Actavir 250/Actavir 500

Actavir 250/Actavir 500

aciclovir

Manufacturer:

Able Medical

Distributor:

Universal Medical Industry
Concise Prescribing Info
Contents
Aciclovir Na
Indications/Uses
Systemic HSV infections. Initial & recurrent mucosal & cutaneous herpes simplex in, & severe initial clinical episodes of genital herpes in immunocompromised patients. Herpes simplex encephalitis. Neonatal herpes infections. Varicella (chicken pox) & herpes zoster (shingles, zoster) infections.
Dosage/Direction for Use
IV Administer by constant infusion over 1 hr. Adult Systemic HSV infections Usual dose: 5 mg/kg IV every 8 hr for 7-14 days. Mucocutaneous HSV Usual dose: 5 mg/kg IV every 8 hr for 7 days. Herpes simplex encephalitis 10 mg/kg IV every 8 hr for 10 days. Severe initial episodes of genital HSV Usual dose: 5 mg/kg IV every 8 hr for 5-7 days. Varicella-zoster infections in immunocompromised patient Usual dose: 10 mg/kg IV every 8 hr for 7 days. HIV-infected patient 5 mg/kg IV every 8 hr followed by oral aciclovir. Ped Systemic HSV infections <12 yr 10 mg/kg IV every 8 hr for 7-14 days. Mucocutaneous HSV ≥12 yr Use adult dose, <12 yr 10 mg/kg IV every 8 hr for 7 days. Herpes simplex encephalitis ≥12 yr 10 mg/kg IV every 8 hr for 10 days. Severe initial episodes of genital HSV ≥12 yr Use adult dose. Neonatal HSV ≤3 mth 20 mg/kg IV every 8 hr. Varicella-zoster infections in immunocompromised patient ≥12 yr Use adult dose, <12 yr 10 mg/kg IV every 8 hr for 7-10 days. Patient w/ CrCl >50 mL/min/1.73 m2 100% of recommended dose every 8 hr; 25-50 mL/min/1.73 m2 100% of recommended dose every 12 hr; 10-25 mL/min/1.73 m2 100% of recommended dose every 24 hr; 0-10 mL/min/1.73 m2 50% of recommended dose every 24 hr. Adult receiving continuous renal replacement therapy & continuous venovenous hemofiltration 5-10 mg/kg IV every 24 hr; continuous venovenous hemodialysis or continuous venovenous hemodiafiltration 5-10 mg/kg IV every 12-24 hr. Higher dose is for viral meningoencephalitis & varicella-zoster virus infections. Adult receiving intermittent hemodialysis 3 times/wk 2.5-5 mg/kg IV every 24 hr after the dialysis session. Higher dose is for viral meningoencephalitis & varicella-zoster virus infections.
Contraindications
Hypersensitivity to aciclovir, valaciclovir.
Special Precautions
Do not administer topically, IM, orally, SC or in the eye. Immediately stop infusion if signs & symptoms of extravasation occur. Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome in immunocompromised patients. Precipitation of crystals in renal tubules & abnormal renal function (decreased CrCl) can occur. Patients who have underlying neurologic abnormalities, w/ serious renal, hepatic or electrolyte abnormalities, hypoxia. Concomitant use w/ nephrotoxic drugs, preexisting renal disease & dehydration may cause renal impairment. Accompany administration by adequate hydration. Impaired renal function. Caution in renal function in patients receiving higher doses of treatment particularly dehydrated or have any renal impairment. Pregnancy & lactation.
Adverse Reactions
Inj site inflammation or phlebitis, transient elevations of serum creatinine or BUN; nausea or vomiting; itching, rash or hives; elevated transaminases. Anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, neutrophilia, anorexia, hematuria. Hypotension; aggressive behavior, agitation, ataxia, coma, confusion, delirium, dizziness, dysarthria, encephalopathy, hallucinations, obtundation, paresthesia, psychosis, seizure, somnolence, tremor; alopecia, erythema multiforme, photosensitive rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, severe local inflammation reactions (eg, tissue necrosis); abdominal pain, diarrhea, GI distress; renal failure; disseminated intravascular coagulation, hemolysis, leukocytoclastic vasculitis, vasculitis, leukopenia, lymphadenopathy; elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice; myalgia; visual abnormalities; anaphylaxis, angioedema, fatigue, fever, headache, pain, peripheral edema.
Drug Interactions
Potentiated antiviral effect w/ amphotericin B. Synergistic antiviral activity w/ ketoconazole. Enhanced nephrotoxic effect w/ foscarnet. Methotrexate. May increase serum conc of mycophenolate, tenofovir products. Increased mean plasma t½ & area under plasma conc-time curve (AUC), & decreased urinary excretion & renal clearance w/ probenecid. May diminish therapeutic effect of talimogene laherparepvec, varicella virus & zoster vaccine. May enhance CNS depressant effect of zidovudine.
MIMS Class
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
Form
Actavir 500 powd for inj 500 mg
Packing/Price
1's
Form
Actavir 250 powd for inj 250 mg
Packing/Price
1's
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