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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 Benzodiazepines, including diazepam, are indicated for the short-term relief (up to 4 weeks only) of anxiety that 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. Cerebral palsy.…
Verbatim from this product's MHRA label. Tap a section to expand.
Recommended dose and dosage schedule:
As directed by a physician. Posology As an anxiolytic, the lowest dose which can control symptoms should be used. It should not be continued beyond 4 weeks. Long-term chronic use is not recommended. Treatment should always be tapered off gradually.
Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced. Adults Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 5 – 30 mg daily in divided doses.
Alcohol withdrawal: 5-20 mg, repeated if necessary in 2-4 hours. Insomnia associated with anxiety: 5-15 mg before bedtime. Cerebral palsy: 5-60mg daily in divided doses. Upper motor neuronic spasticity: 5-60mg daily in divided doses. Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 5-15mg daily in divided doses.
Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses. 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.
Children 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: 5-40mg 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. 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 dependants.
• 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.
• Alcohol should be avoided during treatment with diazepam (additive CNS depression). • 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. • In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. • 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.
• The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. 5). • 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. 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.
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.
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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• Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects. • Extreme caution should be used in prescribing diazepam to patients with personality disorders. • 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. 2) • 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). • 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.
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. Paediatric Population • 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. • 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. • 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.
• Patients with rare hereditary problems of galactose intolerance, the Lapp 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 […]
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. 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 dependants.
• 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.
• Alcohol should be avoided during treatment with diazepam (additive CNS depression). • 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. • In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. • 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.
• Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects. • Extreme caution should be used in prescribing diazepam to patients with personality disorders. • 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. 2) • 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). • 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.
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. In this respect, it is strongly recommended to inform […]