Dichlorphenamide is a carbonic anhydrase inhibitor sold in the U.S. under 2 brand and generic names, for glaucoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Daranide (application NDA011366). Other dichlorphenamide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Initiate dosing at 50 mg by mouth once or twice daily ( 2.1 ) Titrate up or down dose based on individual response ( 2.1 ) The minimum recommended dosage is 50 mg daily, and the maximum recommended dosage is 200 mg daily ( 2.1 ) Evaluate response to KEVEYIS after 2 months of treatment ( 2.2 ) 2.1 Dosage Information Initiate dosing at 50 mg by mouth once or twice daily. The dosage may be increased or decreased based on individual response, at weekly intervals (or sooner in case of adverse reaction). The minimum recommended total daily dosage is 50 mg, and the maximum recommended total daily dosage is 200 mg. 2.2 Monitoring to Assess Effectiveness 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. 2.3 Monitoring to Assess Safety Baseline and periodic measurements of serum potassium and serum bicarbonate during KEVEYIS treatment is recommended [see Warnings and Precautions (5.3 , 5.4) ].
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 SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at 1-855-324-8912, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | — | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | — | — | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| ZD;50 | 50 mg | white | round | — |
| D;50 | 50 mg | white | round | — |
| C;43 | 50 mg | white | round | — |
| ZD;50 | 50 mg | white | round | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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) and Drug Interactions (7.1) ] Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS [see Warnings and Precautions (5.4) ] Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy. Hepatic insufficiency ( 4 ) Severe pulmonary obstruction ( 4 ) Hypersensitivity to dichlorphenamide or other sulfonamides ( 4 ) Concomitant use with high dose aspirin ( 4 )
Aspirin: anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. The concomitant use of KEVEYIS and high-dose aspirin is contraindicated. KEVEYIS 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 KEVEYIS, can cause metabolic acidosis [see Warnings and Precautions ( 5.2 , 5.4 ) ], 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. Therefore, concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Patients with concomitant use of KEVEYIS and low-dose aspirin should be carefully monitored [see Contraindications (4) and Warnings and Precautions (5.2) ]. 7.2 Drugs that are Substrates of Organic Anion Transporter1 (OAT1) In vitro , dichlorphenamide is an inhibitor of OAT1 transporters. The concomitant administration of KEVEYIS may increase the plasma exposures of OAT1 substrates. Use of KEVEYIS with drugs that are sensitive to OAT1 inhibition (e.g., methotrexate, famotidine, oseltamivir) is not recommended [see Clinical Pharmacology (12.3) ]. 7.3 Drugs that Cause Hypokalemia The risk of hypokalemia is greater with coadministration of KEVEYIS and other drugs that can…