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Prescription Medications

Metoprolol Succinate (Page 6 of 6)

15 REFERENCES

Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008; 371:1839-47.

16 HOW SUPPLIED/STORAGE AND HANDLING

Metoprolol Succinate Extended-release Tablets, USP are available containing 23.75 mg, 47.5 mg, 95 mg or 190 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate, USP, respectively.

The 25 mg tablets are white to off-white film-coated, round, scored tablets debossed with M above the score on one side of the tablet and MT1 on the other side. They are available as follows:

NDC 0378-4595-77
bottles of 90 tablets

NDC 0378-4595-10
bottles of 1000 tablets

The 50 mg tablets are white to off-white film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT2 on the other side. They are available as follows:

NDC 0378-4596-77
bottles of 90 tablets

NDC 0378-4596-10
bottles of 1000 tablets

The 100 mg tablets are white to off-white film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT3 on the other side. They are available as follows:

NDC 0378-4597-77
bottles of 90 tablets

NDC 0378-4597-10
bottles of 1000 tablets

The 200 mg tablets are white to off-white film-coated, oval, scored tablets debossed with M on one side of the score on one side of the tablet and MT4 on the other side. They are available as follows:

NDC 0378-4598-77
bottles of 90 tablets

NDC 0378-4598-05
bottles of 500 tablets

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

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

17 PATIENT COUNSELING INFORMATION

Advise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release tablets without consulting the physician.

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with metoprolol succinate extended-release tablets has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release tablets.

Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.

* The brands listed are trademarks of their respective owners.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad — 500 034, India
Code No.: MH/DRUGS/25/NKD/89

REVISED MAY 2014
75054361
MX:MTPSER:R4

PRINCIPAL DISPLAY PANEL — 25 mg

NDC 0378-4595-77

Metoprolol
Succinate
Extended-release
Tablets, USP

25 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
23.75 mg metoprolol succinate, USP
equivalent to 25 mg of
metoprolol tartrate, USP.

Usual Dosage: See accompanying
prescribing information.

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.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4595MM2

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Metoprolol Succinate Extended-release Tablets, USP 25 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 0378-4596-77

Metoprolol
Succinate
Extended-release
Tablets, USP

50 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
47.5 mg metoprolol succinate, USP
equivalent to 50 mg of
metoprolol tartrate, USP.

Usual Dosage: See accompanying
prescribing information.

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.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4596MM2

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Metoprolol Succinate Extended-release Tablets, USP 50 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg

NDC 0378-4597-77

Metoprolol
Succinate
Extended-release
Tablets, USP

100 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
95 mg metoprolol succinate, USP
equivalent to 100 mg of
metoprolol tartrate, USP.

Usual Dosage: See accompanying
prescribing information.

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.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4597MM2

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Metoprolol Succinate Extended-release Tablets, USP 100 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 200 mg

NDC 0378-4598-77

Metoprolol
Succinate
Extended-release
Tablets, USP

200 mg*

Rx only 90 Tablets

*Each film-coated tablet contains
190 mg metoprolol succinate, USP
equivalent to 200 mg of
metoprolol tartrate, USP.

Usual Dosage: See accompanying
prescribing information.

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.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX4598MM2

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

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Metoprolol Succinate Extended-release Tablets, USP 200 mg Bottle Label
(click image for full-size original)
METOPROLOL SUCCINATE metoprolol succinate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4595
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ETHYLCELLULOSES
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code M;MT1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4595-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0378-4595-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202033 12/21/2011
METOPROLOL SUCCINATE metoprolol succinate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4596
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ETHYLCELLULOSES
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code M;MT2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4596-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0378-4596-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202033 12/21/2011
METOPROLOL SUCCINATE metoprolol succinate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4597
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ETHYLCELLULOSES
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code M;MT3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4597-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0378-4597-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202033 12/21/2011
METOPROLOL SUCCINATE metoprolol succinate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-4598
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ETHYLCELLULOSES
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code M;MT4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-4598-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:0378-4598-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202033 12/21/2011
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 05/2014 Mylan Pharmaceuticals Inc.

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