Negara: Filipina
Bahasa: Inggris
Sumber: FDA (Food And Drug Administration)
Midazolam
Zuellig Pharma Corporation; Distributor: Zuellig Pharma Corporation
Midazolam
15 mg
Film-Coated Tablet
Transparent duplex blister pack x 10's (box of 100's)
Recipharm Leganes SLU, Spain
2023-01-18
1 DORMICUM ® Midazolam 1. DESCRIPTION 1.1. THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG Dormicum Tablet is a sleep-inducing agent belonging to the benzodiazepines. ATC code: N05CD08 1.2. TYPE OF DOSAGE FORM Tablets. 1.3. ROUTE OF ADMINISTRATION Oral use. 1.4. STERILE / RADIOACTIVE STATEMENT Not applicable. 1.5. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _midazolam as the maleate. Tablets containing midazolam maleate equivalent to 7.5 mg and 15 mg of midazolam. _Excipients: _ described as per local requirements (Dormicum tablets contain anhydrous lactose. For warning related to lactose monohydrate, see 2.4.1 General (Warnings and Precautions)). 2. CLINICAL PARTICULARS 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). In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without reevaluation 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 giv Baca dokumen lengkapnya