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 capsules and 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
	0-10	200	every 12 hours
400 mg every 12 hours	>10	400	every 12 hours
	0-10	200	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.
Bioequivalence of Dosage Forms: 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

HOW SUPPLIED

Acyclovir Capsules, USP 200mg are available for oral administration as white opaque body, powder blue opaque cap with black ‘Y211’. They are supplied as follows:

Bottle of 100 (NDC 69117-0039-1)

Bottle of 500 (NDC 69117-0039-2)

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

Acyclovir Tablets, USP 400 mg are available for oral administration as white round tablets, engraved Y212 on one side and plain on other. They are supplied as follows:

Bottle of 100 (NDC 69117-0018-1)

Bottle of 500 (NDC 69117-0018-2)

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

Acyclovir Tablets, USP 800 mg are available for oral administration as white capsule-shaped tablets, engraved Y213 on one side and plain on other side. They are supplied as follows:

Bottle of 100 (NDC 69117-0019-1)

Bottle of 500 (NDC 69117-0019-2)

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

Manufacturer:

Yiling Pharmaceutical Ltd

No.36 Zhujiang Road, Shijiazhuang, 050035, China

Distributor:

Yiling Pharmaceutical, Inc.

5348 Vegas Drive, Las Vegas, NV 89108, USA

Revised: 03/2021

Label-200 mg

Label-800mg

Label-400mg

ACYCLOVIR acyclovir capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69117-0039 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 POTASSIUM HYDROXIDE FERROSOFERRIC OXIDE FD&C BLUE NO. 1 TITANIUM DIOXIDE LACTOSE MONOHYDRATE FD&C RED NO. 3 FD&C YELLOW NO. 6 SHELLAC PROPYLENE GLYCOL GELATIN STARCH, CORN SODIUM LAURYL SULFATE MAGNESIUM STEARATE

Product Characteristics Color white (white opaque body) , blue (powder blue opaque cap) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Y211 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69117-0039-1 100 CAPSULE in 1 BOTTLE None 2 NDC:69117-0039-2 500 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212173 03/12/2021

Labeler — YILING PHARMACEUTICAL, INC. (079417422)

Registrant — YILING PHARMACEUTICAL LTD (544322244)

Establishment
Name	Address	ID/FEI	Operations
Yiling Pharmaceutical Ltd		544322244	manufacture (69117-0039)

Revised: 01/2023 YILING PHARMACEUTICAL, INC.