Metoprolol Tartrate (Page 6 of 6)

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 tartrate tablets is required in patients with renal impairment.

Hepatic Impairment

Metoprolol blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol tartrate tablets 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 unchewed with a glass of water. Metoprolol tartrate tablets should always be taken in standardized relation with meals. If the physician asks the patient to take metoprolol tartrate tablets either before breakfast or with breakfast, then the patient should continue taking metoprolol tartrate tablets with the same schedule during the course of therapy.

HOW SUPPLIED

Metoprolol Tartrate Tablets, USP are available containing 50 mg of metoprolol tartrate, USP.

The 50 mg tablets are pink, film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. They are available as follows:

NDC 67046-469-07 blisterpacks of 7

NDC 67046-469-14 blisterpacks of 14

NDC 67046-469-15 blisterpacks of 15

NDC 67046-469-20 blisterpacks of 20

NDC 67046-469-21 blisterpacks of 21

NDC 67046-469-28 blisterpacks of 28

NDC 67046-469-30 blisterpacks of 30

NDC 67046-469-60 blisterpacks of 60

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

Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 9/2016
MTPL:R17

Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Rev: Original—2017.10.04—NJW

meto50
(click image for full-size original)
PRINCIPAL DISPLAY PANEL — 50 mg

NDC 67046-469-30

Metoprolol
Tartrate
Tablets, USP
50 mg

Rx only 30 Tablets

Each film-coated tablet contains:
Metoprolol tartrate, USP 50 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Protect from moisture.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM0032A13

METOPROLOL TARTRATE
metoprolol tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-469(NDC:0378-0032)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
D&C RED NO. 27
FD&C RED NO. 40
Product Characteristics
Color pink Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code M;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67046-469-20 20 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:67046-469-15 15 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:67046-469-14 14 TABLET, FILM COATED in 1 BLISTER PACK None
4 NDC:67046-469-07 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:67046-469-21 21 TABLET, FILM COATED in 1 BLISTER PACK None
6 NDC:67046-469-28 28 TABLET, FILM COATED in 1 BLISTER PACK None
7 NDC:67046-469-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
8 NDC:67046-469-60 60 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076704 10/04/2017
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises Inc. 945429777 repack (67046-469)

Revised: 12/2018 Contract Pharmacy Services-PA

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