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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: Diazepam is indicated for the short-term relief only (2-4 weeks) 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. The use of benzodiazepines to treat short-term "mild"…
Verbatim from this product's MHRA label. Tap a section to expand.
As an anxiolytic, the lowest effective dose which can control the symptoms should be employed; dosage regimes should not exceed beyond 4 weeks and treatment with benzodiazepines should always be gradually withdrawn. Patients who have received benzodiazepines for a long time may require an extended withdrawal period during which the doses are reduced.
Long-term chronic use is not recommended. Long-term chronic use is not recommended; treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment evaluated, especially if the patient is symptom free.
It should not exceed 2-3 months for anxiety and 4 weeks for insomnia, including the tapering off period. Extension beyond these periods should not take place without re-evaluation of the situation. 4). Treatment should be given for the shortest possible duration.
Anxiety States:
Adults Usual dose of 2 mg three times daily. Severe anxiety states: 15-30 mg daily in divided doses.
Insomnia associated with anxiety:
Adults 5 - 15 mg before retiring. The maximum dose should not be exceeded.
Conditions associated with muscle spasm:
Spastic children with minimal brain damage: 2-40 mg daily in divided doses. Cerebral palsy of adults, particularly associated with athetoid movements: 2-60 mg daily in divided doses. Upper motor neuronic spasticity : 5-60 mg daily in divided doses.
Muscle spasm of varied aetiology: fibrositis, cervical spondylosis: 2-15 mg daily in divided doses.
Premedication:
Adults: 5-20 mg Children: 2-10 mg Benzodiazepines should not be given to children without careful assessment of the indication, and the duration of treatment must be kept to a minimum.
Elderly or debilitated patients:
Doses should not exceed half the dose recommended for adults. These patients should be monitored regularly at the start of treatment in order to minimise if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
). These may consist of headache, muscle pain, tension, extreme anxiety, confusion, restlessness and irritability. In severe cases derealization, depersonalisation, numbness and tingling of the extremities, hyperacusis, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures may occur.
Rebound insomnia and anxiety may occur. This is a transient syndrome where the symptoms that led to the use of diazepam recur in an enhanced form. This may occur on withdrawal of treatment and may be accompanied by other reactions including mood changes, anxiety, sleep disturbances and restlessness.
Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be 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 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 benzodiazepines may develop after repeated use for a few weeks.
Alcohol should be avoided during treatment with diazepam (additive CNS depression). 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 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). Amnesia - Benzodiazepines may induce anterograde amnesia. Amnestic effects may be associated with inappropriate behaviour. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
Duration of Treatment - The duration of treatment should be as short as possible depending on the indication, but should not exceed 4 weeks including tapering off process. Treatment should not continue beyond 4 weeks without re-evaluation of the patient's condition.
Where long-term therapy is essential, it is recommended that the patient's requirements be reviewed on a regular basis. 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. 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 dependence potential on benzodiazepines is low, particularly when restricted to short term use, when high doses are used this increases, especially when given over long periods.
Patients with marked personality disorders, a history of alcoholism or drug abuse are most susceptible. Monitoring of patients at regular intervals is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually.
8 Undesirable Effects). These may consist of headache, muscle pain, tension, extreme anxiety, confusion, restlessness and irritability. In severe cases derealization, depersonalisation, numbness and tingling of the extremities, hyperacusis, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures may occur.
Rebound insomnia and anxiety may occur. This is a transient syndrome where the symptoms that led to the use of diazepam recur in an enhanced form. This may occur on withdrawal of treatment and may be accompanied by other reactions including mood changes, anxiety, sleep disturbances and restlessness.
Benzodiazepines should not be used for phobic or obsessional states. They should not be used as monotherapy in patients with depression or those with anxiety and depression as suicide may be precipitated in such patients.. They should not be used for the treatment of chronic psychosis, hyperkinesis (paradoxical reactions may occur).
Amnesia may occur. Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and aggressive behaviour towards self and others may be precipitated. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.
Withdrawal from benzodiazepines may be associated with physiological and psychological symptoms of withdrawal including depression. Withdrawal symptoms may occur following normal therapeutic doses given for short periods of time. An underlying cause of insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.
Benzodiazepines are also contraindicated in patients with known sensitivity to benzodiazepines and any of the excipients, severe or acute pulmonary insufficiency, severe hepatic insufficiency (elimination half-life of diazepam may be prolonged), acute porphyria, myasthenia gravis (condition may be exacerbated), sleep apnoea syndrome (condition may be exacerbated),respiratory depression, acute or chronic severe respiratory insufficiency (ventilatory failure may be exacerbated).
6). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
Patients with chronic pulmonary insufficiency, and patients with chronic hepatic disease may require a reduced dosage. In renal failure the half-life of diazepam is unchanged and therefore no dosage adjustments are required in these patients.
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.
Paradoxical reactions such as 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, the use of the drug should be discontinued. They are more likely to occur in children and in the elderly. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment […]
Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be 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 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 benzodiazepines may develop after repeated use for a few weeks.
Alcohol should be avoided during treatment with diazepam (additive CNS depression). 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 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). Amnesia - Benzodiazepines may induce anterograde amnesia. Amnestic effects may be associated with inappropriate behaviour. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
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.
Patients with chronic pulmonary insufficiency, and patients with chronic hepatic disease may require a reduced dosage. In renal failure the half-life of diazepam is unchanged and therefore no dosage adjustments are required in these patients.
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.
Paradoxical reactions such as 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, the use of the drug should be discontinued. […]