Composition, Properties, Indications, Contraindications, Dosage and administration, Precautions, Side effects, Presentation, Storage, NAFDAC Reg. No. and Manufacturer of Nitrazepam Sedative Tablet Medicine.
Each tablet contains Nitrazepam B. P. 5mg
Nitrazepam is 7-nitro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin
It is an intermediate-acting benzodiazepine. It has anti-convulsant, anxiolytic, sedative, muscle relaxant and amnestic properties.
Nitrazepam is used principally as a hypnotic, as it possess marked sedative properties. It is used in the short-term management of insomnia acting in 30 to 60 minutes to produce sleep lasting for 6 to 8 hours. Nitrazepam has also been used in epilepsy notably for infantile spasms (as for example in West’s syndrome).
It is contra-indicated in chronic psychosis and in phobic or obsessional states. Nitrazepam is also contra-indicated in pregnancy and breast-feeding.
DOSAGE AND ADMINISTRATION
Adults: 1 tablet (5mg) before retiring. This average dosage may, if necessary, be increased up to 10mg for outpatients, and up to 20mg for inpatients.
Elderly: Half tablet (2.5mg). the tablet may be swallowed whole, chewed or dissolved in liquid.
Caution should be exercised in using nitrazepam in conjunction with other drugs that act on the central nervous system.
Hang-over may affect a patient’s ability to drive or operate machinery and increase the effects of alchohol; prolonged use and abrupt withdrawal thereafter should be avoided.
Caution should be taken in obstructive lung disease, respiratory depression, pregnancy, breast-feeding, patients with history of drug abuse. In elderly and debilitated patients, as well as in hepatic and renal impairment, dosage should be reduced.
Nitrazepam may cause hang-over and light-headedness, also hang-over with drowsiness, dizziness, ataxia (particularly in the elderly); occasional confusion, dry mouth, hypersensitivity reactions. Prolonged use may give rise to cumulation, tolerance, rebound insomnia and dependence.
Pack of 250 tablets.
KEEP MEDICINES AWAY FROM CHILDREN.
KEEP IN A COOL, DARK AND DRY PLACE.
NAFDAC REG. NO.: 04-0060
VITABIOTICS (NIG.) LTD.
35, Mobolaji Johnson Avenue
Oregun Industrial Estate, Ikeja, Lagos, Nigeria