Generic Medicine Info
May be taken with or without food.
Myasthenia gravis, narrow-angle glaucoma, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment, porphyria.
Special Precautions
Patient with depression, especially if suicidal risk may be present; history of psychiatric or personality disorders, acute alcoholism or drug abuse; hypoalbuminaemia; respiratory disease, chronic pulmonary insufficiency. Individuals at risk of falls. Elderly and debilitated patients. Renal and mild to moderate hepatic impairment. Patient Counselling This drug may cause sedation, amnesia, impaired concentration and muscle function; if affected, do not drive or operate machinery. Ensure to have an uninterrupted sleep of 7-8 hours after taking a dose. Monitoring Parameters Monitor CV, respiratory and mental status.
Adverse Reactions
Significant: CNS depression, anterograde amnesia, rebound insomnia (after treatment withdrawal); depression, confusional or agitational states, paradoxical reactions, including hyperactive or aggressive behaviour; hazardous sleep-related activities (e.g. sleep-driving, cooking and eating food, making phone calls while asleep); drug tolerance, psychological and physical dependence (long-term use). Rarely, anaphylaxis/anaphylactoid reactions, angioedema; bronchial hypersecretion and excessive salivation or drooling which may result in aspiration pneumonia; transient global amnesia or traveller's amnesia (if taken for sleep induction while travelling). Blood and lymphatic system disorders: Rarely, blood dyscrasias. Ear and labyrinth disorders: Rarely, vertigo. Eye disorders: Visual disturbances, double vision. General disorders and administration site conditions: Fatigue. Gastrointestinal disorders: Rarely, nausea, gastrointestinal upset. Hepatobiliary disorders: Rarely, jaundice. Musculoskeletal and connective tissue disorders: Muscle weakness. Nervous system disorders: Dizziness, drowsiness, ataxia, headache, dysarthria, tremor. Psychiatric disorders: Excitement, libido fluctuations, restlessness. Renal and urinary disorders: Rarely, urinary retention. Skin and subcutaneous tissue disorders: Rarely, rash. Vascular disorders: Rarely, hypotension.
Drug Interactions
Increased risk of sedation, respiratory depression and coma when taken with opioids. Enhanced CNS depressant effects with centrally-acting agents (e.g. other hypnotics, neuroleptics, tranquilisers, antidepressants, anti-epileptics, sedative antihistamines, analgesics, anaesthetics, lofexidine, nabilone). May reduce plasma concentration with rifampicin. Increased sedative effects with moxonidine, tizanidine, and baclofen. May enhance toxic effects with hydantoins or barbiturates. Cimetidine may inhibit the metabolism of nitrazepam.
CIMS Class
Hypnotics & Sedatives
ATC Classification
N05CD02 - nitrazepam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
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