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DIAZEPAM is a brand name for Diazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults 1) The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. 2) Cerebral palsy. 3) Muscle spasm. 4) As an adjunct to certain…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 4 weeks and treatment should be gradually withdrawn. Patients who have received benzodiazepines for a long time may require an extended withdrawal period.
Long-term chronic use is not recommended.
Adults:
Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: Usual dose – 2mg three times daily. Maximum dose up to 30mg daily in divided doses, adjusted on an individual basis. Insomnia associated with anxiety: 5-15mg before retiring.
Cerebral palsy: 2-60mg daily in divided doses. Upper motor neuronic spasticity: 2-60mg daily in divided doses. Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 2-15mg daily in divided doses. Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses.
Alcohol withdrawal: 5-20mg, repeated if necessary in 2 to 4 hours. Oral premedication in dental patients: 5mg the night before, 5mg on waking and 5mg two hours before the appointment. Oral Premedication before surgery: 5mg-20mg.
Paediatric population:
Alternative presentations of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5mg. Spastic children with minimal brain damage: 2-40mg daily in divided doses. 4): 2mg-10mg Elderly and debilitated patients: Doses should be half the above recommended doses.
4): The use of diazepam in hepatic impairment may precipitate coma, therefore the dose should be reduced or an alternative drug considered. In severe renal impairment the dose should be reduced. Method of Administration For oral administration
). These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia and anxiety:
A transient syndrome whereby the symptoms that led to treatment with diazepam may recur in an enhanced form on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
Since the risk of withdrawal phenomena/ rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Epilepsy As sudden discontinuation of benzodiazepines may result in convulsions, particular care should be taken in patients with epilepsy, other patients who have had a history of seizures or in alcohol or drug dependents.
Tolerance Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardio-respiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients. Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks.
Amnesia Diazepam may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours.
Anterograde amnesia may occur using therapeutic doses, the risk increases with higher doses. Hypo-albuminaemia Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects. Risk from concomitant use of opioids Concomitant use of Diazepam and opioids may result in sedation, respiratory depression, coma and death.
Alcohol and/or CNS depressants The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. 5). Diazepam should be used with caution in patients with a history of alcohol or drug abuse as these are patients predisposed to habituation and dependence.
Duration of Treatment The duration of treatment should be as short as possible depending on the indication. The patient must be evaluated after a period of no more than 4 weeks and then regularly thereafter in order to assess the need for continued treatment, especially if the patient is free of symptoms.
In general, treatment must not last any longer than 8-12 weeks, including the tapering off process. Extension beyond these periods should not take place without re- evaluation of the situation. 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 should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while diazepam 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.
When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Dependence and Withdrawal Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time.
Use of diazepam may lead to the development of physical and psychic dependence. The risk of dependence increases with the dose and duration of treatment, and in patients with a history of alcoholism and drug abuse or in patients with marked personality disorders.
1 • Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur) • Acute pulmonary insufficiency; respiratory depression, acute or chronic severe respiratory insufficiency (ventilatory failure may be exacerbated) • Myasthenia gravis (condition may be exacerbated) • Sleep apnoea (condition may be exacerbated) • Severe hepatic insufficiency (elimination half-life of diazepam may be prolonged) • Acute porphyria • Diazepam should not be used as monotherapy in patients with depression or those with anxiety and depression as suicide may be precipitated in such patients.
6). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Diazepam 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). Psychiatric and 'paradoxical' reactions Paradoxical reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
Should this occur, use of the drug should be discontinued. They are more likely to occur in children and the elderly. Caution should be exercised when using diazepam peri-operatively in children, as effects and timing of response may be unreliable and paradoxical effects may occur.
Special populations Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Safety and effectiveness of diazepam in paediatric patients below the age of 6 months have not been established.
2). Due to the myorelaxant effect there is a risk of falls and consequently hip fractures in the elderly. Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves.
2). A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. The usual precautions in treating patients with impaired renal function should be observed. In renal failure, the half-life of diazepam is not clinically significantly changed, and dose adjustment is usually not necessary.
2). Benzodiazepines should not be used in patients with severe hepatic insufficiency as they may precipitate encephalopathy. In patients with chronic hepatic disease dosage may need to be reduced. Patients with mental illness Benzodiazepines are not recommended for the primary treatment of psychotic illness.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients). Potentially suicidal individuals should not have access to large amounts of diazepam due to the risk of overdosing.
Extreme caution should be used in prescribing diazepam to patients with personality disorders. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Important information regarding the ingredients of this medicine Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction Not recommended Alcohol Diazepam should not be used together with alcohol (CNS inhibition enhanced sedative effects: impaired ability to drive/ operate machinery).
Sodium oxybate Avoid concomitant use (enhanced effects of sodium oxybate). HIV-protease inhibitors Avoid concomitant use (increased risk of prolonged sedation) – see below for zidovudine. Take into account Pharmacodynamic interactions If diazepam is used with other centrally acting agents, careful consideration has to be given to the pharmacology of the […]
Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. 8 Undesirable Effects). These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound insomnia and anxiety:
A transient syndrome whereby the symptoms that led to treatment with diazepam may recur in an enhanced form on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
Since the risk of withdrawal phenomena/ rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Epilepsy As sudden discontinuation of benzodiazepines may result in convulsions, particular care should be taken in patients with epilepsy, other patients who have had a history of seizures or in alcohol or drug dependents.
Tolerance Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardio-respiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients. Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks.
Amnesia Diazepam may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours.
Anterograde amnesia may occur using therapeutic doses, the risk increases with higher doses. Hypo-albuminaemia Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects. Risk from concomitant use of opioids Concomitant use of Diazepam 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 Diazepam 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). Psychiatric and 'paradoxical' reactions Paradoxical reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
Should this occur, use of the drug should be discontinued. They are more likely to occur in children and the elderly. Caution should be exercised when using diazepam peri-operatively in children, as effects and timing of response may be unreliable and paradoxical effects may occur.
Special populations Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Safety and effectiveness of diazepam in paediatric patients below the age of 6 months have not been established.
Elderly and debilitated […]