MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Norliqva, Katerzia, Amlodipine Besylate, Amlodipine and Olmesartan Medoxomil, Amlodipine and Atorvastatin
FDA boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. What is the most important information I should know about amlodipine and benazepril hydrochloride capsules? Amlodipine and benazepril hydrochloride capsules can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. …
1 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% 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. …
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine and benazepril hydrochloride during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible. Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue amlodipine and benazepril hydrochloride capsules until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 11/2021
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. 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 clin…
Having one of these?
A doctor will tell you whether it matters and what to do about it. Written answer, a week of free follow-ups.
Ask a doctor — $19.994 CONTRAINDICATIONS NORLIQVA is contraindicated in patients with sensitivity to amlodipine. Sensitivity to amlodipine
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. 2.1 Adults The usual initial antihypertensive oral dose of NORLIQVA 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…
Do not exceed doses greater than 20 mg daily of simvastatin. 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment. CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — dihydropyridine derivatives
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.