Acyclovix (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 should be modified as shown in Table 3:

Table 3
(click image for full-size original)

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: Acyclovir Suspension was shown to be bioequivalent to acyclovir Capsules (n = 20) and 1 acyclovir 800-mg capsule was shown to be bioequivalent to 4 acyclovir 200-mg capsules (n = 24).

HOW SUPPLIED

Acyclovir Capsules, 200 mg oval capsule, opaque light blue cap imprinted with a mark “200” and aqua blue opaque body imprinted with Imprint CTI 114
are supplied in bottles of 100

Bottle of 100…………………………..NDC 61442-114-01

Store at 20° to 25°C (68° to 77°F). Protect from moisture.

Manufactured and distributed by:

Carlsbad Tech
5928 Farnsworth Court
Carlsbad, CA 92008 USA

CTI-18 REV. B
REVISED: February 2017

Zilactin-Active Ingredients

Benzyl alcohol 10%

Zilactin-Purpose & Use

Cold sore/fever blister treatment, Oral pain reliever.

temporarily relieves pain caused by:

  • cold sores/fever blisters
  • canker sores, mouth sores
  • gum irritations

Zilactin-Warnings

Flammable:

  • keep away from fire or flame

Stop use and ask a physician if

  • sore mouth symptoms do not improve in 7 days
  • condition worsens or symptoms clear up and occur again within a few days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • apply only to affected area
  • do not exceed recommended dosage
  • avoid contact with the eyes
  • do not use for more than 7 days unless directed by a physician or dentist

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Zilactin-Dosage & Administration

adults and children
2 years and older dry affected area.
Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds.
children under 12 years adult supervision should be given in the use of this product
children under 2 years do not use, consult a physician or dentist

Zilactin-Other Safety Information

  • do not peel off protective film. Attempting to peel off film may result in skin irritation or tenderness. To remove film, first apply another coat of Zilactin to film, and immediately wipe the area with a moist gauze pad or tissue.
  • contains alcohol 68% by volume
  • store at 15-30°C (59-86°F)

Questions or Comments?

Call TOLL FREE 1-800-252-4739
www.zilactin.com

Zilactin Inactive Ingredients

boric acid, hydroxypropylcellulose, propylene glycol, purified water, salicylic acid, SD alcohol 37, tannic acid

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

NDC 61442-114-01

Acyclovir

Capsules USP

200 mg

Rx Only

Carlsbad Technology, Inc.

100 Capsules

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL
(click image for full-size original)

Zilactin-Label

Zilactin
(click image for full-size original)

Acyclovix Label

aclyclovix
(click image for full-size original)

ACYCLOVIX
acyclovir kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72275-733
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72275-733-77 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 0 TUBE 1 g
Part 2 0 BOTTLE 1
Part 1 of 2
ZILACTIN EARLY RELIEF COLD SORE
benzyl alcohol gel
Product Information
Item Code (Source) NDC:50486-468
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL 0.1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
EUCALYPTOL
THYMOL
MENTHOL
PROPYLENE GLYCOL
SALICYLIC ACID
ALCOHOL
TANNIC ACID
WATER
HYDROXYPROPYL CELLULOSE (TYPE M)
Packaging
# Item Code Package Description Multilevel Packaging
1 7.1 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 06/30/2005
Part 2 of 2
ACYCLOVIR
acyclovir capsule
Product Information
Item Code (Source) NDC:61442-114
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
STARCH, CORN
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code CTI;114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206261 08/17/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206261 09/20/2020
Labeler — Primary Pharmaceuticals, Inc. (066126126)
Establishment
Name Address ID/FEI Operations
Rainbow Gold Products, Inc. 800695152 repack (72275-733)
Establishment
Name Address ID/FEI Operations
Carlsbad Technology, Inc. 968263561 manufacture (61442-114), analysis (61442-114)

Revised: 09/2020 Primary Pharmaceuticals, Inc.

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