Global Pharmaceuticals

Global Pharmaceuticals Drugs

• Sotalol Hydrochloride
  

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  Sotalol Hydrochloride

  

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  As with other antiarrhythmic agents, sotalol hydrochloride should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment (see INDICATIONS AND USAGE). Sotalol should be administered only after appropriate clinical assessment (see INDICATIONS AND USAGE), and the dosage of sotalol must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.

  Adults

  Dosage of sotalol should be adjusted gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the usage of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day (120 to 160 mg twice daily). In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 to 640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia. Because of the long terminal elimination half-life of sotalol, dosing on more than a BID regimen is usually not necessary.

  Pediatrics

  Pediatric dosing information for sotalol hydrochloride tablets is approved for the Berlex Laboratories sotalol hydrochloride tablets. However, due to the Berlex marketing exclusivity rights, this drug product is not labeled for pediatric use.

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• Primidone
  

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  Primidone

  

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  Adult Dosage

  Patients 8 years of age and older who have received no previous treatment may be started on primidone tablets according to the following regimen using either 50 mg or scored 250 mg primidone tablets:

  Days 1 to 3: 100 to 125 mg at bedtime

  Days 4 to 6: 100 to 125 mg b.i.d.

  Days 7 to 9: 100 to 125 mg t.i.d.

  Day 10 to maintenance; 250 mg t.i.d.

  For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg primidone tablets daily in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d.

  Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 mcg/mL.

  In Patients Already Receiving Other Anticonvulsants

  Primidone tablets should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with primidone tablets alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.

  Pediatric Dosage

  For children under 8 years of age, the following regimen may be used:

  Days 1 to 3: 50 mg at bedtime.

  Days 4 to 6: 50 mg b.i.d.

  Days 7 to 9: 100 mg b.i.d.

  Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.

  For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

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