Bydureon

Bydureon Manufacturers

• Amylin Pharmaceuticals, Llc
  

  ×

  Bydureon | Valeant Pharmaceuticals North America Llc

  

  ---

  Mestinon is available in three dosage forms:

  Syrup

  raspberry-flavored, containing 60 mg pyridostigmine bromide per teaspoonful (5 mL). This form permits accurate dosage adjustment for children and "brittle" myasthenic patients who require fractions of 60 mg doses. It is more easily swallowed, especially in the morning, by patients with bulbar involvement.

  Conventional Tablets

  each containing 60 mg pyridostigmine bromide.

  Timespan Tablets

  each containing 180 mg pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Timespan Tablet is about equal to that of a 60 mg Conventional Tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ times that of a 60 mg dose.

  Dosage

  The size and frequency of the dosage must be adjusted to the needs of the individual patient.

  Syrup and Conventional Tablets

  The average dose is ten 60 mg tablets or ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets or teaspoonfuls a day may be required, while in mild cases one to six tablets or teaspoonfuls a day may suffice.

  Timespan Tablets

  One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with Timespan therapy.

  Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

  Close
  No Recall

  More Info
• Astrazeneca Pharmaceuticals Lp
  

  ×

  Bydureon | Mylan Pharmaceuticals Inc.

  

  ---

  2.1 Adults

  The recommended dose for nevirapine tablets is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.

  Nevirapine extended-release tablets (400 mg once daily) are also available for use after the lead-in period. Patients must never take more than one form of nevirapine at the same time.

  2.2 Pediatric Patients

  The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.

  Table 1 Calculation of the Volume of Nevirapine Oral Suspension (50 mg/5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2

  BSA range (m2)

  Volume (mL)

  0.06 to 0.12

  1.25

  0.12 to 0.25

  2.5

  0.25 to 0.42

  5

  0.42 to 0.58

  7.5

  0.58 to 0.75

  10

  0.75 to 0.92

  12.5

  0.92 to 1.08

  15

  1.08 to 1.25

  17.5

  1.25+

  20

   Nevirapine suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 mL or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.

  2.3 Monitoring of Patients

  Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine tablets. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

  2.4 Dosage Adjustment Patients with Rash

  Discontinue nevirapine tablets if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.

  Patients with Hepatic Events

  If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine tablets. Do not restart nevirapine tablets after recovery [see Warnings and Precautions (5.1)].

  Patients with Dose Interruption

  For patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).

  Patients with Renal Impairment

  Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in nevirapine dosing. An additional 200 mg dose of nevirapine tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info