TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponible desde:

Alembic Pharmaceuticals Limited

Designación común internacional (DCI):

TELMISARTAN

Composición:

TELMISARTAN 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ). Telmisartan and hydrochlorothiazide  tablets, USP are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, hydrochlorothiazide, or any other component of this product (see ADVERSE REACTIONS ).  Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with telmisartan and hydrochlorothiazide tablets in patients with diabetes (see PRECAUTIONS , Drug Interactions ).

Resumen del producto:

Telmisartan and hydrochlorothiazide tablets are available in three strengths as 40 mg/12.5 mg, 80 mg/12.5 mg and 80 mg/25 mg. 40 mg/12.5 mg: Oblong shaped, biconvex, bilayered, uncoated tablets with one white to off white color layer and one pink color mottled layer debossed with ‘L199’.White to off white color layer may contains pink color specks. NDC 46708-209-30    bottle of 30 units NDC 46708-209-91    bottle of 1000 units NDC 46708-209-10    100 Tablets (i.e.; 10 blister cards of 10 tablets each) 80 mg/12.5 mg: Oblong shaped, biconvex, bilayered, uncoated tablets with one white to off white color layer and one pink color mottled layer debossed with ‘L200’. White to off white color layer may contains pink color specks. NDC 46708-210-30    bottle of 30 units NDC 46708-210-91    bottle of 1000 units NDC 46708-210-10    100 Tablets (i.e.; 10 blister cards of 10 tablets each)   80 mg/25 mg: Oblong shaped, biconvex, bilayered, uncoated tablets with one white to off white color layer and one yellow color mottled layer debossed with  ‘L201’. White to off white color layer may contains yellow color specks. NDC 46708-211-30   bottle of 30 units NDC 46708-211-91   bottle of 1000 units NDC 46708-211-10   100 Tablets (i.e.; 10 blister cards of 10 tablets each)   Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 03/2014

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TELMISARTAN AND HYDROCHLOROTHIAZIDE - TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
ALEMBIC PHARMACEUTICALS LIMITED
----------
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AND
HYDROCHLOROTHIAZIDE 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
Telmisartan and hydrochlorothiazide
tablets, USP are a combination of telmisartan, an orally active
angiotensin II antagonist
acting on the AT receptor subtype, and hydrochlorothiazide, a
diuretic.Telmisartan, a
non-peptide molecule, is chemically described as
4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-
benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its
empirical formula is
C
H
N O , its molecular weight is 514.63, and its structural formula is:
Telmisartan is a white to slightly yellowish solid. It is practically
insoluble in water and in
the pH range of 3 to 9, sparingly soluble in strong acid (except
insoluble in hydrochloric
acid), and soluble in strong base.
Hydrochlorothiazide is a white, or practically white, practically
odorless, crystalline
powder with a molecular weight of 297.74. It is slightly soluble in
water, and freely
1
33
30
4
2
soluble in sodium hydroxide solution. Hydrochlorothiazide is
chemically described as 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:
Telmisartan and hydrochlorothiazide tablets are formulated for oral
administration in
three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg
telmisartan
and hydrochlorothiazide, respectively. The tablets contain the
following inactive
ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium
stearyl
fumarate, lactose monohydrate, magnesium stearate. As coloring agents,
the 40
mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric