amlodipine/olmesartan (Rx)

Brand and Other Names:Azor
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

amlodipine/olmesartan

tablet

  • 5mg/20mg
  • 5mg/40mg
  • 10mg/20mg
  • 10mg/40mg
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Hypertension

5 mg/20 mg PO qDay intially; may increasedose after 1-2 weeks; not to exceed 10 mg/40 mg

May be adminsitered concomitantly with other antihypertensive agents

Safety and efficacy not established

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Interactions

Interaction Checker

and amlodipine/olmesartan

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Peripheral edema (11%)

            Frequency Not Defined

            Palpitation

            Nocturia

            Urinary frequency

            Orthostatic hypotension

            Pruritus

            Rash

            Postmarketing Reports

            Acute renal failure

            Anaphylactic reactions

            Angioedema

            Diarrhea

            Hepatic enzyme elevations

            Jaundice

            Rhabdomyolysis

            Extrapyramidal disorder

            Increased blood creatinine levels

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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

            Contraindications

            Hypersensitivity to olmesartan, amlodipine or other ingredients

            Pregnancy (2nd/3rd trimesters): Significant risk of fetal and neonatal morbidity & mortality

            Anuria

            Do not coadminister with aliskiren in patients with diabetes mellitus

            Also see individual monographs:

            • amlodipine
            • olmesartan

            Cautions

            Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy

            Increased angina and/or myocardial infarction reported with initiation or dosing titration of dihydropyridine calcium channel blockers

            Olmesartan may be associated with deterioration of renal function and/or increased in serum creatinine in patients with low renal blood flow

            Intestinal problems (ie, sprue-like enteropathy) reported with olmesartan; symptoms may include severe, chronic diarrhea with substantial weight loss

            Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy

            Hypotension may occur in volume or salt depleted patients

            Titrate slowly when administering amlodipine to patients with severe hepatic impairment

            Severe, chronic diarrhea with substantial weight loss may occur with olmesartan therapy

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters). During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

            Lactation: It is not known whether the amlodipine or olmesartan are excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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