Product Information
Registration Status: ActiveSIN00167P
NITRADOS TABLET 5mg is approved to be sold in Singapore with effective from 1988-03-25. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN00167P.
This product contains Nitrazepam 5mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by DOUGLAS PHARMACEUTICALS LTD in NEW ZEALAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A benzodiazepine derivative used as an anticonvulsant and hypnotic.
Indication
Used to treat short-term sleeping problems (insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening.
Mechanism of Action
Nitrazepam belongs to a group of medicines called benzodiazepines. It acts on benzodiazepine receptors in the brain which are associated with the GABA receptors causing an enhanced binding of GABA (gamma amino butyric acid) to GABAA receptors. GABA is a major inhibitory neurotransmitter in the brain, involved in inducing sleepiness, muscular relaxation and control of anxiety and fits, and slows down the central nervous system. The anticonvulsant properties of nitrazepam and other benzodiazepines may be in part or entirely due to binding to voltage-dependent sodium channels rather than benzodiazepine receptors. Sustained repetitive firing seems to be limited by benzodiazepines effect of slowing recovery of sodium channels from inactivation.
Pharmacokinetics
- Absorption
- Bioavailability is 53-94% following oral administration.
- Distribution
- Metabolism
- Elimination
Toxicity
Nitrazepam is a drug which is very frequently involved in drug intoxication, including overdose. Nitrazepam overdose may result in stereotypical symptoms of benzodiazepine overdose including intoxication, impaired balance, slurred speech. In cases of severe overdose this may progress to a comatose state with the possibility of death.
Active Ingredient/Synonyms
1,3-dihydro-7-Nitro-5-phenyl-2H-1,4-benzodiazepin-2-one | 2,3-dihydro-7-Nitro-5-phenyl-1H-1,4-benzodiazepin-2-one | 7-Nitro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one | 7-Nitro-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one | Apodorm | Atempol | Benzalin | Calsmin | Eatan | Eunoctin | Gerson | Hipnax | Hipsal | Ibrovek | Imeson | Imesont | N-Desmethylnimetazepam | Nelbon | Nelmat | Neozepam | Neuchlonic | Nitrazepamum | Paxisyn | Pelson | Persopit | Radedorm | Relact | Somitran | Sonebon | Sonnolin | Trazenin | Nitrazepam |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.