telmisartan (Rx)

Brand and Other Names:Micardis
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 20mg
  • 40mg
  • 80mg

Hypertension

Indicated for treatment of hypertension

Dosage must be individualized

40 mg/day PO initially; titrated to 20-80 mg/day PO, depending on response; patients with volume depletion should receive the lower dosage initially, under close supervision

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks

When additional blood pressure reduction is required after the 80-mg dose, a diuretic may be added

Cardiovascular risk reduction

Indicated for cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors

80 mg PO qDay

Unknown whether doses lower than 80 mg are effective in reducing the risk of cardiovascular morbidity and mortality

Dosage Modifications

Renal impairment: No dosage adjustment necessary; hemodialysis (HD) patients at risk for orthostatic hypotension

Hepatic impairment

  • In patients with hepatic insufficiency, plasma concentrations of telmisartan increased, and absolute bioavailability approached 100%
  • Monitor carefully and titrate up slowly in patients with biliary obstructive disorders or hepatic insufficiency

Dosing Considerations

Use of telmisartan with an ACE inhibitor is not recommended

<18 years old: Safety and efficacy not established

Next:

Interactions

Interaction Checker

and telmisartan

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            1-10%

            Upper respiratory tract infection (7%)

            Back pain (3%)

            Sinusitis (3%)

            Diarrhea (3%)

            Cough (1.6%)

            Influenza-like symptoms (≥1%)

            Dyspepsia (≥1%)

            Myalgia (≥1%)

            Urinary tract infection (≥1%)

            Abdominal pain ≥1%)

            Headache (≥1%)

            Dizziness (≥1%)

            Pain (≥1%)

            Fatigue (≥1%)

            Coughing (≥1%)

            Hypertension (≥1%)

            Chest pain (≥1%)

            Nausea (≥1%)

            Peripheral edema (≥1%)

            Pharyngitis (1%)

            Frequency Not Defined

            Autonomic nervous system: Impotence, increased sweating, flushing

            Body as a whole: Allergy, fever, leg pain, malaise

            Cardiovascular: Palpitations, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG

            Central nervous system: Insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia

            Gastrointestinal: Flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, nonspecific gastrointestinal disorders

            Metabolic: Gout, hypercholesterolemia, diabetes mellitus

            Musculoskeletal: Arthritis, arthralgia, leg cramps

            Psychiatric: Anxiety, depression, nervousness

            Resistance mechanism: Infection, fungal infection, abscess, otitis media

            Respiratory: Asthma, bronchitis, rhinitis, dyspnea, epistaxis

            Skin: Dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis;

            Vascular: Cerebrovascular disorder

            Special senses: Abnormal vision, conjunctivitis, tinnitus, earache

            Postmarketing Reports

            Most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome)

            Rare cases of rhabdomyolysis have been reported

            Previous
            Next:

            Warnings

            Black Box Warnings

            Fetal toxicity

            • When pregnancy is detected, discontinue telmisartan as soon as possible
            • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

            Contraindications

            Hypersensitivity to telmisartan or any other component of this product

            Coadministration with aliskiren in patients with diabetes

            Cautions

            Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

            Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium level

            As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduce clearance

            Pregnancy (2nd and 3rd trimesters); significant risk of fetal or neonatal morbidity and mortality (see Black Box Warnings)

            Dual blockade of the renin-angiotensin system with angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy

            Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function and electrolytes in patients on benazepril and other agents that affect the RAS

            Drug interaction overview

            • Not for coadministration with aliskiren in patients with diabetes; avoid use of aliskiren with telmisartan in patients with renal impairment (GFR <60 ml/min/1.73 m2)
            • When coadministered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed; monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            May cause fetal harm when administered to a pregnant woman

            Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

            Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents

            When pregnancy is detected, discontinue as soon as possible

            Animal data

            • Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses

            Clinical considerations

            • Disease-associated maternal and/or embryo/fetal risk
              • Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
              • Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
              • Carefully monitor pregnant women with hypertension and managed accordingly
            • Fetal/neonatal adverse reactions
              • Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
              • During pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment
              • Fetal testing may be appropriate, based on the week of gestation
              • If oligohydramnios is observed, discontinue telmisartan, unless it is considered lifesaving for the mother
              • Note: Oligohydramnios may not appear until after the fetus has sustained irreversible injury
              • Closely observe infants with histories of in utero exposure to telmisartan for hypotension, oliguria, and hyperkalemia
              • If oliguria or hypotension occurs, support blood pressure and renal perfusion
              • May require transfusions or dialysis as a means of reversing hypotension and/or substituting for disordered renal function

            Lactation

            There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production

            Present in the milk of lactating rats

            Advise a nursing woman not to breastfeed during treatment

            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.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Angiotensin II receptor blocker; inhibits vasoconstrictor and aldosterone-secreting effects of angiotensin II

            Absorption

            Onset: 1-2 hr

            Duration: <24 hr

            Peak plasma time: 0.5-1 hr

            Distribution

            Protein bound: >99.5%

            Vd: 500 L

            Metabolism

            Metabolized in liver to inactive metabolite

            Elimination

            Half-life: 24 hr

            Dialyzable: No (HD)

            Excretion: Feces (>97%), urine (small amount)

            Previous
            Next:

            Administration

            Oral Administration

            Take with or without food

            Storage

            Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Tablets should not be removed from blisters until immediately before administration

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.