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
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus.
WARNINGS, Fetal/Neonatal Morbidity and Mortality

LISINOPRIL DESCRIPTION


Lisinopril






CLINICAL PHARMACOLOGY

Mechanism of Action:PRECAUTIONS




PHARMACOKINETICS AND METABOLISM




DOSAGE AND ADMINISTRATION



PHARMACODYNAMICS AND CLINICAL EFFECTS

Hypertension:
WARNINGS






PRECAUTIONS

DOSAGE AND ADMINISTRATION

Heart Failure:



Acute Myocardial Infarction:

DOSAGE AND ADMINISTRATION


ADVERSE REACTIONS - Acute Myocardial Infarction

INDICATIONS & USAGE

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:
Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway should be promptly provided. (ADVERSE REACTIONS

Intestinal Angioedema:

INDICATIONS AND USAGECONTRAINDICATIONS

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





PRECAUTIONS, Drug Interactions


NOTE:

DRUG INTERACTIONS

WARNINGSDOSAGE AND ADMINISTRATIONDOSAGE AND ADMINISTRATION







CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY

Pregnancy Categories C (first trimester) and D (second and third trimesters).WARNINGS, Fetal/Neonatal Morbidity and Mortality

NURSING MOTHERS



PEDIATRIC USE


CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamics and Clinical EffectsDOSAGE AND ADMINISTRATION

GERIATRIC USE


CLINICAL PHARMACOLOGYPharmacodynamics and Clinical EffectsHeart FailureCLINICAL PHARMACOLOGYPharmacodynamics and Clinical EffectsAcute Myocardial Infarction

CLINICAL PHARMACOLOGYPharmacokinetics and Metabolism
DOSAGE AND ADMINISTRATION


LISINOPRIL ADVERSE REACTIONS



Hypertension





Heart Failure






Acute Myocardial Infarction




WARNINGS, Anaphylactoid Reactions and Possibly Related Reactions
WARNINGS, Hypotension
Digestive: Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (seeWARNINGS, Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth.
Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.
Endocrine: Diabetes mellitus.
Metabolic: Weight loss, dehydration, fluid overload, gout, weight gain.
Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or insulin have been reported in post-marketing experience (SeePRECAUTIONS, Drug Interactions).
Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, lumbago.
Nervous System/Psychiatric: Stroke, ataxia, memory impairment, tremor, peripheral neuropathy (e.g., dysesthesia), spasm, paresthesia, confusion, insomnia, somnolence, hypersomnia, irritability and nervousness.
Respiratory System: Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, bronchitis, wheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea.
Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, flushing, diaphoresis, cutaneous pseudolymphoma. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson syndrome; causal relationship has not been established.
Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances.
Urogenital System: Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction (seePRECAUTIONSandDOSAGE AND ADMINISTRATION), pyelonephritis, dysuria, urinary tract infection, breast pain.
Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia and leukocytosis. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.
Angioedema: Angioedema has been reported in patients receiving lisinopril (0.1%) with an incidence higher in Black than in non-Black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with lisinopril should be discontinued and appropriate therapy instituted immediately. (SeeWARNINGS.)
In rare cases, intestinal angioedema has been reported in post marketing experience.
Hypotension: In hypertensive patients, hypotension occurred in 1.2% and syncope occurred in 0.1% of patients with an incidence higher in Black than in non-Black patients. Hypotension or syncope was a cause of discontinuation of therapy in 0.5% of hypertensive patients. In patients with heart failure, hypotension occurred in 5.3% and syncope occurred in 1.8% of patients. These adverse experiences were possibly dose-related (see above data from ATLAS Trial) and caused discontinuation of therapy in 1.8% of these patients in the symptomatic trials. In patients treated with lisinopril for six weeks after acute myocardial infarction, hypotension (systolic blood pressuremmHg) resulted in discontinuation of therapy in 9.7% of the patients. (SeeWARNINGS.)
Fetal/Neonatal Morbidity and Mortality: SeeWARNINGS, Fetal/Neonatal Morbidity and Mortality.
Cough: SeePRECAUTIONS Cough
Pediatric Patients: No relevant differences between the adverse experience profile for pediatric patients and that previously reported for adult patients were identified.

Clinical Laboratory Findings
Serum Electrolytes: Hyperkalemia (SeePRECAUTIONS), hyponatremia.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2.0% of patients with essential hypertension treated with lisinopril alone. Increases were more common in patients receiving concomitant diuretics and in patients with renal artery stenosis. (SeePRECAUTIONS.) Reversible minor increases in blood urea nitrogen and serum creatinine were observed in approximately 11.6% of patients with heart failure on concomitant diuretic therapy. Frequently, these abnormalities resolved when the dosage of the diuretic was decreased.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred frequently in patients treated with lisinopril but were rarely of clinical importance in patients without some other cause of anemia. In clinical trials, less than 0.1% of patients discontinued therapy due to anemia. Hemolytic anemia has been reported; a causal relationship to lisinopril cannot be excluded.
Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred. (SeeWARNINGS,Hepatic Failure.)
In hypertensive patients, 2.0% discontinued therapy due to laboratory adverse experiences, principally elevations in blood urea nitrogen (0.6%), serum creatinine (0.5%) and serum potassium (0.4%).
In the heart failure trials, 3.4% of patients discontinued therapy due to laboratory adverse experiences; 1.8% due to elevations in blood urea nitrogen and/or creatinine and 0.6% due to elevations in serum potassium.
In the myocardial infarction trial, 2.0% of patients receiving lisinopril discontinued therapy due to renal dysfunction (increasing creatinine concentration to over 3 mg/dL or a doubling or more of the baseline serum creatinine concentration); less than 1.0% of patients discontinued therapy due to other laboratory adverse experiences: 0.1% with hyperkalemia and less than 0.1% with hepatic enzyme alterations.

OVERDOSAGE


WARNINGSAnaphylactoid Reactions During Membrane Exposure

DOSAGE & ADMINISTRATION

Hypertension

WARNINGS
WARNINGSPRECAUTIONSDrug Interactions
PRECAUTIONS

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

WARNINGSPRECAUTIONS, Drug Interactions

Acute Myocardial Infarction

WARNINGSDOSAGE AND ADMINISTRATION, Heart Failure


Use in Elderly


Pediatric Hypertensive Patients6 years of age
CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamicsClinical Effects.
CLINICAL PHARMACOLOGY, Pharmacokinetics and MetabolismPharmacodynamics and Clinical EffectsPRECAUTIONS

HOW SUPPLIED









STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Lisinopril

Lisinopril

Lisinopril TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-548(NDC:0591-0408)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 20 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
mannitol
STARCH, CORN
FD&C YELLOW NO. 5

Product Characteristics

Color Size Imprint Code Shape
yellow 8 mm WATSON;408 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-548-30 400 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076059 2011-09-29


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