FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Acyclovir tablet is intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Acyclovir tablet is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Acyclovir tablet is indicated for the treatment of chickenpox (varicella).
Acyclovir tablet is indicated for the acute treatment of herpes zoster (shingles).
History
There is currently no drug history available for this drug.
Other Information
Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir tablet is a formulation for oral administration. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. Each 400 mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.2. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25.
The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H-purin-6-one; it has the following structural formula:
Sources
Strivectin Clinical Corrector Advanced Anti-aging Face Tint Medium Manufacturers
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Strivectin Operating Company, Inc.
Strivectin Clinical Corrector Advanced Anti-aging Face Tint Medium | Blenheim Pharmacal, Inc.
Acute Treatment of Herpes Zoster800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes Treatment of Initial Genital Herpes200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
Intermittent Therapy200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox Children (2 years of age and older)20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg800 mg 4 times daily for 5 days.
Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients with Acute or Chronic Renal ImpairmentIn patients with renal impairment, the dose of acyclovir should be modified as shown in Table 3:
Table 3. Dosage Modification for Renal ImpairmentCreatinine
Adjusted Dosage Regimen
Normal Dosage
Regimen
Clearance
(mL/min/1.73 m 2)
Dose (mg)
Dosing Interval
200 mg every 4 hours
>10
200
every 4 hours, 5x daily
0-10
200
every 12 hours
400 mg every 12 hours
>10
0-10
400
200
every 12 hours
every 12 hours
800 mg every 4 hours
>25
800
every 4 hours, 5x daily
10-25
800
every 8 hours
0-10
800
every 12 hours
HemodialysisFor patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal DialysisNo supplemental dose appears to be necessary after adjustment of the dosing interval.
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