Fosinopril Sodium (Page 5 of 7)

Pediatric Use

The antihypertensive effects of fosinopril have been evaluated in a double-blind study in pediatric patients 6 to 16 years of age (see CLINICAL PHARMACOLOGY, Hypertension ). The pharmacokinetics of fosinopril have been evaluated in pediatric patients 6 to 16 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Fosinopril was generally well tolerated and adverse effects were similar to those described in adults (see ADVERSE REACTIONS, Pediatric Patients ).

ADVERSE REACTIONS

Fosinopril sodium has been evaluated for safety in more than 2,100 individuals in hypertension and heart failure trials, including approximately 530 patients treated for a year or more. Generally, adverse events were mild and transient, and their frequency was not prominently related to dose within the recommended daily dosage range.

Hypertension

In placebo-controlled clinical trials (688 fosinopril sodium-treated patients), the usual duration of therapy was two to three months. Discontinuations due to any clinical or laboratory adverse event were 4.1% and 1.1% in fosinopril sodium-treated and placebo-treated patients, respectively. The most frequent reasons (0.4% to 0.9%) were headache, elevated transaminases, fatigue, cough (see PRECAUTIONS, General , Cough), diarrhea, and nausea and vomiting.

During clinical trials with any fosinopril sodium regimen, the incidence of adverse events in the elderly (≥ 65 years old) was similar to that seen in younger patients. Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril sodium alone and at least as frequent on fosinopril sodium as on placebo in placebo-controlled clinical trials are shown in the table below.

Clinical Adverse Events In Placebo-Controlled Trials (Hypertension)

Fosinopril Sodium

Placebo

(N=688)

(N=184)

Incidence (Discontinuation)

Incidence (Discontinuation)

Cough

2.2 (0.4)

0.0 (0.0)

Dizziness

1.6 (0.0)

0.0 (0.0)

Nausea/Vomiting

1.2 (0.4)

0.5 (0.0)

The following events were also seen at >1% on fosinopril sodium tablets but occurred in the placebo group at a greater rate: headache, diarrhea, fatigue, and sexual dysfunction. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.2% to 1.0% of patients (except as noted) treated with fosinopril sodium in controlled or uncontrolled clinical trials (N=1,479) and less frequent, clinically significant events include (listed by body system):

General: Chest pain, edema, weakness, excessive sweating.

Cardiovascular: Angina/myocardial infarction, cerebrovascular accident, hypertensive crisis, rhythm disturbances, palpitations, hypotension, syncope, flushing, claudication.

Orthostatic hypotension occurred in 1.4% of patients treated with fosinopril monotherapy.

Hypotension or orthostatic hypotension was a cause for discontinuation of therapy in 0.1% of patients.

Dermatologic: Urticaria, rash, photosensitivity, pruritus.

Endocrine/Metabolic: Gout, decreased libido.

Gastrointestinal: Pancreatitis, hepatitis, dysphagia, abdominal distention, abdominal pain, flatulence, constipation, heartburn, appetite/weight change, dry mouth.

Hematologic: Lymphadenopathy.

Immunologic: Angioedema. (See WARNINGS, Anaphylactoid and Possible Related Reactions , Head and Neck AngioedemaHead and Neck and Intestinal Angioedema).

Musculoskeletal: Arthralgia, musculoskeletal pain, myalgia/muscle cramp.

Nervous/Psychiatric: Memory disturbance, tremor, confusion, mood change, paresthesia, sleep disturbance, drowsiness, vertigo.

Respiratory: Bronchospasm, pharyngitis, sinusitis/rhinitis, laryngitis/hoarseness, epistaxis. A

symptom-complex of cough, bronchospasm, and eosinophilia has been observed in two patients treated with fosinopril.

Special Senses: Tinnitus, vision disturbance, taste disturbance, eye irritation.

Urogenital: Renal insufficiency, urinary frequency.

Heart Failure

In placebo-controlled clinical trials (361 fosinopril sodium-treated patients), the usual duration of therapy was 3 to 6 months. Discontinuations due to any clinical or laboratory adverse event, except for heart failure, were 8.0% and 7.5% in fosinopril sodium-treated and placebo-treated patients, respectively. The most frequent reason for discontinuation of fosinopril sodium was angina pectoris (1.1%). Significant hypotension after the first dose of fosinopril sodium occurred in 14/590 (2.4%) of patients; 5/590 (0.8%) patients discontinued due to first dose hypotension.

Clinical adverse events probably or possibly related or of uncertain relationship to therapy, occurring in at least 1% of patients treated with fosinopril sodium and at least as common as the placebo group, in placebo-controlled trials are shown in the table below.

Clinical Adverse Events in Placebo-Controlled Trials (Heart Failure)

Fosinopril Sodium

Placebo

(N=361)

(N=373)

Incidence (Discontinuation)

Incidence (Discontinuation)

Dizziness

11.9 (0.6)

5.4 (0.3)

Cough

9.7 (0.8)

5.1 (0.0)

Hypotension

4.4 (0.8)

0.8 (0.0)

Musculoskeletal Pain

3.3 (0.0)

2.7 (0.0)

Nausea/Vomiting

2.2 (0.6)

1.6 (0.3)

Diarrhea

2.2 (0.0)

1.3 (0.0)

Chest Pain (non-cardiac)

2.2 (0.0)

1.6 (0.0)

Upper Respiratory Infection

2.2 (0.0)

1.3 (0.0)

Orthostatic Hypotension

1.9 (0.0)

0.8 (0.0)

Subjective Cardiac

Rhythm Disturbance

1.4 (0.6)

0.8 (0.3)

Weakness

1.4 (0.3)

0.5 (0.0)

The following events also occurred at a rate of 1% or more on fosinopril sodium but occurred on placebo more often: fatigue, dyspnea, headache, rash, abdominal pain, muscle cramp, angina pectoris, edema, and insomnia.

The incidence of adverse events in the elderly (≥ 65 years old) was similar to that seen in younger patients. Other clinical events probably or possibly related, or of uncertain relationship to therapy occurring in 0.4% to 1.0% of patients (except as noted) treated with fosinopril sodium in controlled clinical trials (N=516) and less frequent, clinically significant events include (listed by body system):

General: Fever, influenza, weight gain, hyperhidrosis, sensation of cold, fall, pain.

Cardiovascular: Sudden death, cardiorespiratory arrest, shock (0.2%), atrial rhythm disturbance, cardiac rhythm disturbances, non anginal chest pain, edema lower extremity, hypertension, syncope, conduction disorder, bradycardia, tachycardia.

Dermatologic: pruritus.

Endocrine/Metabolic: Gout, sexual dysfunction.

Gastrointestinal: Hepatomegaly, abdominal distention, decreased appetite, dry mouth, constipation,flatulence.

Immunologic: Angioedema (0.2%).

Musculoskeletal: Muscle ache, swelling of an extremity, weakness of an extremity.

Nervous/Psychiatric: Cerebral infarction, TIA, depression, numbness, paresthesia, vertigo, behavior change, tremor.

Respiratory: Abnormal vocalization, rhinitis, sinus abnormality, tracheobronchitis, abnormal breathing,pleuritic chest pain.

Special Senses: Vision disturbance, taste disturbance.

Urogenital: Abnormal urination, kidney pain.

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