Acyclovir (Page 4 of 4)

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 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

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 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

Principal Display Panel

Acyclovir Tablets USP 400mg #60
(click image for full-size original)
ACYCLOVIR
acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-414(NDC:0093-8943)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape OVAL (capsule shaped) Size 15mm
Flavor Imprint Code N943;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-414-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074556 04/23/1997
Labeler — MedVantx, Inc. (806427725)
Registrant — Teva Pharmaceuticals USA Inc (118234421)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-414)

Revised: 02/2013 MedVantx, Inc.

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