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 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 m2)	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:

Cartons of 100 capsules (10 capsules each blister pack x 10) NDC 0904-5789-61

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.

Manufactured by: Manufactured for:

Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, Florida

Canada M9L 1T9 33326

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Revised: December 2005

Rev. 4

PRINCIPAL DISPLAY PANEL — 200 mg

Acyclovir Capsules USP

200 mg

100 count

ACYCLOVIR acyclovir capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-5789(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 MICROCRYSTALLINE CELLULOSE GELATIN, UNSPECIFIED 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:0904-5789-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-5789-61)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075677 03/20/2006

Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2021 Major Pharmaceuticals