"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
ATACAND HCT is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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. There are no controlled trials demonstrating risk reduction with ATACAND 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.
This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.
Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.
Use in Renal Impairment: Dosing recommendations for ATACAND HCT in patients with creatinine clearance < 30 mg/min cannot be provided (see Special Populations, Renal Insufficiency).
Use in moderate to severe Hepatic Impairment: ATACAND HCT is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given (see Special Populations, Hepatic Insufficiency).
The combination may be substituted for the titrated components.
Dose Titration by Clinical Effect
A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from ATACAND HCT 16-12.5 mg and serum potassium may improve.
A patient whose blood pressure is not controlled on 32 mg of ATACAND can expect incremental blood pressure effects from ATACAND HCT 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of ATACAND HCT can be expected within 4 weeks of initiating that dose.
ATACAND HCT may be administered with other antihypertensive agents.
ATACAND HCT may be administered with or without food.
No. 3825 — Tablets ATACAND HCT 16-12.5, are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied as follows:
NDC 0186-0162-28 unit dose packages of 100.
NDC 0186-0162-54 unit of use bottles of 90.
No. 3826 — Tablets ATACAND HCT 32-12.5, are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied as follows:
NDC 0186-0322-28 unit dose packages of 100.
NDC 0186-0322-54 unit of use bottles of 90.
No. 3899 — Tablets ATACAND HCT 32–25, are pink, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACD on one side. They are supplied as follows:
NDC 0186–0324–54 unit of use bottles of 90.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Manufactured under the license from: Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, S-151 85 Södertälje, Sweden for: AstraZeneca LP, Wilmington, DE 19850. Revised: Feb 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/20/2015
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