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

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Lisinopril and Hydrochlorothiazide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY


LISINOPRIL AND HYDROCHLOROTHIAZIDE DESCRIPTION



Lisinopril and Hydrochlorothiazide




Lisinopril and Hydrochlorothiazide





CLINICAL PHARMACOLOGY

Lisinopril and Hydrochlorothiazide





Lisinopril

Mechanism of Action




PHARMACOKINETICS

Pharmacokinetics and Metabolism






PHARMACODYNAMICS









Hydrochlorothiazide





INDICATIONS & USAGE






LISINOPRIL AND HYDROCHLOROTHIAZIDE CONTRAINDICATIONS



WARNINGS

Lisinopril

Anaphylactoid and Possibly Related Reactions


Head and Neck Angioedema


Intestinal Angioedema



Anaphylactoid Reactions During Desensitization


Anaphylactoid Reactions During Membrane Exposure


Hypotension and Related Effects





Leukopenia/Neutropenia/Agranulocytosis


Hepatic Failure


Pregnancy

Lisinopril and Hydrochlorothiazide



Lisinopril

Fetal/Neonatal Morbidity and Mortality









Hydrochlorothiazide

Acute Myopia and Secondary Angle-Closure Glaucoma


Teratogenic Effects


Nonteratogenic Effects


Hydrochlorothiazide






PRECAUTIONS

General

Lisinopril

Aortic Stenosis/Hypertrophic Cardiomyopathy


Impaired Renal Function





Hyperkalemia


Cough


Surgery/Anesthesia


Hydrochlorothiazide














INFORMATION FOR PATIENTS

Angioedema


Symptomatic Hypotension



Hyperkalemia


Leukopenia/Neutropenia


Pregnancy



DRUG INTERACTIONS

Lisinopril

Hypotension - Patients on Diuretic Therapy


Non-steroidal Anti-inflammatory Agents


Other Agents


Agents Increasing Serum Potassium


Lithium


Hydrochlorothiazide


Alcohol, Barbiturates, or Narcotics


Antidiabetic Drugs (oral agents and insulin)


Other Antihypertensive Drugs


Cholestyramine and Colestipol Resins


Corticosteroids, ACTH


Pressor Amines (e.g., norepinephrine)


Skeletal Muscle Relaxants, Nondepolarizing (e.g., tubocurarine)


Lithium


Non-steroidal Anti-inflammatory Drugs


Gold


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Lisinopril and Hydrochlorothiazide


Lisinopril





Hydrochlorothiazide




PREGNANCY

Pregnancy Categories C (first trimester) and D (second and third trimesters)


NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE




LISINOPRIL AND HYDROCHLOROTHIAZIDE ADVERSE REACTIONS


























Angioedema



Hypotension


Cough


Clinical Laboratory Test Findings

Serum Electrolytes


Creatinine, Blood Urea Nitrogen


Serum Uric Acid, Glucose, Magnesium, Cholesterol, Triglycerides and Calcium


Hemoglobin and Hematocrit


Liver Function Tests



Lisinopril


Body as a Whole


Cardiovascular


Digestive


Endocrine


Hematologic


Metabolic


Musculoskeletal


Nervous System/Psychiatric


Respiratory


Skin


Special Senses


Urogenital


Miscellaneous


Fetal/Neonatal Morbidity and Mortality


Hydrochlorothiazide

Body as a Whole


Digestive


Hematologic


Musculoskeletal


Nervous System/Psychiatric


Renal


Skin


Special Senses


Hypersensitivity


DOSAGE & ADMINISTRATION





Dose Titration Guided by Clinical Effect





Replacement Therapy


Use in Renal Impairment


HOW SUPPLIED









PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Lisinopril and Hydrochlorothiazide

Lisinopril and Hydrochlorothiazide

Lisinopril and Hydrochlorothiazide

Lisinopril and Hydrochlorothiazide TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-283(NDC:0172-5033)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 10 mg
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
mannitol
STARCH, CORN
talc
FD&C BLUE NO. 1
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
blue 6 mm 5033;10;12;5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-283-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075776 2011-06-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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