Important Safety 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/ADVERSE REACTIONS
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.
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.
Talk to your healthcare provider about 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 Prescribing Information for additional safety information.
1 FDA Guidance, “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the FD&C Act” (January 2018); 21 CFR § 503A. 2 Isra Dmour. Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022. (2022 Nov 16 ,https://pmc.ncbi.nlm.nih.gov/articles/PMC9666930/ – (In a study of 141 FDA warning letters) 3 United States Pharmacopeia. (2022, November 1). USP General Chapters on compounding nonsterile and sterile preparations [Updated]. 4 Christine De Maria, Marie-Thérèse Lussier, Jana Bajcar. What do children know about medications? PMCID: PMC3056675 PMID: 21520667 https://pmc.ncbi.nlm.nih.gov/articles/PMC3056675/ 5 Yana Gvozdeva, Radiana Staynova. Choosing the “Ideal” Oral Dosage Form for Pediatric Patients: Parents’ Perspectives on Children’s Preferences with a Focus on Orodispersible Tablets. PMCID: PMC12468621 PMID: 41007052 https://pmc.ncbi.nlm.nih.gov/articles/PMC12468621/ 6 El-Sahn, M., Elliott, R., El-Sahn, M., Lucas, I., Kong, K., Walsh, J., & Lucas, J. (2025, April 22). Poor-tasting pediatric medicines: part 2. Exploring caregiver and healthcare provider values and preferences for a novel taste-blocker product to improve acceptability. Frontiers in Drug Delivery, 5, 1555522. https://doi.org/10.3389/fddev.2025.1555522 https://www.frontiersin.org/journals/drug-delivery/articles/10.3389/fddev.2025.1555522/full




