Spironolactone (Page 5 of 5)

14.2 Hypertension

The dose response of spironolactone for hypertension has not been well characterized. In patients with hypertension, decreases in systolic blood pressure have been observed at doses ranging from 25 to 100 mg/day. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure [see Dosage and Administration (2.3)] .

16 HOW SUPPLIED/STORAGE AND HANDLING

Spironolactone Tablets, USP are available containing 25 mg, 50 mg or 100 mg of spironolactone, USP.

The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M over 146 on one side of the tablet and blankon the other side. They are available as follows:

NDC 51079-103-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 50 mg tablets are white, film-coated, round tablets debossed with M over 243 on one side of the tablet and scored on the other side. They are available as follows:

NDC 51079-979-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 100 mg tablets are white, film-coated, round tablets debossed with M over 437 on one side of the tablet and scored on the other side. They are available as follows:

NDC 51079-980-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
NDC 51079-980-08 – Unit dose blister packages of 80 (10 cards of 8 tablets each).

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

17 PATIENT COUNSELING INFORMATION

Patients who receive spironolactone tablets should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.

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

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12586
4/19

PRINCIPAL DISPLAY PANEL – 25 mg

NDC 51079-103-20

Spironolactone
Tablets, USP
25 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Spironolactone, USP 25 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Rx only

S-3976 R12

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Spironolactone 25 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg

NDC 51079-979-20

Spironolactone
Tablets, USP
50 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Spironolactone, USP 50 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Rx only

S-7841 R4

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Spironolactone 50 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg

NDC 51079-980-08

Spironolactone
Tablets, USP
100 mg

80 Tablets (10 x 8)

Each film-coated tablet contains:
Spironolactone, USP 100 mg

Usual Dosage: See accompanying
prescribing information.

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

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

Rx only

S-12569

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

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

This container provides light-resistance.

See window for lot number and expiration date.

Spironolactone 100 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
SPIRONOLACTONE spironolactone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-103(NDC:0378-2146)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code M;146
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-103-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-103-01)
1 NDC:51079-103-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-103-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040424 12/23/1996
SPIRONOLACTONE spironolactone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-979(NDC:0378-0243)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M;243
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-979-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-979-01)
1 NDC:51079-979-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-979-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040424 02/20/2002
SPIRONOLACTONE spironolactone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-980(NDC:0378-0437)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 100 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
CALCIUM SULFATE DIHYDRATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 13mm
Flavor Imprint Code M;437
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-980-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-980-01)
1 NDC:51079-980-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-980-20)
2 NDC:51079-980-08 80 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-980-01)
2 NDC:51079-980-01 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51079-980-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040424 02/20/2002
Labeler — Mylan Institutional Inc. (039615992)

Revised: 09/2019 Mylan Institutional Inc.

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