For: Primary Hyperkalemic and Hypokalemic Periodic Paralysis
Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic and hypokalemic periodic paralysis. VISIT KEVEYIS.COM FOR ALL INFO.
KEVEYIS- dichlorphenamide tablet
Taro Pharmaceuticals U.S.A., inc.
1 INDICATIONS AND USAGE
KEVEYIS� is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
2 DOSAGE AND ADMINISTRATION
Initiate dosing at 50 mg twice daily. The initial dose may be increased or decreased based on individual response, at weekly intervals (or sooner in case of adverse reaction). The maximum recommended total daily dose is 200 mg.
Primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants are a heterogeneous group of conditions, for which the response to KEVEYIS� may vary. Therefore, prescribers should evaluate the patient's response to KEVEYIS� after 2 months of treatment to decide whether KEVEYIS� should be continued.
3 DOSAGE FORMS AND STRENGTHS
Round, white tablets, scored on one side, engraved with "TARO" on one side and on the other side "D" above the score and "50″ below the score, 50 mg each.
4 CONTRAINDICATIONS
KEVEYIS� is contraindicated in the following circumstances:
Hypersensitivity to dichlorphenamide or other sulfonamides [see Warnings and Precautions (5.1)]
Concomitant use of KEVEYIS� and high dose aspirin [see Warnings and Precautions (5.2)]
Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS� [see Warnings and Precautions (5.4)]
Hepatic insufficiency: KEVEYIS� may aggravate hepatic encephalopathy.
DESCRIPTION
KEVEYIS� (dichlorphenamide) tablets is an oral carbonic anhydrase inhibitor. Dichlorphenamide, a dichlorinated benzenedisulfonamide, is known chemically as 4, 5�dichloro-1,3-benzenedisulfonamide.
Its empirical formula is C6 H6 Cl2 N2 O4 S2 and its structural formula is:
Chemical Structure
Dichlorphenamide USP is a white or practically white, crystalline compound with a molecular weight of 305.16. It is very slightly soluble in water but soluble in dilute solutions of sodium carbonate and sodium hydroxide. Dilute alkaline solutions of dichlorphenamide are stable at room temperature.
KEVEYIS� (dichlorphenamide) tablets is supplied as tablets, for oral administration, each containing 50 mg dichlorphenamide. Inactive ingredients are lactose monohydrate, magnesium stearate and pregelatinized maize starch.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Dichlorphenamide is a carbonic anhydrase inhibitor. However, the precise mechanism by which dichlorphenamide exerts its therapeutic effects in patients with periodic paralysis is unknown
