Country: United States
Language: English
Source: NLM (National Library of Medicine)
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Alembic Pharmaceuticals Limited
TELMISARTAN
TELMISARTAN 40 mg
ORAL
PRESCRIPTION DRUG
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 ).
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
Abbreviated New Drug Application
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 Read the complete document