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 22:34:44

Additional information

Size/Count

30 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 a prescription medicine taken by mouth to treat high blood pressure. They may be used alone or with other blood pressure medicines. Lowering blood pressure can reduce the risk of serious cardiovascular events such as stroke and heart attack.

This medicine combines amlodipine, a calcium channel blocker, and olmesartan medoxomil, an angiotensin II receptor blocker. 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.

The label includes a boxed warning about fetal toxicity. If pregnancy is detected, the medicine should be discontinued as soon as possible. The label also warns about low blood pressure, possible changes in kidney function, increased angina or myocardial infarction when starting or increasing the dose, and sprue-like enteropathy with severe, chronic diarrhea and weight loss.

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 exactly as prescribed.
  • It is used to lower high blood pressure.
  • The usual starting dose is 5/20 mg once daily.
  • Your dose may be increased after 1 to 2 weeks, up to a maximum of 10/40 mg once daily.
  • This medicine has a boxed warning for fetal toxicity; it should be stopped as soon as possible if pregnancy is detected.
  • Low blood pressure may occur, especially in patients who are volume- or salt-depleted when treatment starts.
  • Tell your healthcare professional if you develop worsening chest pain or symptoms of a heart attack after starting or increasing the dose.
  • The label warns that kidney function may change and that electrolytes may need periodic monitoring.
  • Severe, chronic diarrhea with weight loss can occur and should be reported because sprue-like enteropathy has been reported.
  • Ask a healthcare professional before using other medicines, including NSAIDs, lithium, simvastatin, cyclosporine, tacrolimus, or aliskiren, because interactions are listed in the label.

Helpful Patient Education

Amlodipine and olmesartan medoxomil tablets are a prescription combination medicine used to treat hypertension, also called high blood pressure. The tablet contains amlodipine, a calcium channel blocker, and olmesartan medoxomil, an angiotensin II receptor blocker. According to the label, lowering blood pressure helps reduce the risk of serious cardiovascular events such as stroke and myocardial infarction.

DailyMed label information also notes important safety considerations, including fetal toxicity, possible low blood pressure, kidney function changes, and sprue-like enteropathy. The product is available in multiple strengths and is intended for oral use once daily as directed on the prescription label.

Medication Summary last generated: 2026-07-17 02:44:47


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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