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

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Amlodipine 5 mg / Olmesartan 40 mg Tablets — Generic For Azor — Alembic is available through Pill Pals Pharmacy with cash-pay pharmacy pricing and free shipping where available. Prescription required.

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Description

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prescription required

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

Source: This information is taken from the official DailyMed drug label page when available. It is provided for educational purposes and is not a substitute for pharmacist counseling, prescriber instructions, or the full official labeling.

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

Additional information

Size/Count

1 Count

Dose/Strength

5 MG / 40 MG

Form

Tablet

Medication Guide

Official DailyMed Drug Label Information

This product has a DailyMed drug label PDF from the National Library of Medicine.

View / Download PDF View on DailyMed

  • Source: DailyMed, National Library of Medicine
  • DailyMed Label: AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL (AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]
  • Matched NDC: 62332-213-90
  • Published Date: Nov 17, 2025

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Amlodipine and olmesartan medoxomil tablets are used to treat high blood pressure. They may be used alone or with other blood pressure medicines, and they may also be used as initial therapy in patients likely to need more than one antihypertensive medicine.

This medicine combines amlodipine, a calcium channel blocker, and olmesartan, an angiotensin II receptor blocker. Lowering blood pressure can reduce the risk of serious cardiovascular events such as stroke and heart attack.

The label includes a boxed warning for fetal toxicity. If pregnancy is detected, the medicine should be discontinued as soon as possible.

The usual starting dose is 5/20 mg once daily, and the dose may be increased after 1 to 2 weeks if needed, up to a maximum of 10/40 mg once daily.

Storage Information

STORAGE AND HANDLING Amlodipine and Olmesartan Medoxomil Tablets, USP are supplied as follows: 5 mg/20 mg: White round shape, film-coated debossed with ‘454’ on one side and plain on other side. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Key Counseling Points

  • Take this medicine by mouth once daily exactly as directed on the prescription label.
  • Do not use it during pregnancy; the label warns it can cause fetal harm.
  • Tell your healthcare provider if you become pregnant while taking this medicine.
  • Let your healthcare provider know if you have low blood pressure, kidney problems, liver problems, or a history of severe coronary artery disease.
  • This medicine may be used with other blood pressure medicines when needed to reach blood pressure goals.
  • Some patients may develop edema, dizziness, or hypotension, especially when treatment is started or the dose is increased.
  • Report severe, chronic diarrhea or substantial weight loss to your healthcare provider, since sprue-like enteropathy has been reported.
  • Tell your healthcare provider about all medicines you take, including NSAIDs, lithium, simvastatin, cyclosporine, tacrolimus, and other blood pressure medicines.
  • If you have diabetes, do not take aliskiren with this medicine.
  • Monitoring of blood pressure, kidney function, serum electrolytes, or lithium levels may be needed with certain medicines or conditions.

Helpful Patient Education

Amlodipine and olmesartan medoxomil tablets are a combination prescription medicine used to treat hypertension, also called high blood pressure. The label describes this medicine as a calcium channel blocker plus an angiotensin II receptor blocker, and it may be used alone or with other antihypertensive agents.

Educational product information should also reflect key label warnings and precautions, including fetal toxicity, possible low blood pressure when starting treatment, kidney function changes, electrolyte issues, and important drug interactions. The tablet strengths listed on the label include 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg.

Medication Summary last generated: 2026-07-10 02:46:31


Amlodipine 5 mg / Olmesartan 40 mg Tablets --- Generic For Azor --- Alembic may require patient-specific counseling based on your prescription, directions, allergies, medical history, and other medications.

This Medication Guide section is provided for general educational purposes only. It does not replace the official medication guide, patient information leaflet, counseling from your pharmacist, or medical advice from your prescriber.

Please read all information provided with your prescription. Contact Pill Pals Pharmacy or your prescriber with questions before using this medication.

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