Metoprolol Tartrate (Page 5 of 5)

Angina Pectoris

The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.

The usual initial dosage of metoprolol tartrate tablets is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of metoprolol tartrate tablets is 100 mg to 400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS).

Myocardial Infarction

Early Treatment:

During the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated 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 each; give the injections at approximately 2-minute intervals. During the intravenous administration of metoprolol, monitor blood pressure, heart rate, and electrocardiogram.

In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below).

Start patients who appear not to tolerate the full intravenous dose on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows.

In patients with severe intolerance, discontinue metoprolol (See WARNINGS).

Late Treatment:

Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1 to 3 years.

Special populations
Pediatric patients: No pediatric studies have been performed. The safety and efficacy of metoprolol in pediatric patients have not been established.

Renal impairment: No dose adjustment of metoprolol is required in patients with renal impairment.

Hepatic impairment: Metoprolol blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol should be initiated at low doses with cautious gradual dose titration according to clinical response.

Geriatric patients (>65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Method of administration:
For oral treatment, the tablets should be swallowed un-chewed with a glass of water. Metoprolol should always be taken in standardized relation with meals. If the physician asks the patient to take metoprolol either before breakfast or with breakfast, then the patient should continue taking metoprolol with the same schedule during the course of therapy.

HOW SUPPLIED

Metoprolol Tartrate Tablets, USP 50 mg — round, scored pink tablets embossed with Watson 462 , supplied in bottles of 100 and 1000.

Metoprolol Tartrate Tablets, USP 100 mg — round, scored light blue tablets embossed with Watson 463 , supplied in bottles of 100 and 1000.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Do not store above 30°C (86°F).

Dispense in a tight, light-resistant container (USP).

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: October 2014

PRINCIPAL DISPLAY PANEL

Blenheim Pharmacal, Inc.

NDC 10544-879-14
Metoprolol Tartrate
Tabets, USP 50 mg 100 Tablets Rx only

Label 50mg 14ct
(click image for full-size original)
METOPROLOL TARTRATE metoprolol tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-879(NDC:0591-0462)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
POVIDONES
MAGNESIUM STEARATE
HYPROMELLOSES
TITANIUM DIOXIDE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
D&C RED NO. 30
ALUMINUM OXIDE
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code Watson;462
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-879-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:10544-879-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074217 05/27/1994
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-879)

Revised: 09/2015 Blenheim Pharmacal, Inc.

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