DORMICUM TABLET 15 mg

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**2.2. Dosage and Administration** Duration of treatment should be as short as possible. Generally the duration of treatment varies from a few days to a maximum of 2 weeks. The tapering-off process should be tailored to the individual. Treatment with Dormicum should not be terminated abruptly (see 2.4.2 Drug Abuse and Dependence – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status. Owing to the rapid onset of action Dormicum tablets should be taken immediately before going to sleep, and swallowed whole with fluid. Dormicum can be taken any time of the day, provided the patient is subsequently assured of at least 7 – 8 hours undisturbed sleep. _Standard Dosage_ Dosage range: 7.5 – 15 mg Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of CNS adverse effects possibly including clinically relevant respiratory and cardiovascular depression. _Premedication_ In premedication, Dormicum should be given 30 – 60 minutes before the procedure. **2.2.1. Special Dosage Instructions** _Elderly and/or debilitated patients_ In elderly and/or debilitated patients the recommended dose is 7.5 mg. Elderly patients showed a larger sedative effect; therefore they may be at increased risk of cardio-respiratory depression as well. Thus, Dormicum should be used very carefully in elderly patients, and if needed, a lower dose should be considered. _Patients with hepatic impairment_ Patients with severe hepatic impairment should not be treated with Dormicum (see section 2.3 Contraindications). In patients with mild to moderate hepatic impairment, the lowest dose possible should be considered, not exceeding 7.5mg. (see 3.2.5 Pharmacokinetics in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with renal impairment_ In patients with severe renal impairment, Dormicum may be accompanied by more pronounced and prolonged sedation possibly including clinically relevant respiratory and cardiovascular depression. Dormicum should therefore be dosed carefully in this patient population and titrated for the desired effect. The lowest dose should be considered, not exceeding 7.5 mg; (see 3.2.5 Pharmacokinetics in Special Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).