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Nustendi increases serum uric acid possibly due to inhibition of renal tubular OAT2 by bempedoic acid (see section 4.5). A mean increase of 0.6 mg/dL (35.7 micromole/L) in uric acid compared to baseline was observed with Nustendi at week 12. The elevations in serum uric acid usually occurred within the first 4 weeks of treatment and returned to baseline following discontinuation of treatment. There were no reports of gout with Nustendi. In the pooled placebo-controlled trials of bempedoic acid, gout was reported in 1.4% of patients treated with bempedoic acid and 0.4% of patients treated with placebo. In both treatment groups, patients who reported gout were more likely to have a medical history of gout and/or baseline levels of uric acid above the ULN (see section 4.4).

No specific pharmacokinetic drug interaction studies with Nustendi have been conducted. Drug interactions that have been identified in studies with bempedoic acid or ezetimibe determine the interactions that may occur with Nustendi. In other words, the ratio of 25 males to students in the classroom is equivalent to 50% of students in the classroom being male. Percentage formula In pooled placebo-controlled clinical trials with bempedoic acid, more patients on bempedoic acid compared to placebo discontinued treatment due to muscle spasms (0.7% versus 0.3%), diarrhoea (0.5% versus < 0.1%), pain in extremity (0.4% versus 0), and nausea (0.3% versus 0.2%) although differences between bempedoic acid and placebo were not significant.Pharmacotherapeutic group: Lipid modifying agents in combination with other drugs, ATC code: C10BA10. Nustendi contains bempedoic acid and ezetimibe, two LDL-C lowering compounds with complementary mechanisms of action. Nustendi reduces elevated LDL-C through dual inhibition of cholesterol synthesis in the liver and cholesterol absorption in the intestine.

Multiples of 13: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247, 260 The bempedoic acid apparent volume of distribution (V/F) was 18 L. Plasma protein binding of bempedoic acid, its glucuronide and its active metabolite, ESP15228, were 99.3%, 98.8% and 99.2%, respectively. Bempedoic acid does not partition into red blood cells. Concomitant cholestyramine administration decreased the mean AUC of total ezetimibe (ezetimibe plus ezetimibe glucuronide) approximately 55%. The incremental low-density lipoprotein cholesterol (LDL-C) reduction due to adding Nustendi to cholestyramine may be lessened by this interaction (see section 4.2). There is limited experience with bempedoic acid in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m 2), and patients with ESRD on dialysis have not been studied with bempedoic acid (see section 5.2). Additional monitoring for adverse reactions may be warranted in these patients when Nustendi is administered.No clinically significant pharmacokinetic interaction was seen when ezetimibe was coadministered with bempedoic acid. Total ezetimibe (ezetimibe and its glucuronide form) and ezetimibe glucuronide AUC and C max increased approximately 1.6- and 1.8-fold, respectively, when a single dose of ezetimibe was taken with steady-state bempedoic acid. This increase is likely due to inhibition of OATP1B1 by bempedoic acid, which results in decreased hepatic uptake and subsequently decreased elimination of ezetimibe-glucuronide. Increases in the AUC and C max for ezetimibe were less than 20%. Ezetimibe 10 mg has been shown to reduce the frequency of cardiovascular events. The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. Administration of bempedoic acid and ezetimibe alone and in combination with other lipid modifying medicinal products decreases LDL-C, non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and total cholesterol (TC) in patients with hypercholesterolaemia or mixed dyslipidaemia. Percentages are computed by multiplying the value of a ratio by 100. For example, if 25 out of 50 students in a classroom are male, . The value of the ratio is therefore 0.5, and multiplying this by 100 yields:

Administration of bempedoic acid to male and female rats prior to mating and through gestation day 7 in females resulted in changes in estrous cyclicity, decreased numbers of corpora lutea and implants at ≥ 30 mg/kg/day with no effects on male or female fertility or sperm parameters at 60 mg/kg/day (4 and 9 times the systemic exposure in humans at 180 mg, respectively).atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin (used to lower cholesterol and known as statins). Multiples of 15: 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270, 285, 300 Multiples of 14: 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, 168, 182, 196, 210, 224, 238, 252, 266, 280