Metoprolol Tartrate
Generic: METOPROLOL TARTRATE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
a2669da1-b712-5fd5-e053-2a95a90a52f3
Indications & Usage
INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension.
They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol.
Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event.
(See DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ).
They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol.
Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event.
(See DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS ).
Adverse Reactions
ADVERSE REACTIONS Hypertension and Angina Most adverse effects have been mild and transient.
Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients.
Depression has been reported in about 5 of 100 patients.
Mental confusion and short-term memory loss have been reported.
Headache, nightmares, and insomnia have also been reported.
Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients.
Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients.
Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS , WARNINGS, and PRECAUTIONS ).
Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS ).
Rhinitis has also been reported.
Gastrointestinal Diarrhea has occurred in about 5 of 100 patients.
Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients.
Vomiting was a common occurrence.
Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction.
Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported.
Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients.
Very rarely, photosensitivity and worsening of psoriasis has been reported.
Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients.
Musculoskeletal pain, blurred vision, and tinnitus have also been reported.
There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes.
Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.
There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to metoprolol has not been definitely established).
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol.
Myocardial Infarction 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 the randomized comparison of metoprolol and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets Placebo Hypotension (systolic BP < 90 mm Hg) 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.
Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear.
Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear.
Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol.
Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular Intensification of AV block (see CONTRAINDICATIONS ).
Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura.
Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm and respiratory distress.
Post-Marketing Experience The following adverse reactions have been reported during post-approval use of metoprolol: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL).
Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.
Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients.
Depression has been reported in about 5 of 100 patients.
Mental confusion and short-term memory loss have been reported.
Headache, nightmares, and insomnia have also been reported.
Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients.
Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients.
Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS , WARNINGS, and PRECAUTIONS ).
Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS ).
Rhinitis has also been reported.
Gastrointestinal Diarrhea has occurred in about 5 of 100 patients.
Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients.
Vomiting was a common occurrence.
Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction.
Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported.
Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients.
Very rarely, photosensitivity and worsening of psoriasis has been reported.
Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients.
Musculoskeletal pain, blurred vision, and tinnitus have also been reported.
There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes.
Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.
There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to metoprolol has not been definitely established).
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol.
Myocardial Infarction 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 the randomized comparison of metoprolol and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets Placebo Hypotension (systolic BP < 90 mm Hg) 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.
Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear.
Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear.
Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol.
Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Cardiovascular Intensification of AV block (see CONTRAINDICATIONS ).
Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura.
Hypersensitive Reactions Fever combined with aching and sore throat, laryngospasm and respiratory distress.
Post-Marketing Experience The following adverse reactions have been reported during post-approval use of metoprolol: confusional state, an increase in blood triglycerides and a decrease in High Density Lipoprotein (HDL).
Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.