In addition, the active metabolite showed no evidence of genotoxicity in the microbial mutagenesis, in vitro alkaline elution, and in vitro chromosomal aberration assays. A class of drugs is a group of medications that work in a similar way. 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. It is also used to treat kidney problems in patients with type 2 diabetes and a history of hypertension. Patients receiving the combination of Losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. Symptoms include: If you develop these symptoms, call 911 or go to the nearest emergency room. 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. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of Losartan. Each Losartan potassium tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg of Losartan potassium. The systemic bioavailability of Losartan is approximately 33%. Cozaar (losartan potassium, also known as losartan), is a commonly used oral medication for treating high blood pressure (hypertension) and complications of other diseases affected by high … Anaphylactic reactions have been reported. Your doctor may … Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3), Clinical Studies (14.1), and Warnings and Precautions (5.2)]. The primary endpoint of the study was the time to first occurrence of any one of the following events: doubling of serum creatinine, end-stage renal disease (ESRD) (need for dialysis or transplantation), or death. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Losartan potassium should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response [see Clinical Studies (14.2)]. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If this happens, lie down and call your doctor right away. You should always consult your doctor or healthcare professional before taking any medication. Some may be better suited for you than others. Other ARBs include olmesartan, valsartan, and telmisartan. Discontinuations of Losartan potassium because of side effects were similar to placebo (19% for Losartan potassium, 24% for placebo). While blood pressure was reduced in all racial subgroups examined, too few non-White patients were enrolled to compare the dose-response of Losartan in the non-White subgroup. Consuming alcoholic drinks while taking losartan can cause a sedative effect. The mean baseline blood pressures were 152/82 mmHg for Losartan potassium plus conventional antihypertensive therapy and 153/82 mmHg for placebo plus conventional antihypertensive therapy. In this study, renal clearance was reduced by 55 to 85% for both Losartan and its active metabolite in patients with mild or moderate renal insufficiency. Losartan potassium has not been studied in patients with severe hepatic impairment [see Use in Special Populations (8.8) and Clinical Pharmacology (12.3)]. AUC values for losartan, its active metabolite and hydrochlorothiazide, extrapolated from data obtained with losartan administered to rats at a dose of 50 mg/kg/day in combination with 12.5 mg/kg/day of hydrochlorothiazide, were approximately 6, 2, and 2 times greater than those achieved in humans with 100 mg of losartan … The usual starting dose of losartan potassium tablets USP are 50 mg once daily. The starting dose is 50 mg losartan/12.5 mg hydrochlorothiazide or 100 mg losartan/12.5 mg hydrochlorothiazide, taken once per day. 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. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see … Dosage Forms and Strengths Losartan potassium tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side. 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). In the Losartan Intervention for Endpoint (LIFE) study, adverse reactions with Losartan potassium were similar to those reported previously for patients with hypertension. Treatment with Losartan potassium reduced the risk of stroke by 25% relative to atenolol (p=0.001) (see Figure 2 and Table 3). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. See "What is the most important information I should know about Losartan potassium tablets?". Losartan helps relax and widen your blood vessels. The following additional adverse reactions have been reported in postmarketing experience with Losartan potassium. Dosage Form: tablet, film coated. In general, avoid combined use of RAS inhibitors. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Losartan may be taken as part of a combination therapy with other medications to lower your blood pressure. reduce your risk of a stroke if you have high blood pressure and left ventricular hypertrophy (LVH), a condition that causes the walls in the heart’s left ventricle to thicken, treat diabetic nephropathy, which is kidney disease caused by diabetes, upper respiratory infections, such as the common cold. The following list contains some of the key side effects that may occur while taking losartan. Overall, 72% of patients received the 100-mg daily dose more than 50% of the time they were on study drug. It is freely soluble in water; soluble in isopropyl alcohol; slightly soluble in acetonitrile. The principal pharmacokinetic parameters in adults and children are shown in the table below. 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. Although not measured directly, the difference between Losartan potassium and placebo is compelling because there is evidence that atenolol is itself effective (vs. placebo) in reducing cardiovascular events, including stroke, in hypertensive patients. Losartan potassium has been shown to produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity. Patients were randomized to receive once daily Losartan potassium 50 mg or atenolol 50 mg. 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. Wedgewood Pharmacy’s oral suspensions and solutions are a familiar and convenient dosage form. 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. Protect from light. A dose of 100 mg inhibits the pressor effect by about 85% at peak with 25 to 40% inhibition persisting for 24 hours. There may be new information. How do I store Losartan potassium tablets? At the end of the study, the mean blood pressures were 143/76 mmHg for the group treated with Losartan potassium and 146/77 mmHg for the group treated with placebo. 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. All rights reserved. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Losartan is a prescription drug used to treat hypertension (high blood pressure). Cases of cough, including positive re-challenges, have been reported with the use of Losartan in postmarketing experience. Monitor renal function periodically in patients receiving Losartan and NSAID therapy. Losartan can cause a severe allergic reaction. The pharmacodynamic consequences of concomitant use of Losartan and inhibitors of P450 2C9 have not been examined. Common Questions and Answers about Losartan dosage forms. Use a starting dose of 25 mg for patients with mild to moderate hepatic impairment. Overall, the two higher doses (25 to 50 mg in patients <50 kg; 50 to 100 mg in patients ≥50 kg) reduced diastolic blood pressure by 5 to 6 mmHg more than the lowest dose used (2.5 mg in patients <50 kg; 5 mg in patients ≥50 kg). Limited data are available in regard to overdosage in humans. If you don’t take it at all: Losartan lowers high blood pressure. Generic drugs usually cost less than the brand-name version. 50mg/12.5mg; 100mg/12.5mg; 100mg/25mg Injury or death of unborn babies. For women who are breastfeeding: It isn’t known if losartan passes into breast milk. What to do if you miss a dose: If you forget to take your dose, take it as soon as you remember. The Components of Primary Endpoint (as a first event) counts only the events that define the primary endpoint, while the Secondary Endpoints count all first events of a particular type, whether or not they were preceded by a different type of event. 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. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Baseline mean blood pressure was 174/98 mmHg in both treatment groups. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Studies in rats indicate that Losartan crosses the blood-brain barrier poorly, if at all. For the primary endpoint and stroke, the effects of Losartan potassium in patient subgroups defined by age, gender, race and presence or absence of isolated systolic hypertension (ISH), diabetes, and history of cardiovascular disease (CVD) are shown in Figure 3 below. The pharmacokinetics of Losartan and its active metabolite are linear with oral Losartan doses up to 200 mg and do not change over time. 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 antihypertensive effect of angiotensin II receptor antagonists, including Losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. You may need to check your blood pressure at home. When the low dose of Losartan was randomly withdrawn, the rise in trough diastolic blood pressure was the same in patients receiving placebo and in those continuing Losartan, again suggesting that the lowest dose did not have significant antihypertensive efficacy. Low blood pressure. The starting dose of losartan for pediatric patients 6 years of age or … You may increase your risk of a heart attack or stroke. Losartan oral tablet is available as a brand-name drug and a generic drug. These monitors are available at most pharmacies. 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. Keep these considerations in mind if your doctor prescribes losartan for you. LVH can happen from several things. Find…, A person’s blood pressure is one indication of their overall heart health. Losartan is used for three main purposes. If you don’t take it, your blood pressure will stay high. The addition of hydrochlorothiazide 12.5 mg to losartan 50 mg daily … This list does not contain all drugs that may interact with losartan. Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P450 enzymes. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of losartan potassium and hydrochlorothiazide tablet 50/12.5 once daily or one tablet of losartan … Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. If symptomatic hypotension should occur, supportive treatment should be instituted. Many patients will require more than 1 drug to achieve blood pressure goals. Who should not take Losartan potassium tablets? The effect of Losartan is substantially present within one week but in some studies the maximal effect occurred in 3 to 6 weeks. Don’t take this drug again if you’ve ever had an allergic reaction to it. The usual dosage is around 0.7 mg/kg of body weight taken once per day. In patients with mild-to-moderate hepatic impairment the recommended starting dose of Losartan potassium is 25 mg once daily. 3 DOSAGE FORMS AND STRENGTHS • COZAAR, 25 mg, are white, oval, film-coated tablets with code 951 on one side. In nonpregnant rats dosed at 135 mg/kg/day for 7 days, systemic exposure (AUCs) for Losartan and its active metabolite were approximately 66 and 26 times the exposure achieved in man at the maximum recommended human daily dosage (100 mg). What should I tell my doctor before taking Losartan potassium tablets? Losartan Potassium (loe-SAR-tan poe-TASS-ee-um) Tablets, USP. Debra Rose Wilson, Ph.D., MSN, R.N., IBCLC, AHN-BC, CHT. If they’re more severe or don’t go away, talk to your doctor or pharmacist. The volume of distribution of Losartan and the active metabolite is about 34 liters and 12 liters, respectively. This means that losartan may not work as well to lower your blood pressure if you take it with these drugs. Taking losartan with lithium, a drug used to treat bipolar disorder, may increase the levels of lithium in your body. Treatment with Losartan potassium was well-tolerated with an overall incidence of adverse events similar to that of placebo. #Other includes Asian, Hispanic, Asiatic, Multi-race, Indian, Native American, European. 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). Never try to catch up by taking two doses at once. As a result, a normal adult dosage may cause levels of this drug to be higher than normal in your body. Avoid use of aliskiren with Losartan potassium in patients with renal impairment (GFR <60 mL/min). If you need to take these drugs together, your doctor may reduce your lithium dosage. In some cases, they may not be available in every strength or form as the brand-name drug. Aldosterone plasma concentrations fall following Losartan administration. In addition to the active carboxylic acid metabolite, several inactive metabolites are formed. 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)]. It’s also available as a generic drug. Treatment with Losartan potassium also reduced the occurrence of sustained doubling of serum creatinine by 25% and ESRD by 29% as separate endpoints, but had no effect on overall mortality (see Table 4). The sitting diastolic blood pressure (SiDBP) on entry into the study was higher than the 95th percentile level for the patient's age, gender, and height. Losartan is used for long-term treatment. Initial dose: 50 mg orally once a day. There is no apparent rebound effect after abrupt withdrawal of Losartan. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). The dosage form available for Losartan Potassium is Capsule. 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. Are losartan and losartan potassium the same drug or two different ones? The dosage is based on your child’s weight. I'm currently on 12.5 mg atenenol and 25 mg losartan/cozaar. Total plasma clearance of Losartan and the active metabolite is about 600 mL/min and 50 mL/min, respectively, with renal clearance of about 75 mL/min and 25 mL/min, respectively. Tell your doctor if you’re pregnant or plan to become pregnant. At the end of study or at the last visit before a primary endpoint, the mean blood pressures were 144.1/81.3 mmHg for the group treated with Losartan potassium and 145.4/80.9 mmHg for the group treated with atenolol; the difference in systolic blood pressure (SBP) of 1.3 mmHg was significant (p<0.001), while the difference of 0.4 mmHg in diastolic blood pressure (DBP) was not significant (p=0.098). Losartan potassium tablets are a prescription medicine called an angiotensin receptor blocker (ARB). 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