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

Herpes Zoster Infections


Genital Herpes


Chickenpox


ACYCLOVIR CONTRAINDICATIONS



WARNINGS



PRECAUTIONS



INFORMATION FOR PATIENTS



Herpes Zoster


Genital Herpes Infections


Chickenpox


DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY







PREGNANCY

Teratogenic Effects

Pregnancy category B



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



ACYCLOVIR 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



DOSAGE & 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



Hemodialysis


Peritoneal Dialysis


Bioequivalence of Dosage Forms


HOW SUPPLIED

















STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Acyclovir

Acyclovir

Acyclovir

Acyclovir CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-620(NDC:0093-8940)
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
STARCH, CORN
lactose monohydrate
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
titanium dioxide
GELATIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
D&C RED NO. 28
D&C RED NO. 33
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
blue 19 mm N940;200 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-620-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074578 2011-12-06


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