telmisartan/amlodipine (Rx)

Brand and Other Names:Twynsta
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

telmisartan/amlodipine

tablet

  • 40mg/10mg
  • 40mg/5mg
  • 80mg/10mg
  • 80mg/5mg
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Hypertension

Initiate with 40 mg/5 mg or 80 mg/5 mg PO qDay, OR

Substitute for individually titrated components

May increase dose after at least 2 weeks, not to exceed 80 mg/10 mg qDay

Dosage range: Telmisartan 20-80 mg/amlodipine 2.5-10 mg PO qDay

Hepatic impairment or elderly: Initiate with decreased dose containing 2.5 mg amlodipine

May be adminsitered concomitantly with other antihypertensive agents

Renal Impairment

Mild to moderate impairment: Dose adjustment not recommended

Hepatic Impairment

Severe impairment: Titrate slowly; dose adjustment not recommended

Safety & efficacy not established

Not recommended as initial therapy for patients >75 years of age

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Interactions

Interaction Checker

and telmisartan/amlodipine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Peripheral edema (1-11%)

            1-10%

            Dizziness (3%)

            Orthostatic hypotension (6%)

            Syncope (2%)

            Back pain (2%)

            Postmarketing Reports

            Most common reported include headache, asthenia, coughing, nausea, fatigue, hypoglycemia (in patients with diabetes), and angioedema (with fatal outcome), upper respiratory tract infection; gynecomastia, jaundice and hepatic enzyme elevations, extrapyramidal disorder

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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

            Do not coadminister with aliskiren in patients with diabetes mellitus

            Cautions

            Discontinue immediately with pregnancy; increased fetal/neonatal morbidity and mortality (see Black Box Warnings)

            May cause hypotension, particularly if volume or salt depleted (correct before initiating)

            Symptomatic hypotension with or without syncope may occur

            Titrate slowly in patients with hepatic or severe renal impairment

            May increase serum creatinine or BUN in patients w/ renal artery stenosis

            Monitor for hyperkalemia

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

            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

            Monitor for worsening heart failure; may lead to oliguria or progressive azotemia

            Initiating calcium channel blockers in patients with severe obstructive coronary artery disease may precipitate MI or increase angina

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            Pregnancy & Lactation

            Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)

            Discontinue as soon as possible, drugs that act directly on renin-angiotensin system known to cause injury or death to developing fetus

            Reports of hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death

            Oligohydramnios reported, presumably resulting from decreased fetal renal function

            Oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development

            Lactation: Discontinue drug or do not breast feed

            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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            Pharmacology

            Mechanism of Action

            Telmisartan is a vasoconstrictor angiotensin II receptor blocker (ARB); prevents angiotensin II from binding to its receptor, which in turn blocks the vasoconstriction and aldosterone secreting effects of angiotensin II.

            Amlodipine is a dihydropyridine calcium channel blocker (CCB); acts in vascular smooth muscle to produce peripheral aterial vasodilation, which in turn reduces peripheral vascular resistance and blood pressure

            Pharmacokinetics

            Telmisartan

            • Half-Life: 24 hr
            • Onset: 1-2 hr
            • Bioavailability: 42-58%; dose-dependent
            • Vd: 500 L
            • Peak Plasma Time: 0.5-1 hr
            • Protein Bound: >99.5%
            • Metabolism: Liver to inactive metabolite (not metabolized via CYP)
            • Clearance: 800 mL/min
            • Excretion: Feces (97%)

            Amlodipine

            • Half-Life: 30-50 hr
            • Bioavailability: 64-90%
            • Vd: 21 L/kg
            • Peak Plasma Time: 6-12 hr
            • Protein Bound: 93-98%
            • Metabolism: Liver (>90%); P450 CYP3A4
            • Clearance: 25 L/hr
            • Excretion: Urine (70%)
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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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