Acyclovir description, usages, side effects, indications, overdosage, supplying and lots more!

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Acyclovir

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACYCLOVIR DESCRIPTION



Acyclovir




VIROLOGY

Mechanism of Antiviral Action



Antiviral Activities


Drug Resistance


CLINICAL PHARMACOLOGY

Pharmacokinetics


**




Special Populations

Adults With Impaired Renal Function


Geriatrics


Pediatrics


Drug Interactions


Clinical Trials

Initial Genital Herpes


Recurrent Genital Herpes



Herpes Zoster Infections




Chickenpox


INDICATIONS & USAGE

INDICATIONS AND USAGE

Herpes Zoster Infections


Genital Herpes


Chickenpox


ACYCLOVIR CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

WARNINGS


PRECAUTIONS



INFORMATION FOR PATIENTS

Information for Patients


Herpes Zoster


Genital Herpes Infections


Chickenpox


DRUG INTERACTIONS

Drug Interactions


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility






PREGNANCY

Teratogenic Effects

Pregnancy category B



NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use


GERIATRIC USE

Geriatric Use


ACYCLOVIR ADVERSE REACTIONS

ADVERSE REACTIONS

Herpes Simplex

Short-Term Administration


Long-Term Administration


Herpes Zoster


Chickenpox


Observed During Clinical Practice


General


Nervous


Digestive


Hematologic and Lymphatic


Hepatobiliary Tract and Pancreas


Musculoskeletal


Skin


Special Senses


Urogenital


OVERDOSAGE

OVERDOSAGE


DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

Acute Treatment of Herpes Zoster


Genital Herpes

Treatment of Initial Genital Herpes


Chronic Suppressive Therapy for Recurrent Disease



Intermittent Therapy


Treatment of Chickenpox

Children (2 Years of age and Older)


Adults and Children Over 40 kg




Patients With Acute or Chronic Renal Impairment


Table 3: Dosage Modification for Renal Impairment
Hemodialysis


Peritoneal Dialysis


Bioequivalence of Dosage Forms


STORAGE AND HANDLING



INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
STARCH, CORN

LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
GELATIN
FD&C BLUE NO. 1
D&C RED NO. 28
D&C RED NO. 33
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C YELLOW NO. 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

















Acyclovir


Acyclovir


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION












Acyclovir


Acyclovir

Acyclovir

Acyclovir CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-269(NDC:67253-100)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACYCLOVIR ACYCLOVIR 200 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
black 15 mm A05;200 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-269-02 30 in 1 BLISTER PACK
2 NDC:49349-269-03 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075090 2011-05-09


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