Vimpat

Vimpat Manufacturers

• Physicians Total Care, Inc.
  

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  Vimpat | Physicians Total Care, Inc.

  

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  VIMPAT may be taken with or without food.

  When using VIMPAT oral solution, it is recommended that a calibrated measuring device be obtained and used. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  2.1 Partial-Onset Seizures

  VIMPAT can be initiated with either oral or intravenous administration. The initial dose should be 50 mg twice daily (100 mg per day). VIMPAT can be increased at weekly intervals by 100 mg/day given as two divided doses up to the recommended maintenance dose of 200 to 400 mg/day, based on individual patient response and tolerability. In clinical trials, the 600 mg daily dose was not more effective than the 400 mg daily dose, and was associated with a substantially higher rate of adverse reactions. [see Clinical Studies (14.1)]

  Switching from Oral to Intravenous Dosing

  When switching from oral VIMPAT, the initial total daily intravenous dosage of VIMPAT should be equivalent to the total daily dosage and frequency of oral VIMPAT and should be infused intravenously over a period of 30 to 60 minutes. There is experience with twice daily intravenous infusion for up to 5 days.

  Switching from Intravenous to Oral Dosing

  At the end of the intravenous treatment period, the patient may be switched to VIMPAT oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  Compatibility and Stability

  VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents. VIMPAT injection was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or polyvinyl chloride (PVC) bags at ambient room temperature 15-30°C (59-86°F).

  Diluents:

  Sodium Chloride Injection 0.9% (w/v)
  Dextrose Injection 5% (w/v)
  Lactated Ringer's Injection

  The stability of VIMPAT injection in other infusion solutions has not been evaluated. Product with particulate matter or discoloration should not be used.

  Any unused portion of VIMPAT injection should be discarded.

  2.2 Patients with Renal Impairment

  No dose adjustment is necessary in patients with mild to moderate renal impairment. A maximum dose of 300 mg/day VIMPAT is recommended for patients with severe renal impairment [creatinine clearance (CLCR) ≤30mL/min] and in patients with endstage renal disease. VIMPAT is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered. In all renally impaired patients, the dose titration should be performed with caution. [see Use in Specific Populations (8.6)]

  2.3 Patients with Hepatic Impairment

  The dose titration should be performed with caution in patients with hepatic impairment. A maximum dose of 300 mg/day is recommended for patients with mild or moderate hepatic impairment.

  VIMPAT use is not recommended in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

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• Kremers Urban Pharmaceuticals Inc
  

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  Vimpat | Ucb, Inc.

  

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  2.1 Dosage for VIMPAT Tablet and Oral Solution

  Monotherapy

  The initial recommended dose of VIMPAT is 100 mg twice daily (200 mg per day); the dose should be increased by 50 mg twice daily (100 mg per day) every week, up to a recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). Alternatively, VIMPAT may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day); this dose regimen should be continued for one week. Based on individual response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)].

  For patients who are already on a single antiepileptic and will convert to VIMPAT monotherapy, the therapeutic dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day) should be maintained for at least 3 days before initiating withdrawal of the concomitant antiepileptic drug. A gradual withdrawal of the concomitant antiepileptic drug over at least 6 weeks is recommended.

  Adjunctive Therapy

  The initial recommended dose is 50 mg twice daily (100 mg per day). Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day). The recommended maintenance dose is 100 mg twice daily to 200 mg twice daily (200 mg to 400 mg per day). In clinical trials, the 300 mg twice daily (600 mg per day) dose was not more effective than the 200 mg twice daily dose (400 mg per day), but was associated with a substantially higher rate of adverse reactions [see Clinical Studies (14.1)].

  Alternatively, VIMPAT may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg per day); this maintenance dose regimen should be continued for one week. Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the maximum recommended maintenance dose of 200 mg twice daily (400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)]. When discontinuing VIMPAT, a gradual withdrawal over at least 1 week is recommended [see Warnings and Precautions (5.5)].

  2.2 Dosage for VIMPAT Injection

  Intravenous VIMPAT can be administered in the same dosing regimens described for oral dosing, including the loading dose. These dosages may be infused intravenously over a period of 15 minutes to 60 minutes. Intravenous infusion of 30 to 60 minutes is preferable, and should be used when a 15 minute administration is not required [see Adverse Reactions (6.1), Clinical Pharmacology (12.3))].

  Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g., myocardial ischemia, heart failure), as intravenous infusion of VIMPAT may cause bradycardia or AV blocks in these patients [see Warnings and Precautions (5.3)].

  When switching from oral to intravenous VIMPAT, the initial total daily intravenous dosage regimen of VIMPAT should be equivalent to the dosage regimen of oral VIMPAT. The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment. At the end of the intravenous treatment period, the patient may be switched to VIMPAT oral administration at the equivalent daily dosage and frequency of the intravenous administration.

  2.3 Dosage Information in Patients with Renal Impairment

  No dose adjustment is necessary in patients with mild to moderate renal impairment. A maximum dose of 300 mg per day VIMPAT is recommended for patients with severe renal impairment [creatinine clearance (CLCR) less than or equal to 30 mL/min] and in patients with endstage renal disease. VIMPAT is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered. In all renally impaired patients, the dose titration should be performed with caution. Patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

  2.4 Dosage Information in Patients with Hepatic Impairment

  The dose titration should be performed with caution in patients with hepatic impairment. A maximum dose of 300 mg per day is recommended for patients with mild or moderate hepatic impairment.

  VIMPAT use is not recommended in patients with severe hepatic impairment. Patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

  2.5 Administration Instructions

  VIMPAT may be taken with or without food.

  VIMPAT Oral Solution

  A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

  VIMPAT Injection

  VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature.

  Diluents:

  Sodium Chloride Injection 0.9% (w/v)
  Dextrose Injection 5% (w/v)
  Lactated Ringer's Injection

  Product with particulate matter or discoloration should not be used.
  Any unused portion of VIMPAT injection should be discarded.

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