Renal Impairment. The pharmacokinetics of eszopiclone were studied in 24 patients with mild, moderate, or severe renal impairment. AUC and Cmax were similar in the patients compared with demographically matched healthy control subjects. No dose adjustment is necessary in patients with renal impairment, since less than 10% of the orally administered eszopiclone dose is excreted in the urine as parent drug. Eszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation. There were no pharmacokinetic or pharmacodynamic interactions between eszopiclone and paroxetine, digoxin, or warfarin. When eszopiclone was coadministered with olanzapine, no pharmacokinetic interaction was detected in levels of eszopiclone or olanzapine, but a pharmacodynamic interaction was seen on a measure of psychomotor function. Eszopiclone and lorazepam decreased each other’s Cmax by 22%. Coadministration of eszopiclone 3 mg to subjects receiving ketoconazole 400 mg, a potent inhibitor of CYP3A4, resulted in a 2.2-fold increase in exposure to eszopiclone. LUNESTA would not be expected to alter the clearance of drugs metabolized by common CYP450 enzymes. (See PRECAUTIONS.) The effect of LUNESTA on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18-86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 months’ duration. Two of these trials were in elderly patients (n=523). Overall, at the recommended adult dose (2-3 mg) and xxxxxxx xxxx (0-0 xx), XXXXXXX significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset [WASO] and subjectively measured as total sleep time).
Renal Impairment. Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, elimination half-life is
Renal Impairment. No dose adjustment is recommended for patients with renal impairment (see section 5.2).
Renal Impairment. Binimetinib undergoes minimal renal elimination. Results from a dedicated clinical study showed that patients with severe renal impairment (eGFR ≤ 29 mL/min/1.73 m2), had a 29 % increase in exposure (AUCinf), a 21 % increase in Cmax, and a 22 % decrease in CL/F compared to matching healthy subjects. These differences were within the variability observed for these parameters in both cohorts of this study (25 % - 49 %) and the variability previously observed in patient clinical studies, hence these differences are unlikely to be clinically relevant. The effects of renal impairment on the pharmacokinetics of binimetinib in combination with encorafenib have not been evaluated clinically.
Renal Impairment. Monitor renal function closely if eGFR trending downwards. Check for other causes e.g. dehydration, infection etc. Repeat U&Es when patient stable and if still reduced renal function contact the HF team for advice. An increase in creatinine up to 50% above baseline or 266micromol/l, whichever is smaller is acceptable. If creatinine increases by >100% or to above 310 micromol/l sacubitril/valsartan should be stopped and specialist advice sought. Hepatic impairment Severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Xxxx C classification) discontinue sacubitril/valsartan. Moderate liver impairment; consider dose reduction (Child-Xxxx B classification) and contact HF team for advice. Angioedema Discontinue sacubitril/valsartan if angioedema occurs. Patient should be given appropriate therapy and monitored for airway compromise. Refer to secondary care.
Renal Impairment. Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Care should be taken in dose selection of EXPAREL.
Renal Impairment. Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Care should be taken in dose selection of EXPAREL [See Use in Specific Populations (8.7)]. Various pharmacokinetic parameters of the local anesthetics such as bupivacaine can be significantly altered by the age of the patient. In clinical studies, differences in various pharmacokinetic parameters have been observed between elderly and younger patients. Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection of EXPAREL [See Use in Specific Populations (8.5)].
Renal Impairment. The potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced. Serious cardiovascular adverse events including cases of cardiomyopathy, cardiomegaly, congestive heart failure and cardiac arrhythmias have been reported. Anagrelide should be used with caution in patients of any age with known or suspected heart disease. Moreover, serious cardiovascular adverse events have also occurred in patients without suspected heart disease and with normal pre-treatment cardiovascular examination. Anagrelide should only be used if the potential benefits of therapy outweigh the potential risks. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic effects, a pre-treatment cardiovascular examination (including further investigation such as echocardiography, electrocardiogram) is recommended. Patients should be monitored during treatment for evidence of cardiovascular effects that may require further cardiovascular examination and investigation. The effects of inotropes may be exacerbated by anagrelide but no other clinically significant interactions have been documented. There is no interaction with drugs commonly co-prescribed – warfarin, aspirin, hydroxycarbamide and allopurinol. Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives. If you have any concerns regarding individual patients, the most recent patient letters from the Haematology Medical Team will contain our up-to-date contact details or you can contact one of the following: Haematology & Oncology patient EmergencyNumber 023 9228 3316 The on-call Haematologist is available via switchboard if advice is required out of hours The cost of a 100 capsule pack of Anagrelide 0.5mg is £397 (excluding VAT)
Renal Impairment. The effect of renal impairment on the pharmacokinetics of APADAZ has not been determined. Patients with renal impairment may have higher plasma concentrations than those with normal function. Use a low initial dose of APADAZ in patients with renal impairment and monitor closely for adverse events such as respiratory depression.
Renal Impairment. The effect of renal insufficiency on the pharmacokinetics of APADAZ has not been determined [see Use in Specific Populations (8.7)].
