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Zovirax

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Zovirax

INDICATIONS

Herpes Zoster Infections: ZOVIRAX (acyclovir) is indicated for the acute treatment of herpes zoster (shingles).

Genital Herpes: ZOVIRAX (acyclovir) is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.

Chickenpox: ZOVIRAX (acyclovir) is indicated for the tr eatment of chickenpox (varicella).

DOSAGE AND ADMINISTRATION

Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

Chronic Suppressive Therapy for Recurrent Disease: 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 ZOVIRAX (acyclovir) .

Intermittent Therapy: 200 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 kg: 800 mg 4 times daily for 5 days.

Intravenous ZOVIRAX (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 Impairment: In patients with renal impairment, the dose of ZOVIRAX (acyclovir) Capsules, Tablets, or Suspension 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
0-10 200 every 12 hours
400 mg every 12 hours > 10 400 every 12 hours
0-10 200 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

Hemodialysis: 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.

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

Bioequivalence of Dosage Forms: ZOVIRAX (acyclovir) Suspension was shown to be bioequivalent to ZOVIRAX (acyclovir) Capsules (n = 20) and 1 ZOVIRAX (acyclovir) 800-mg tablet was shown to be bioequivalent to 4 ZOVIRAX (acyclovir) 200-mg capsules (n = 24).

HOW SUPPLIED

ZOVIRAX (acyclovir) Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with "Wellcome ZOVIRAX (acyclovir) 200."

Bottle of 100 (NDC 0173-0991-55).

Store at 15° to 25°C (59° to 77°F) and protect from moisture.

ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and engraved with "ZOVIRAX (acyclovir) 800."

Bottle of 100 (NDC 0173-0945-55).

Store at 15° to 25°C (59° to 77°F) and protect from moisture.

ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with "ZOVIRAX (acyclovir) " on one side and a triangle on the other side.

Bottle of 100 (NDC 0173-0949-55).

Store at 15° to 25°C (59° to 77°F) and protect from moisture.

ZOVIRAX (acyclovir) Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).

Bottle of 1 pint (473 mL) (NDC 0173-0953-96).

Store at 15° to 25°C (59° to 77°F).

GlaxoSmithKline Research Triangle Park, NC 27709. November 2007. FDA Rev date: 8/8/2008

Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.

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