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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 has anti-convulsant, anxiolytic, sedative, muscle relaxant and amnesic properties. It is indicated: Adults: i) For the short-term relief (2 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…
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 14 days. 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: 2 mg, three times daily up to 30 mg daily in divided doses. Insomnia associated with anxiety: 5 mg to 15 mg before retiring. Muscle spasms: 2 mg to 15 mg daily in divided doses up to 60 mg in severe spastic disorders such as cerebral spasticity, epilepsy and muscle spasms associated with upper-motor neurone disease.
In the control of muscle spasms as in tetanus: 3 mg to 10 mg/kg body weight daily. Alcohol withdrawal symptoms: 5 mg to 20 mg repeated within 2 to 4 hours if necessary. Premedication in dental patients: 5 mg the night before, 5 mg on waking and another 5 mg 2 hours before the appointment.
Older people or debilitated patients:
The dosage should be half that recommended in adults.
Use in children and adolescents:
Night terrors and somnambulism: 1 mg to 5 mg daily before retiring. Premedication: 2 mg to 10mg. Management of cerebral spasticity: 2 mg to 40 mg daily in divided doses. In the control of muscle spasms as in tetanus: 3 mg to 10mg/kg body weight daily.
Doses should be repeated only on medical advice. Long-term chronic use is not recommended and treatment should always be tapered off gradually. When a benzodiazepine is used as hypnotic, treatment should, if possible, be intermittent.
Method of administration:
Oral.
Diazepam may cause drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, sedation, blurring of vision and ataxia. These may occur at the start of therapy but usually disappear with repeated administration.
Among elderly patients there may be confusion conditions at high dose levels. There is an increased risk of falls and associated fractures in elderly patients using benzodiazepines. Increased salivary and bronchial secretion has been reported, in particular in children.
Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. 4). 4). Abuse of benzodiazepines has been reported.
The frequencies of adverse events are ranked according to the following:
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 the available data). System Organ Class Frequency Undesirable effects Rare Blood dyscrasiasBlood and lymphatic system disorders Very rare Leukopenia Immune system disorders Very rare Anaphylaxis.
b Very common Drowsiness. Common Ataxia, impaired motor ability, tremor. c Concentration difficulties, balance disorders, dizziness, headache, slurred speech. Nervous system disorders Rare Unconsciousness, insomnia, dysarthria. Eye disorders Not known Reversible disorders of vision: blurred vision, diplopia, nystagmus.
Cardiac disorders Rare Bradycardia, heart failure including cardiac arrest. Vascular disorders Rare Hypotension, syncope. Uncommon Respiratory depression. Rare Respiratory arrest, Increased bronchial secretion. Respiratory, thoracic and mediastinal disorders Not Known Apnoea Gastrointestinal disorders Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), Increased salivary secretion.
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, 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. 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 long duration of action such as diazepam, withdrawal phenomena can become manifest between doses, 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. 2 Posology and Method of Administration), porphyria, coma and organic brain changes, particularly arteriosclerosis.
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.
6) • Acute porphyria Diazepam should not be used as monotherapy in patients with depression or those with anxiety with depression as suicide may be precipitated in such patients.
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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Rare Dry mouth, increased appetite. Hepatobiliary disorders Rare Jaundice, changes of hepatic parameters (elevation of ALT, AST, alkaline phosphatase). Skin and subcutaneous tissue disorders Uncommon Allergic skin reactions (itching, erythema, rash).
Musculoskeletal and connective tissue disorders Uncommon Myasthenia. Renal and urinary disorders Rare Urinary retention, incontinence. Reproductive system and breast disorders Rare Gynaecomastia, impotence, increased or reduced libido.
d conditions Not known Anaphylaxis Investigations Very rare Elevation of transaminases. a Known to occur when using benzodiazepines or benzodiazepine-like agents. These reactions may be quite severe. They are more likely to occur in children and the elderly.
4). b Pre-existing depression may be unmasked during benzodiazepine use. c May occur using therapeutic dosages, the risk increasing at higher dosages. 4). d The likelihood and degree of severity of withdrawal symptoms is dependent on the duration of treatment, dose level and degree of dependency.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 2 Posology and Method of Administration). Tolerance Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.
Loss of efficacy to the hypnotic effects may develop after repeated use for a few weeks. Dependence The risk of dependence (physical or psychological) increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse, or in patients with a marked personality disorder.
2). If physical dependence has developed, abrupt termination of treatment results in withdrawal symptoms. 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, confusional states, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures.
Withdrawal symptoms will be worse in patients with epilepsy, patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.
Rebound symptoms Symptoms including insomnia and anxiety may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. 2). Amnesia Anterograde amnesia may occur, most often several hours after ingestion.
8). Amnestic effects may be associated with inappropriate behaviour. 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. Potentially suicidal individuals should not have access to large amounts of diazepam due to the risk of overdosing.
Alcohol should be avoided during treatment with diazepam (additive […]