DORMICUM TABLET 15 MG [SIN00476P]

Product Info

DORMICUM TABLET 15 MG

[SIN00476P]

2.1. Therapeutic Indications

• Short-term treatment of insomnia

  Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

• Sedation in premedication before surgical or diagnostic procedures.

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).

2.3. Contraindications
Dormicum must not be used in patients with:

• Severe respiratory insufficiency;

• Severe hepatic impairment (benzodiazepines are not indicated to treat patients with severe hepatic impairments as they may cause encephalopathy);

• Sleep apnea syndrome;

• Known hypersensitivity to benzodiazepines or to any of their formulation excipients;

• Myasthenia gravis;

Dormicum tablets should not be given to children because the available strengths of tablets do not allow for appropriate dosing in this patient population.

Dormicum tablets should not be given to patients receiving concomitant therapy with very strong CYP3A inducers or inhibitors (ketoconazole, itraconazole, voriconazole, HIV protease inhibitors including ritonavir-boosted formulations and the HCV protease inhibitors boceprevir and telaprevir (see 2.4.4 Interactions with other Medicinal Products and other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).