Losartan potassium has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. 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 systemic bioavailability of losartan is approximately 33%. Losartan is metabolized to an aldehyde intermediate, E-3179, which is further metabolized to a carboxylic acid, E-3174, by cytochrome P450s like CYP2C9. Discontinuations of losartan potassium because of side effects were similar to placebo (19% for losartan potassium, 24% for placebo). These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. (, Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. Aurobindo Pharma Limited Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA. (current), Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Aldosterone plasma concentrations fall following losartan administration. There were no significant differences in the rates of these endpoints between the losartan potassium and atenolol groups. 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. 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 mean length of follow-up was 4.8 years. The lowest dose, corresponding to an average daily dose of 0.07 mg/kg, did not appear to offer consistent antihypertensive efficacy. 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. It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. 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. Plasma protein binding is constant over the concentration range achieved with recommended doses. Losartan Potassium Available types of drugs 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. The study population was diverse with regard to race (Asian 16.7%, Black 15.2%, Hispanic 18.3%, White 48.6%). Blood pressure reduction measured at trough was similar for both treatment groups but blood pressure was not measured at any other time of the day. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see Clinical Studies (14.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Antihypertensive effects of losartan potassium have been established in hypertensive pediatric patients aged 6 to 16 years. 25 mg 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. View all Active Pharmaceutical Ingredients (API) with APIs manufactured or supplied by Aurobindo Pharma Limited on PharmaCompass.com. This includes the Pillbox drug identification and search websites as well as production of the Pillbox dataset, image library, and application programming interfaces (APIs). 65862-201-30, The majority of the children had hypertension associated with renal and urogenital disease. Some … Manufacturers and exporters of bulk drugs, formulations, and oral suspensions. Hydrochlorothiazide/losartan is used in the treatment of high blood pressure and belongs to the drug class angiotensin II inhibitors with thiazides. Reproductive system and breast disorders: Impotence. Losartan is also not recommended in children with hepatic impairment (see also section 4.4). We regard ourselves as a service provider and focus on the customer`s interests. Race: Pharmacokinetic differences due to race have not been studied [see Use in Specific Populations (8.6)]. In general, avoid combined use of RAS inhibitors. The usual starting dose is 50 mg of losartan potassium tablets once daily. 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. 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]). In long-term follow-up studies (without placebo control) the effect of losartan appeared to be maintained for up to a year. The primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. 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. In controlled clinical trials, discontinuation of therapy for adverse events occurred in 2.3% of patients treated with losartan potassium and 3.7% of patients given placebo. alone or with other blood pressure medicines to lower high blood pressure (hypertension). 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 to 10.5/3.5 to 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. The antihypertensive effect of losartan was studied in one trial enrolling 177 hypertensive pediatric patients aged 6 to 16 years old. Aurobindo LTD (India) Investors; Contact Us; 866.850.2876; Font Size Header Navigation. Otto Brandes Gmbh was founded in 1923 and is an independent distributor of high quality Pharmaceutical Active Ingredients and excipients for the pharmaceutical industry. The 4 studies of losartan monotherapy included a total of 1075 patients randomized to several doses of losartan and 334 to placebo. 10 aluminum lake. No dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted [see Dosage and Administration (2.3), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. 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. 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. View Labeling Archives, High Blood Pressure (hypertension). For a complete list, ask your doctor or pharmacist. Pediatric: Pharmacokinetic parameters after multiple doses of losartan (average dose 0.7 mg/kg, range 0.36 to 0.97 mg/kg) as a tablet to 25 hypertensive patients aged 6 to 16 years are shown in Table 4 below. (, Monitor renal function and potassium in susceptible patients. For coadministration with aliskiren in patients with diabetes. Patients were randomized to receive once daily losartan potassium 50 mg or atenolol 50 mg. If you take too much losartan potassium, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. PubMed, 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. (, Agents increasing serum potassium: Risk of hyperkalemia. Studies in rats indicate that losartan crosses the blood-brain barrier poorly, if at all. 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. This is not a complete list of side effects. Back to top. Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. 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. 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 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)]. Losartan was ordered but what I received, according to the pill identifier, was losartan potassium. Nervous system disorders: Dysgeusia. It is used: Losartan potassium tablets have not been studied in children less than 6 years old or in children with certain kidney problems. Patients with myocardial infarction or stroke within six months prior to randomization were excluded. (, Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. Conversion of losartan to its active metabolite after intravenous administration is not affected by ketoconazole, an inhibitor of P450 3A4. At 100 mg/kg/day only a decrease in the number of corpora lutea/female was observed. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Bottles of 30                    NDC 65862-202-30Bottles of 90                    NDC 65862-202-90Bottles of 1,000               NDC 65862-202-99 Do not use losartan potassium tablets for a condition for which it was not prescribed. Plasma concentrations of losartan and its active metabolite are similar in elderly and young hypertensives. Anaphylactic reactions have been reported. Losartan Potassium Tablets USP, 50 mg are green colored, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘4’ and ‘6’ separated by scoreline on other side. Losartan potassium tablets are indicated for the treatment of 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. 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. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT1 receptor. 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). Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Compared to normal subjects the total plasma clearance of losartan in patients with hepatic insufficiency was about 50% lower and the oral bioavailability was about doubled. 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. General disorders and administration site conditions: Edema. FDA Safety Recalls, 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. Presence in Breast Milk, Medline Plus, (2.2), •  Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium tablets to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. 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. AUROBINDO                      30 Tablets, All Drug https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=31366b4b-dfd6-4fda-babe-2cb3d2c14a2b, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. When pregnancy is detected, discontinue losartan potassium as soon as possible. Distributed by: 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. “What is the most important information I should know about losartan potassium tablets?”. Active ingredient: losartan potassium. In the Losartan Intervention for Endpoint (LIFE) study, adverse reactions with losartan potassium were similar to those reported previously for patients with hypertension. Losartan Potassium Tablets USP Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: •  Usual adult dose: 50 mg once daily. Inactive Ingredients microcrystalline cellulose, lactose monohydrate, corn starch, low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 2910 (6 mPa.s), titanium dioxide, FD&C Blue No. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP,  titanium dioxide, FD&C blue #2/indigo carmine aluminum lake, D&C yellow #10 aluminum lake, and purified water. Some ingredients are more obvious than others. 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. This leaflet does not take the place of talking with your doctor about your condition and treatment. Overall, 63.2% of the patients were men, and 66.4% were under the age of 65 years. 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). These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. Aurobindo LTD (India) Investors; Contact Us; 866.850.2876; Primary Navigation. Neither losartan nor its active metabolite can be removed by hemodialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.7)]. Figure 2: Kaplan-Meier estimates of the time to fatal/nonfatal stroke in the groups treated with losartan potassium and atenolol. Significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk. 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. Monitor serum potassium in such patients. (, Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. 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. Advise female patients of childbearing age about the consequences of exposure to losartan potassium during pregnancy. Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected above the ... in the losartan active pharmaceutical ingredient (API) manufactured by … 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 recommended starting dose of losartan potassium is 25 mg in patients with mild-to-moderate hepatic impairment. 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). 65862-203-90, Table 3 shows the results for the primary composite endpoint and the individual endpoints. 65862-203-30, When patients were randomized to continue losartan at the two higher doses or to placebo after 3 weeks of therapy, trough diastolic blood pressure rose in patients on placebo between 5 and 7 mmHg more than patients randomized to continuing losartan. Geriatric and Gender: Losartan pharmacokinetics have been investigated in the elderly (65 to 75 years) and in both genders. Type 2 Diabetes with Nephropathy. Generic Salts. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. Limited data are available in regard to overdosage in humans. 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. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively. Font Size Header Navigation. Losartan potassium was not carcinogenic when administered at maximally tolerated dosages to rats and mice for 105 and 92 weeks, respectively. The primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an ITT approach. Treatment with losartan potassium was well-tolerated with an overall incidence of adverse events similar to that of placebo. Revised: 03/2019, NDC 65862-201-90 Rx only 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. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart’s main pumping chamber). Aurobindo Pharma USA – Generic Pharmaceuticals. 65862-201-90, These considerations may guide selection of therapy. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. The 10 and 25 mg doses produced some effect at peak (6 hours after dosing) but small and inconsistent trough (24 hour) responses. These findings are attributed to drug exposure in late gestation and during lactation. Take losartan potassium tablets exactly as prescribed by your doctor. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Renal Insufficiency: 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. Site provides product details, company profile and information to the six manufacturing facilities in India. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.

Woodlands Plantation Columbia Sc, Mtg Arena Infinite Combos, Chief Joseph Speech To Congress 1879, Manix 2 Lightweight, Jamal Daniel Syria, Gran Hotel Season 3 Episode 20, Elite Four Platinum, 1 Bedroom Apartments In Louisville, Ky With All Utilities Included, Liebe Black Clover,