Lisinopril

LISINOPRIL- lisinopril tablet
Dispensing Solutions, Inc.

2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg

Rx only

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. When pregnancy is detected, lisinopril should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION

Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21 H31 N3 O5 (2H2 O and its structural formula is:

Lisinopril USP

Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol.

Lisinopril tablets are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration.

Inactive Ingredients:

2.5 mg tablets — colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch.

5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide, starch.

40 mg tablets — colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch, starch, yellow iron oxide.

CONTRAINDICATIONS

Lisinopril is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema.

ADVERSE REACTIONS

Lisinopril has been found to be generally well tolerated in controlled clinical trials involving 1969 patients with hypertension or heart failure. For the most part, adverse experiences were mild and transient.

Hypertension

In clinical trials in patients with hypertension treated with lisinopril, discontinuation of therapy due to clinical adverse experiences occurred in 5.7% of patients. The overall frequency of adverse experiences could not be related to total daily dosage within the recommended therapeutic dosage range.

For adverse experiences occurring in greater than 1% of patients with hypertension treated with lisinopril or lisinopril plus hydrochlorothiazide in controlled clinical trials, and more frequently with lisinopril and/or lisinopril plus hydrochlorothiazide than placebo, comparative incidence data are listed in the table below:

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 (0.5) 1.0 (0.0)
Asthenia 1.3 (0.5) 2.1 (0.2) 1.0 (0.0)
Orthostatic Effects 1.2 (0.0) 3.5 (0.2) 1.0 (0.0)
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 (0.0)
Nausea 2.0 (0.4) 2.5 (0.2) 2.4 (0.0)
Vomiting 1.1 (0.2) 1.4 (0.1) 0.5 (0.0)
Dyspepsia 0.9 (0.0) 1.9 (0.0) 0.0 (0.0)
Musculoskeletal
Muscle Cramps 0.5 (0.0) 2.9 (0.8) 0.5 (0.0)
Nervous / Psychiatric
Headache 5.7 (0.2) 4.5 (0.5) 1.9 (0.0)
Dizziness 5.4 (0.4) 9.2 (1.0) 1.9 (0.0)
Paresthesia 0.8 (0.1) 2.1 (0.2) 0.0 (0.0)
Decreased Libido 0.4 (0.1) 1.3 (0.1) 0.0 (0.0)
Vertigo 0.2 (0.1) 1.1 (0.2) 0.0 (0.0)
Respiratory
Cough 3.5 (0.7) 4.6 (0.8) 1.0 (0.0)
Upper Respiratory Infection 2.1 (0.1) 2.7 (0.1) 0.0 (0.0)
Common Cold 1.1 (0.1) 1.3 (0.1) 0.0 (0.0)
Nasal Congestion 0.4 (0.1) 1.3 (0.1) 0.0 (0.0)
Influenza 0.3 (0.1) 1.1 (0.1) 0.0 (0.0)
Skin
Rash 1.3 (0.4) 1.6 (0.2) 0.5 (0.5)
Urogenital
Impotence 1.0 (0.4) 1.6 (0.5) 0.0 (0.0)

Chest pain and back pain were also seen, but were more common on placebo than lisinopril.

Heart Failure

In patients with heart failure treated with lisinopril for up to four years, discontinuation of therapy due to clinical adverse experiences occurred in 11% of patients. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks.
The following table lists those adverse experiences which occurred in greater than 1% of patients with heart failure treated with lisinopril or placebo for up to 12 weeks in controlled clinical trials, and more frequently on lisinopril than placebo.

Controlled Trials 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 (0.0)
Abdominal Pain 2.2 (0.7) 1.9 (0.0)
Cardiovascular
Hypotension 4.4 (1.7) 0.6 (0.6)
Digestive
Diarrhea 3.7 (0.5) 1.9 (0.0)
Nervous/Psychiatric
Dizziness 11.8 (1.2) 4.5 (1.3)
Headache 4.4 (0.2) 3.9 (0.0)
Respiratory
Upper Respiratory Infection 1.5 (0.0) 1.3 (0.0)
Skin
Rash 1.7 (0.5) 0.6 (0.6)

Also observed at > 1% with lisinopril but more frequent or as frequent on placebo than lisinopril in controlled trials were asthenia, angina pectoris, nausea, dyspnea, cough, and pruritus.
Worsening of heart failure, anorexia, increased salivation, muscle cramps, back pain, myalgia, depression, chest sound abnormalities, and pulmonary edema were also seen in controlled clinical trials, but were more common on placebo than lisinopril.
In the two-dose ATLAS trial in heart failure patients, withdrawals due to adverse events were not different between the low and high groups, either in total number of discontinuation (17-18%) or in rare specific events (less than 1%). The following adverse events, mostly related to ACE inhibition, were reported more commonly in the high dose group:

% of patients Events High Dose (N=1568) Low Dose (N=1596)
Dizziness 18.9 12.1
Hypotension 10.8 6.7
Creatinine-increased 9.9 7.0
Hyperkalemia 6.4 3.5
NPN* increased 9.2 6.5
Syncope 7.0 5.1


*NPN = non-protein nitrogen

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