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

Lisinopril

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING

FETAL TOXICITY
See full prescribing information for complete boxed warning.
     When pregnancy is detected, discontinue lisinopril tablets as soon as possible.
     Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.

DESCRIPTION


DESCRIPTION




CLINICAL PHARMACOLOGY

Mechanism of Action
Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidly dispeptidase that catalyzes the conversion of angiotension I to the vasoconstrictor substance, angiotensin II. Angiotension II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system.Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassum. In hypertensive patiens with normal renal function treated with lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L (see
PRECAUTIONS). Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity.




Pharmacokinetics and Metabolism

Adult Patients



DOSAGE AND ADMINISTRATION). Lisinopril can be removed by hemodialysis.


Pediatric Patients


Pharmacodynamics and Clinical Effects

Hypertension

WARNINGS). When given together with thiazide-type diuretics, the blood pressure lowering effects of the two drugs are approximately additive.






PRECAUTIONS).


DOSAGE AND ADMINISTRATION, Preparation of Suspension (for 200 mL of a 1 mg/mL Suspension)).

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).

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 (seeADVERSE REACTIONS).

Intestinal Angioedema
Intestinal angiodema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vimiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angiedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

INDICATIONS AND USAGE and CONTRAINDICATIONS).

Anaphylactoid Reactions During Desensitization


Anaphylactoid Reactions During Membrane Exposure


Hypotension

DOSAGE AND ADMINISTRATION).
PRECAUTIONS, Drug Interactions, andADVERSE REACTIONS).




Leukopenia/Neutropenia/Agranulocytosis


Hepatic Failure


Fetal Toxicity

Pregnancy Category D

PRECAUTIONS,Pediatric Use).

PRECAUTIONS

General

Aortic Stenosis/Hypertrophic Cardiomyopathy


Impaired Renal Function




Evaluation of patients with hypertension, heart failure, or myocardial infarction should always include assessment of renal function (seeDOSAGE AND ADMINISTRATION).

Hyperkalemia


Cough


Surgery/Anesthesia


Information for Patients

Angioedema


Symptomatic Hypotension



Hyperkalemia


Hypoglycemia
PRECAUTIONS, Drug Interactions).

Leukopenia/Neutropenia


Pregnancy

NOTE:As with many other drugs, certain advice to patients being treated with lisinopril is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Drug Interactions

Hypotension-Patients on Diuretic Therapy
WARNINGSandDOSAGE AND ADMINISTRATION). When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed. Studies with ACE inhibitors in combination with diuretics indicate that the dose of the ACE inhibitor can be reduced when it is given with a diuretic (seeDOSAGE AND ADMINISTRATION).

Antidiabetics

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)



Other Agents


Agents Increasing Serum Potassium


Lithium


Gold


Carcinogenesis, Mutagenesis, Impairment of Fertility





Nursing Mothers


Pediatric Use
Neonates with a history of in utero exposure to lisinopril:


CLINICAL PHARMACOLOGY, Pharmacokineticsand MetabolismandPharmacodynamics and Clinical Effects,andDOSAGE AND ADMINISTRATION).

Geriatric Use

CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Heart Failure and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Acute Myocardial Infarction).

CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism).
DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS



Hypertension



PERCENT OF PATIENTS IN CONTROLLED STUDIES
Lisinopril
(n = 1349)
Incidence (discontinuation)Lisinopril/Hydrochlorothiazide (n = 629)
Incidence (discontinuation) Placebo
(n = 207)
Incidence (discontinuation) Body As A Whole Cardiovascular Digestive Musculoskeletal Nervous/Psychiatric Respiratory Skin Urogenital


Heart Failure



CONTROLLED TRIALS
Lisinopril
(n = 407)
Incidence
(discontinuation)
12 weeks Placebo
(n = 155)
Incidence(discontinuation)
12 weeks Body As A Whole Cardiovascular Digestive Nervous/Psychiatric Respiratory Skin




*
% of Patients
Events High Dose (n = 1568) Low Dose (n = 1596)



*increased











Acute Myocardial Infarction





Body as a Whole
WARNINGS,Anaphylactoid and Possibly Related Reactions), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise

Cardiovascular
WARNINGS,Hypotension); pulmonary embolsim and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibillation, bradycardia and premature ventricular contractions), palpitations, transient ischemic attacks, paroxysmal nocturnal dyspnea, orthostatic hypotension, decreased blood pressure, peripheral edema, vasculitis

Digestive
WARNINGS,Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth

Hematologic


Endocrine


Metabolic

PRECAUTIONS, Drug Interactions).

Musculoskeletal


Nervous System/Psychiatric


Respiratory System


Skin


Special Senses


Urogenital System
PRECAUTIONSandDOSAGE AND ADMINISTRATION), pyelonephritis, dysuria, urinary tract infection, breast pain

Miscellaneous


Angioedema



Hypotension
WARNINGS).

Cough
PRECAUTIONS,Cough.

Pediatric Patients


Clinical Laboratory Test Findings

Serum Electrolytes
PRECAUTIONS), hyponatremia

Creatinine, Blood Urea Nitrogen
PRECAUTIONS). 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


Liver Function Tests
WARNINGS, Hepatic Failure).



OVERDOSAGE


WARNINGS,AnaphylactoidReactions During Membrane Exposure).

DOSAGE & ADMINISTRATION

Hypertension

Initial Therapy


Diuretic Treated Patients
WARNINGS). The dosage of lisinopril tablets USP should be adjusted according to blood pressure response. If the patientblood pressure is not controlled with lisinopril tablets USP alone, diuretic therapy may be resumed as described above.
WARNINGSandPRECAUTIONS, Drug Interactions).


Dosage Adjustment in Renal Impairment


*
WARNINGS, Anaphylactoid ReactionsDuring Membrane Exposure.



*
Heart Failure
WARNINGSandPRECAUTIONS, Drug Interactions). The appearance of hypotension after the initial dose of lisinopril tablets USP does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.


Dosage Adjustment in Patients With Heart Failure and Renal Impairment or Hyponatremia
WARNINGSandPRECAUTIONS, Drug Interactions).

Acute Myocardial Infarction

WARNINGS). If hypotension occurs (systolic blood pressure100 mmHg), a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril tablets USP should be withdrawn. For patients who develop symptoms of heart failure, seeDOSAGE AND ADMINISTRATION, Heart Failure.

Dosage Adjustment in Patients With Myocardial Infarction With Renal Impairment


Use in Elderly


Pediatric Hypertensive Patients6 Years of Age
CLINICAL PHARMACOLOGY,PharmacokineticsandMetabolism and Pharmacodynamics and Clinical Effects).
CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism and Pharmacodynamics and Clinical Effects andPRECAUTIONS).

Preparation of Suspension (for 200 mL of a 1 mg/mL Suspension)

HOW SUPPLIED


HOW SUPPLIED




HOW SUPPLIED




HOW SUPPLIED




HOW SUPPLIED




HOW SUPPLIED





HOW SUPPLIED







PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Lisinopril

LISINOPRIL TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-213(NDC:0172-3758)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
mannitol
STARCH, CORN
talc

Product Characteristics

Color Size Imprint Code Shape
white 6 mm 3758 SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-213-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075752 2012-12-31


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