PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

זמין מ:

Mylan Pharmaceuticals Inc.

INN (שם בינלאומי):

PROPRANOLOL HYDROCHLORIDE

הרכב:

PROPRANOLOL HYDROCHLORIDE 40 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Propranolol hydrochloride and hydrochlorothiazide tablets, USP are indicated in the management of hypertension. This fixed combination is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; 4) congestive heart failure (see WARNINGS) unless the failure is secondary to a tachyarrhythmia treatable with propranolol. Hydrochlorothiazide is contraindicated in patients with anuria or hypersensitivity to this or other sulfonamide-derived drugs.

leaflet_short:

Propranolol Hydrochloride and Hydrochlorothiazide Tablets, USP are available in the following combinations: The 40 mg/25 mg tablets contain 40 mg of propranolol hydrochloride, USP and 25 mg of hydrochlorothiazide, USP. Each white round scored tablet is debossed with MYLAN over 731 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0731-01 bottles of 100 tablets The 80 mg/25 mg tablets contain 80 mg of propranolol hydrochloride, USP and 25 mg of hydrochlorothiazide, USP. Each white round scored tablet is debossed with MYLAN over 347 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0347-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 4/2020 PRAN/HCTZ:R21

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- PROPRANOLOL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Propranolol hydrochloride and hydrochlorothiazide tablets, USP for
oral administration combine two
antihypertensive agents: propranolol hydrochloride, USP, a
beta-adrenergic blocking agent, and
hydrochlorothiazide, USP, a thiazide diuretic-antihypertensive.
Propranolol hydrochloride and
hydrochlorothiazide tablets, 40/25 contain 40 mg propranolol
hydrochloride and 25 mg
hydrochlorothiazide; propranolol hydrochloride and hydrochlorothiazide
tablets, 80/25 contain 80 mg
propranolol hydrochloride and 25 mg hydrochlorothiazide.
Propranolol hydrochloride is a synthetic beta-adrenergic
receptor-blocking agent chemically described
as 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanol hydrochloride. Its
structural formula is:
Propranolol hydrochloride, USP is a stable, white, crystalline solid
which is readily soluble in water
and ethanol. Its molecular weight is 295.81.
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline powder. It
is slightly soluble in water; freely soluble in sodium hydroxide
solution; sparingly soluble in methanol;
insoluble in ether, chloroform, benzene, and dilute mineral acids. Its
chemical name is: 6-Chloro-3,4-
dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its
structural formula is:
Propranolol hydrochloride and hydrochlorothiazide tablets, 40 mg/25 mg
and 80 mg/25 mg are for oral
administration and contain the following inactive ingredients:
colloidal silicon dioxide, croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, pregelatinized
starch (corn) and sodium lauryl
sulfate.
CLINICAL PHARMACOLOGY
PROPRANOLOL HYDROCHLORIDE
Propranolol hydrochloride is a nonselective beta-adrenergic receptor
blocking agent possessing no
other autonomic nervous system activity. It specifically competes with
beta-adrenergic receptor
stimulating agents for available receptor sites. When acc