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Glimepiride plus Rosiglitazone should be given once daily with the first meal of the day. The dosage of antidiabetic therapy with Glimepiride plus Rosiglitazone should be individualized on the basis of effectiveness and tolerability. No exact dosage relationship exists between Glimepiride plus Rosiglitazone and other antidiabetic agents. For patients inadequately controlled on sulfonylurea monotherapy or who have initially responded to Rosiglitazone alone and require additional glycemic control, the usual starting dose of Glimepiride plus Rosiglitazone is 1 mg/4 mg or 2 mg/4 mg once daily.

When switching from combination therapy of Glimepiride plus Rosiglitazone as separate tablets, the usual starting dose of Glimepiride plus Rosiglitazone is the dose of Glimepiride and Rosiglitazone already being taken. The maximum recommended daily dose of Glimepiride plus Rosiglitazone is 4 mg of Glimepiride and 8 mg of Rosiglitazone.

Sufficient time should be given to assess adequacy of therapeutic response. Fasting glucose should be used to determine the therapeutic response to Glimepiride plus Rosiglitazone.

For patients previously treated with sulfonylurea monotherapy switched to Glimepiride plus Rosiglitazone, it may take 2 weeks to see a reduction in blood glucose and 2 to 3 months to see the full effect of the Rosiglitazone component. If additional glycemic control is needed, the dose of the Glimepiride component may be increased. The dose of the Rosiglitazone component should not exceed 8 mg. As with other sulfonylurea-containing antidiabetic agents, no transition period is necessary when transferring patients to Glimepiride plus Rosiglitazone. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half life sulfonylureas (e.g., chlorpropamide) to Glimepiride plus Rosiglitazone due to potential overlapping of drug effect.

For patients previously treated with thiazolidinedione monotherapy switched to Glimepiride plus Rosiglitazone dose titration is recommended if patients are not adequately controlled after 1 to 2 weeks. If additional glycemic control is needed, the daily dose of Glimepiride plus Rosiglitazone may be increased by increasing the Glimepiride component in no more than 2 mg increments at 1 to 2 week intervals up to the maximum recommended total daily dose of 4 mg Glimepiride/8 mg Rosiglitazone.

If hypoglycemia occurs during up-titration of the dose or while maintained on therapy, a dosage reduction of the sulfonylurea component of Glimepiride plus Rosiglitazone may be considered.

Use in Pediatric patients: Safety and effectiveness of combination of Glimepiride or Rosiglitazone in pediatric patients have not been established.

Use in Geriatric patients:

• Glimepiride: The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
• Rosiglitazone: Results of the population pharmacokinetic analysis showed that age does not significantly affect the pharmacokinetics of Rosiglitazone. Therefore, no dosage adjustments are required for the elderly.

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