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
PRINCIPAL DISPLAY PANEL — 50 mgNDC 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
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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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