TELMISARTAN AND HYDROCHLORTHIAZIDE 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:

Torrent Pharmaceuticals Limited

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 Commit

Product summary:

Telmisartan and hydrochlorothiazide tablets, USP are available in three strengths as biconvex two-layered, capsule-shaped, uncoated tablets containing telmisartan and hydrochlorothiazide: Bottles of 30                         NDC 13668-159-30 Bottles of 100                       NDC 13668-159-01 30 Unit dose Tablets             NDC 13668-159-72 100 Unit dose Tablets           NDC 13668-159-74 Bottles of 30                         NDC 13668-160-30 Bottles of 100                       NDC 13668-160-01 30 Unit dose Tablets             NDC 13668-160-72 100 Unit dose Tablets           NDC 13668-160-74 Bottles of 30                          NDC 13668-161-30 Bottles of 100                        NDC 13668-161-01 30 Unit dose Tablets             NDC 13668-161-72 100 Unit dose Tablets           NDC 13668-161-74 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Tablets should not be removed from containers and blisters until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN AND HYDROCHLORTHIAZIDE- TELMISARTAN AND
HYDROCHLORTHIAZIDE TABLET
TORRENT PHARMACEUTICALS LIMITED
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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
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 fluid or electrolyte imbalance (5.4)
Hypersensitivity