TELMISARTAN AND HYDROCHLOROTHIAZIDE - telmisartan and hydrochlorothiazide tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Macleods Pharmaceuticals Limited

INN (International namn):

TELMISARTAN

Sammansättning:

TELMISARTAN 40 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Commit

Produktsammanfattning:

Telmisartan and hydrochlorothiazide tablets USP are available in three strengths as two-layered, capsule shaped (40 mg/12.5 mg), oval shaped (80 mg/12.5 mg and 80 mg/25 mg) uncoated tablets containing telmisartan and hydrochlorothiazide: • 40 mg/12.5 mg tablet: white and red colored, bilayered, capsule shaped, uncoated tablets debossed with CL48 on one side and plain on other side Container pack of 30’s NDC 33342-128-07 Container pack of 90’s NDC 33342-128-10 Carton of 100 tablets (10 x 10 unit-dose) NDC 33342-128-12 • 80 mg/12.5 mg tablet: white and red colored, bilayered, oval shaped, uncoated tablets debossed with CL50 on one side and plain on other side Container pack of 30’s NDC 33342-129-07 Container pack of 90’s NDC 33342-129-10 Carton of 100 tablets (10 x 10 unit-dose) NDC 33342-129-12 • 80 mg/25 mg tablet: white and yellow colored, bilayered, oval shaped, uncoated tablets debossed with CL51 on one side and plain on other side Container pack of 30’s NDC 33342-130-07 Container pack of 90’s NDC 33342-130-10 Carton of 100 tablets (10 x 10 unit-dose) NDC 33342-130-12 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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TELMISARTAN AND HYDROCHLOROTHIAZIDE - TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
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 TABLETS 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 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)
Telmisartan and hydrochlorothiazide tablets are not indicated for
initial therapy (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)
DOSAGE FORMS AND STRENGTHS
Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg (3)
CONTRAINDICATIONS
• Hypersensitivity to telmisartan or any component (4)
• Anuria (4)
• Co-Administration with aliskiren in patients with diabetes (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)
• Monitor renal function and potassium in susceptible patients (5.3)
• Observe for clinical signs of flu