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Losartan Potassium is a brand name for Losartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Hypertension • Usual adult dose: 50 mg once daily. 7 mg per kg once daily (up to 50 mg). 1) Hypertensive Patients with Left Ventricular Hypertrophy • Usual starting dose: 50 mg once daily. 5 mg and/or increase losartan potassium to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed.
2) Nephropathy in Type 2 Diabetic Patients • Usual dose: 50 mg once daily. 3) • Increase dose to 100 mg once daily if further blood pressure response is needed. 1 Hypertension Adult Hypertension The usual starting dose of losartan potassium tablets is 50 mg once daily.
1) ]. , on diuretic therapy). 5) ]. Dosage should be adjusted according to blood pressure response. 2) ]. 3) , and Clinical Studies (14) ]. 2 Hypertensive Patients with Left Ventricular Hypertrophy The usual starting dose is 50 mg of losartan potassium tablets once daily.
2) ]. 3 Nephropathy in Type 2 Diabetic Patients The usual starting dose is 50 mg once daily. 3) ]. 4 Dosage Modifications in Patients with Hepatic Impairment In patients with mild-to-moderate hepatic impairment the recommended starting dose of losartan potassium is 25 mg once daily.
3) ]. 5 mg/mL suspension) Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents.
Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients.
The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. 1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Hypertension Losartan potassium has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year.
Treatment with losartan potassium was well-tolerated with an overall incidence of adverse events similar to that of placebo. 7% of patients given placebo. In 4 clinical trials involving over 1000 patients on various doses (10 to 150 mg) of losartan potassium and over 300 patients given placebo, the adverse events that occurred in ≥2% of patients treated with losartan potassium and more commonly than placebo were: dizziness (3% vs.
2%), upper respiratory infection (8% vs. 7%), nasal congestion (2% vs. 1%), and back pain (2% vs. 1%).
The following less common adverse reactions have been reported:
Blood and lymphatic system disorders: Anemia.
Psychiatric disorders:
Depression.
Nervous system disorders:
Somnolence, headache, sleep disorders, paresthesia, migraine.
5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. 2) • Monitor renal function and potassium in susceptible patients. 1 Fetal Toxicity Losartan potassium can 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. 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. 1) ]. , those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium.
1) ]. 3 Renal Function Deterioration Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. , patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium.
Monitor renal function periodically in these patients. 7) ]. 4 Hyperkalemia Monitor serum potassium periodically and treat appropriately. 1) ]. 1) ].
4 CONTRAINDICATIONS Losartan potassium is contraindicated: • In patients who are hypersensitive to any component of this product. • For coadministration with aliskiren in patients with diabetes. • Hypersensitivity to any component. (4) • Coadministration with aliskiren in patients with diabetes.
(4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Losartan in United States of America.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. Cough Persistent dry cough (with an incidence of a few percent) has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy.
Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135).
The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below. Table Study 1 Demographics = (89% Caucasian, 64% female) HCTZ Losartan Lisinopril Cough 25% 17% 69% Study 2 Demographics = (90% Caucasian, 51% female) Placebo Losartan Lisinopril Cough 35% 29% 62% These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy.
Cases of cough, including positive re-challenges, have been reported with the use of losartan in postmarketing experience. Hypertensive Patients with Left Ventricular Hypertrophy In the losartan Intervention for Endpoint (LIFE) study, adverse reactions with losartan potassium were similar to those reported previously for patients with hypertension.
Nephropathy in Type 2 Diabetic Patients In the Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan (RENAAL) study involving 1513 patients treated with losartan potassium or placebo, the overall incidences of reported adverse events were similar for the two groups.
Discontinuations of losartan potassium because of side effects were similar to placebo (19% for losartan potassium, 24% for placebo). The adverse events, regardless of drug relationship, reported with an incidence of ≥4% of patients treated with losartan potassium and occurring with ≥2% difference in the losartan group vs.
placebo on a background of conventional antihypertensive therapy, were asthenia/fatigue, chest pain, hypotension, orthostatic hypotension, diarrhea, anemia, hyperkalemia, hypoglycemia, back pain, muscular weakness, and urinary tract infection.
2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience with losartan potassium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Digestive: Hepatitis.
General Disorders and Administration Site Conditions:
Malaise.
Hematologic:
Thrombocytopenia.
Hypersensitivity:
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors.
Vasculitis, including Henoch-Schőnlein purpura, has been reported. Anaphylactic reactions have been reported.
Metabolic and Nutrition:
Hyponatremia.
Musculoskeletal:
Rhabdomyolysis.
Nervous System Disorders :
Dysgeusia.
Skin :
Erythroderma.