Acyclovir - Dosage SUSPENSION

ACYCLOVIR (suspension) comes in different strengths and amounts, which is referred to as the dosing of Acyclovir. The appearance of Acyclovir can differ based on the dosing.

Overdosage

Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION).

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

Bottle of 1 pint (473 mL) (NDC 40085-842-96).

Store at 15° to 25°C (59° to 77°F).

Manufactured for:
Renaissance Pharma, Inc.
Newtown, PA 18940
by
Glaxosmithkline
Mississauga, ON, CANADA

March 2014

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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