TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE ER- trandolapril and verapamil hydrochloride tablet, film coated, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TRANDOLAPRIL (UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O), VERAPAMIL HYDROCHLORIDE (UNII: V3888OEY5R) (VERAPAMIL - UNII:CJ0O37KU29)

थमां उपलब्ध:

Greenstone LLC

INN (इंटरनेशनल नाम):

TRANDOLAPRIL

रचना:

TRANDOLAPRIL 2 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Trandolapril/verapamil hydrochloride ER tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril/verapamil hydrochloride ER tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis ). Trandolapril/verapamil hydrochloride ER tablets are contraindicated in patients who are hypersensitive to any ACE inhibitor or verapamil. Because of the verapamil component, trandolapril/verapamil hydrochloride ER tablets are contraindicated in: - Severe left ventricular dysfunction (see WARNINGS ). - Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock. - Sick sinus syndrome (exce

उत्पाद समीक्षा:

Trandolapril/verapamil hydrochloride ER 2/180 mg tablets are supplied as pink, oval, film-coated tablets containing 2 mg trandolapril in an immediate release form and 180 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 182 on one side and plain on the other side. NDC 59762-0142-1 - bottles of 100 Trandolapril/verapamil hydrochloride ER 2/240 mg tablets are supplied as gold, oval, film-coated tablets containing 2 mg trandolapril in an immediate release form and 240 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 242 on one side and plain on the other side. NDC 59762-0132-1 - bottles of 100 Trandolapril/verapamil hydrochloride ER 4/240 mg tablets are supplied as reddish-brown, oval, film-coated tablets containing 4 mg trandolapril in an immediate release form and 240 mg verapamil hydrochloride in a sustained release form. The tablet is debossed with a triangle and 244 on one side and plain on the other side. NDC 59762-0122-1 - bottles of 100 Dispense in well-closed container with safety closure. Store at 15°-25°C (59°-77°F) see USP.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE ER- TRANDOLAPRIL AND
VERAPAMIL
HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE
GREENSTONE LLC
----------
TRANDOLAPRIL/VERAPAMIL HYDROCHLORIDE ER TABLETS
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE TRANDOLAPRIL/VERAPAMIL
HYDROCHLORIDE ER
TABLETS AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS(SEE WARNINGS: FETAL TOXICITY).
DESCRIPTION
Trandolapril/verapamil hydrochloride ER tablets combine a slow release
formulation of a calcium
channel blocker, verapamil hydrochloride, and an immediate release
formulation of an angiotensin
converting enzyme inhibitor, trandolapril.
VERAPAMIL COMPONENT
Verapamil hydrochloride is chemically described as
benzeneacetonitrile, α[3-[[2-(3,4-
dimethoxyphenyl)ethyl]methylamino]propyl]-3,
4-dimethoxy-α-(1-methylethyl) hydrochloride. Its
empirical formula is C
H N O HCl and its structural formula is:
Verapamil hydrochloride is an almost white crystalline powder, with a
molecular weight of 491.08. It
is soluble in water, chloroform, and methanol. It is practically free
of odor, with a bitter taste.
TRANDOLAPRIL COMPONENT
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin
converting enzyme (ACE)
inhibitor, trandolaprilat. It is chemically described as
(2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-
phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl
ester. Its empirical formula is C
H N O and its structural formula is:
27
38
2
4
24
34
2
5
Trandolapril is a white or almost white powder with a molecular weight
of 430.54. It is soluble (>100
mg/mL) in chloroform, dichloromethane, and methanol.
Trandolapril/verapamil hydrochloride ER tablets are formulated for
oral administration, containing
verapamil hydrochloride as a controlled release formulation and
trandolapril as an immediate release
formulation. The tablet strengths are trandolapril 2 mg/verapamil
hydrochloride ER 180 mg, trandolapril
2 mg/verapamil hydrochloride ER 2