In the Losartan Intervention for Endpoint (LIFE) study, adverse reactions with Losartan potassium were similar to those reported previously for patients with hypertension. The usual starting dose is 50 mg of Losartan potassium tablets once daily. amlodipine, metoprolol, lisinopril, furosemide, hydrochlorothiazide, atenolol, enalapril, irbesartan, ramipril, benazepril. Available for Android and iOS devices. These include: Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. Patients were randomized to receive Losartan potassium 50 mg once daily or placebo on a background of conventional antihypertensive therapy excluding ACE inhibitors and angiotensin II antagonists. Analysis of age, gender, and race subgroups of patients showed that men and women, and patients over and under 65, had generally similar responses. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including Losartan) may result in deterioration of renal function, including possible acute renal failure. Does Losartan block the receptor used by the Coronavirus? Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Don’t put this medication in your car’s glove compartment or leave it in the car. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. This is because high blood pressure raises your risk of kidney damage that’s caused by the high blood sugar levels linked with diabetes. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. Neither Losartan nor its active metabolite can be removed by hemodialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.7)]. Share on Pinterest The dosage for losartan potassium can vary, and people should take it as prescribed. The effect of Losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks. Treatment with Losartan potassium resulted in a 13% reduction (p=0.021) in risk of the primary endpoint compared to the atenolol group (see Figure 1 and Table 3); this difference was primarily the result of an effect on fatal and nonfatal stroke. In addition, each tablet contains the following inactive ingredients: colloidal silica anhydrous, hydroxypropyl cellulose (low substituted), hypromellose, lactose monohydrate, magnesium stearate, maize starch (corn starch), microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Losartan is used to treat high blood pressure (hypertension) in adults and children who are at least 6 … Losartan comes only as an oral tablet. Neonates with a history of in utero exposure to Losartan potassium: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. If oligohydramnios is observed, discontinue Losartan potassium, unless it is considered lifesaving for the mother. Bring this log with you to your doctor appointments. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. I'm currently on 12.5 mg atenenol and 25 mg losartan/cozaar. 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. The secondary endpoints of the study were change in proteinuria, change in the rate of progression of renal disease, and the composite of morbidity and mortality from cardiovascular causes (hospitalization for heart failure, myocardial infarction, revascularization, stroke, hospitalization for unstable angina, or cardiovascular death). In vitro binding studies indicate that Losartan is a reversible, competitive inhibitor of the AT1 receptor. Examples of diuretics include: Losartan can increase the levels of a substance called potassium in your blood. The primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an intention-to-treat (ITT) approach. When pregnancy is detected, discontinue Losartan potassium as soon as possible [see Use in Specific Populations (8.1)]. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. Following oral administration, plasma concentrations and AUCs of Losartan and its active metabolite are increased by 50 to 90% in patients with mild (creatinine clearance of 50 to 74 mL/min) or moderate (creatinine clearance 30 to 49 mL/min) renal insufficiency. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Always carry your medication with you. The volume of distribution of Losartan and the active metabolite is about 34 liters and 12 liters, respectively. Age 6 to 16 given 0.7 mg/kg once daily for 7 days. Consuming alcoholic drinks while taking losartan can cause a sedative effect. Do not use Losartan potassium tablets for a condition for which it was not prescribed. Fluconazole, an inhibitor of cytochrome P450 2C9, decreased the AUC of the active metabolite by approximately 40%, but increased the AUC of Losartan by approximately 70% following multiple doses. The studies allowed comparisons of two doses (50 to 100 mg/day) as once-daily or twice-daily regimens, comparisons of peak and trough effects, and comparisons of response by gender, age, and race. Shake the suspension prior to each use and return promptly to the refrigerator. There are no specific recommendations for senior dosage. This drug has a black box warning. Medically reviewed by Drugs.com. Children in the lowest dose group were given Losartan in a suspension formulation [see Dosage and Administration (2.1)]. What is the most important information I should know about Losartan potassium tablets? If you don’t take it on schedule: Your blood pressure may not improve or may get worse. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. The primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. Other ARBs include olmesartan, valsartan, and telmisartan. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. efficacy as monotherapy in … The maximum dose is 100 mg daily. Following oral administration in patients with mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of Losartan and its active metabolite were, respectively, 5-times and about 1.7-times those in young male volunteers. If you don’t take it at all: Losartan lowers high blood pressure. Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium tablets may cause the following side effects that may be serious: The most common side effects of Losartan potassium tablets in people with high blood pressure are: The most common side effects of Losartan potassium tablets in people with type 2 diabetes with diabetic kidney disease are: Tell your doctor if you get any side effect that bothers you or that won't go away. I know Marfans is a connective tissue disorder but i have questions about my arota. Following oral administration in patients with mild-to-moderate hepatic impairment, plasma concentrations of Losartan and its active metabolite were, respectively, 5 times and 1.7 times those seen in healthy volunteers. Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA. Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), and Clinical Studies (14)]. Losartan can cause a severe allergic reaction. The starting dose is 50 mg losartan/12.5 mg hydrochlorothiazide or 100 mg losartan/12.5 mg hydrochlorothiazide, taken once per day. This lowers your blood pressure. Your child’s doctor will increase or decrease the dosage depending on your child’s response to the medication. The typical dosage is 50 mg taken once daily. Overview; Side Effects; … Oral suspensions and solutions … cozaar. Does losartan cause rapid heart rate, irregular heartbeat or low blood pressure? For seniors: Older adults may process drugs more slowly. Following an intravenous dose of 14C-labeled Losartan, about 45% of radioactivity is recovered in the urine and 50% in the feces. It comes as an oral tablet. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood … Do not take Losartan potassium tablets if you are allergic to any of the ingredients in Losartan potassium tablets. For women who are breastfeeding: It isn’t known if losartan passes into breast milk. Losartan vs Valsartan - What's the difference between them? In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Medically reviewed by Drugs.com. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. MNT is the registered trade mark of Healthline Media. Studies show a risk of adverse effects to the fetus when the mother takes the drug. Protect from light. The dosage is based on your child’s weight. The systemic bioavailability of Losartan is approximately 33%. What are the possible side effects of Losartan potassium tablets? Losartan potassium tablets, USP 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan can cause mild or serious side effects. Common Blood Pressure Meds Won't Up Risks for COVID Patients: Study. In long-term follow-up studies (without placebo control) the effect of Losartan appeared to be maintained for up to a year. The following information describes dosages that are commonly used or recommended. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin II receptor antagonism that follows Losartan treatment. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Almost all of the patients (96.6%) had a history of hypertension, and the patients entered the trial with a mean serum creatinine of 1.9 mg/dL and mean proteinuria (urinary albumin/creatinine) of 1808 mg/g at baseline. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Learn which of these oils may help and how to use them…, It is common to have your blood pressure checked at the doctor's office, but there are many cases where it is important to monitor it at home. This means that losartan may not work as well to lower your blood pressure if you take it with these drugs. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. The maximally tolerated dosages (270 mg/kg/day in rats, 200 mg/kg/day in mice) provided systemic exposures for Losartan and its pharmacologically active metabolite that were approximately 160 and 90 times (rats) and 30 and 15 times (mice) the exposure of a 50 kg human given 100 mg per day. Losartan potassium tablets USP, 50 mg … Losartan contraindication Contraindicated in patients with severe kidney problem, during third trimester of pregnancy, and hypersensitivity. 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%). Each Losartan potassium tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg of Losartan potassium. For instance, some can interfere with how well a drug works, while others can cause increased side effects. Initial treatment: Hydrochlorothiazide 12.5 mg-Losartan 50 mg orally once a day; if blood pressure remains uncontrolled after 2 to 4 weeks, may initiate maximum dose. Taking losartan with lithium, a drug used to treat bipolar disorder, may increase the levels of lithium in your body. Three additional studies examined the antihypertensive effects of Losartan and hydrochlorothiazide in combination. 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. Dosage should be adjusted according to blood pressure response. Closely observe infants with histories of in utero exposure to Losartan potassium for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)]. 8 strengths of Losartan … Of the randomized patients, 4963 (54%) were female and 533 (6%) were Black. Of the patients still taking study medication, the mean doses of Losartan potassium and atenolol were both about 80 mg/day, and 15% were taking atenolol or Losartan as monotherapy, while 77% were also receiving hydrochlorothiazide (at a mean dose of 20 mg/day in each group). Symptoms of worsening kidney disease include: For pregnant women: Losartan is a category D pregnancy drug. These data suggest that the conversion of Losartan to its active metabolite is mediated primarily by P450 2C9 and not P450 3A4. In a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients (62%) were 65 years and over, while 808 patients (18%) were 75 years and over. Drug class: angiotensin receptor blockers, * Rate per 1000 patient-years of follow-up, † Adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy, ‡ Death due to heart failure, non-coronary vascular disease, pulmonary embolism, or a cardiovascular cause other than stroke or coronary heart disease. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Keep taking this drug unless your doctor tells you to stop. Hypertension. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. This action helps treat high blood pressure as well as the other two conditions losartan is usually prescribed for. This finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. The antihypertensive effects of Losartan potassium were demonstrated principally in 4 placebo-controlled, 6- to 12 week trials of dosages from 10 to 150 mg per day in patients with baseline diastolic blood pressures of 95 to 115. Dosages range between 25 and 100 mg per day. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. They will slowly taper your dosage so that you can stop using the drug safely. Doses of 50, 100 and 150 mg once daily gave statistically significant systolic/diastolic mean decreases in blood pressure, compared to placebo in the range of 5.5-10.5/3.5-7.5 mmHg, with the 150-mg dose giving no greater effect than 50 to 100 mg. Twice-daily dosing at 50 to 100 mg/day gave consistently larger trough responses than once-daily dosing at the same total dose. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., 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. The table shows the number of events for each component in two different ways. If you’re a senior, you may need a lower dosage, or a different dosing schedule. Figure 2: Kaplan-Meier estimates of the time to fatal/nonfatal stroke in the groups treated with Losartan potassium and atenolol. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. For people with kidney problems: This medication can make kidney disease worse. Do not coadminister aliskiren with Losartan potassium in patients with diabetes. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. After single doses of Losartan administered orally, about 4% of the dose is excreted unchanged in the urine and about 6% is excreted in urine as active metabolite. High blood pressure increases your risk of a stroke or heart attack. In patients with mild-to-moderate hepatic impairment the recommended starting dose of Losartan potassium is 25 mg once daily. This medicine is available only with your doctor's prescription. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. Keep container tightly closed. Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: NDC 68382-137-01 in bottle of 100 tablets, NDC 68382-137-10 in bottle of 1,000 tablets, NDC 68382-137-77 in cartons of 100 tablets (10 x 10 unit-dose). If it does, it may cause side effects in a child who is breastfed. Last medically reviewed on November 14, 2018, People sometimes call high blood pressure the silent killer because it often has no symptoms, but it can lead to life threatening complications. Active ingredients: Losartan potassium, USP. Neither Losartan nor its metabolite accumulates in plasma upon repeated once-daily dosing. Patients were randomized to receive once daily Losartan potassium 50 mg or atenolol 50 mg. Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)] is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. The RENAAL study was a randomized, placebo-controlled, double-blind, multicenter study conducted worldwide in 1513 patients with type 2 diabetes with nephropathy (defined as serum creatinine 1.3 to 3.0 mg/dL in females or males ≤60 kg and 1.5 to 3.0 mg/dL in males >60 kg and proteinuria [urinary albumin to creatinine ratio ≥300 mg/g]). Advise the patient to read the FDA-approved patient labeling (Patient Information). A meal slows absorption of Losartan and decreases its Cmax but has only minor effects on Losartan AUC or on the AUC of the metabolite (~10% decrease). The favorable effects of Losartan potassium were seen in patients also taking other anti-hypertensive medications (angiotensin II receptor antagonists and angiotensin converting enzyme inhibitors were not allowed), oral hypoglycemic agents and lipid-lowering agents. Older adults may process drugs more slowly. Losartan potassium has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. The safety and scientific validity of this study is the responsibility of the study sponsor and … When pregnancy is detected, discontinue Losartan potassium as soon as possible. Dosage Form: tablet, film coated. Coadministration of Losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Figure 4: Kaplan-Meier curve for the primary composite endpoint of doubling of serum creatinine, end stage renal disease (need for dialysis or transplantation) or death. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart's main pumping chamber). The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. For people who already have kidney problems, you may see a worsening in how well your kidneys work. Keep it in your carry-on bag. You may take losartan once or twice per day. The incidence of cough is shown in Table 1 below. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. It is also used for prevention of stroke, and diabetic nephropathy. Advise female patients of childbearing age about the consequences of exposure to Losartan potassium during pregnancy. About 14% of an orally-administered dose of Losartan is converted to the active metabolite. Generic drugs usually cost less than the brand-name version. Last updated on Aug 1, 2020. Advise patients receiving Losartan potassium not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)]. The relationship of these findings to drug-treatment is uncertain since there was no effect at these dosage levels on implants/pregnant female, percent post-implantation loss, or live animals/litter at parturition. The majority of the children had hypertension associated with renal and urogenital disease. In the subgroup of Black patients (n=533, 6% of the LIFE study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 26 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 42 per 1000 patient-years) on Losartan potassium. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. The usual dosage is around 0.7 mg/kg of body weight taken once per day. If necessary, other antihypertensive treatments (e.g., increase in dose of hydrochlorothiazide therapy to 25 mg or addition of other diuretic therapy, calcium-channel blockers, alpha-blockers, or centrally acting agents, but not ACE inhibitors, angiotensin II antagonists, or beta-blockers) were added to the treatment regimen to reach the goal blood pressure. Losartan potassium was effective in reducing blood pressure regardless of race, although the effect was somewhat less in Black patients (usually a low-renin population). If it’s just a few hours until the time for your next dose, wait and only take one dose at that time. Mean peak concentrations of Losartan and its active metabolite are reached in 1 hour and in 3 to 4 hours, respectively. Losartan dosage Your doctor will monitor your blood pressure at your checkups. Respiratory, thoracic and mediastinal disorders: Musculoskeletal and connective tissue disorders: Reproductive system and breast disorders: General disorders and administration site conditions: General Disorders and Administration Site Conditions: Losartan potassium tablets can cause harm or death to an unborn baby. Your risk may be higher if: NSAIDs may also reduce the blood pressure-lowering effects of losartan. Losartan Potassium (loe-SAR-tan poe-TASS-ee-um) Tablets, USP. In some cases, they may not be available in every strength or form as the brand-name drug. Neither Losartan nor its principal active metabolite exhibits any partial agonist activity at the AT1 receptor, and both have much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. The primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an ITT approach. Adult Dosing . Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity. Avoid use of aliskiren with Losartan potassium in patients with renal impairment (GFR <60 mL/min). Losartan … tablet. Using losartan with NSAIDs raises your risk of kidney damage.
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