BOXED WARNING
BOXED WARNING
USE IN PREGNANCY
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Pharmacokinetics and Metabolism
Pharmacodynamics and Clinical Effects
Hypertension
Heart Failure
Acute Myocardial Infarction
INDICATIONS AND USAGE
Hypertension
Heart Failure
Acute Myocardial Infarction
CONTRAINDICATIONS
WARNINGS
Anaphylactoid and Possibly Related Reactions
Head and Neck Angioedema
Intestinal Angioedema
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Hypotension
Leukopenia/Neutropenia/Agranulocytosis
Hepatic Failure
Fetal/Neonatal Morbidity and Mortality
PRECAUTIONS
General
Aortic Stenosis/Hypertrophic Cardiomyopathy
Impaired Renal Function
Hyperkalemia
Cough
Surgery/Anesthesia
Information for Patients
Angioedema
Symptomatic Hypotension
Hyperkalemia
Hypoglycemia
Leukopenia/Neutropenia
Pregnancy
Drug Interactions
Hypotension - Patients on Diuretic Therapy
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
Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
Hypertension
| 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
| 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) |
| 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
Clinical Laboratory Findings
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Hypertension
| Normal Renal Function to Mild Impairment | >30 | 10 |
| Moderate to Severe Impairment | ≥10 ≤30 | 5 |
| Dialysis Patients* | <10 | 2.5** |
Heart Failure
Acute Myocardial Infarction
Use in Elderly
Pediatric Hypertensive Patients ≥ 6 years of age
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:
And Repackaged By:
State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
| 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 |