TEVETEN HCT- eprosartan mesylate and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPROSARTAN MESYLATE (UNII: 8N2L1NX8S3) (Eprosartan - UNII:2KH13Z0S0Y), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

EPROSARTAN MESYLATE

Composition:

Eprosartan 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TEVETEN® HCT is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensives such as calcium channel blockers. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ). TEVETEN® HCT is contraindicated in patients who are hypersensitive to this product or any of its components. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Product summary:

TEVETEN® HCT is available as film-coated, capsule-shaped tablets, debossed with “SOLVAY” on one side and “5147” or “5150” on the other, supplied as bottles of 30 tablets as follows:

Authorization status:

New Drug Application

Summary of Product characteristics

TEVETEN HCT - EPROSARTAN MESYLATE AND HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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TEVETEN HCT
(EPROSARTAN MESYLATE/HYDROCHLOROTHIAZIDE)600/12.5MG 600/25MG
RX ONLY
PRESCRIBING INFORMATION
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, TEVETEN HCT Tablets should be discontinued as
soon as possible.
See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
TEVETEN HCT 600/12.5 mg and TEVETEN HCT 600/25 mg (eprosartan
mesylate-
hydrochlorothiazide) combine an angiotensin II receptor (AT subtype)
antagonist and a diuretic,
hydrochlorothiazide. TEVETEN (eprosartan mesylate) is a non-biphenyl
non-tetrazole angiotensin II
receptor (AT ) antagonist. A selective non-peptide molecule, TEVETEN
is chemically described as
the monomethanesulfonate of
(_E_)-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimidazole-5-acrylic
acid. Its empirical formula is C
H N O S•CH O S and molecular weight is 520.625. Its structural
formula is:
Eprosartan mesylate is a white to off-white free-flowing crystalline
powder that is insoluble in water,
freely soluble in ethanol, and melts between 248°C and 250°C.
Hydrochlorothiazide is 6-chloro-3,4-
dihydro-2 H 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its
empirical formula is C H ClN O S
and its structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.74, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
TEVETEN HCT is available for oral administration in film-coated,
non-scored, capsule-shaped tablet
combinations of eprosartan mesylate and hydrochlorothiazide. TEVETEN
HCT 600/12.5 mg contains
®
®
®
®
1
®
1
®
23
24
2
4
4
3
7
8
3
4
2
®
®
735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and
12.5 mg hydrochlorothiazide in a
butterscotch-colored tablet. TEVETEN HCT