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Pharmacists

Important Safety Information

Full Prescribing Information

Indications and Usage

NORLIQVA is a calcium channel blocker for the treatment of:

HYPERTENSION
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

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%

Contraindications

NORLIQVA is contraindicated in patients with sensitivity to amlodipine.

Warnings and Precautions

NORLIQVA may cause the following conditions.

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORLIQVA, particularly in patients with severe obstructive coronary artery disease.
Titrate slowly in patients with severe hepatic impairment.

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.

See full Prescribing Information for other possible side effects with NORLIQVA. 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.

Drug Interactions

Do not exceed doses greater than 20 mg daily of simvastatin.

CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.
CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

Dosage and Administration

NORLIQVA is an oral solution: 1 mg/mL. Adult recommended starting dose: 5 mg orally once daily with a maximum of 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. Pediatric starting dose: 2.5 mg to 5 mg orally once daily.

Please see full Prescribing Information for additional safety information.

Important Safety Information

Full Prescribing Information

Indication

Norliqva is a calcium channel blocker for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Norliqva is indicated for the treatment of coronary artery disease: chronic stable angina, vasospastic angina (Prinzmetal’s or variant angina), and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction <40%.

NORLIQVA is contraindicated in patients with sensitivity to amlodipine.

Read More About the Safety Information of Norliqva

Indications and Usage: NORLIQVA is a calcium channel blocker for the treatment of:

HYPERTENSION
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

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%

Contraindications

NORLIQVA is contraindicated in patients with sensitivity to amlodipine.

Warnings and Precautions

NORLIQVA may cause the following conditions.

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely.
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORLIQVA, particularly in patients with severe obstructive coronary artery disease.
Titrate slowly in patients with severe hepatic impairment.

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.

See full Prescribing Information for other possible side effects with NORLIQVA. 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.

Drug Interactions

Do not exceed doses greater than 20 mg daily of simvastatin.

CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.
CYP3A Inducers: No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

Dosage and Administration

NORLIQVA is an oral solution: 1 mg/mL. Adult recommended starting dose: 5 mg orally once daily with a maximum of 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. Pediatric starting dose: 2.5 mg to 5 mg orally once daily.

Please see full Prescribing Information for additional safety information.

See full Important Safety Information