losartan (Rx)

Brand and Other Names:Cozaar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

Hypertension

50 mg PO qDay initially; may increase to up to 100 mg/day

Patients with possible intravascular depletion or receiving diuretics (eg, on diuretic therapy): 25 mg PO qDay initially

Diabetic Nephropathy

Type 2 diabetes and hypertension: 50-100 mg PO qDay

Hypertension with Left Ventricular Hypertrophy

Indicated to reduce risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients

50 mg PO qDay initially; may increase to up to 100 mg/day

Hydrochlorothiazide 12.5 mg PO qDay may be added in combination; may increase to up to 25 mg/day

Nephropathy in Type 2 Diabetes

Indicated for diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension

50 mg PO qDay initially; may increase to up to 100 mg/day

Dosage Modifications

Renal impairment

  • Mild, moderate, or severe: No dosage adjustment necessary, except if the patient is volume depleted

Hepatic impairment

  • Mild-to-moderate: 25 mg PO qDay initially
  • Severe: Not studied

Marfan Syndrome (Orphan)

Orphan designation for treatment of Marfan syndrome

Orphan sponsor

  • National Marfan Foundation, 22 Manhasset Ave, Port Washington, NY 11050

Epidermolysis Bullosa (Orphan)

Orphan designation for treatment of epidermolysis bullosa

Orphan sponsor

  • 3R Pharma Consulting GmbH; 3 Wildbader Strabe; Dobel, Germany

Dosage Forms & Strengths

tablet

  • 25mg
  • 50mg
  • 100mg

Hypertension

<6 years: Safety and efficacy not established

≥6 years

  • 0.7 mg/kg PO qDay (up to 50 mg total); adjust dosage according to blood pressure response  
  • Doses >1.4 mg/kg (or in excess of 100 mg) daily have not been studied

Dosage Modifications

Renal impairment

  • CrCl <30 mL/min/1.73m2: Not recommended
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Interactions

Interaction Checker

and losartan

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            Adverse Effects

            >10%

            Cough (17-29%)

            1-10%

            Upper respiratory tract infection (8%)

            Dizziness (3%)

            Nasal congestion (2%)

            Back pain (2%)

            Frequency Not Defined

            Blood and lymphatic system disorders: Anemia

            Psychiatric disorders: Depression

            Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine

            Ear and labyrinth disorders: Vertigo, tinnitus

            Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA

            Respiratory, thoracic and mediastinal disorders: Dyspnea

            Gastrointestinal disorders: Abdominal pain, constipation, nausea, vomiting

            Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity

            Musculoskeletal and connective tissue disorders: Myalgia, arthralgia

            Reproductive system and breast disorders: Impotence

            General disorders and administration site conditions: Edema

            Postmarketing Reports

            Digestive: Hepatitis

            General disorders and administration site conditions: Malaise

            Hematologic: Thrombocytopenia

            Hypersensitivity: Angioedema, vasculitis, anaphylactic reactions

            Metabolic and nutrition: Hyponatremia

            Musculoskeletal: Rhabdomyolysis

            Nervous system disorders: Dysgeusia

            Skin: Erythroderma

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            Warnings

            Black Box Warnings

            Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death (see Pregnancy & Lactation)

            Contraindications

            Hypersensitivity

            Coadministration with aliskiren in patients with diabetes mellitus

            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

            In volume- or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment; correct volume or salt depletion before administration

            Monitor serum potassium periodically and treat appropriately; dosage reduction or discontinuation of treatment may be required

            Renal function deterioration

            • Patients whose renal function may depend in part on the activity of the renin-angiotensin system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at risk of developing acute renal failure
            • Monitor renal function periodically in these patients; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function

            Drug interaction overview

            • Coadministration with other drugs that raise serum potassium levels may result in hyperkalemia
            • Increases in serum lithium concentrations and toxicities have been reported during coadministration of lithium with angiotensin II receptor antagonists; monitor serum lithium levels during concomitant use
            • Coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function may result in deterioration of renal function, including possible acute renal failure; these effects are usually reversible
            • Do not coadminister aliskiren with losartan in patients with diabetes; avoid use of aliskiren with losartan in patients with renal impairment (GFR <60 mL/min)
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            Pregnancy & Lactation

            Pregnancy

            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

            Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations

            Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death

            When pregnancy is detected, discontinue treatment as soon as possible

            Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus

            Animal data

            • May produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity
            • With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (~3x the maximum recommended human dose of 100 mg on a mg/m2 basis)
            • Significant levels of losartan and its active metabolite were present in rat fetal plasma during late gestation and in rat milk

            Lactation

            Unknown whether drug is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk

            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

            Blocks binding of angiotensin II to type 1 angiotensin II receptors; blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II

            Absorption

            Bioavailability: 25%

            Onset: 6 hr

            Duration: 24 hr

            Peak plasma time: 1-1.5 hr

            Distribution

            Protein bound: Losartan, 98.7%; E-3174, 99.8%

            Vd: Losartan, 34 L; E-3174, 12 L

            Metabolism

            Metabolized by hepatic P450 enzyme CYP2C9

            Metabolites: 5-Carboxylic acid (E-3174) (active metabolite; 40 times as potent as losartan in angiotensin II-blocking activity)

            Elimination

            Half-life: Losartan, 1.5-2 hr; E-3174, 6-9 hr; increased in end-stage renal failure or CHF

            Dialyzable: HD, no; PD, no

            Renal clearance: Losartan, 43-75 mL/min; E-3174, 18-25 mL/min

            Total plasma clearance: Losartan, 600 mL/min; E-3174, 50 mL/min

            Excretion: Urine (4%)

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            Administration

            Extemporaneous Oral Suspension Preparation

            Place ten 50-mg tablets into an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle

            Add 10 mL of purified water to the amber bottle

            Immediately shake for at least 2 minutes

            Allow concentrate to stand for 1 hr and then shake for 1 min to disperse drug contents

            Separately, prepare a 50/50 Oral-Plus/Ora-Sweet mixture

            Add 190 mL of the 50/50 Ora-Plus/Ora-Sweet mixture to amber bottle with the tablet and water slurry; shake for 1 min to disperse content

            Oral Administration

            May take with or without food

            Suspension: Shake prior to each use and return promptly to the refrigerator

            Storage

            Suspension: Refrigerate at 2-8ºC (36-46ºF) for up to 4 weeks

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

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