Amlodipine besylate and Olmesartan medoxomil
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Black Box Warning
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WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
*When pregnancy is detected, discontinue Azor as soon as possible.
|
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)
There is limited information regarding Amlodipine besylate and Olmesartan medoxomil FDA-Labeled Indications and Dosage (Adult) in the drug label.
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.
|
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.