Metoprolol Tartrate description, usages, side effects, indications, overdosage, supplying and lots more!

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Metoprolol Tartrate

Legacy Pharmaceutical Packaging

Metoprolol Tartrate Tablets, USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

METOPROLOL TARTRATE DESCRIPTION


1pdextro
Metoprolol Tartrate




CLINICAL PHARMACOLOGY


In vitroin vivo12



121211









2











Pharmacokinetics






















METOPROLOL TARTRATE INDICATIONS AND USAGE

Hypertension


Angina Pectoris


Myocardial Infarction


DOSAGE AND ADMINISTRATIONCONTRAINDICATIONSWARNINGSDOSAGE AND ADMINISTRATION

METOPROLOL TARTRATE CONTRAINDICATIONS

Hypertension and Angina


WARNINGS







WARNINGS

Myocardial Infarction


WARNINGS

WARNINGS

Hypertension and Angina

Cardiac Failure


In Patients Without a History of Cardiac Failure


Ischemic Heart Disease


Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol therapy abruptly even in patients treated only for hypertension.
Bronchospastic Diseases

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS, including metoprolol. Because of its relative beta1 selectivity, however, metoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta1 selectivity is not absolute, a beta2-stimulating agent should be administered concomitantly, and the lowest possible dose of metoprolol tartrate should be used. In these circumstances it would be prudent initially to administer metoprolol in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval. (See DOSAGE AND ADMINISTRATION.)
Major Surgery

The necessity or desirability of withdrawing beta-blocking therapy, including metoprolol, prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Metoprolol, like other beta-blockers, is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. However, such patients may be subject to protracted severe hypotension. Difficulty in restarting and maintaining the heartbeat has also been reported with beta-blockers.
Diabetes and Hypoglycemia

Metoprolol should be used with caution in diabetic patients if a beta-blocking agent is required. Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
Pheochromocytoma

In patients known to have, or suspected of having, a pheochromocytoma, metoprolol is contraindicated (see CONTRAINDIATIONS). If metoprolol is required, 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 have been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.
Thyrotoxicosis

Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm.

Myocardial Infarction

Cardiac Failure





Bradycardia


AV Block




Hypotension


Bronchospastic Diseases


PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS, including metoprolol. Because of its relative beta1 selectivity, metoprolol may be used with extreme caution in patients with bronchospastic disease. Because it is unknown to what extent beta2-stimulating agents may exacerbate myocardial ischemia and the extent of infarction, these agents should not be used prophylactically. If bronchospasm not related to congestive heart failure occurs, metoprolol should be discontinued. A theophylline derivative or a beta2 agonist may be administered cautiously, depending on the clinical condition of the patient. Both theophylline derivatives and beta2 agonists may produce serious cardiac arrhythmias.

PRECAUTIONS

General


Information for Patients




Drug Interactions








General Anesthetics


WARNINGS, Major Surgery

CYP2D6 Inhibitors


Clonidine


Carcinogenesis, Mutagenesis, Impairment of Fertility






Pregnancy Category C



Nursing Mothers


Pediatric Use


Geriatric Use




METOPROLOL TARTRATE ADVERSE REACTIONS

Hypertension and Angina




Central Nervous System:


Cardiovascular: CONTRAINDICATIONSWARNINGSPRECAUTIONS

Respiratory: WARNINGS

Gastrointestinal:

Hypersensitive Reactions:

Miscellaneous:



Myocardial Infarction


Central Nervous System: 

Cardiovascular: CLINICAL PHARMACOLOGY
  
 Metoprolol
 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:

Gastrointestinal:

Dermatologic:

Miscellaneous:

Potential Side Effects




Central Nervous System:

Cardiovascular: CONTRAINDICATIONS

Hematologic:

Hypersensitive Reactions:

Postmarketing Experience

OVERDOSAGE


Acute Toxicity:

50

Signs and Symptoms


Treatment




WARNINGS: Myocardial Infarction



Elimination of the Drug:


Bradycardia:


Hypotension:


Bronchospasm:
2

Cardiac Failure:

METOPROLOL TARTRATE DOSAGE AND ADMINISTRATION

Hypertension




1

Angina Pectoris




WARNINGS

Myocardial Infarction

Early Treatment






Late Treatment

WARNINGS

Late Treatment


HOW SUPPLIED

Metoprolol Tartrate Tablets, USP are available as follows:
 
Tablets 50 mg are pink round shaped, film coated tablets debossed with ‘C over 74’ on one side and deep break line on other side.
 
               Bottles of 60         NDC 68645-190-59
              
Tablets 100 mg
are light blue round shaped, film coated tablets debossed with ‘C over 75’ on one side and deep break line on other side.

               Bottles of 60         NDC 68645-191-59              

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].



Protect from moisture.


Dispense



Aurobindo Pharma Limited

Packaged by:
Legacy Pharmaceutical Packaging
Earth City, MO 63045

Distributed by:
Wal-Mart
Bentonville, AR 72716

Revised: 01/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

NDC 68645-190-59
Metoprolol
Tartrate 
Tablets, USP
50 mg
Rx only           
60 Tablets

Metoprolol Tartrate

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 68645-191-59
Metoprolol
Tartrate
Tablets, USP
100mg
Rx Only
60 Tablets

Metoprolol Tartrate

Metoprolol Tartrate

Metoprolol Tartrate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68645-190(NDC:65862-063)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE METOPROLOL 50 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SODIUM LAURYL SULFATE
talc
MAGNESIUM STEARATE
HYPROMELLOSES
titanium dioxide
polyethylene glycol 400
polysorbate 80
D&C RED NO. 30

Product Characteristics

Color Size Imprint Code Shape
PINK 8 mm C;74 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68645-190-59 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077739 2007-09-11


Metoprolol Tartrate

Metoprolol Tartrate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68645-191(NDC:65862-064)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE METOPROLOL 100 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
SODIUM LAURYL SULFATE
talc
MAGNESIUM STEARATE
HYPROMELLOSES
titanium dioxide
polyethylene glycol 400
polysorbate 80
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
BLUE (Light Blue) 11 mm C;75 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68645-191-59 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077739 2007-09-11


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