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

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Hydrochlorothiazide

Aurobindo Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

HYDROCHLOROTHIAZIDE DESCRIPTION


H
Hydrochlorothiazide

CLINICAL PHARMACOLOGY








Pharmacokinetics and Metabolism


HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE






Use in Pregnancy




PRECAUTIONS, Pregnancy

HYDROCHLOROTHIAZIDE CONTRAINDICATIONS




WARNINGS












PRECAUTIONS, Drug Interactions

Acute Myopia and Secondary Angle-Closure Glaucoma

PRECAUTIONS

General
























Laboratory Tests


Drug Interactions






































Drug/Laboratory Test Interactions


PRECAUTIONS, General

Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitroSalmonella typhimuriumin vivoDrosophilain vitroAspergillus nidulans

Pregnancy

Teratogenic Effects






Nonteratogenic Effects


Nursing Mothers


Pediatric Use


DOSAGE AND ADMINISTRATION, Infants and Children

HYDROCHLOROTHIAZIDE ADVERSE REACTIONS




Body as a Whole




Cardiovascular




Digestive




Hematologic




Hypersensitivity




Metabolic


PRECAUTIONS

Musculoskeletal




Nervous System/Psychiatric




Renal


WARNINGS

Skin




Special Senses




Urogenital




OVERDOSAGE




50

HYDROCHLOROTHIAZIDE DOSAGE AND ADMINISTRATION


Adults

For Edema


For Control of Hypertension


PRECAUTIONS

Infants and Children

For Diuresis and for Control of Hypertension


PRECAUTIONS, Pediatric Use

HOW SUPPLIED


Hydrochlorothiazide Tablets USP, 25 mg




Hydrochlorothiazide Tablets USP, 50 mg





PHARMACIST:


Store at



Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (100 Tablet Bottle)


NDC 65862-133-01
Hydrochlorothiazide Tablets, USP
25 mg
Rx only                       100 Tablets
AUROBINDO
Hydrochlorothiazide

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablet Bottle)


NDC 65862-134-01
Hydrochlorothiazide Tablets, USP
50 mg
Rx only                        100 Tablets
AUROBINDO
Hydrochlorothiazide

Hydrochlorothiazide

Hydrochlorothiazide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-133
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
lactose monohydrate
STARCH, PREGELATINIZED CORN
FD&C YELLOW NO. 6
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
PINK (Light Pink) 6 mm D;27 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-133-01 100 in 1 BOTTLE
2 NDC:65862-133-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040780 2007-07-20


Hydrochlorothiazide

Hydrochlorothiazide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-134
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
lactose monohydrate
STARCH, PREGELATINIZED CORN
FD&C YELLOW NO. 6
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
PINK (Light Pink) 8 mm D;28 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-134-01 100 in 1 BOTTLE
2 NDC:65862-134-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040780 2007-07-20


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Be sure to consult your doctor before taking any medication!
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