Examples from Patients with Primary Periodic Paralysis скачать в хорошем качестве

Examples from Patients with Primary Periodic Paralysis

Dr Jonathan Santoro talks about: • How difficult it can be for patients with Primary Periodic Paralysis to describe their symptoms • How weakness varies from patient to patient and understanding why it occurs • How you can be astute in looking at the patterns and history of each patient to reach diagnosis This video is aimed at healthcare providers in the US. ©2024 Cycle Pharmaceuticals Limited. All rights reserved. ORMALVI is a trademark of Torrent Pharma Inc. in the United States. Cycle Vita is a trademark of Cycle Pharmaceuticals Limited in the United States. Dr Santoro was compenstated for his services. US-DCP-2400013 (January 2024) Indications ORMALVI is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. Important Safety Information Contraindications • Hypersensitivity to dichlorphenamide or other sulfonamides • Concomitant use of ORMALVI and high dose aspirin • Severe pulmonary disease, limiting compensation to metabolic acidosis caused by ORMALVI • Hepatic insufficiency: ORMALVI may aggravate hepatic encephalopathy Warnings and Precautions Hypersensitivity and Other Life-threatening Reactions • Fatalities associated with the administration of sulfonamides have occurred because of adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. • Pulmonary involvement can occur in isolation or as part of a systemic reaction. • Discontinue ORMALVI at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction. Concomitant Use of Aspirin or Other Salicylates • Carbonic anhydrase inhibitors, including ORMALVI, can cause metabolic acidosis, which can increase the risk of salicylate toxicity. • Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. • Concomitant use of ORMALVI and high-dose aspirin is contraindicated. Use with caution and carefully monitor patients receiving low-dose aspirin. Hypokalemia • ORMALVI increases potassium excretion and can cause hypokalemia. • The risk of hypokalemia is greater when ORMALVI is used in patients with conditions associated with hypokalemia (e.g., adrenocortical excess, renal tubular acidosis type 1 and 2), and in patients receiving other drugs that may case hypokalemia (e.g., loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline). • Baseline and periodic measurements of serum potassium during ORMALVI treatment are recommended. • If hypokalemia develops or persists, consider reducing the dose or discontinuing ORMALVI and correction of potassium levels. Metabolic Acidosis • ORMALVI can cause hyperchloremic non-anion gap metabolic acidosis. • Concomitant use of ORMALVI with other drugs that cause metabolic acidosis may increase the severity of acidosis. • Concomitant use of ORMALVI in compensated patients with respiratory acidosis, such as in advanced lung diseases, may lead to respiratory decompensation. • Baseline and periodic measurements of serum bicarbonate during ORMALVI treatment are recommended. • If metabolic acidosis develops or persists, consider reducing the dose or discontinuing ORMALVI. Falls • ORMALVI increases the risk of falls; risk is greater in the elderly and with higher doses. • Consider dose reduction or discontinuation of ORMALVI in patients who experience falls while treated with ORMALVI. Pregnancy and Lactation • Based on animal data, ORMALVI may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. • It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman. Adverse Reactions: The most common adverse reactions seen in clinical trials (incidence ≥10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state. Drug Interactions: Aspirin: anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. The concomitant use of ORMALVI and high-dose aspirin is contraindicated. ORMALVI should be used with caution in patients receiving lower doses of aspirin. For more detailed information, please refer to the full Prescribing Information and at www.ORMALVI.com/PI To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. #PrimaryPeriodicParalysis #Hyperkalemia #Hypokalemia #TemporaryParalysis