Acyclovir (Page 3 of 3)

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 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 >100-10 200200 every 4 hours, 5x dailyevery 12 hours
400 mg every 12 hours >100-10 400200 every 12 hoursevery 12 hours
800 mg every 4 hours >2510-250-10 800800800 every 4 hours, 5x dailyevery 8 hoursevery 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:
One Acyclovir 800-mg tablet was shown to be bioequivalent to four Acyclovir 200-mg capsules (n = 24).

HOW SUPPLIED

Acyclovir Tablets, USP 400 mg is White to off white, oval, biconvex, uncoated tablets, debossed with ‘CP114’ on one side and ‘400’ on other side. It is available as follows:

Bottle of 100 (NDC 72241-026-05)

Bottle of 500 (NDC 72241-026-10)

Acyclovir Tablets, USP 800 mg is Light blue to blue, oval, biconvex, uncoated tablets, debossed with ‘CP113’ on one side and ‘800’ on the other side. It is available as follows:

Bottle of 100 (NDC 72241-027-05)

Bottle of 500 (NDC 72241-027-10)

Store at 15° to 25°C (59° to 77°F) and protect from light and moisture. Dispense in tight, light-resistant container as defined in the USP.

Made in India by:

Cadila Pharmaceuticals Limited,

1389, Dholka, District — Ahmedabad,

Gujarat State, INDIA

Manufactured for:

Modavar Pharmaceuticals LLC.

1016, 16th Street, Suite 602,

Washington, DC 20036

Toll free: 800 688 4697

Revised: June 2021

PRINCIPAL DISPLAY PANEL

NDC 72241-026-05
ACYCLOVIR
TABLETS, USP
400 mg
Rx only 100 TABLETS

acyclovir-400mg-100tabs
(click image for full-size original)

NDC 72241-026-10
ACYCLOVIR
TABLETS, USP
400 mg
Rx only 500 TABLETS

acyclovir-400mg-500tabs
(click image for full-size original)

NDC 72241-027-05
ACYCLOVIR
TABLETS, USP
800 mg
Rx only 100 TABLETS

acyclovir-800mg-100tabs
(click image for full-size original)


NDC 72241-027-10
ACYCLOVIR
TABLETS, USP
800 mg

Rx only 500 TABLETS

acyclovir-800mg-500tabs
(click image for full-size original)

ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72241-026
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color BLUE (Light blue to blue) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code CP114;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72241-026-05 100 TABLET in 1 BOTTLE None
2 NDC:72241-026-10 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202168 08/18/2021
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72241-027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 800 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 2
POVIDONE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off white) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code CP113;800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72241-027-05 100 TABLET in 1 BOTTLE None
2 NDC:72241-027-10 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202168 08/18/2021
Labeler — Modavar Pharmaceuticals LLC (858949204)
Establishment
Name Address ID/FEI Operations
Cadila Pharmaceuticals Limited 918451696 ANALYSIS (72241-026), ANALYSIS (72241-027), LABEL (72241-026), LABEL (72241-027), MANUFACTURE (72241-026), MANUFACTURE (72241-027), PACK (72241-026), PACK (72241-027)

Revised: 11/2021 Modavar Pharmaceuticals LLC

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