/1.73 m2 & receiving hemodialysis ½ of recommended dose or 2.5 or 5 mg/kg every 24 hr w/ supplemental dose of same dose after hemodialysis, 0-10 mL/min/1.73 m2 receiving continuous ambulatory peritoneal dialysis ½ of recommended dose or 2.5 or 5 mg/kg every 24 hr w/o supplemental dose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to acyclovir or valacyclovir.
Special Precautions
Increased risk of acyclovir-associated acute renal failure w/ high doses, dehydration & pre-existing renal impairment. Maintain adequate hydration in patients receiving high oral doses. Monitor for evidence of neurological adverse effects. Avoid sexual contact while visible lesions are present & during therapy. Concomitant use w/ other nephrotoxic drugs. Renal impairment in elderly. Not to be administered during pregnancy. Avoid breast-feeding in mothers w/ herpetic lesions near or on the breast. Ped <2 yr. Elderly. Inj: Patients on controlled Na diet. Adjust water & electrolyte balances in patients w/ dehydration before administration. Administer in slow, constant rate.
Adverse Reactions
Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, encephalopathy, hallucinations, obtundation, paresthesia, psychosis, seizures, somnolence, tremor; nausea, vomiting, diarrhea, GI distress; anemia, hemolysis, leukocytoclastic vasculitis, leukocytosis, leukopenia, lymphadenopathy, neutrophilia, thrombocytosis, thrombocytopenia; rash, pruritus, urticaria, SJS; hepatitis, jaundice; increased BUN &/or serum creatinine conc, hematuria; fever; hypotension, myalgia, peripheral edema, thirst, visual abnormalities. Tab: Dysarthria, headache, malaise; TTP, hemolytic uremia syndrome; alopecia, angioedema, anaphylaxis, erythema multiforme, photosensitivity rash, TEN; elevated LFT results, hyperbilirubinemia; renal failure; pain. Inj: Disseminated intravascular coagulation, hemoglobinemia, neutropenia; hypersensitivity reaction; anuria, abnormal urinalysis; local inj site reaction w/ inflammation, phlebitis & tissue necrosis; liver dysfunction.
Drug Interactions
Synergistic effect w/ amphotericin B & ketoconazole. Inhibited renal secretion/decreased renal clearance w/ probenecid. Neurotoxicity w/ zidovudine. Tab: Decreased plasma conc & increased seizure activity of valproic acid. Inj: Additive or synergistic antiviral effect w/ interferon. Concomitant use/ intrathecal MTX; drugs affecting other aspects of renal physiology eg, cyclosporine, tacrolimus. Increased plasma conc w/ inactive metabolite of mycophenolate mofetil.
MIMS Class
Antivirals
ATC Classification
J05AB01 - aciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
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Vilerm powd for infusion 250 mg
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Vilerm tab 800 mg
Packing/Price
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