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Acyclovir (Acyclovir) - Indications and Dosage

 
 



INDICATIONS & USAGE

Acyclovir is indicated for the acute treatment of herpes zoster (shingles).

 

Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.

 

Acyclovir is indicated for the treatment of chickenpox (varicella).

 

DOSAGE & ADMINISTRATION

800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

 

200 mg every 4 hours, 5 times daily for 10 days.

 

400 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.

 

200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.

 

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.

 

800 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.

 

In patients with renal impairment, the dose of acyclovir capsules and tablets should be modified as shown in Table 3:

Table 3: Dosage Modification for Renal Impairment
Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2) Adjusted Dosage Regimen
Dose (mg) Dosing Interval
200 mg every 4 hours > 10 200 every 4 hours, 5x daily
0 to 10 200 every 12 hours
400 mg every 12 hours > 10 400 every 12 hours
0 to 10 200 every 12 hours
800 mg every 4 hours > 25 800 every 4 hours, 5x daily
10 to 25 800 every 8 hours
0 to 10 800 every 12 hours

For 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.

 

No supplemental dose appears to be necessary after adjustment of the dosing interval.

 

Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

 

HOW SUPPLIED

Acyclovir capsules USP are available containing 200 mg acyclovir. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N 940 and 200 on opposing cap and body portion of the capsule.

They are supplied as follows:

NDC 0093-8940-01 Bottles of 100

NDC 0093-8940-05 Bottles of 500

NDC 0093-8940-93 Unit dose boxes of 100

Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N943 on one side and 400 on the other side.

They are supplied as follows:

NDC 0093-8943-01 Bottles of 100

NDC 0093-8943-05 Bottles of 500

NDC 0093-8943-93 Unit dose boxes of 100

Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N947 on one side and 800 on the other side.

They are supplied as follows:

NDC 0093-8947-01 Bottles of 100

NDC 0093-8947-05 Bottles of 500

NDC 0093-8947-93 Unit dose boxes of 100

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Manufactured In Canada By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. H 8/2012

 

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