Source: Registered Drug Product Database (NG) Publisher: SWISS PHARMA NIGERIA LTD, 5 Dopemu Road, Agege, Lagos, Nigeria
Flunitrazepam is a benzodiazepine used to manage anxiety disorders and insomnia.
For short-term treatment of severe insomnias, that are not responsive to other hypnotics.
The recommended dosage for adult patients is 0.5-1 mg/day. In exceptional circumstances the dose may be increased to 2 mg. Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. The product should be taken just before going to bed.
Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to 2 weeks, with a maximum of 4 weeks including a tapering-off process.
In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without a re-evaluation of the patient’s status. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient be made aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
The recommended dosage for elderly patients is 0.5 mg. In exceptional circumstances the dose may be increased to 1 mg.
Patients with impaired liver function should receive a reduced dose.
A lower dose is recommended for patients with chronic respiratory insufficiency, due to the risk of respiratory depression.
Flunitrazepam has a long half-life of 18-26 hours and an active metabolite which has a half life of 36-200 hours, which means flunitrazepam effects after nighttime administration persist throughout the next day. Residual ‘hangover’ effects after nighttime administration of flunitrazepam such as sleepiness, impaired psychomotor and cognitive may persist into the next day which may impair the ability of users to drive safely and increase risks of falls and hip fractures.
Flunitrazepam is lipophilic and is metabolised hepatically via oxidative pathways. The enzyme CYP3A4 is the main enzyme in its phase 1 metabolism.
3 years.
The recommended maximum storage temperature for Swinol tablets is 30°C.
All packs should be protected from light and the blister packs should be protected from moisture i.e., stored in a dry place.
SWINOL Tablets are packed in a strip foil of 3 × 10 tablets.
Any unused product should be disposed of in accordance with local requirements.
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