TRANDOLAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANDOLAPRIL (UNII: 1T0N3G9CRC) (TRANDOLAPRILAT - UNII:RR6866VL0O)

Available from:

Dispensing Solutions, Inc.

INN (International Name):

TRANDOLAPRIL

Composition:

TRANDOLAPRIL 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trandolapril Tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Trandolapril tablets are contraindicated in patients who are hypersensitive to this product, in patients with hereditary/idiopathic angioedema, and in patients with a history of angioedema related to previous treatment with an ACE inhibitor.

Product summary:

Trandolapril Tablets are supplied as follows: 1 mg: mottled salmon, capsule-shaped tablet, scored on one side and debossed with “9” on one side of the score and with “3” on the other side. Debossed with “7325” on the other side of the tablet. Available in bottles of 100 tablets. 2 mg: mottled yellow, capsule-shaped tablet, debossed with “93” on one side and with “7326” on the other side of the tablet. Available in bottles of 100 tablets. 4 mg: mottled rose, capsule-shaped tablet, debossed with “93” on one side and with “7327” on the other side of the tablet. Available in bottles of 100 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANDOLAPRIL- TRANDOLAPRIL TABLET
DISPENSING SOLUTIONS, INC.
----------
TRANDOLAPRIL TABLETS
7325
7326
7327
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE TRANDOLAPRIL 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 is the ethyl ester prodrug of a nonsulfhydryl angiotensin
converting enzyme (ACE)
inhibitor, trandolaprilat. Trandolapril is chemically described as
(2_S_,3a_R_,7a_S_)-1-[(_S_)-N-[(_S_)-1-carboxy-
3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl
ester. Its structural formula is:
C
H N O M.W. 430.54
Melting range is 130° to 135°C
Trandolapril is a white or almost white powder that is soluble (> 100
mg/mL) in chloroform,
dichloromethane, and methanol. Trandolapril tablets contain 1 mg, 2
mg, or 4 mg of trandolapril for oral
administration. Each tablet also contains ferric oxide yellow, lactose
anhydrous, povidone,
pregelatinized starch, and sodium stearyl fumarate. In addition, 1 mg
tablets contain FD&C Blue #2 Lake,
FD&C Red #40 Lake, and FD&C Yellow #6 Lake and 4 mg tablets contain
ferric oxide red.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Trandolapril is deesterified to the diacid metabolite, trandolaprilat,
which is approximately eight times
more active as an inhibitor of ACE activity. ACE is a peptidyl
dipeptidase that catalyzes the conversion
of angiotensin I to the vasoconstrictor, angiotensin II. Angiotensin
II is a potent peripheral
vasoconstrictor that also stimulates secretion of aldosterone by the
adrenal cortex and provides
negative feedback for renin secretion. The effect of trandolapril in
hypertension appears to result
primarily from the inhibition of circulating and tissue ACE activity
thereby reducing angiotensin II
24
34
2
5
formation, decreasing vasoconstriction, decreasing aldosterone
secretion, and increasing plasma renin.
Decreased aldosterone secretion leads to diuresis, natriuresis, and a
small inc