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

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Isoniazid

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING













ISONIAZID DESCRIPTION


Isoniazid




CLINICAL PHARMACOLOGY






Mechanism of Action



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

MICROBIOLOGY







INDICATIONS & USAGE









































ISONIAZID CONTRAINDICATIONS



WARNINGS

See boxed warning

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 preventative therapy also should be weighed against a possible risk of exposure; the low levels of isoniazid in breast milk do not threaten the neonate. Since isoniazid is known to cross the placenta 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 placenta barrier, neonates of isoniazid-treated mothers should be carefully observed for any evidence of adverse effects.

NURSING MOTHERS



ISONIAZID ADVERSE REACTIONS



Nervous System Reactions



Hepatic Reactions
See boxed warning

Gastrointestinal Reactions
Nausea, vomiting, and epigastric distress.

Hematologic Reactions


Hypersensitivity Reactions
Fever, skin eruptions (morbilliform, maculopapular, purpuric, or exfoliative), lymphadenopathy, and vasculitis.

Metabolic and Endocrine Reactions
Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis, and gynecomastia.

Miscellaneous Reactions
Rheumatic syndrome and systemic lupus erythematosus-like syndrome.

OVERDOSAGE

Signs and Symptoms


Treatment


For the Asymptomatic Patient


For the Symptomatic Patient


General


Rapid Control of Metabolic Acidosis



Dialysis



DOSAGE & ADMINISTRATION

(See also INDICATIONS0.)



For Treatment of Tuberculosis







Patients with Pulmonary Tuberculosis Without HIV Infection












(see also Directly Observed Therapy


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








HOW SUPPLIED












STORAGE AND HANDLING






REFERENCES











PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Isoniazid

Isoniazid

Isoniazid

Isoniazid TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-786(NDC:0555-0071)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ISONIAZID ISONIAZID 300 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
cellulose, microcrystalline
STARCH, CORN
talc

Product Characteristics

Color Size Imprint Code Shape
white 18 mm b;071;300 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-786-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080937 2011-09-28


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