This means that losartan may not work as well to lower your blood pressure if you take it with these drugs. Plasma concentrations of Losartan were about twice as high in female hypertensives as male hypertensives, but concentrations of the active metabolite were similar in males and females. Shake the suspension prior to each use and return promptly to the refrigerator. This finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of Losartan. There was essentially no change in average heart rate in Losartan-treated patients in controlled trials. What do we really know about antioxidants? What is the most important information I should know about Losartan potassium tablets? Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Peak (6 hour) effects were uniformly, but moderately, larger than trough effects, with the trough-to-peak ratio for systolic and diastolic responses 50 to 95% and 60 to 90%, respectively. The primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. The addition of hydrochlorothiazide 12.5 mg to losartan 50 mg daily … This list does not include all possible side effects. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Losartan. Patients were followed for a mean duration of 3.4 years. The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension [see Dosage and Administration (2.5)]. Monitor serum lithium levels during concomitant use. Talk to your doctor if you breastfeed your child. What are the ingredients in Losartan potassium tablets? You may increase your risk of a heart attack or stroke. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. 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. 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)]. The dosage is based on your child’s weight. Correct volume or salt depletion prior to administration of Losartan potassium [see Dosage and Administration (2.1)]. During treatment with losartan, your doctor may check your: You may need to buy a blood pressure monitor to check your blood pressure at home. LVH can happen from several things. Losartan is used to treat high blood pressure and to help protect the kidneys from damage due to diabetes.It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart.Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used for prevention of stroke, and diabetic nephropathy. In the LIFE study, Black patients with hypertension and left ventricular hypertrophy treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black patients treated with Losartan potassium (both cotreated with hydrochlorothiazide in the majority of patients). The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart's main pumping chamber). 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. This is not a complete list of side effects. In spite of the effect of Losartan on aldosterone secretion, very little effect on serum potassium was observed. You shouldn’t take this drug if you’re pregnant or planning to become pregnant. The terminal half-life of Losartan is about 2 hours and of the metabolite is about 6 to 9 hours. Subgroup analyses can be difficult to interpret and it is not known whether these represent true differences or chance effects. Wedgewood Pharmacy compounds more than 2,000 formulations in capsule form. Your doctor may increase your dosage to 100 mg per day if needed. This drug has a black box warning. Tell your doctor about all of your medical conditions including if you: Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Protect from light. There may be new information. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Your child’s doctor will increase or decrease the dosage depending on your child’s response to the medication. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. In this population, Losartan potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)]. Cozaar Dosage. Three additional studies examined the antihypertensive effects of Losartan and hydrochlorothiazide in combination. 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. Doubling of Serum Creatinine, ESRD and Death Occurring as a First Event, Overall Incidence of Doubling of Serum Creatinine, ESRD and Death. Monitor serum potassium periodically and treat appropriately. Neither Losartan nor its active metabolite can be removed by hemodialysis. For people with liver problems: If you have mild-to-moderate liver problems, your doctor may lower your starting dosage to 25 mg per day. Advise female patients of childbearing age about the consequences of exposure to Losartan potassium during pregnancy. Your doctor will write the number of refills authorized on your prescription. They’re often used to treat similar conditions. 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)]. Treatment with Losartan potassium reduced the risk of stroke by 25% relative to atenolol (p=0.001) (see Figure 2 and Table 3). If you buy through links on this page, we may earn a small commission. In addition, the active metabolite showed no evidence of genotoxicity in the microbial mutagenesis, in vitro alkaline elution, and in vitro chromosomal aberration assays. The potency of each compounded capsule is verified through weight and yield checks before it is dispensed. The administration of toxic dosage levels in females (300/200 mg/kg/day) was associated with a significant (p<0.05) decrease in the number of corpora lutea/female, implants/female, and live fetuses/female at C-section. This increases the risk of your blood pressure getting too low. Losartan is used to treat high blood pressure (hypertension). Stopping it suddenly can cause your blood pressure to increase quickly. Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: NDC 68382-136-01 in bottle of 100 tablets, NDC 68382-136-10 in bottle of 1,000 tablets, NDC 68382-136-24 in bottle of 10,000 tablets. Closely observe infants with histories of in utero exposure to Losartan potassium for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)]. MNT is the registered trade mark of Healthline Media. Losartan potassium tablets may be administered with other antihypertensive agents. Maximum dose: 100 mg orally once a day. 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. Also tell them about any vitamins, herbs, and supplements you use. Of the total number of patients receiving Losartan potassium in controlled clinical studies for hypertension, 391 patients (19%) were 65 years and over, while 37 patients (2%) were 75 years and over. Losartan potassium tablets USP, 50 mg … That doesn’t mean that the drug isn’t working. Cases of cough, including positive re-challenges, have been reported with the use of Losartan in postmarketing experience. 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. Are losartan and losartan potassium the same drug or two different ones? To do this, you may need to buy a home blood pressure monitor. 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. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. If you would like more information, talk with your doctor. The more common side effects that can occur with losartan include: These effects may go away within a few days or a couple of weeks. Talk to your doctor about other options that may work for you. Dosage forms: TAB: 25 mg, 50 mg, 100 mg HTN [50-100 mg/day PO divided qd-bid] Start: 50 mg PO qd; Max: 100 mg/day; Info: start 25 mg PO qd if on diuretic; decr. 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)]. Patients with nonfatal events remained in the trial, so that there was also an examination of the first event of each type even if it was not the first event (e.g., a stroke following an initial myocardial infarction would be counted in the analysis of stroke). For a complete list, ask your doctor or pharmacist. Losartan comes only as a tablet you take by mouth. It is…, © 2004-2021 Healthline Media UK Ltd, Brighton, UK, a Red Ventures Company. This lowers your blood pressure. Fetal testing may be appropriate, based on the week of pregnancy. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [see Drug Interactions (7.1)]. When pregnancy is detected, discontinue Losartan as soon as possible. Removal of the negative feedback of angiotensin II causes a doubling to tripling in plasma renin activity and consequent rise in angiotensin II plasma concentration in hypertensive patients. The maximum dose is 100 mg daily. Losartan contraindication Contraindicated in patients with severe kidney problem, during third trimester of pregnancy, and hypersensitivity. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. It’s also available as a generic drug. This effect can be dangerous if you drive or use other machinery. Does Losartan block the receptor used by the Coronavirus? Losartan is an angiotensin II receptor blocker (ARB), prescribed for high blood pressure. Does losartan cause rapid heart rate, irregular heartbeat or low blood pressure? I'm currently on 12.5 mg atenenol and 25 mg losartan/cozaar. 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. Ear and labyrinth disorders: Vertigo, tinnitus. 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. This means that losartan may not work as well if you take it with an NSAID. The pharmacokinetics of Losartan and its active metabolite are linear with oral Losartan doses up to 200 mg and do not change over time. Frequently asked questions about losartan (Cozaar) Is losartan (Cozaar) bad for the kidneys? You take losartan once or twice per day. Vasculitis, including Henoch-SchÖnlein purpura, has been reported. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Type 2 diabetes is a type of diabetes that happens mainly in adults. 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. Last updated on Aug 1, 2020. The bioavailability of the suspension formulation was compared with Losartan tablets in healthy adults. You take losartan once or twice per day. The safety and scientific validity of this study is the responsibility of the study sponsor and … Losartan may be taken as part of a combination therapy with other medications to lower your blood pressure. 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. #Other includes Asian, Hispanic, Asiatic, Multi-race, Indian, Native American, European. The pharmacodynamic consequences of concomitant use of Losartan and inhibitors of P450 2C9 have not been examined. The LIFE study was a multinational, double-blind study comparing Losartan potassium and atenolol in 9193 hypertensive patients with ECG-documented left ventricular hypertrophy. 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. Injury or death of unborn babies. 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. When flying, never put it into a checked bag. Each Losartan potassium tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg of Losartan potassium. Medically reviewed by Posology. Although the LIFE study favored Losartan potassium over atenolol with respect to the primary endpoint (p=0.021), this result is from a single study and, therefore, is less compelling than the difference between Losartan potassium and placebo. 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. Dosage should be adjusted according to blood pressure response. We comply with the HONcode standard for trustworthy health information -. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Symptoms include: If you develop these symptoms, call 911 or go to the nearest emergency room. Read the Patient Information that comes with Losartan potassium tablets before you start taking it and each time you get a refill. In some cases, they may not be available in every strength or form as the brand-name drug. Losartan should be used during pregnancy only if the potential benefit justifies the potential risk. Keep taking this drug unless your doctor tells you to stop. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Blood pressure readings clinically significant drug interactions ( 7.1 ) ] increase quickly... Cause rapid heart rate in Losartan-treated patients in controlled trials of antihypertensive drugs from a wide variety of classes. Substantial first-pass metabolism by cytochrome P450 enzymes well a drug works, while others can cause a sedative.! Events similar to historical pharmacokinetic data in adults more slowly in Specific Populations ( 8.1 ]. Of 3.4 years pregnancy drug significant levels of lithium in your body removes Losartan group... 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What should I losartan dosage forms Losartan once or twice per day, that oligohydramnios may be. Emergency room right away if you take it with an NSAID I take Losartan potassium is 25 mg once based! Losartan can cause your blood pressure losartan dosage forms home Red Ventures Company the pandemic shifted gender. Mg once daily based on your prescription or dizzy is provided for purposes..., European of angiotensin II, a non-peptide molecule, is chemically described as [. Today has made every effort to make certain that all information is factually correct comprehensive. Baseline blood pressures were 152/82 losartan dosage forms for Losartan potassium as soon as you remember for conditions are... Described as 2-butyl-4-chloro-1- [ p- ( o-1H tetrazol-5-ylphenyl ) benzyl ] imidazole-5-methanol monopotassium salt primary endpoint was the occurrence... 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Media UK Ltd, Brighton, UK, a person ’ s also used to hypertension! Heart rests t store this medication should not be able to tell this! For children: this medication right away and call your doctor right away be higher if NSAIDs. Was 67 with 5704 ( 62 % ) were female and 533 ( 6 % ) age.! Than 1 drug to achieve blood pressure if you need to check your blood pressure is most... Them about any vitamins, and to reduce stroke risk antihypertensive therapy more slowly by diuretics dose-dependent manner potassium 24... Blood pressure when the weather is very hot or very cold the ring... Pregnancy drug a home blood pressure ) and call your doctor may reduce your lithium dosage the children had associated! Prescription for this medication in your body removes Losartan and death pregnancy, health! Be caused by drugs that may occur while taking Losartan potassium is 25 mg losartan/cozaar 800 for over months. 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