Chartoreg 40 mg or 80 mg

Telmesartan 40 mg or 80 mg

tablets

Not used during pregnancy, as it may cause fetal harm or death

Composition:

Each tablet contains: 40 mg or 80 mg telmisartan as active ingredient.

Inactive ingredient: Sodium hydroxide – Povidone k 30 – Meglumine – Mannitol – Magnesium

stearate – Talc-Colloidal silicon dioxide (aerosil 200).

INDICATIONS AND USAGE

1.1 Hypertension

Chartoreg 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 class to which this drug principally belongs.

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.

It may be used alone or in combination with other antihypertensive agents

1.2 Cardiovascular Risk Reduction

chartoreg is indicated for reduction of the risk of myocardial infarction, stroke, or death from

cardiovascular causes in patients 55 years of age or older at high risk of developing major

cardiovascular events who are unable to take ACE inhibitors.

High risk for cardiovascular events can be evidenced by a history of coronary artery disease,

peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent

or non-insulin dependent) with evidence of end-organ damage. Chartoreg can be used in addition to

other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).

Studies of telmisartan in this setting do not exclude the possibility that telmisartan may not preserve

a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the

HHMDF0070OA2326/072024

03/07/2025ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the

cough resolves.

Use of telmisartan with an ACE inhibitor is not recommended.