RxNorm, Other clinical endpoints of the LIFE study were: total mortality, hospitalization for heart failure or angina pectoris, coronary or peripheral revascularization procedures, and resuscitated cardiac arrest. Overall, 63.2% of the patients were men, and 66.4% were under the age of 65 years. You can find general information regarding this recall, including impacted lot numbers, on the FDA website: Express Scripts will mail letters to patients who have received medication impacted by the recall. These CBD candies offer a simple and flexible . It is a resource to help you make the best decisions and get the most from the medical services available to you. Learn how to monitor your own blood pressure, and share the results with your doctor. Musculoskeletal: Rhabdomyolysis. Compared with placebo, losartan potassium significantly reduced proteinuria by an average of 34%, an effect that was evident within 3 months of starting therapy, and significantly reduced the rate of decline in glomerular filtration rate during the study by 13%, as measured by the reciprocal of the serum creatinine concentration. Download HDA Sheet. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax. 31722-701-90, Monitor renal function periodically in patients receiving losartan and NSAID therapy. Reproductive system and breast disorders: Impotence. CAPTCHA: What letter comes after Q? If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. 2023 Kaiser Foundation Health Plan, Inc. We are unable to switch you to this area of care. 31722-700-05, The information on this site is not intended to take the place of your doctor or other healthcare professionals. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Note: product and packaging images are not actual size, 1031 Centennial Avenue Revised: 10/2018, Losartan Potassium Tables USP 25 mg 90s count, Losartan Potassium Tables USP 50 mg 30s count, Losartan Potassium Tables USP100 mg 30s count, Boxed Warnings, The health information contained here in is provided for educational purposes only and is not intended to replace discussions with a health care provider. Give us a call or drop by anytime, we endeavour to answer all enquiries within 24 hours on business days. Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine. 1 Express Way, St. Louis, MO 63121, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-losartan-potassium-tablets-usp-25-mg, https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home, https://www.fda.gov/MedWatch/getforms.htm. If you have diabetic nephropathy it means that your kidneys do not work properly because of damage from the diabetes. Subjects who do not metabolize losartan to active metabolite have been shown to have a specific, rare defect in cytochrome P450 2C9. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Losartan Potassium Tablets, USP (loe sar' tan poe tas' ee um) It belongs to a group of drugs. Losartanpotassium tablets can cause harm or death to an unborn baby. What will it do for me? LVH can happen from several things. 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: Pregnancy Advise female patients of childbearing age about the consequences of exposure to losartan potassium during pregnancy. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. ), More about getting RSS News & Updates from DailyMed, Components of Primary Composite Endpoint (as a first event), Doubling of Serum Creatinine, ESRD and Death Occurring as a First Event, Overall Incidence of Doubling of Serum Creatinine, ESRD and Death, 30 in 1 BOTTLE; Type 0: Not a Combination Product, 60 in 1 BOTTLE; Type 0: Not a Combination Product, 90 in 1 BOTTLE; Type 0: Not a Combination Product, 500 in 1 BOTTLE; Type 0: Not a Combination Product, 1000 in 1 BOTTLE; Type 0: Not a Combination Product, ANALYSIS(31722-700, 31722-701, 31722-702) , MANUFACTURE(31722-700, 31722-701, 31722-702), 4 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)]. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. ", For people who already have kidney problems, you may see a worsening in how well your kidneys work. 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. This finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. March 20, 2019. Symptoms of overdose may include: severe dizziness, fainting. When pregnancy is detected, discontinue losartan as soon as possible. Agents increasing serum potassium: Risk of hyperkalemia. 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. Teratogenic Effects Pregnancy Category D See 17 for PATIENT COUNSELING INFORMATION. Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at. Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Skin: Erythroderma. Treatment with losartan potassium was well-tolerated with an overall incidence of adverse events similar to that of placebo. Tell your doctor if you are pregnant or plan to become pregnant. Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy. Perform serial ultrasound examinations to assess the intra-amniotic environment. Avoid use of aliskiren with losartan potassium in patients with renal impairment (GFR <60 mL/min). In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium tablets. Store tablets at room temperature away from light and moisture. We comply with the HONcode standard for trustworthy health information. Losartan is used to treat high blood pressure (hypertension). Conversion of losartan to its active metabolite after intravenous administration is not affected by ketoconazole, an inhibitor of P450 3A4. The product code (s) for this leaflet is: PL 14017/0143. are pregnant or planning to become pregnant. Pharmacokinetics of losartan and its active metabolite were generally similar across the studied age groups and similar to historical pharmacokinetic data in adults. Cost Ask your doctor Q&A What is losartan? Add 190 mL of the 50/50 Ora-PlusTM/Ora-Sweet SFTM mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. Meridia was recalled from the U.S. market in 2010 after it was found to increase a person's risk of heart attack and stroke. Who should not take losartan potassium tablets? 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. If you have any questions, ask your doctor or pharmacist. (2.2, 14.2) Nephropathy in Type 2 Diabetic Patients Usual dose: 50 mg once daily. Your medication may look different. Do not take losartan potassium tablets if you are allergic to any of the ingredients in losartan potassium tablets. 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. Keep losartan potassium tablets and all medicines out of the reach of children. Losartan Potassium Tablets USP 25 mg WARNING: Keep this and all medications out of the reach of children. * 50 mg and 100 mg are available in 90 and1000 count bottles. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient?s health may be higher if the treatment is stopped immediately without any alternative treatment. Learn more about link terms and conditions. Camber Pharmaceutical: Country of Origin: India: Alternate Manufacturer Number: 3518990: . Of the randomized patients, 4963 (54%) were female and 533 (6%) were Black. (5.2) Monitor renal function and potassium in susceptible patients. Table 4: Incidence of Primary Endpoint Events, 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). This site and the product information provided on this site are intended for residents of the United States. Especially tell your doctor if you are taking: potassium supplements salt substitutes containing potassium water pills (diuretics) lithium (a medicine used to treat a certain kind of depression) medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors other medicines to reduce blood pressure The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see Clinical Studies ()]. Lab and/or medical tests (such as kidney function, potassium levels) should be done while you are taking this medication. The impurity detected in the API is . Clinical Trials, Losartan Losartan, sold under the brand name Cozaar among others, is a medication used to treat high blood pressure (hypertension). It may harm them. Your doctor may change your dose if needed. The majority of the children had hypertension associated with renal and urogenital disease. 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. Plasma concentrations of losartan and its active metabolite are similar in elderly and young hypertensives. Losartan potassium tablets can be taken with or without food. General Disorders and Administration Site Conditions: Table 2: Pharmacokinetic Parameters in Hypertensive Adults and Children Age 6 to 16 Following Multiple Dosing, Table 4: Incidence of Primary Endpoint Events, Table 5: Efficacy Outcomes within Demographic Subgroups. US Contact Number: 866-495-1995 Keep container tightly closed. Studies in rats indicate that losartan crosses the blood-brain barrier poorly, if at all. Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity. 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. 31722-701-30, Talk to your pharmacist for more details. Dosage should be adjusted according to blood pressure response. Losartan potassium was negative in the microbial mutagenesis and V-79 mammalian cell mutagenesis assays and in the in vitro alkaline elution and in vitro and in vivo chromosomal aberration assays. 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. Film Coated No Image #1015396; 44; (current). Losartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). Do not freeze. If symptomatic hypotension should occur, supportive treatment should be instituted. High blood pressure is the most common cause of LVH. Copy the URL below and paste it into your RSS Reader application. Allergic reaction. Overall, 72% of patients received the 100-mg daily dose more than 50% of the time they were on study drug. (7.3) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. Injury or death of unborn babies. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Losartan potassium tablets can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg. Read the Patient Information Leaflet if available from your pharmacist before you start taking losartan and each time you get a refill. If you get pregnant while taking losartan potassium tablets, tell your doctor right away. On February 28th 2019, Camber Pharmaceuticals announced a voluntary recall of 87 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with 'H'on one side and '145' on the other side. 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. Fosinopril Sodium and Hydrochlorothiazide, Drug class: angiotensin receptor blockers. to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. Psychiatric disorders: Depression. Losartan potassium tablets USP, 25 mg are white to off white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side. In spite of the effect of losartan on aldosterone secretion, very little effect on serum potassium was observed. Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Losartan potassium tablets USP, 25 mg are white to off white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side. The usual starting dose of losartan potassium tablets is 50 mg once daily. It is supplied by Lupin Pharmaceuticals, Inc. Losartan is used in the treatment of high blood pressure; diabetic kidney disease and belongs to the drug class angiotensin receptor blockers.There is positive evidence of human fetal risk during pregnancy. You have high blood pressure when the force is too much. It's a prescription drug that's used to: treat high blood. 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. How should I take losartan potassium tablets? 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. Do not give losartan potassium tablets to other people, even if they have the same symptoms that you have. High Blood Pressure (hypertension). You should not become pregnant while using losartan. ---To the attention of:---Customer ServiceMarketingSalesBusiness DevelopmentGeneral InquiriesDrug Info/Medical Affairs However, rifampin has been shown to decrease the AUC of losartan and its active metabolite by 30% and 40%, respectively. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. If you would like more information, talk with your doctor. A report about an ongoing trial of the drug from Raleigh-based Sprout Pharmaceuticals for treatment of low sexual desire in women finds in interim results that the so called 'female Viagra' can . See "What is the most important information I should know about losartan potassium tablets? * 25 mg is available in 90, 500 and 1000 count bottles In vitro studies indicate that cytochrome P450 2C9 and 3A4 are involved in the biotransformation of losartan to its metabolites. Tell your doctor right away if you have any serious side effects, including: Although losartan may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause serious kidney problems or make them worse. Events, (What At the end of three weeks, losartan reduced systolic and diastolic blood pressure, measured at trough, in a dose-dependent manner. Losartan potassium tablets USP, 25 mg are white to off white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side. 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. The Risk Reduction is adjusted for baseline Framingham risk score and level of electrocardiographic left ventricular hypertrophy. Strengths & Sizes. Its molecular formula is C22H22ClKN6O, and its structural formula is: Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. 4 CONTRAINDICATIONS Losartan potassium tablets are contraindicated: In patients who are hypersensitive to any component of this product. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . It is freely soluble in water and slightly soluble in acetonitrile. 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. PubMed, There is positive evidence of human fetal risk during pregnancy. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Nephropathy in Type 2 Diabetic Patients Table 3 shows the results for the primary composite endpoint and the individual endpoints. Properly discard this product when it is expired or no longer needed. The mean length of follow-up was 4.8 years. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. Bottles of 30 tablets (NDC 31722-700-30) Bottles of 60 tablets (NDC 31722-700-60) Bottles of 90 tablets (NDC 31722-700-90) Bottles of 500 tablets (NDC 31722-700-05) Bottles of 1000 tablets (NDC 31722-700-10) Losartan potassium tablets USP, 50 mg are white to off-white, film coated, oval shaped tablets debossed with 'I' on one side and '6' on the other side with score line. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. If you are using the liquid form of this medication, shake the bottle well before each dose. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Print; The incidence of cough is shown in Table 1 below. 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