Telmisartan 40mg Tablet, 100ct Bottle

Description

What is Telmisartan and how is it used?

Telmisartan is a prescription medicine used to treat the symptoms of high blood pressure (hypertension) and to reduce the risk of cardiovascular disease such as stroke and heart attack. Telmisartan may be used alone or with other medications.

Telmisartan belongs to a class of drugs called ARBs.

It is not known if Telmisartan is safe and effective in children younger than 18 years of age.

What are the possible side effects of Telmisartan?

Telmisartan may cause serious side effects including:

• lightheadedness,
• swelling,
• rapid weight gain,
• nausea,
• weakness,
• tingly feeling,
• chest pain,
• irregular heartbeats, and
• loss of movement

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Telmisartan include:

• stuffy nose,
• sinus pain,
• back pain, and
• diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Telmisartan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

TELMISARTAN HCT (telmisartan and hydrochlorothiazide) is 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 HCT.

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 Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies].

TELMISARTAN HCT is not indicated for initial therapy for the treatment of hypertension [see DOSAGE AND ADMINISTRATION].

TELMISARTAN HCT may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Dosing Information

Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on TELMISARTAN HCT, 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on TELMISARTAN HCT 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of TELMISARTAN HCT.

TELMISARTAN HCT may be administered with other antihypertensive drugs.

Dose Adjustment For Hepatic Impairment

Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. TELMISARTAN HCT tablets are not recommended for patients with severe hepatic impairment [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Important Administration Instructions

TELMISARTAN HCT tablets should not be removed from blisters until immediately before administration.

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.