ORMALVI

After single-dose administration in healthy subjects in fasted state, dichlorphenamide C max and AUC increased in a dose-proportional manner within the range of 25 mg to 400 mg (2 times the maximum recommended dose). The steady-state is expected to be achieved within 10 days of twice-daily dosing.

AbsorptionThe median time to reach maximum concentration (T max ) of dichlorphenamide was about 1.5 to 3 hours postdose after both single and multiple dose administrations.

DistributionThe plasma pro...

The efficacy of dichlorphenamide was evaluated in two clinical studies, Study 1 and Study 2.

Study 1Study 1 was a 9-week, double-blind, placebo-controlled multi-center study. Study 1 consisted of two substudies: a substudy in patients with hypokalemic periodic paralysis (n=44), and a substudy in patients with hyperkalemic periodic paralysis (n=21). The primary efficacy endpoint in both substudies was the average number of self-reported attacks of muscle weakness per week over the final 8 weeks of the trial. Withdrawal from the study for acute severe worsening (increase in attack frequency or ...

The following serious adverse reactions are described elsewhere in labeling: Hypersensitivity and Other Life-Threatening Reactions [see Warnings and Precautions ( 5.1 )] Hypokalemia [see Warnings and Precautions ( 5.3 )] Metabolic Acidosis [see Warnings and Precautions ( 5.4 )] Falls [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence at least 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state ( 6.1 ) To report SU...

ORMALVI is contraindicated in the following circumstances: Hypersensitivity to dichlorphenamide or other sulfonamides [see Warnings and Precautions ( 5.1 )] Concomitant use of ORMALVI and high dose aspirin [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.1 )] Severe pulmonary disease, limiting compensation to metabolic acidosis caused by ORMALVI [see Warnings and Precautions ( 5.4 )...

Hypersensitivity and Other Life-Threatening Reactions: discontinue ORMALVI at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction ( 5.1 ) Hypokalemia: baseline and periodic measurements of serum potassium are recommended; if hypokalemia develops or persists, consider reducing the dose or discontinuing ORMALVI and correcting potassium levels ( 5.3 ) Metabolic acidosis: baseline and periodic measurements of serum bicarbonate are recommended; if metabo...

7 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 ( 4 , 5.2 , 7.1 ) 7.1 Aspirin and Other Salicylates Carbonic anhydrase inhibitors, including O...