BETAXOLOL HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAXOLOL HYDROCHLORIDE (UNII: 6X97D2XT0O) (BETAXOLOL - UNII:O0ZR1R6RZ2)

Available from:

KVK-TECH, INC.

INN (International Name):

BETAXOLOL HYDROCHLORIDE

Composition:

BETAXOLOL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betaxolol tablets, USP is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics. Betaxolol tablets, USP is contraindicated in patients with known hypersensitivity to the drug. Betaxolol tablets, USP is contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see Warnings ).

Product summary:

Betaxolol Tablets, USP are available as follows: Betaxolol Tablets, USP 10 mg: (Each tablet contains 10 mg betaxolol HCl equivalent to 8.94 mg betaxolol) are as white, round, film-coated biconvex tablets, debossed "k" above bisect "13" on one side and plain on the other. Bottles of 100, NDC 10702-013-01 Betaxolol Tablets, USP 20 mg: (Each tablet contains 20 mg betaxolol HCl equivalent to 17.88 mg betaxolol) are as white, round, film-coated biconvex tablets, debossed "K" above "14" on one side and plain on the other. Bottles of 100, NDC 10702-014-01 Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940 ID # 006037/10 02/2024 Manufacturer’s Code: 10702

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAXOLOL HYDROCHLORIDE- BETAXOLOL HYDROCHLORIDE TABLET, COATED
KVK-TECH, INC.
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BETAXOLOL TABLETS, USP
DESCRIPTION:
Betaxolol hydrochloride is a ß
-selective (cardioselective) adrenergic receptor blocking
agent available as 10-mg and 20-mg tablets for oral administration.
Betaxolol
hydrochloride is chemically described as 2-propanol, 1-
[4-[2-(cyclopropylmethoxy)
ethyl] phenoxy]-3-[(1-methylethyl) amino]-, hydrochloride, (±)-. It
has the following
chemical structure:
Betaxolol hydrochloride is a water-soluble white crystalline powder
with a molecular
formula of C 18H 29NO 3•HCl and a molecular weight of 343.9. It is
freely soluble in
water, ethanol, chloroform, and methanol, and has a pKa of 9.4.
The inactive ingredients are carnauba wax, hypromellose, anhydrous
lactose,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
pregelatinized starch,
sodium starch glycolate, stearic acid and titanium dioxide.
CLINICAL PHARMACOLOGY:
Betaxolol is a ß
-selective (cardioselective) adrenergic receptor blocking agent that
has
weak membrane-stabilizing activity and no intrinsic sympathomimetic
(partial agonist)
activity. The preferential effect on ß
receptors is not absolute, however, and some
inhibitory effects on ß
receptors (found chiefly in the bronchial and vascular
musculature) can be expected at higher doses.
PHARMACOKINETICS AND METABOLISM: In man, absorption of an oral dose is
complete.
There is a small and consistent first-pass effect resulting in an
absolute bioavailability of
89% ± 5% that is unaffected by the concomitant ingestion of food or
alcohol. Mean
peak blood concentrations of 21.6 ng/ml (range 16.3 to 27.9 ng/ml) are
reached
between 1.5 and 6 (mean about 3) hours after a single oral dose, in
healthy volunteers,
of 10 mg of betaxolol. Peak concentrations for 20-mg and 40-mg doses
are 2 and 4
times that of a 10-mg dose and have been shown to be linear over the
dose range of 5
to 40 mg. The peak to trough ratio of plasma concentrations over 24
hours is 2.7. The
mean elimination