Amlodipine 5 mg / Olmesartan 40 mg Tablets — Generic For Azor — Ascend

These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS.

AMLODIPINE and OLMESARTAN MEDOXOMIL tablets, for oral use

Initial U.S. Approval: 2007

Warning: Fetal Toxicity

See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue Amlodipine and Olmesartan Medoxomil Tablets as soon as possible (5.1, 8.1).

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1, 8.1).

Indications And Usage

Dosage And Administration

Recommended starting dose: 5/20 mg once daily (2).

Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily (2).

Dosage Forms And Strengths

Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg (3).

Contraindications

Warnings And Precautions

• Anticipate hypotension in volume- or salt-depleted patients with treatment initiation. Start treatment under close supervision (5.2).
• Increased angina or myocardial infarction may occur upon dosage initiation or increase (5.3).
• Impaired renal function: changes in renal function may occur. (5.4)
• Sprue-like enteropathy has been reported. Consider discontinuation of Amlodipine and Olmesartan Medoxomil Tablets in cases where no other etiology is found (5.6).

• Anticipate hypotension in volume- or salt-depleted patients with treatment initiation. Start treatment under close supervision (5.2).
• Increased angina or myocardial infarction may occur upon dosage initiation or increase (5.3).
• Impaired renal function: changes in renal function may occur. (5.4)
• Sprue-like enteropathy has been reported. Consider discontinuation of Amlodipine and Olmesartan Medoxomil Tablets in cases where no other etiology is found (5.6).

Adverse Reactions

Most common adverse reaction (incidence ≥3%) is edema (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Amlodipine (7.1):

If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin.

Increased exposure of cyclosporine and tacrolimus.

Increased exposure of amlodipine when coadministered with CYP3A inhibitors.

Olmesartan medoxomil (7.2):

Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect.

Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia.

Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose.

Lithium: Increases in serum lithium concentrations and lithium toxicity.

Use In Specific Populations

Lactation: Breastfeeding is not recommended (8.2).

Geriatric: Not recommended for initial therapy in patients ≥75 years old (8.5).

Hepatic Impairment: Not recommended for initial therapy (8.6).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2025