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

Isoniazid

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING






DESCRIPTION



DESCRIPTION



CLINICAL PHARMACOLOGY






Mechanism of Action

Isoniazid resistant Mycobacterium tuberculosis bacilli develop rapidly when isoniazid monotherapy is administered.

MICROBIOLOGY






INDICATIONS & USAGE

















CONTRAINDICATIONS



WARNINGS



PRECAUTIONS

General













LABORATORY TESTS



DRUG INTERACTIONS

Food


Acetaminophen


Carbamazepine


Ketoconazole


Phenytoin


Theophylline


Valproate


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Teratogenic Effects

Pregnancy Category C

Isoniazid has been shown to have an embryocidal effect in rats and rabbits when given orally during pregnancy. Isoniazid was not teratogenic in reproduction studies in mice, rats and rabbits. There are no adequate and well-controlled studies in pregnant women. Isoniazid should be used as a treatment for active tuberculosis during pregnancy because the benefit justifies the potential risk to the fetus. The benefit of preventive therapy also should be weighed against a possible risk to the fetus. Preventive therapy generally should be started after delivery to prevent putting the fetus at risk of exposure; the low levels of isoniazid in breast milk do not threaten the neonate. Since isoniazid is known to cross the placental barrier, neonates of isoniazid treated mothers should be carefully observed for any evidence of adverse effects.
Nonteratogenic Effects
Since isoniazid is known to cross the placental barrier, neonates of isoniazid-treated mothers should be carefully observed for any evidence of adverse effects.

NURSING MOTHERS



ADVERSE REACTIONS


Nervous System Reactions:

Hepatic Reactions:
Gastrointestinal Reactions:
Hematologic Reactions:
Hypersensitivity Reactions:
Metabolic And Endocrine Reactions:
Miscellaneous Reactions:

OVERDOSAGE

Signs and Symptoms


Treatment


For the Asymptomatic Patient


For the Symptomatic Patient


General


Rapid Control of Metabolic Acidosis


Dialysis



DOSAGE & ADMINISTRATION

INDICATIONS AND USAGE


For Treatment of Tuberculosis



Adults



Children



Patients with Pulmonary Tuberculosis Without HIV Infection




Directly Observed Therapy (DOT)


Patients with Pulmonary Tuberculosis and HIV Infection


Patients with Extra Pulmonary Tuberculosis




Pregnant Women with Tuberculosis


Treatment of Patients with Multi-Drug Resistant Tuberculosis (MDRTB)


Directly Observed Therapy (DOT)


For Preventative Therapy of Tuberculosis


Adults over 30 Kg


Infants and Children





HOW SUPPLIED


100 mg Tablets:
300 mg Tablets:

STORAGE AND HANDLING



REFERENCES












PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Isoniazid

Isoniazid TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-393(NDC:0185-4351)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ISONIAZID ISONIAZID 100 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
lactose monohydrate
STARCH, CORN
povidone

Product Characteristics

Color Size Imprint Code Shape
white 8 mm E;4354 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-393-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA008678 2011-07-19


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