Amlodipine besylate and Olmesartan medoxomil

Amlodipine besylate and Olmesartan medoxomil
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: FETAL TOXICITY See full prescribing information for complete Boxed Warning. *When pregnancy is detected, discontinue Azor as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Overview

Amlodipine besylate and Olmesartan medoxomil is an antihypertensive agent that is FDA approved for the treatment of hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include edema, dizziness, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amlodipine besylate and Olmesartan medoxomil in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amlodipine besylate and Olmesartan medoxomil in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Amlodipine besylate and Olmesartan medoxomil in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Amlodipine besylate and Olmesartan medoxomil in pediatric patients.

Contraindications

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Contraindications in the drug label.

Warnings

WARNING: FETAL TOXICITY See full prescribing information for complete Boxed Warning. *When pregnancy is detected, discontinue Azor as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Amlodipine besylate and Olmesartan medoxomil in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Amlodipine besylate and Olmesartan medoxomil in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Amlodipine besylate and Olmesartan medoxomil during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in geriatric settings.

Gender

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil with respect to specific gender populations.

Race

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Amlodipine besylate and Olmesartan medoxomil in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Amlodipine besylate and Olmesartan medoxomil in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Administration in the drug label.

Monitoring

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Amlodipine besylate and Olmesartan medoxomil and IV administrations.

Overdosage

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Mechanism of Action in the drug label.

Structure

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Structure in the drug label.

Pharmacodynamics

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Clinical Studies in the drug label.

How Supplied

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil How Supplied in the drug label.

Storage

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Amlodipine besylate and Olmesartan medoxomil interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Amlodipine besylate and Olmesartan medoxomil Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.