Acyclovir (Page 4 of 4)

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 oral 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

0-10

200

200

every 4 hours, 5x daily

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

10-25

0-10

800

800

800

every 4 hours, 5x daily

every 8 hours

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 oral suspension, USP 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 oral suspension, USP (white to off-white, banana-flavored) containing 200 mg acyclovir, USP in each teaspoonful (5 mL).

Bottle of 1 pint (473 mL) (NDC 66689-342-16).

Store at 15° to 25°C (59° to 77°F). Protect from light.

Manufactured and Distributed by:

VistaPharm, Inc.

Largo, FL 33771, USA

VP2502

Issue Date: 10/2019

PRINCIPAL DISPLAY PANEL — Bottle

NDC 66689-342 -16

Acyclovir Oral Suspension, USP

200 mg per 5 mL


WARNING: For Oral Use Only.
Shake Well Before Using.

1 pint (473 mL)

Rx Only

VistaPharm®

Acyclovir Bottle Label 07-20
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Carton

NDC 66689-342 -16

Acyclovir Oral Suspension, USP

200 mg per 5 mL


WARNING: For Oral Use Only.
Shake Well Before Using.

1 pint (473 mL)

Rx Only

VistaPharm®

Acyclovir Carton 07-20
(click image for full-size original)

ACYCLOVIR
acyclovir suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-342
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
MICROCRYSTALLINE CELLULOSE
WATER
SORBITOL
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor BANANA (banana) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66689-342-16 1 BOTTLE in 1 CARTON contains a BOTTLE
1 473 mL in 1 BOTTLE This package is contained within the CARTON (66689-342-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213951 09/27/2021
Labeler — VistaPharm, Inc. (116743084)

Revised: 02/2022 VistaPharm, Inc.

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