Sdamlo is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients 6 years of age and older. 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 amlodipine.
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.
Sdamlo may be used alone or in combination with other antihypertensive agents.
Coronary Artery Disease (CAD)
Chronic Stable Angina
Sdamlo is indicated for the symptomatic treatment of chronic stable angina in adults. Sdamlo may be used alone or in combination with other antianginal agents.
Vasospastic-Angina (Prinzmetal's or Variant Angina)
Sdamlo is indicated for the treatment of confirmed or suspected vasospastic angina in adults. Sdamlo may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In adult patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Sdamlo is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
Hypertension
The usual initial antihypertensive oral dose of Sdamlo is 5 mg orally once daily, and the maximum dose is 10 mg orally once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg orally once daily and this dose may be used when adding Sdamlo to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Angina
The recommended dose for chronic stable or vasospastic angina is 5 mg to 10 mg orally once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg orally once daily for adequate effect.
Coronary Artery Disease
The recommended dose range for patients with coronary artery disease is 5 mg to 10 mg once daily. In clinical studies, the majority of patients required 10 mg orally once daily.
The recommended antihypertensive dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg orally once daily. Doses in excess of 5 mg orally once daily have not been studied in pediatric patients.
• Remove the cap and peel off the seal.
• Use one tablespoon to measure 15 mL of room temperature water. Add the 15 ml water to the container.
• Wait for 60 seconds to allow the content to fully dissolve. Shaking the container is not required.
• Consume the entire content of the container immediately or within 60 minutes.
• Rinse the container with similar amount of water 1 to 2 times and consume the rinses.
Sdamlo is contraindicated in patients with known sensitivity to amlodipine.
Full Prescribing Information: DailyMed
