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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 short term use (up to 4 weeks) and only when the disorder is severe, disabling or subjecting the patients to extreme distress. The use of benzodiazepines to treat short-term "mild" anxiety is considered to be inappropriate and unsuitable. Adults: • symptomatic treatment of anxiety occurring…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration: oral. 4). When treatment is started the patient should be informed that treatment will be of limited duration the dosage will be progressively decreased there is the possibility of rebound phenomena (thereby minimising concerns about symptoms that may develop on dose reduction) Anxiety Adults Patients should not be started on 5mg and 10mg tablets as the usual starting dose is 2mg three times daily (use lowest effective dose).
Usual dose 2-5 mg three times daily (adjusted to individual response) Maximum -30mg daily (in divided doses) Insomnia associated with anxiety-5 to 15mg before retiring Treatment should not continue at full dose for more than 2 weeks with a 2 week tapering off process.
4) Limits of tolerance very wide Care with dose selection/revision Patients who have taken benzodiazepines for prolonged time may require a longer period of dosage reduction and specialist help may be appropriate. 4). Treatment should be given for the shortest possible duration.
If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary.
Dose related adverse effects which occur commonly with diazepam and which may persist into the following day, even after a single dose includes sedation, drowsiness, unsteadiness and ataxia. During the first week of administration or when high doses are used they may have a sedative effect and cause some degree of drowsiness.
In such cases there is an advantage in administering half the total daily intake at night, the remainder being given in divided doses during the day. The elderly and debilitated are particularly sensitive to the effect of centrally-depressant drugs and may experience confusion, especially if organic brain changes are present, the dosage of diazepam should not exceed one-half that recommended for other adults.
The most commonly reported undesirable effects are drowsiness, reduced alertness and muscle weakness. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Pre-existing depression may be unmasked during benzodiazepine use.
4 Special warnings and special precautions for use). Skin and subcutaneous tissue disorder Allergic reactions (skin rash or itching) occur rarely. Central and peripheral nervous disorders Drowsiness, sedation, unsteadiness, ataxia is common (these effects are dose- related and may persist into the following day even after a single dose).
Headache, light headedness, vertigo, dystonic effects occur rarely. Impaired motor ability, dizziness, muscle weakness, tremor, dysarthia and slurred speech. Vision disorders Blurred vision. Diplopia Visual disturbances occur rarely. Psychiatric disorders Libido fluctuations occur rarely.
4 Special warnings and precautions for use), concentration difficulties, abnormal psychological reactions, behavioural adverse effects include paradoxical aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, aggressiveness, delusions, rages, nightmares, hallucinations, psychoses, inappropriate behaviour, numbed emotions and the uncovering of depression with suicidal tendencies and dependence.
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. Tolerance Limits of tolerance in patients with organic cerebral changes ( particularly arteriosclerosis) or cardio-respiratory insufficiency may be very wide.
2) 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). Dependence 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. The risk of dependence is greater in patients with history of alcohol or drug abuse, or in patients with a marked personality disorder.
Therefore regular monitoring of such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should occur while diazepam Is being discontinued.
• Hypersensitivity to benzodiazepines and any other ingredients of diazepam tablets • Acute pulmonary insufficiency, respiratory depression: sleeps apnoea syndrome (risk of further respiratory depression. • Phobic or obsessional states/ chronic psychosis (inadequate evidence of safety and efficacy).
6) • Myasthenia gravis (increased muscle weakness) • Acute porphyria (may precipitate an attack) Diazepam should not be used alone in depression or anxiety with depression (may precipitate suicide). They should not be used for the treatment of chronic psychosis, hyperkinesis (paradoxical reactions may occur).
Amnesia may occur. 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take these tablets.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Diazepam in United Kingdom.
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4). Abuse of benzodiazepines has been reported. 4) Gastro-intestinal system disorders Gastrointestinal upsets occur rarely. Increased salivary secretion, gastrointestinal disturbances, constipation, nausea, dry mouth. Hepatobiliary disorders Jaundice occurs rarely.
Very rarely elevated transaminases and alkaline phosphatases. Endocrine disorders Gynaecomastia. Cardio disorders Hypotension occurs rarely. Respiratory system disorders Respiratory depression, apnoea. Blood disorders Blood dyscrasias occur rarely.
Urinary system disorders Urinary retention occurs rarely. Incontinence General disorders and administration site conditions Fatigue most commonly reported. Anaphylaxis. 4 Special warnings and precautions) The elderly and patients with impaired hepatic function will be particularly susceptible to the adverse effects listed above.
It is advisable to review treatment regularly and to discontinue use as soon as possible. Discontinuation of therapy may result in withdrawal or rebound phenomena.
Withdrawal effects Withdrawal symptoms:
Development of dependence is common after regular use, even in therapeutic doses for short periods, particularly in patients with a history of drug or alcohol abuse or marked personality disorders. 4 Special Warnings and Special Precautions for Use).
Symptoms of benzodiazepine withdrawal include anxiety, depression, impaired concentration, insomnia, headache, dizziness, tinnitus, loss of appetite, tremor, perspiration, irritability, perceptual disturbances such as hypersensitivity to physical, visual, and auditory stimuli and abnormal taste, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, and orthostatic hypotension.
Rare and more serious symptoms include muscle twitching, confusional or paranoid psychosis, convulsions, hallucinations, and a state resembling delirium tremens. Broken sleep with vivid dreams and increased REM sleep may persist for some weeks after withdrawal of benzodiazepines.
Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via:
United Kingdom Yellow Card Scheme […]
2). Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time. 8). These include headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability; sleep disturbance, diarrhoea and mood changes.
In severe cases the following may occur: a feeling of unreality or of being separated from the body, depersonalisation, confusion state, numbness and tingling of extremities, hypersensitivity of light, noise and physical contact, psychotic manifestations including hallucinations, or epileptic seizures (particular care in patients with history of fits/seizures).
Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past (particular care required), but can occur following abrupt cessation in patients on normal therapeutic doses for short period of time.
When diazepam is being used it is important not to change to a benzodiazepine with short duration of action ,as withdrawal symptoms may be precipitated. Rebound symptoms 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 Symptoms including insomnia, anxiety, mood changes and restlessness may occur on withdrawal of treatment.
2) Amnesia Benzodiazepines may induce anterograde amnesia. Amnestic effects may be associated with inappropriate behaviour. Anterograde amnesia may occur using therapeutic doses, the risk increases with higher doses. This condition may occur, most often several hours after ingestion.
8). Bereavement/loss Psychological adjustment may be inhibited by benzodiazepines Psychiatric and ‘paradoxical’ reactions Reactions such as restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects can occur.
These reactions are more likely in children and the elderly, and extreme caution should be used in prescribing benzodiazepines to patients with personality disorders. Should they occur, treatment should be discontinued. 2) Avoid in those at risk of becoming confused and/or ataxic (increased likelihood of a fall and injury to themselves) if, based on clinical need, a decision to treat is nevertheless taken, start treatment at a lower dose.
• Children-use as pre-medication Extreme caution required as the effects and timing of action/response of diazepam used peri-operatively in children may be unreliable and/or paradoxical effects may occur. • Patients with depression Diazepam should not be used alone to treat depression or anxiety associated with depression as may precipitate suicide.
• Patients with a history of alcohol &drug abuse Use with extreme caution (risk of abuse/dependence). 3) Patients with marked personality disorderUse with extreme caution • Patients with severe hepatic insufficiency Not recommended (may precipate 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). Intolerance to […]