TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committ

Product summary:

Telmisartan and hydrochlorothiazide tablets, USP 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 62332-209-30                bottle of 30 units NDC 62332-209-91                bottle of 1000 units  NDC 62332-209-10                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 62332-210-30                bottle of 30 units NDC 62332-210-91                bottle of 1000 units  NDC 62332-210-10                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 62332-211-30                bottle of 30 units NDC 62332-211-91                bottle of 1000 units  NDC 62332-211-10                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 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN AND HYDROCHLOROTHIAZIDE - TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS.
TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AND
HYDROCHLOROTHIAZIDE AS
SOON AS POSSIBLE. (5.1, 8.1)
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1, 8.1)
INDICATIONS AND USAGE
• Telmisartan and hydrochlorothiazide tablets are a combination of
an angiotensin II receptor blocker
(ARB) and a thiazide diuretic indicated for the treatment of
hypertension, alone or with other
antihypertensive agents, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily strokes and myocardial
infarctions (1) (1)
• Telmisartan and hydrochlorothiazide tablets are not indicated for
initial therapy (1). (1)
DOSAGE AND ADMINISTRATION
• Usual starting dose is 80 mg/12.5 mg once daily (2.1)
• Titrate up to 160 mg/25 mg as needed (2.1)
• Initiate patients with biliary obstructive disorders or hepatic
insufficiency at 40 mg/12.5 mg (2.2) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3) (3)
CONTRAINDICATIONS
• Hypersensitivity to telmisartan or any component (4)
• Anuria (4)
• Co-Administration with aliskiren in patients with diabetes (4) (4)
WARNINGS AND PRECAUTIONS
• Avoid fetal or neonatal exposure (5.1)
· Correct volume or salt depletion before initiating therapy. Observe
for signs and symptoms of
hypotension (5.2) (5)
· Monitor renal function and potassium in susceptible patients (5.3)
(5)
· Observe f