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

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Lisinopril

State of Florida DOH Central Pharmacy


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


N2 2131352


Lisinopril













CLINICAL PHARMACOLOGY


Mechanism of Action


PRECAUTIONS






Pharmacokinetics and Metabolism


Adult Patients:





DOSAGE AND ADMINISTRATION

14

Pediatric Patients:2

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

LISINOPRIL INDICATIONS AND 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. (See ADVERSE REACTIONS.)

Intestinal Angioedema




INDICATIONS AND USAGE CONTRAINDICATIONS

Anaphylactoid Reactions During Desensitization



Anaphylactoid Reactions During Membrane Exposure



Hypotension




DOSAGE AND ADMINISTRATION

PRECAUTIONS, Drug Interactions ADVERSE REACTIONS






Leukopenia/Neutropenia/Agranulocytosis



Hepatic Failure



Fetal/Neonatal Morbidity and Mortality














in utero


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.  (See DOSAGE AND ADMINISTRATION.)

Hyperkalemia


Drug Interactions

Cough



Surgery/Anesthesia



Information for Patients

Angioedema



Symptomatic Hypotension





Hyperkalemia

 

Hypoglycemia

 
 PRECAUTIONS, Drug Interactions

Leukopenia/Neutropenia



Pregnancy




NOTE:

Drug Interactions

Hypotension - Patients on Diuretic Therapy


WARNINGS DOSAGE AND ADMINISTRATION DOSAGE AND ADMINISTRATION

Antidiabetics



Non-steroidal Anti-inflammatory Agents



Other Agents



Agents Increasing Serum Potassium



Lithium



Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including lisinopril.

Carcinogenesis, Mutagenesis, Impairment of Fertility




2

in vitroin vitroin vivo

2

Pregnancy


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

Nursing Mothers


14

Pediatric Use




2 CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism Pharmacodynamics and Clinical Effects DOSAGE AND ADMINISTRATION

Geriatric Use




CLINICAL PHARMACOLOGY – Pharmacodynamics and Clinical Effects – Heart Failure CLINICAL PHARMACOLOGY – Pharmacodynamics and Clinical Effects – Acute Myocardial Infarction



CLINICAL PHARMACOLOGY – Pharmacokinetics and Metabolism

DOSAGE AND ADMINISTRATION

LISINOPRIL 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
    Fatigue
         2.5 (0.3)
              4 (0.5)
          1 (0)
    Asthenia
         1.3 (0.5)
             2.1 (0.2)
          1 (0)
    Orthostatic Effects
          1.2 (0)
             3.5 (0.2)
          1 (0)
Cardiovascular
    Hypotension
         1.2 (0.5)
             1.6 (0.5)
        0.5 (0.5)
Digestive
    Diarrhea
         2.7 (0.2)
             2.7 (0.3)
         2.4 (0)
    Nausea
         2 (0.4)
             2.5 (0.2)
         2.4 (0)
    Vomiting
         1.1 (0.2)
             1.4 (0.1)
         0.5 (0)
    Dyspepsia
          0.9 (0)
              1.9 (0)
           0 (0)
Musculoskeletal
    Muscle Cramps
          0.5 (0)
             2.9 (0.8)
         0.5 (0)
Nervous/Psychiatric
    Headache
        5.7 (0.2)
             4.5 (0.5)
         1.9 (0)
    Dizziness
        5.4 (0.4)
              9.2 (1)
         1.9 (0)
    Paresthesia
        0.8 (0.1)
             2.1 (0.2)
           0 (0)
    Decreased Libido
         0.4 (0.1)
             1.3 (0.1)
           0 (0)
    Vertigo
         0.2 (0.1)
             1.1 (0.2)
           0 (0)
Respiratory
    Cough
        3.5 (0.7)
             4.6 (0.8)
           1 (0)
    Upper Respiratory 
    Infection
        2.1 (0.1)
            2.7 (0.1)
          0 (0)
    Common Cold
        1.1 (0.1)
             1.3 (0.1)
           0 (0)
    Nasal Congestion
         0.4 (0.1)
             1.3 (0.1)
           0 (0)
    Influenza
         0.3 (0.1)
             1.1 (0.1)
           0 (0)
Skin
    Rash
        1.3 (0.4)
             1.6 (0.2)
         0.5 (0.5)
Urogenital
    Impotence
         1 (0.4)
             1.6 (0.5)
           0 (0)



Heart Failure





 
 Controlled Trials
 
 Lisinopril
(n=407)
Incidence
(discontinuation)
12 weeks		 Placebo   
(n=155)     
Incidence
(discontinuation)
12 weeks
Body as a Whole
    Chest Pain
        3.4 (0.2)
          1.3 (0)
    Abdominal Pain
        2.2 (0.7)
          1.9 (0)
Cardiovascular
    Hypotension
        4.4 (1.7)
         0.6 (0.6)
Digestive
    Diarrhea
        3.7 (0.5)
          1.9 (0)
Nervous/Psychiatric
    Dizziness
        11.8 (1.2)
         4.5 (1.3)
    Headache
         4.4 (0.2)
          3.9 (0)
Respiratory
    Upper Respiratory  
    Infection
           1.5 (0)
           1.3 (0)
Skin
    Rash
         1.7 (0.5)
          0.6  (0.6)







% of patients Events High Dose
(N=1568)		 Low dose
(N=1596)
*NPN = non-protein nitrogen
Dizziness
       18.9
       12.1
Hypotension
       10.8
        6.7
Creatinine increased
        9.9
         7
Hyperkalemia
        6.4
       3.5
NPN* increased
        9.2
       6.5
Syncope
         7
      5.1

Acute Myocardial Infarction










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

Cardiovascular: WARNINGS, Hypotension

Digestive: WARNINGS, Hepatic Failure

Hematologic:

Endocrine:

Metabolic:

PRECAUTIONS, Dug Interactions

Musculoskeletal:

Nervous System/Psychiatric:

Respiratory System:

Skin:

Special Senses:

Urogenital System: PRECAUTIONS DOSAGE 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 Findings


Serum Electrolytes: PRECAUTIONS

Creatinine, Blood Urea Nitrogen: PRECAUTIONS

Hemoglobin and Hematocrit:

Liver Function Tests: WARNINGS, Hepatic Failure






OVERDOSAGE




WARNINGS, Anaphylactoid Reactions During Membrane Exposure

LISINOPRIL DOSAGE AND ADMINISTRATION

Hypertension


Initial Therapy:

Diuretic Treated Patients: WARNINGS

WARNINGS PRECAUTIONS, Drug Interactions

PRECAUTIONS

Dosage Adjustment in Renal Impairment:
Renal Status Creatinine
Clearance
mL/min		 Initial Dose
mg/day
* See WARNINGS, Anaphylactoid Reactions During Membrane Exposure .
**Dosage or dosing interval should be adjusted depending on the blood pressure response.
Normal Renal Function to
Mild Impairment		         >30
         10
Moderate to Severe
Impairment 		        ≥10 ≤30
         5
Dialysis Patients*
        <10
         2.5**

Heart Failure


WARNINGS PRECAUTIONS, Drug Interactions



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

Acute Myocardial Infarction




WARNINGS DOSAGE AND ADMINISTRATION, Heart Failure

Dosage Adjustment in Patients With Myocardial Infarction with Renal Impairment:

Use in Elderly



Pediatric Hypertensive Patients ≥ 6 years of age


CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism  Pharmacodynamics and Clinical Effects

2 CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism Pharmacodynamics and Clinical Effects PRECAUTIONS

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


®†™††

†
††

HOW SUPPLIED

2.5 mg Tablets – White to off-white, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and ‘20’ on the other side.

5 mg Tablets – Light red colored, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘2&1’ on either side of score line.

10 mg Tablets – Light yellow colored, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘22’.

20 mg Tablets – Light yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘23’.

30 mg Tablets – Light yellow colored, round shaped, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘24’.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0700-1 10 mg 30 Tablets in a Blister Pack Light 65862-039
53808-0617-1 20 mg 30 Tablets in a Blister Pack Light 65862-040
Storage








Aurobindo Pharma USA, Inc




Aurobindo Pharma Limited

And Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

Label Image for 10mg 30 Count Pack

Lisinopril

Label Image for 20mg 30 Count Pack

Lisinopril

Lisinopril

LISINOPRIL TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0700(NDC:65862-039)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LISINOPRIL LISINOPRIL ANHYDROUS 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
mannitol
STARCH, CORN
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
YELLOW (Light) 6 mm A;22 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0700-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077622 2009-07-01


Lisinopril

LISINOPRIL TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0617(NDC:65862-040)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
mannitol
STARCH, CORN
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
YELLOW (Light) 10 mm A;23 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0617-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077622 2009-07-01


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Be sure to consult your doctor before taking any medication!
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