Propranolol Hydrochloride (Page 6 of 6)

DOSAGE AND ADMINISTRATION

General

Because of the variable bioavailability of propranolol, the dose should be individualized based on response.

Hypertension

The usual initial dosage is 40 mg propranolol hydrochloride tablets twice daily, whether used alone or added to a diuretic. Dosage may be increased gradually until adequate blood pressure control is achieved. The usual maintenance dosage is 120 mg to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.

While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. 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. If control is not adequate, a larger dose, or 3-times-daily therapy may achieve better control.

Angina Pectoris

Total daily doses of 80 mg to 320 mg propranolol hydrochloride tablets, when administered orally, twice a day, three times a day, or four times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG. If treatment is to be discontinued, reduce dosage gradually over a period of several weeks (see WARNINGS).

Atrial Fibrillation

The recommended dose is 10 mg to 30 mg propranolol hydrochloride tablets three or four times daily before meals and at bedtime.

Myocardial Infarction

In the Beta-Blocker Heart Attack Trial (BHAT), the initial dose was 40 mg t.i.d., with titration after 1 month to 60 mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride tablets per day in divided doses. Although a t.i.d. regimen was used in the BHAT and a q.i.d. regimen in the Norwegian Multicenter Trial, there is a reasonable basis for the use of either a t.i.d. or b.i.d. regimen (see CLINICAL PHARMACOLOGY: Pharmacodynamics and Clinical Effects). The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established. However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above).

Migraine

The initial dose is 80 mg propranolol hydrochloride tablets daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day. The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, propranolol hydrochloride tablets therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks.

Essential Tremor

The initial dosage is 40 mg propranolol hydrochloride tablets twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day. Occasionally, it may be necessary to administer 240 mg to 320 mg per day.

Hypertrophic Subaortic Stenosis

The usual dosage is 20 mg to 40 mg propranolol hydrochloride tablets three or four times daily before meals and at bedtime.

Pheochromocytoma

The usual dosage is 60 mg propranolol hydrochloride tablets daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade. For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.

HOW SUPPLIED

Propranolol Hydrochloride Tablets, USP are available containing 10 mg, 20 mg, 40 mg, 60 mg or 80 mg of propranolol hydrochloride, USP.

The 10 mg tablets are orange, round, scored tablets debossed with MYLAN above the score and 182 below the score on one side of the tablet and 10 on the other side. They are available as follows:

NDC 51407-235-01
bottles of 100 tablets

NDC 51407-235-10
bottles of 1000 tablets

The 20 mg tablets are blue, round, scored tablets debossed with MYLAN above the score and 183 below the score on one side of the tablet and 20 on the other side. They are available as follows:

NDC 51407-236-01
bottles of 100 tablets

NDC 51407-236-10
bottles of 1000 tablets

The 40 mg tablets are green, round, scored tablets debossed with MYLAN above the score and 184 below the score on one side of the tablet and 40 on the other side. They are available as follows:

NDC 51407-237-01
bottles of 100 tablets

NDC 51407-237-10
bottles of 1000 tablets

The 60 mg tablets are light purple, round, scored tablets debossed with MYLAN above the score and PR60 below the score on one side of the tablet and 60 on the other side. They are available as follows:

NDC 51407-239-01
bottles of 100 tablets

The 80 mg tablets are yellow, round, scored tablets debossed with MYLAN above the score and 185 below the score on one side of the tablet and 80 on the other side. They are available as follows:

NDC 51407-238-01


bottles of 100 tablets

NDC 51407-238-05
bottles of 500 tablets

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

Protect from light.

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

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

Manufactured by:
Auro PR Inc.
RD 156 Caguas West Industrial Park, Lot 24
Caguas, PR 00725 U.S.A.

Revised: 3/2022
PRAN:R29

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 51407-235-01

Propranolol
Hydrochloride
Tablets, USP
10 mg

Rx only 100 Tablets

Each tablet contains:
Propranolol
hydrochloride, USP 10 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 light.

Usual Adult Dosage: See
accompanying prescribing
information.

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

Made in Puerto Rico

RM0182A12

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

//medlibrary.org/lib/images-rx/propranolol-hydrochloride-70/51407-235-01lb-300x121.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 51407-236-01

Propranolol
Hydrochloride
Tablets, USP
20 mg

Rx only 100 Tablets

Each tablet contains:
Propranolol
hydrochloride, USP 20 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 light.

Usual Adult Dosage: See
accompanying prescribing
information.

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

Made in Puerto Rico

RM0183A10

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

//medlibrary.org/lib/images-rx/propranolol-hydrochloride-70/51407-236-01lb-300x120.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg

NDC 51407-237-01

Propranolol
Hydrochloride
Tablets, USP
40 mg

Rx only 100 Tablets

Each tablet contains:
Propranolol
hydrochloride, USP 40 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 light.

Usual Adult Dosage: See
accompanying prescribing
information.

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

Made in Puerto Rico

RM0184A10

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

//medlibrary.org/lib/images-rx/propranolol-hydrochloride-70/51407-237-01lb-300x120.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg

NDC 51407-239-01

Propranolol
Hydrochloride
Tablets, USP
60 mg

Rx only 100 Tablets

Each tablet contains:
Propranolol
hydrochloride, USP 60 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 light.

Usual Adult Dosage: See
accompanying prescribing
information.

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

Made in Puerto Rico

RM0187A3

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

//medlibrary.org/lib/images-rx/propranolol-hydrochloride-70/51407-239-01lb-300x119.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg

NDC 51407-238-01

Propranolol
Hydrochloride
Tablets, USP
80 mg

Rx only 100 Tablets

Each tablet contains:
Propranolol
hydrochloride, USP 80 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 light.

Usual Adult Dosage: See
accompanying prescribing
information.

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

Made in Puerto Rico

RM0185A10

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

//medlibrary.org/lib/images-rx/propranolol-hydrochloride-70/51407-238-01lb-300x120.jpg
(click image for full-size original)
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-235(NDC:0378-0182)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code MYLAN;182;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-235-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:51407-235-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070213 11/19/1985
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-236(NDC:0378-0183)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code MYLAN;183;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-236-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:51407-236-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070213 11/19/1985
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-237(NDC:0378-0184)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code MYLAN;184;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-237-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:51407-237-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070213 11/19/1985
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-239(NDC:0378-0187)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
Product Characteristics
Color purple (light purple) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code MYLAN;PR60;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-239-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070213 04/08/2011
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-238(NDC:0378-0185)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL HYDROCHLORIDE 80 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code MYLAN;185;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-238-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:51407-238-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070213 11/19/1985
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-235), repack (51407-235), relabel (51407-236), repack (51407-236), relabel (51407-237), repack (51407-237), relabel (51407-238), repack (51407-238), relabel (51407-239), repack (51407-239)

Revised: 04/2022 Golden State Medical Supply, Inc.

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