Metoprolol Tartrate and Hydrochlorothiazide (Page 5 of 5)

DOSAGE AND ADMINISTRATION

Dosage should be determined by individual titration (see INDICATIONS AND USAGE).
Hydrochlorothiazide is usually given at a dosage of 12.5 to 50 mg per day. The usual initial dosage of metoprolol tartrate tablets is 100 mg daily in single or divided doses. Dosage may be increased gradually until optimum blood pressure control is achieved. The effective dosage range is 100 to 450 mg per day. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as dosage of metoprolol tartrate tablets is increased.
The following dosage schedule may be used to administer from 100 to 200 mg of metoprolol tartrate per day and from 25 to 50 mg of hydrochlorothiazide per day:

Metoprolol Tartrate and Hydrochlorothiazide Dosage
Tablets of 50/25 2 tablets per day in single or divided doses
Tablets of 100/25 1 to 2 tablets per day in single or divided doses
Tablets of 100/50 1 tablet per day in single or divided doses

Dosing regimens that exceed 50 mg of hydrochlorothiazide per day are not recommended. When necessary, another antihypertensive agent may be added gradually, beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.

HOW SUPPLIED

Metoprolol Tartrate and Hydrochlorothiazide Tablets USP are available containing 50 mg/25 mg, 100 mg/25 mg or 100 mg/50 mg of metoprolol
tartrate, USP and hydrochlorothiazide, USP.
50 mg/25 mg tablets are white to off-white colored, round shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one
side of score line and “230” on another side of score line and plain on
other side.
NDC 46708-115-30 bottle of 30 tablets
NDC 46708-115-31 bottles of 100 tablets
NDC 46708-115-91 bottles of 1000 tablets
100 mg/25 mg tablets are white to off-white colored, oval shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one
side of score line and “232” on another side of score line and plain on other side.
NDC 46708-116-30 bottle of 30 tablets
NDC 46708-116-31 bottle of 100 tablets
NDC 46708-116-71 bottle of 500 tablets
100 mg/50 mg tablets are white to off-white colored, capsule shaped, biconvex, bevel edged scored uncoated tablet debossed with “L” on one side
of score line and “231” on another side of score line and plain on other side.
NDC 46708-117-30 bottle of 30 tablets
NDC 46708-117-31 bottle of 100 tablets
NDC 46708-117-71 bottle of 500 tablets
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)
[see USP Controlled Room Temperature]. Protect from moisture.
Dispense in tight, light-resistant container (USP).
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:
Alembic Pharmaceuticals Limited (Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.
Issued: 02/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 50 mg/25 mg

Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 50 mg/25 mg (30 Tablets in 1 Bottle)
Each tablet contains metoprolol tartrate USP 50 mg hydrochlorothiazide USP 25 mg46708-115-30

30 Tablets in 1 Bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg/25 mg

Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 100 mg/25 mg (30 Tablets in 1 Bottle)
Each tablet contains metoprolol tartrate USP 100 mg hydrochlorothiazide USP 25 mg 46708-116-30

30 Tablets in 1 Bottle
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg/50 mg

Metoprolol Tartrate and Hydrochlorothiazide Tablets USP 100 mg/50 mg (30 Tablets in 1 Bottle)
Each tablet contains metoprolol tartrate USP 100 mg hydrochlorothiazide USP 50 mg 46708-117-30

30 Tablets in 1 Bottle
(click image for full-size original)
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ANHYDROUS LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off-White) Score 2 pieces
Shape ROUND (biconvex-bevel edged) Size 10mm
Flavor Imprint Code L;230
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-115-30 30 TABLET in 1 BOTTLE None
2 NDC:46708-115-10 100 TABLET in 1 BOTTLE None
3 NDC:46708-115-01 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202870 09/17/2013
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ANHYDROUS LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off-White) Score 2 pieces
Shape OVAL (biconvex-bevel edged) Size 18mm
Flavor Imprint Code L;232
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-116-30 30 TABLET in 1 BOTTLE None
2 NDC:46708-116-10 100 TABLET in 1 BOTTLE None
3 NDC:46708-116-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202870 09/17/2013
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL TARTRATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
ANHYDROUS LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off-White) Score 2 pieces
Shape CAPSULE (biconvex-bevel edged) Size 17mm
Flavor Imprint Code L;231
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-117-30 30 TABLET in 1 BOTTLE None
2 NDC:46708-117-10 100 TABLET in 1 BOTTLE None
3 NDC:46708-117-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202870 09/17/2013
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-115), MANUFACTURE (46708-116), MANUFACTURE (46708-117)

Revised: 01/2023 Alembic Pharmaceuticals Limited

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