NITRAZEPAM

Posology:

Adults: 5mg before retiring. This dose may, if necessary, be increased to 10mg.

Elderly:

Elderly or debilitated patients: the elderly or patients with impaired renal and/or hepatic function will be particularly susceptible to the adverse effects of Nitrazepam. Doses should not exceed half those normally recommended. If organic brain changes are present, the dosage of Nitrazepam should not exceed 5mg in these patients.

Other Populations In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, the dosage may need to be reduced. Paediatric population Nitrazepam tablets are contraindicated for use in children.

Dosage should be adjusted on an individual basis. Treatment should, if possible, be on an intermittent basis. Treatment should be as short as possible and should be started with the lowest recommended dose. The maximum dose should not be exceeded.

Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks; including the tapering off process. Patients who have taken Benzodiazepines for a prolonged time may require a longer period during which doses are reduced.

Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use. In certain cases extension beyond the maximum treatment period may be necessary, if so, it should not take place without re-evaluation of the patient’s status.

Long-term chronic use is not recommended. 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 decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena (see Undesirable Effects) thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.

Nitrazepam therapy should not be stopped abruptly, but the dose tapered off. The product should be taken just before going to bed. In addition, for long acting benzodiazepines, it must be stated that the patient should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.

Within the system organ classes, adverse drug reactions are listed under heading of frequency (number of patients expected to experience the reaction, using the following convention: Very common (>1/10) : common (>1/100 to <1/10); uncommon (>1/1,000 to >1/100); rare (>1/10,000 to >1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data) Blood and lymphatic system disorders: Frequency not known: Blood disorder Immune system disorders: Frequency not known: Allergic skin reaction, anaphylactic reaction, angioedema Psychiatric disorders: Common: Numbed emotions, confusion state, depression (pre-existing depression may be unmasked).

Rare:

Libido disorder Frequency not know: Emotional disorder, delirium, insomnia, cognitive impairment, physical and psychological dependence (even at therapeutic doses), withdrawal syndrome accompanies by reactions including mood changes, anxiety, and restlessness, drug abuse, agitation, aggression, delusion, anger, nightmare, hallucination, psychotic disorder.

Since the risk of withdrawal/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

Nervous system disorders:

Common: Drowsiness, reduced alertness, headache, dizziness Rare: Vertigo, dysarthria Frequently not known: Balance disorder, hypokinesia, tremor, anterograde amnesia, epilepsy. The elderly are particularly sensitive to the effects of centrally-depressant drugs.

Eye disorders:

Common: Diplopia Rare: Visual impairments Vascular disorders: Rare: Hypotension Respiratory, thoracic and mediastinal disorders: Frequency not known: Respiratory depression, increased bronchial secretion Gastrointestinal disorders: Rare: Abdominal discomfort, nausea Hepatobiliary disorders: Frequency not known: Jaundice Skin and subcutaneous tissue disorders: Rare: Skin rashes Frequency not known: Urticaria, pruritus, dermatitis, erythema multiforme, Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders: Common: Muscle weakness Frequency not known: Muscle spasm Due to the myorelaxant effect there is a risk of falls and consequently fractures in theelderly Renal and urinary disorders: Rare: Urinary retention General disorders and administration site conditions: Common: Fatigue, ataxia Frequency not known: Irritability, rebound effect Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced. Benzodiazepines are contraindicated in patients with severe hepatic insufficiency. Nitrazepam should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients.

An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Benzodiazepines are not recommended for the primary treatment of phobic or obsessional states, chronic psychosis or psychotic illness.

Concomitant use of Nitrazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Nitrazepam with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). If the patient is awoken during the period of maximum drug activity, recall may be impaired. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

Use of Benzodiazepines may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders.

Regular monitoring in such patients is essential; routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as depression, headaches, muscle weakness, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia, irritability, sweating, and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.

1. Hypersensitivity reactions with the benzodiazepines including rash, angioedema and hypertension have been reported on rare occasions in susceptible patients. Use of this drug is also contraindicated in patients with severe respiratory insufficiency, short-term treatment of insomnia in children and juveniles, acute pulmonary insufficiency; respiratory depression; phobic or obsessional states; chronic psychosis; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency; use in children.