Description
Amlodipine 5 mg / Olmesartan 40 mg Tablets is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.
Drug Label Highlights
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
Dosage Forms And Strengths
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg (3).
Contraindications
Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes (4).
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 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 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 Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Amlodipine (7.1):
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
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2025
DailyMed highlights last updated: 2026-06-24 22:21:15









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