PROPRANOLOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Composition:

PROPRANOLOL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Prop

Product summary:

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 0378-0182-01 bottles of 100 tablets NDC 0378-0182-10 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 0378-0183-01 bottles of 100 tablets NDC 0378-0183-10 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 0378-0184-01 bottles of 100 tablets NDC 0378-0184-10 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 0378-0187-01 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 0378-0185-01 bottles of 100 tablets NDC 0378-0185-05 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROPRANOLOL HYDROCHLORIDE- PROPRANOLOL HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Propranolol hydrochloride is a synthetic beta-adrenergic receptor
blocking agent
chemically described as
(±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol
hydrochloride. Its molecular and structural formulae are:
C
H
NO • HCL
Propranolol hydrochloride, USP is a stable, white to off-white,
crystalline powder which is
readily soluble in water and ethanol. Its molecular weight is 295.80.
Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg,
40 mg, 60 mg, or
80 mg tablets for oral administration.
The inactive ingredients contained in propranolol hydrochloride
tablets are: colloidal
silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch (corn) and sodium lauryl sulfate.
The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20
mg tablets
also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also
contain FD&C Blue
No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow
No. 10
Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum
Lake and
FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C
Yellow No. 6
Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.
CLINICAL PHARMACOLOGY
GENERAL
Propranolol is a nonselective beta-adrenergic receptor blocking agent
possessing no
other autonomic nervous system activity. It specifically competes with
beta-adrenergic
receptor agonist agents for available receptor sites. When access to
beta-receptor sites
is blocked by propranolol, the chronotropic, inotropic, and
vasodilator responses to
beta-adrenergic stimulation are decreased proportionately. At dosages
greater than
required for beta blockade, propranolol also exerts a quinidine-like
or anesthetic-like
membrane action, which affects the cardiac action potential. The
significance of the
16 21
2
membrane action in the treatment of arrhythmias is uncertain.
MECHANISM OF ACTION
The mecha