RISPERDAL CONSTA FOR INJECTION 37.5 mg/vial

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**Dosage and Administration** For risperidone naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL® CONSTA®. **Adults (older than 18 years of age)** The recommended dose is 25 mg intramuscular every two weeks. Some patients may benefit from the higher doses of 37.5 mg or 50 mg. Doses higher than 50 mg every 2 weeks are not recommended. Where patients are not stabilized on oral risperidone the recommended dose is 25 mg RISPERDAL® CONSTA® every two weeks. Should a dosage adjustment be required, see two paragraphs down for guidance on dose increments. Patients who have no previous history of risperidone use should be pretreated with oral RISPERDAL® for several days as clinically feasible, to assess tolerability before the first injection. For those patients stabilized on a fixed dose of oral risperidone for two weeks or more, the following conversion schemes should be considered. Patients treated with a dosage of 4mg or less oral risperidone should receive 25mg RISPERDAL® CONSTA®, patients treated with higher oral doses should be considered for the higher RISPERDAL® CONSTA® dose of 37.5 mg. Dose increments from 25mg to 37.5mg or from 37.5mg to 50mg should be considered after a minimum of four weeks after the previous dose of adjustment. The effect of this dosage adjustment on the patient’s clinical status should not be anticipated earlier than 3 weeks after the first injection with the higher dose. Supplementation with oral risperidone, where appropriate, with the previously used dose, should be provided during the first three weeks after the first injection of RISPERDAL® CONSTA® to ensure coverage until main release of risperidone from the injection site has begun. After the first three weeks of RISPERDAL® CONSTA® treatment, oral risperidone should be discontinued. However, if clinically appropriate, oral risperidone up to 4mg/day can be temporarily added to the treatment with RISPERDAL® CONSTA® while establishing an individual patient’s optimal dose. The clinical value of adding oral risperidone should be routinely reassessed and, if there is continuing need for oral supplementation, consideration should be given to increasing dose of RISPERDAL® CONSTA®. **Special populations** **_Elderly (65 years of age and older)_** The recommended dose is 25 mg intramuscular every two weeks. Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL® CONSTA® injection (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Hepatic and renal impairment_** RISPERDAL® CONSTA® has not been studied in hepatically and renally impaired patients. If hepatically or renally impaired patients require treatment with RISPERDAL® CONSTA®, a starting dose of 0.5 mg twice daily oral risperidone is recommended during the first week. The second week 1 mg twice daily or 2 mg once daily can be given. If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL® CONSTA® can be administered every 2 weeks. **_Children (18 years of age and younger)_** RISPERDAL® CONSTA® has not been studied in children younger than 18 years. **Administration** RISPERDAL® CONSTA® should be administered every two weeks by deep intramuscular deltoid or gluteal injection using the appropriate safety needle. For deltoid administration, use the 1-inch needle alternating injections between the two arms. For gluteal administration, use the 2-inch needle alternating injections between the two buttocks. Do not administer intravenously (see _Warnings and Precautions – Administration_ and _Instructions for use and Handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).