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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: Adult - Short-term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to extreme distress - Symptomatic treatment of acute alcohol withdrawal.
Verbatim from this product's MHRA label. Tap a section to expand.
Standard dosage For optimal effect, the dosage should be carefully individualised. Treatment should begin at the lowest effective dose appropriate to the particular condition. In order to obtain suitable doses of less than 5mg diazepam alternative products have to be used.
Duration of treatment The duration of treatment should be as short as possible. In general, treatment should not last longer than 4 weeks including tapering off process. Extension beyond this period should not take place without re-evaluation of the patient’s status.
The patient must be re-evaluated after a period of no more than 4 weeks and then regularly thereafter in order to assess the need for continued treatment. - Long-term chronic use is not recommended. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status with special expertise.
Tapering off Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced.
Adults:
Anxiety - Usual dose: 2 mg to 5 mg diazepam two to three times daily. - Maximum dose: In severe cases the dose may be incrementally increased up to 30 mg diazepam daily in 2 to 4 divided doses. Adjusted on an individual basis. Alcohol withdrawal symptoms - 5 mg to 20 mg diazepam repeated once within 2 to 4 hours if necessary.
Special populations:
Individuals in the following patient groups should be checked regularly at the start of treatment. Monitoring during treatment is essential in order to minimise the dosage and/or the frequency of administration to prevent overdose due to accumulation, such as in children and adolescents, elderly patients and patients with impaired liver function.
In order to obtain suitable doses of less than 5mg diazepam alternative products have to be used. Elderly patients Distribution, elimination and clearance are changed in elderly patients, resulting in an extended half-life. The dose level should therefore be reduced to 50 % of the normal recommended dose.
These patients should be checked regularly at the start of treatment in order to minimise the dosage and/or the frequency of administration to prevent overdose due to accumulation. 5 mg once or twice daily. Increased gradually as necessary and tolerated.
Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly 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). 3 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 depressionRespiratory, thoracic and mediastinal disorders Rare Respiratory arrest, increased bronchial secretion Uncommon Gastrointestinal disorders (nausea, vomiting, constipation, diarrhoea), increased salivary secretion.
4 Investigations Very rare Elevation of transaminases 1 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). 2 Pre-existing depression may be unmasked during benzodiazepine use.
Concomitant use of alcohol/CNS depressants The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. 5).
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 benzodiazepines and opioids should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe benzodiazepines concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible. 5). Medical history of alcohol or drug abuse Diazepam should be used with extreme caution in patients with a history of alcohol or drug abuse.
Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Dependence Treatment with diazepam can result in mental or physical dependency. The risk increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or 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. Withdrawal Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
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 a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
1. - Myasthenia gravis. - Sleep apnoea syndrome. - Severe hepatic insufficiency. - Severe respiratory insufficiency. g. hypnotics, analgesics, antidepressants, antipsychotics).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Impaired renal function Dose adjustment is usually not necessary. However, caution should be exercised when treating renally impaired patients with diazepam. Impaired liver function The dose must be reduced for individuals with cirrhosis and impaired liver function.
3). 1) as safety and efficacy have not been established. No data are available. Method of Administration For oral administration.
3 May occur using therapeutic dosages, the risk increasing at higher dosages. 4). 4 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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Sudden discontinuation of treatment with diazepam in patients with epilepsy or other patients who have had a history of seizures can result in convulsions or epileptic status.
Convulsions can also be seen following sudden discontinuation in individuals with alcohol or drug abuse. Discontinuation should be gradual in order to minimise the risk of withdrawal symptoms. 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.
Amnesia Anterograde amnesia may occur even if benzodiazepines are used within the normal dose range, though this is seen in particular at high dose levels. 8). Amnestic effects may be associated with inappropriate behaviour. Psychiatric and 'paradoxical' reactions Paradoxical reactions (such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects) have been reported from the use of benzodiazepines.
Such reactions are possibly seen more often in the treatment of children and elderly patients and should result in the discontinuation of treatment. Specific patient groups 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.
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.
Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy. In patients with chronic hepatic disease dosage may need to be reduced. 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. Diazepam Tablet contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.