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If hypersensitivity reactions occur, discontinue use of Xeplion; initiate general supportive measures as clinically appropriate and monitor the patient until signs and symptoms resolve (see sections 4. Hyperglycaemia and diabetes mellitus. Hyperglycaemia, diabetes mellitus, and exacerbation of pre-existing diabetes including diabetic coma and ketoacidosis, have been reported during treatment with paliperidone. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines. Patients treated with Xeplion should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control. Significant weight gain has been reported with Xeplion use. Weight should be monitored regularly. Use in patients with prolactin-dependent tumours. Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin. Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history. Paliperidone should be used with caution in patients with a pre-existing tumour that may be prolactin-dependent. Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity. Based on pooled data from the three placebo-controlled, 6-week, fixed-dose trials with oral paliperidone prolonged release tablets (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2. Xeplion should be used with caution in patients with known cardiovascular disease (e. Xeplion should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. The plasma concentrations of paliperidone are increased in patients with renal impairment and therefore, dose adjustment is recommended in patients with mild renal impairment. Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance a. Blood and lymphatic system disorders. Metabolism and nutrition disorders. Respiratory, thoracic and mediastinal disorders. Skin and subcutaneous tissue disorders. Musculoskeletal and connective tissue disorders. Renal and urinary disorders. Pregnancy, puerperium and perinatal conditions. General disorders and administration site conditions, steroid use red.
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