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 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 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 m 2) 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.

HOW SUPPLIED

Acyclovir Tablets USP, 400 mg are white to off-white colored, round shaped, biconvex, uncoated tablets, debossed with “791” on one side and plain on the other side and are supplied as follows:

NDC: 70518-1332-00

NDC: 70518-1332-01

NDC: 70518-1332-02

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 21 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container (USP).

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: acyclovir

GENERIC: acyclovir

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1332-0

NDC: 70518-1332-1

NDC: 70518-1332-2

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: 791

PACKAGING: 30 in 1 BOTTLE, PLASTIC

PACKAGING: 21 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ACYCLOVIR 400mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • STARCH, CORN
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
MM3
(click image for full-size original)
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1332(NDC:68382-791)
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
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 791
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1332-0 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:70518-1332-1 21 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:70518-1332-2 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204314 07/30/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 05/2021 REMEDYREPACK INC.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.