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

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Hydrochlorothiazide

Aurobindo Pharma Limited

Hydrochlorothiazide Capsules USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

HYDROCHLOROTHIAZIDE DESCRIPTION


H78342
Hydrochlorothiazide


CLINICAL PHARMACOLOGY


Pharmacokinetics and Metabolism






Pharmacodynamics




Clinical Studies


HYDROCHLOROTHIAZIDE INDICATIONS AND USAGE


Usage in Pregnancy




HYDROCHLOROTHIAZIDE CONTRAINDICATIONS


Hydrochlorothiazide capsules are con­traindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also con­traindicated.

WARNINGS


Diabetes and Hypoglycemia:

Renal Disease:

PRECAUTIONS


Electrolyte and Fluid Balance Status:







Hyperuricemia:

Impaired Hepatic Function:

Parathyroid Disease:

Drug Interactions




Alcohol, barbiturates, or narcotics -

Antidiabetic drugs  

Other antihypertensive drugs  - 

Cholestyramine and colestipol resins -

Corticosteroid, ACTH -

Pressor amines (e.g., norepinephrine) -

Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine)

Lithium -

Non-steroidal anti-inflammatory drugs

Drug/Laboratory Test Interactions


PRECAUTIONS , General

Carcinogenesis, Mutagenesis, Impairment Of Fertility


in vitroSalmonella typhimuriumin vivoDrosophilain vitroAspergillus nidulans

Pregnancy

Teratogenic Effects


Pregnancy Category B:

Nonteratogenic Effects


Nursing Mothers


Pediatric Use


Geriatric Use


A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e., >65 years) with hydrochlorothiazide. Starting treatment with the lowest available dose of hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.

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


For Control of Hypertension:

HOW SUPPLIED


Hydrochlorothiazide Capsules USP 12.5 mg





Store at



Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12.5 mg (100 Capsule Bottle)


NDC 65862-113-01
Hydrochlorothiazide Capsules USP
12.5 mg
Rx only                  100 Capsules
AUROBINDO
Hydrochlorothiazide

Hydrochlorothiazide

Hydrochlorothiazide CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-113
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
lactose monohydrate
MAGNESIUM STEARATE
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
D&C RED NO. 28
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
BLUE 15 mm D;26 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65862-113-01 100 in 1 BOTTLE
2 NDC:65862-113-33 300 in 1 BOTTLE
3 NDC:65862-113-99 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078164 2007-09-19


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