ACYCLOVIR (Page 4 of 4)

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 should be modified as shown in Table 3:

Table 3. Dosage Modification for Renal Impairment

Creatinine

Adjusted Dosage Regimen

Normal Dosage

Regimen

Clearance

(mL/min/1.73 m 2)

Dose

(mg)

Dosing Interval

200 mg every 4 hours

>10

200

every 4 hours, 5x daily

0-10

200

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

800

every 4 hours, 5x daily

10-25

800

every 8 hours

0-10

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 Capsules USP 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and an aqua blue opaque cap. “APO 042” is imprinted on each capsule in black ink. They are supplied as follows:

Bottles of 5 (43063-826-05)

Bottles of 50 (43063-826-50)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture.

PRINCIPAL DISPLAY PANEL — 200 mg

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

Acyclovir Capsules USP

200 mg

Rx only

image
(click image for full-size original)
ACYCLOVIR
acyclovir capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-826(NDC:60505-0042)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
GELATIN
FD&C BLUE NO. 1
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (white body) , blue (aqua blue opaque cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APO;042
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-826-05 5 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:43063-826-50 50 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075677 03/20/2006
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-826)

Revised: 05/2022 PD-Rx Pharmaceuticals, Inc.

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