Dichlorphenamide Tablets

Name: Dichlorphenamide Tablets

Side effects

The following serious adverse reactions are described elsewhere in labeling:

  • Hypersensitivity / Anaphylaxis / Idiosyncratic reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]
  • Metabolic Acidosis [see WARNINGS AND PRECAUTIONS]
  • Falls [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 9-week randomized controlled trial in adults with hyperkalemic or hypokalemic periodic paralysis (Study 1), the most common adverse reactions in patients treated with KEVEYIS™ , with rates greater than placebo, were paresthesia, cognitive disorder, dysgeusia, and confusional state. The mean dose of KEVEYIS™ was 94 mg/day in patients with hypokalemic periodic paralysis and 82 mg/day in patients with hyperkalemic periodic paralysis.

Table 1 lists the incidence of adverse reactions that occurred in ≥ 5% of patients treated with KEVEYIS™ and more commonly than in patients treated with placebo in Study 1.

Table 1: Adverse Reactions in Patients Treated with KEVEYIS™ with Incidence ≥ 5% and more common than in Patients Treated with Placebo in Study 1

  Adverse Reaction KEVEYIS™
N = 36
(%)		 Placebo
N = 29
(%)
Nervous system disorders Paresthesia 44 14
Cognitive disorder1 14 7
Dysgeusia 14 0
Confusional state 11 0
Headache 8 7
Hypoesthesia 8 0
Lethargy 8 0
Dizziness 6 0
Gastrointestinal disorders Diarrhea 6 3
Nausea 6 0
General disorders and administration site conditions Fatigue 8 0
Malaise 6 0
Investigations Weight decreased 6 0
Musculoskeletal and connective tissue disorders Muscle spasms 8 0
Arthralgia 6 3
Muscle twitching 6 0
Respiratory Dyspnea 6 0
Pharyngolaryngeal pain 6 0
Skin Rash 8 0
Pruritus 6 0
1Cognitive disorder combined cases with the preferred terms of cognitive disorder, disturbance in attention, and mental impairment.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of dichlorphenamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following are adverse reactions which have been reported for dichlorphenamide that were serious adverse events or are not reported in the previous section of labeling [see Clinical Trials Experience]: amnesia, cardiac failure, condition aggravated, convulsion, fetal death, hallucination, nephrolithiasis, pancytopenia, psychotic disorder, renal tubular necrosis, stupor, syncope, tremor.

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