Acyclovir (Page 3 of 3)

Herpes Zoster

The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir tablets 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).

Chickenpox

The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir tablets at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir tablets. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir tablets or a combination of these factors.
General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.
Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS).
Digestive: Diarrhea, gastrointestinal distress, nausea.
Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.
Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.
Musculoskeletal: Myalgia.
Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Special Senses: Visual abnormalities. Urogenital: Renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS).

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 tablets.
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 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.

HOW SUPPLIED


Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets debossed with ‘J’ on one side and ’49′ in triangle on the other. They are supplied as follows:

NDC: 70518-2455-00

PACKAGING: 30 in 1 BLISTER PACK

NDC: 70518-2455-01

PACKAGING: 15 in 1 BOTTLE PLASTIC

Repackaged and Distributed By:

Remedy Repack, Inc.

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


Store between 15º and 25ºC. Protect from light and moisture.

>


http://medlibrary.org/lib/images-rx/acyclovir-90/address.jpg

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

By:

HETERO TM

Hetero Labs Limited, Unit V, Polepally, 2022708

Jadcherla, Mahaboob Nagar-509 301, India.

Barcode

Revised: June 2013

DRUG: Acyclovir

GENERIC: Acyclovir

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2455-0

NDC: 70518-2455-1

COLOR: pink

SHAPE: HEXAGON (6 sided)

SCORE: No score

SIZE: 12 mm

IMPRINT: J;49

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 15 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • ACYCLOVIR 400mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • COLLOIDAL SILICON DIOXIDE
  • POVIDONE
  • FERRIC OXIDE RED
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
MM1
(click image for full-size original)
MM2
(click image for full-size original)
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2455(NDC:31722-777)
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
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color pink Score no score
Shape HEXAGON (6 sided) (shield,flat) Size 12mm
Flavor Imprint Code J;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2455-0 30 TABLET in 1 BLISTER PACK None
2 NDC:70518-2455-1 15 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203834 11/25/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2020 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 © 2020. All Rights Reserved.