PINDOLOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PINDOLOL (UNII: BJ4HF6IU1D) (PINDOLOL - UNII:BJ4HF6IU1D)

Available from:

Bayshore Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Pindolol tablets are contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia. (See WARNINGS.)

Product summary:

Pindolol Tablets, USP are available containing 5 mg or 10 mg of pindolol, USP The 5 mg tablets are white to off-white colored, round shaped, biconvex scored tablets debossed with 'P' above the score and '5' below the score on one side of the tablet and plain on the other side, free from physical defects. They are available as follows: NDC 76385-131-01 Bottles of 100 tablets The 10 mg tablets are white to off-white colored, round shaped, biconvex scored tablets debossed with 'P' above the score and '10' below the score on one side of the tablet and plain on the other side, free from physical defects. They are available as follows: NDC 76385-132-01 Bottles of 100 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 by: Centaur Pharmaceuticals Pvt.Ltd, Plot No. 4, International Biotech Park, Phase II, Hinjewadi, Pune – 411 057. INDIA Distributed by: Bayshore Pharmaceuticals LLC 788 Morris Turnpike, Suite 200 Short Hills, NJ 07078 USA Issued: 09/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PINDOLOL- PINDOLOL TABLET
BAYSHORE PHARMACEUTICALS LLC
----------
PINDOLOL TABLETS, USP 5 MG AND 10 MG
DESCRIPTION
Pindolol, a synthetic beta-adrenergic receptor blocking agent with
intrinsic sympathomimetic activity is
1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol.
Its structural formula is:
Pindolol, USP is a white to off-white, crystalline powder having a
faint odor which is practically
insoluble in water; slightly soluble in methanol; and very slightly
soluble in chloroform.
Each tablet for oral administration contains pindolol, USP and the
following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch (corn), and sodium lauryl sulfate.
CLINICAL PHARMACOLOGY
Pindolol tablets are a nonselective beta-adrenergic antagonist
(beta-blocker) which possesses intrinsic
sympathomimetic activity (ISA) in therapeutic dosage ranges but does
not possess quinidine-like
membrane stabilizing activity.
PHARMACODYNAMICS
In standard pharmacologic tests in man and animals, pindolol tablets
attenuate increases in heart rate,
systolic blood pressure, and cardiac output resulting from exercise
and isoproterenol administration,
thus confirming its beta-blocking properties. The ISA or partial
agonist activity of pindolol tablets is
mediated directly at the adrenergic receptor sites and may be blocked
by other beta-blockers. In
catecholamine depleted animal experiments, ISA is manifested as an
increase in the inotropic and
chronotropic activity of the myocardium. In man, ISA is manifested by
a smaller reduction in the resting
heart rate (4 to 8 beats/min) than is seen with drugs lacking ISA.
There is also a smaller reduction in
resting cardiac output. The clinical significance of this observation
has not been evaluated and there is
no evidence, or reason to believe, that exercise cardiac output is
less affected by pindolol tablets.
Pindolol tablets have been shown in controlled, double-blind clinical
studies to be an effective
antihypertensive ag