Losartan Potassium and Hydrochlorothiazide Tablets, USP, (loe-SAR-tanpoe-TAS-see-um and hye-droe-klor-oh-THYE-ah-zide). Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. Type 2 Diabetes with Nephropathy. Studies in rats indicate that Losartan crosses the blood-brain barrier poorly, if at all. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics. In vitro binding studies indicate that Losartan is a reversible, competitive inhibitor of the AT1 receptor. Active ingredients/generics: hydrochlorothiazide, losartan potassium. 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. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration. Losartan Potassium and Hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Mean peak concentrations of Losartan and its active metabolite are reached in 1 hour and in 3 to 4 hours, respectively. 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. 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. 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. Unfortunately, very occasionally, the development of seemingly innocuous symptoms such as a rash and/or itching can be the presenting symptoms of a life threatening condition—namely anaphylaxis or meningococcal septicaemia. The systemic bioavailability of Losartan is approximately 33%. The dose should be increased to 100 mg once daily based on blood pressure response [see Clinical Studies (14.3)]. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). 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. 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. Pharmacokinetic differences due to race have not been studied [see Use in Specific Populations (8.6)]. Psychiatric disorders: Insomnia, restlessness. Discuss treatment options with women planning to become pregnant. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Safety and effectiveness of Losartan Potassium and Hydrochlorothiazide tablets in patients with severe renal impairment (creatinine clearance <30 mL/min) have not been established. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (, [see Use in Special Populations (8.8) and Clinical Pharmacology (, Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia. 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. Its empirical formula is C22H22ClKN6O, and its structural formula is: Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. The principal pharmacokinetic parameters in adults and children are shown in the table below. Caffeine withdrawal: How to beat the symptoms while breaking the habit. 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. At the end of study or at the last visit before a primary endpoint, 77% of the group treated with losartan and 73% of the group treated with atenolol were still taking study medication. If symptomatic hypotension should occur, supportive treatment should be instituted. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. 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. Call your doctor for medical advice about side effects. 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. "What is the most important information I should know about Losartan Potassium and Hydrochlorothiazide tablets?". 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. The following adverse reactions have been identified during post-approval use of Losartan Potassium and Hydrochlorothiazide tablets. We have created a list of the most popular prescribed medications in UK hospitals. LVH can happen from several things. The AUC of active metabolite following oral Losartan was not affected by erythromycin, an inhibitor of P450 3A4, but the AUC of Losartan was increased by 30%. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. The primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an ITT approach. There are a number of types of edema. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Shake the suspension prior to each use and return promptly to the refrigerator. Losartan does not affect the response to bradykinin, whereas ACE inhibitors increase the response to bradykinin. Candesartan, losartan); should I stop? When pregnancy is detected, discontinue Losartan potassium as soon as possible. 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. Invokana (canagliflozin) is a brand-name prescription drug that's used in adults with type 2 diabetes. Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine. 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. If goal blood pressure (<140/90 mmHg) was not reached, hydrochlorothiazide (12.5 mg) was added first and, if needed, the dose of losartan or atenolol was then increased to 100 mg once daily. Reproductive system and breast disorders: Impotence. Adverse reactions include fetal or neonatal jaundice, thrombocytopenia [see Use in Specific Populations (8.1)]. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. The recommended starting dose of Losartan potassium is 25 mg in patients with mild-to-moderate hepatic impairment. You can ask your pharmacist or doctor for information that is written for health professionals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). 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. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. For the primary endpoint and ESRD, the effects of Losartan potassium in patient subgroups defined by age, gender and race are shown in Table 5 below. Monitor renal function periodically in patients receiving losartan and NSAID therapy. The following less common adverse reactions have been reported: Blood and lymphatic system disorders: Anemia. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Protect from light. The primary endpoint was the first occurrence of cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction. 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. Losartan Potassium and Hydrochlorothiazide tablets 50/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide tablets 100/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide tablets 100/25 mg contain 8.48 mg (0.216 mEq) of potassium. Safety and effectiveness have not been established in pediatric patients under the age of 6 or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2 [see Dosage and Administration (2.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)]. Dosage Form: tablet, film coated. Fetal testing may be appropriate, based on the week of pregnancy. Correct volume or salt depletion prior to administration of Losartan Potassium and Hydrochlorothiazide tablets. What are the ingredients in Losartan potassium tablets? Limited data are available in regard to overdosage in humans. 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. Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).
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