Post by syedsanaullah on Apr 17, 2013 12:55:52 GMT -5
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Pharmacists have a role in the management of hypertension, a medical condition that affects nearly one in three adults in the United States. Patients whose hypertension remains not adequately controlled with monotherapy are likely to need multiple drugs to help achieve blood pressure goals.
Edarbyclor (azilsartan medoxomil and chlorthalidone), a combination medication indicated for the treatment of hypertension, has been available in the U.S. since the beginning of 2012. It is the only hypertension therapy to combine an angiotensin II receptor blocker with chlorthalidone.
The purpose of this guide is to aid pharmacists in answering questions patients may have if they are unfamiliar with this medication. Please visit www.PharmacyTimes.com or click the button below to be directed to a digital version of the article.
Important Safety Information
WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warning.
• When pregnancy is detected, discontinue EDARBYCLOR as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
EDARBYCLOR is contraindicated in patients with anuria.
Do not coadminister aliskiren with EDARBYCLOR in patients with diabetes.
Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.
In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBYCLOR.
Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. Avoid use of aliskiren with EDARBYCLOR in patients with renal impairment (GFR <60 mL/min).
Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.
Adverse Reactions (AEs):
AEs that occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).
Incidence of consecutive elevations of creatinine (≥50% from baseline and >ULN) was 2% and were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.
Drug Interactions:
Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity.
Monitor renal function periodically in patients receiving EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may interfere with antihypertensive effect.
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
Indications and Usage
EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBYCLOR, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.
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.
EDARBYCLOR may be used with other antihypertensive agents.
For further information, please click here for complete Edarbyclor Prescribing Information.
20816
Pharmacy Times | Pharmacy & Healthcare Communications, LLC
666 Plainsboro Rd | Bldg 300 | Plainsboro | NJ 08536
Phone: (609) 716-7777 | Fax: (609) 257-0101 | www.PharmacyTimes.com
Pharmacists have a role in the management of hypertension, a medical condition that affects nearly one in three adults in the United States. Patients whose hypertension remains not adequately controlled with monotherapy are likely to need multiple drugs to help achieve blood pressure goals.
Edarbyclor (azilsartan medoxomil and chlorthalidone), a combination medication indicated for the treatment of hypertension, has been available in the U.S. since the beginning of 2012. It is the only hypertension therapy to combine an angiotensin II receptor blocker with chlorthalidone.
The purpose of this guide is to aid pharmacists in answering questions patients may have if they are unfamiliar with this medication. Please visit www.PharmacyTimes.com or click the button below to be directed to a digital version of the article.
Important Safety Information
WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warning.
• When pregnancy is detected, discontinue EDARBYCLOR as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
EDARBYCLOR is contraindicated in patients with anuria.
Do not coadminister aliskiren with EDARBYCLOR in patients with diabetes.
Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.
In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBYCLOR.
Monitor for worsening renal function in patients with renal impairment. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing EDARBYCLOR if progressive renal impairment becomes evident. Avoid use of aliskiren with EDARBYCLOR in patients with renal impairment (GFR <60 mL/min).
Hypokalemia is a dose-dependent adverse reaction that may develop with chlorthalidone. Coadministration of digitalis may exacerbate the adverse effects of hypokalemia. EDARBYCLOR attenuates chlorthalidone-associated hypokalemia.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.
Adverse Reactions (AEs):
AEs that occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%).
Incidence of consecutive elevations of creatinine (≥50% from baseline and >ULN) was 2% and were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.
Drug Interactions:
Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity.
Monitor renal function periodically in patients receiving EDARBYCLOR and NSAIDs who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function, as deterioration of renal function, including possible acute renal failure, may result. These effects are usually reversible. NSAIDs may interfere with antihypertensive effect.
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
Indications and Usage
EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBYCLOR, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.
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.
EDARBYCLOR may be used with other antihypertensive agents.
For further information, please click here for complete Edarbyclor Prescribing Information.
20816
Pharmacy Times | Pharmacy & Healthcare Communications, LLC
666 Plainsboro Rd | Bldg 300 | Plainsboro | NJ 08536
Phone: (609) 716-7777 | Fax: (609) 257-0101 | www.PharmacyTimes.com