Metoprolol Tartrate

METOPROLOL TARTRATE- metoprolol tartrate injection, solution
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

Metoprolol Tartrate Injection, USP is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy.

2 DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Initiate treatment in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.

Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Metoprolol Tartrate Injection each; give the injections at approximately 2-minute intervals. During the intravenous administration of Metoprolol Tartrate Injection, monitor blood pressure, heart rate, and electrocardiogram.

Transition to Oral Metoprolol:

Following administration of Metoprolol Tartrate Injection, transition patients to an oral formulation of metoprolol. See prescribing information for oral metoprolol for dose selection.

3 DOSAGE FORMS AND STRENGTHS

Injection: 5 mg Metoprolol Tartrate as a clear liquid supplied in 5 mL single dose vials. Also available in oversized vials (10 mL) with large mouth (20 mm).

4 CONTRAINDICATIONS

Hypersensitivity to Metoprolol Tartrate Injection and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur).

Metoprolol Tartrate Injection is contraindicated in patients with a heart rate <45 beats/min; second-and third-degree heart block (unless a functioning pacemaker is present); significant first-degree heart block (PR interval ≥0.24 sec); systolic blood pressure <100 mmHg; or decompensated cardiac failure.

5 WARNINGS AND PRECAUTIONS

5.1 Bradycardia

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Metoprolol Tartrate Injection. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving Metoprolol Tartrate Injection. If severe bradycardia develops, reduce or stop Metoprolol Tartrate Injection.

5.2 Heart Failure

Worsening cardiac failure may occur during metoprolol use. If such symptoms occur, increase diuretics and restore clinical stability before administering the next dose of metoprolol [see Dosage and Administration (2)]. Such episodes do not preclude subsequent successful titration of oral metoprolol.

5.3 Bronchospastic Disease

PATIENTS WITH BRONCHOSPASTIC DISEASES, IN GENERAL, SHOULD NOT RECEIVE BETA-BLOCKERS because they can exacerbate bronchospasm. Because of its relative beta1 cardio-selectivity, however, metoprolol may be used in patients with bronchospastic disease for initial treatment of myocardial infarction. Bronchodilators, including beta2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2)].

5.4 Pheochromocytoma

If Metoprolol Tartrate is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

5.5 Peripheral Vascular Disease

Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.

6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Myocardial Infarction

These adverse reactions were reported from treatment regimens where intravenous Metoprolol Tartrate Injection was administered, when tolerated.

Central Nervous System: Tiredness has been reported in about 1 of 100 patients. Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear.

Cardiovascular: In a randomized comparison of Metoprolol Tartrate Injection and placebo, the following adverse reactions were reported:

Metoprolol Tartrate Injection

Placebo

Hypotension (systolic BP <90 mmHg)

27.4%

23.2%

Bradycardia (heart rate <40 beats/min)

15.9%

6.7%

Second-or third-degree heart block

4.7%

4.7%

First-degree heart block (P-R ≥0.26 sec)

5.3%

1.9%

Heart failure

27.5%

29.6%

Respiratory: Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients.

Gastrointestinal: Nausea and abdominal pain have been reported in fewer than 1 of 100 patients.

Miscellaneous: Unstable diabetes and claudication have been reported.

6.2 Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of metoprolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, and hypotension.

Respiratory: Wheezing (bronchospasm), dyspnea.

Central Nervous System: Confusion, short-term memory loss, headache, nightmares, insomnia, nervousness, hallucinations.

Gastrointestinal: Nausea, dry mouth, constipation, flatulence, heartburn, hepatitis, vomiting.

Hypersensitive Reactions: Pruritus.

Miscellaneous: Musculoskeletal pain, arthritis, blurred vision, decreased libido, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, photosensitivity.

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