NORLIQVA
Generic: AMLODIPINE
Basic Information
Manufacturer
CMP Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
614d974f-51c7-4b18-8171-39eb6e8d4c03
Indications & Usage
1 INDICATIONS AND USAGE NORLIQVA is a calcium channel blocker for the treatment of: Hypertension ( 1.1 ) NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40% 1.1 Hypertension NORLIQVA ® is indicated for the treatment of hypertension, to lower blood pressure in adults and children 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 NORLIQVA.
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.
NORLIQVA may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD) Chronic Stable Angina NORLIQVA is indicated for the symptomatic treatment of chronic stable angina.
NORLIQVA may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina) NORLIQVA is indicated for the treatment of confirmed or suspected vasospastic angina.
NORLIQVA may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, NORLIQVA is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40% 1.1 Hypertension NORLIQVA ® is indicated for the treatment of hypertension, to lower blood pressure in adults and children 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 NORLIQVA.
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.
NORLIQVA may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD) Chronic Stable Angina NORLIQVA is indicated for the symptomatic treatment of chronic stable angina.
NORLIQVA may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina) NORLIQVA is indicated for the treatment of confirmed or suspected vasospastic angina.
NORLIQVA may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, NORLIQVA is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions to amlodipine were edema, dizziness, flushing and palpitation which occurred in a dose related manner.
Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc.
at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amlodipine has been evaluated for safety in more than 11,000 patients in U.S.
and foreign clinical trials.
In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily.
Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity.
In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%).
The most commonly reported adverse reactions more frequent than placebo are reflected in the table below.
The incidence (%) of adverse reactions that occurred in a dose-related manner are as follows: Amlodipine Placebo 2.5 mg N=275 5 mg N=296 10 mg N=268 N=520 Edema 1.8 3.0 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0.0 Palpitation 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose-related but were reported include: Amlodipine (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5 2.8 Nausea 2.9 1.9 For several adverse reactions that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table: Amlodipine Placebo Male=% (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336) Edema 5.6 14.6 1.4 5.1 Flushing 1.5 4.5 0.3 0.9 Palpitations 1.4 3.3 0.9 0.9 Somnolence 1.3 1.6 0.8 0.3 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: gynecomastia Hepatic: jaundice and hepatic enzyme elevations, some requiring hospitalization Neurologic: extrapyramidal disorder
Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc.
at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amlodipine has been evaluated for safety in more than 11,000 patients in U.S.
and foreign clinical trials.
In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily.
Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity.
In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%).
The most commonly reported adverse reactions more frequent than placebo are reflected in the table below.
The incidence (%) of adverse reactions that occurred in a dose-related manner are as follows: Amlodipine Placebo 2.5 mg N=275 5 mg N=296 10 mg N=268 N=520 Edema 1.8 3.0 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0.0 Palpitation 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose-related but were reported include: Amlodipine (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5 2.8 Nausea 2.9 1.9 For several adverse reactions that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table: Amlodipine Placebo Male=% (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336) Edema 5.6 14.6 1.4 5.1 Flushing 1.5 4.5 0.3 0.9 Palpitations 1.4 3.3 0.9 0.9 Somnolence 1.3 1.6 0.8 0.3 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: gynecomastia Hepatic: jaundice and hepatic enzyme elevations, some requiring hospitalization Neurologic: extrapyramidal disorder