Information for Doctors

Warnings and precautions for Physicians considering prescribing Meridia (sibutramine).

1. You should monitor the blood pressure and heart rate of all patients who have been prescribed Meridia. During the first three months of treatment, blood pressure and heart rate should be checked every two weeks; monthly during the second three months of treatment and at intervals not exceeding three months thereafter.
   
   Treatment with meridia should be stopped if an increase in resting heart rate of greater than or equal to 10 bpm is seen in two consecutive visits, or an increase in blood pressure of greater than or equal to 10 mmHg is seen, in two consecutive visits.
   
   In patients who previously had well controlled high blood pressure, treatment should be stopped in blood pressure exceeds 145/90 mmHg in two consecutive visits.
   
   
2. Use with caution in patients with mild to moderate liver impairment, as an increase in plasma has been seen in these patients. However, no adverse effects were reported.
   
   
3. Use with caution in patients who have mild to moderate kidney impairment.
   
   
4. Use with caution in patients who have epilepsy.
   
   
5. Use with caution in patients who have a family history of tics (motor or verbal).
   
   
6. Use with caution in patients who have a family history of glaucome or raised pressure within the eye ball.
   
   
7. Cardiac Valvulopathy has historically been linked to appetite suppressant drugs, although there is no clinical evidence to suggest that this is the case with Meridia.
   
   
8. There is concern in general that anti-obesity drugs may be associated with primary pulmonary hypertension. There is no evidence that this is the case with Meridia. Nevertheless, it would be prudent to look out for symptoms including progressive dyspnoea (shortness of breath or chest tightening), chest pain and swollen ankles during check-ups. The patient should be advised to consult a doctor immediately should any of these symptoms occur.
   
   
9. If you are going to prescribe Meridia, you will need to make arrangements to counsel and support your patient, offering appropriate advice on diet and exercise, and monitor the weight loss and any side effects.
   
   
10. Drug Interactions
    
    Caution should be used when prescribing Meridia with other drugs that affect the hepatic enzymes CYP2A4, CYP2C9 and CYP1A2 as these enzymes are involved in the metabolism of Meridia. For example, these drugs are CYP3A4 inhibitors: ketoconazole, erythromycin, cyclosporin.
    
    You should not prescribe other drugs which can increase the levels of serotonin in the brain, or the serious interaction serotonin syndrome can occur. Certain antimigraine drugs and opiods can increase brain serotonin levels, eg dihydroergotamine, pethidine.
    
    Caution should be used in prescribing Meridia alongside other drugs that can raise the patient's blood pressure or heart rate.
    
    You should allow two weeks to pass before stopping Meridia and starting a monoamine oxidase inhibitor.
    
    There is no data on the concurrent use of Meridia and Xenical.