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

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Lisinopril

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY
WARNINGS, Fetal/Neonatal Morbidity and Mortality.

LISINOPRIL DESCRIPTION


Lisinopril










CLINICAL PHARMACOLOGY

Mechanism of Action
PRECAUTIONS




PHARMACOKINETICS AND METABOLISM

Adult Patients:



DOSAGE AND ADMINISTRATION


Pediatric Patients:


PHARMACODYNAMICS AND CLINICAL EFFECTS

Hypertension:

Adult Patients
WARNINGS




PRECAUTIONS

Pediatric Patients

DOSAGE AND ADMINISTRATION, Preparation of Suspension

Heart Failure



Acute Myocardial Infarction

DOSAGE AND ADMINISTRATION


ADVERSE REACTIONS - ACUTE MYOCARDIAL INFARCTION

INDICATIONS & USAGE SECTION

Hypertension


Heart Failure


Acute Myocardial Infarction

WARNINGS
WARNINGS, Anaphylactoid and Possibly Related Reactions

LISINOPRIL CONTRAINDICATIONS



WARNINGS

Anaphylactoid and Possibly Related Reactions


Head and Neck Angioedema
ADVERSE REACTIONS

Intestinal Angioedema

CONTRAINDICATIONS

Anaphylactoid Reactions During Desensitization


Anaphylactoid Reactions During Membrane Exposure



Hypotension
DOSAGE AND ADMINISTRATION
PRECAUTIONS, Drug InteractionsADVERSE REACTIONS




Leukopenia/Neutropenia/Agranulocytosis


Hepatic Failure


Fetal/Neonatal Morbidity and Mortality








PRECAUTIONS

General

Aortic Stenosis/Hypertrophic Cardiomyopathy:


Impaired Renal Function:




DOSAGE AND ADMINISTRATION.

Hyperkalemia:
Drug Interactions.

Cough:


Surgery/Anesthesia:


INFORMATION FOR PATIENTS

Angioedema:


Symptomatic Hypotension:


Hyperkalemia:


Hypoglycemia:
PRECAUTIONS, Drug Interactions

Leukopenia/Neutropenia:


Pregnancy:



DRUG INTERACTIONS

Hypotension:
WARNINGSDOSAGE AND ADMINISTRATIONDOSAGE AND ADMINISTRATION

Antidiabetics:


Non-steroidal Anti-inflammatory Agents:


Other Agents:


Agents Increasing Serum Potassium:


Lithium:


Gold:


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY

WARNINGSFetal/Neonatal Morbidity and Mortality

NURSING MOTHERS



PEDIATRIC USE


CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamics and Clinical Effects,DOSAGE AND ADMINISTRATION

GERIATRIC USE


CLINICAL PHARMACOLOGY,Pharmacodynamics and Clinical Effects, Heart FailureCLINICAL PHARMACOLOGY, Pharmacodynamics and ClinicalEffects, Acute Myocardial Infarction

CLINICAL PHARMACOLOGYPharmacokinetics and Metabolism
DOSAGE AND ADMINISTRATION

LISINOPRIL ADVERSE REACTIONS



Hypertension





Heart Failure






Acute Myocardial Infarction:





Body as a Whole:
WARNINGS, Anaphylactoid and Possibly Related Reactions

Cardiovascular:
WARNINGS, Hypotension

Digestive:
Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (seeWARNINGS, Hepatic Failure


Hematologic:


Endocrine:


Metabolic:

PRECAUTIONS, Drug Interactions

Musculoskeletal:


Nervous System/Psychiatric:


Respiratory System:


Skin:


Special Senses:


Urogenital System:
PRECAUTIONSDOSAGE AND ADMINISTRATION

Miscellaneous:


Angioedema:
WARNINGS


Hypotension:
WARNINGS

Fetal/Neonatal Morbidity and Mortality:
WARNINGS, Fetal/Neonatal Morbidity and Mortality

Cough:
PRECAUTIONS - Cough

Pediatric Patients:

Clinical Laboratory Test Findings

Serum Electrolytes:
PRECAUTIONS

Creatinine, Blood Urea Nitrogen:
PRECAUTIONS

Liver Function Tests:
WARNINGS, Hepatic Failure



OVERDOSAGE


WARNINGS, Anaphylactoid Reactions During Membrane Exposure.

DOSAGE & ADMINISTRATION

Hypertension

Initial Therapy:


Diuretic Treated Patients:
WARNINGS
WARNINGSPRECAUTIONS, Drug Interactions
PRECAUTIONS

Dosage Adjustment in Renal Impairment:

WARNINGS, Anaphylactoid Reactions During Membrane Exposure
Heart Failure
WARNINGSPRECAUTIONS, Drug Interactions


Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia:
WARNINGSPRECAUTIONS, Drug Interactions

Acute Myocardial Infarction:

WARNINGSDOSAGE AND ADMINISTRATION, Heart Failure

Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment:


Use in Elderly


Pediatric Hypertensive Patientsyears of age
CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamics and Clinical Effects
CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamicsand Clinical EffectsPRECAUTIONS

Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)




HOW SUPPLIED



STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Lisinopril



Lisinopril



Lisinopril

Lisinopril TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-316(NDC:64679-953)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 30 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
mannitol
ferric oxide red
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
pink 8 mm W953 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-316-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078402 2011-06-21


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Be sure to consult your doctor before taking any medication!
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