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DIAZEPAM RECTUBES is a brand name for Diazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Diazepam rectal tubes may be used in severe or disabling anxiety and agitation; epileptic and febrile convulsions; to relieve muscle spasm caused by tetanus; as a sedative in minor surgical and dental procedures, or other circumstances in which a rapid effect is required but where intravenous injection is…
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage depends on age and weight. 5mg/kg If convulsions are not controlled other anticonvulsive measures should be instituted. The dose can be repeated every 12 hours. Elderly and debilitated patients should be given not more than one half the appropriate adult dose.
Dosage reduction may also be required in patients with liver or kidney dysfunction. The solution is administered rectally. Adults should be in the lateral position; children should be in the prone or lateral position. a) Tear open the foil pack.
Remove the cap. b) Insert the tube nozzle completely into the rectum. For children under 15kg, insert only halfway. Hold the tube with the spout downwards. The contents of the tube should be completely emptied by using firm pressure with the index finger and thumb.
c) To avoid suction, maintain pressure on the tube until it is withdrawn from the rectum. Press together the patients buttocks for a short time. In anxiety, the duration of treatment should be as short as possible and generally not more than 8-12 weeks, including a tapering off process (see
8 Withdrawal symptoms). Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that dose is decreased gradually. When benzodiazepines with a long duration of action, such as diazepam, 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) 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. 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.
Rebound 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 or sleep disturbances and restlessness.
It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. Benzodiazepines should not be given to children for anxiety without careful assessment of the need to do so.
8 Undesirable Effects). The condition occurs most often several hours after administration. To reduce the risk, where appropriate and possible, patients should be able to have an uninterrupted sleep of 7-8 hours after administration.
8 Undesirable Effects). Should they occur, use of diazepam should be discontinued. Use in patients with concomitant mental illness or addiction Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
4 Special Warnings and Special Precautions for Use). Patients requiring chronic dosing should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration, to prevent overdose due to accumulation.
3 Contraindications Known hypersensitivity to benzodiazepines or any of the ingredients. Severe or acute respiratory insufficiency/depression. Sleep apnoea syndrome Severe hepatic insufficiency Diazepam should not be used in phobic or obsessional states, nor be used alone in the treatment of depression or anxiety associated with depression due to the risk of suicide being precipitated in this patient group.
Diazepam should not be used for the primary treatment of psychotic illness. In common with other benzodiazepines the use of diazepam may be associated with amnesia and diazepam should not be used in cases of loss or bereavement as psychological adjustments may be inhibited.
2 Posology and Method of Administration), chronic pulmonary insufficiency, porphyria, myasthenia gravis, coma, organic brain changes, particularly arteriosclerosis. Diazepam may enhance the effects of other CNS depressants; their concurrent use should be avoided.
2 Posology and Method of Administration). Dependence and withdrawal symptoms Use of benzodiazepines may lead to the development of physical and psychological dependence upon these products. This should be considered when treating patients for more than a few days.
The dependence potential of diazepam is low when limited to short-term use but increases with the dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse. 8 Withdrawal symptoms). Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that dose is decreased gradually.
When benzodiazepines with a long duration of action, such as diazepam, 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) 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.
Known hypersensitivity to benzodiazepines or any of the ingredients. Severe or acute respiratory insufficiency/depression. Sleep apnoea syndrome Severe hepatic insufficiency Diazepam should not be used in phobic or obsessional states, nor be used alone in the treatment of depression or anxiety associated with depression due to the risk of suicide being precipitated in this patient group.
Diazepam should not be used for the primary treatment of psychotic illness. In common with other benzodiazepines the use of diazepam may be associated with amnesia and diazepam should not be used in cases of loss or bereavement as psychological adjustments may be inhibited.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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As with other benzodiazepines, extreme caution should be used if prescribing diazepam for patients with personality disorders. The disinhibiting effects of benzodiazepines may be manifested as the precipitation of suicide in patients who show aggressive behaviour towards self and others.
The excipient benzoic acid may be mildly irritant to mucous membranes. 70mmol sodium per dose. To be taken into consideration by patients on a controlled sodium diet. 5 Interaction with other medicinal products and other forms of interaction Alcohol: Concomitant intake of alcohol is not recommended.
The sedative effect of diazepam may be enhanced. 7 Effects on ability to drive and use machines).
Anaesthetics and narcotic analgesics:
Enhanced sedation or respiratory and cardiovascular depression. In the case of narcotic analgesics, enhancement of euphoria may also occur leading to an increase in psychological dependence. g. erythromycin and isoniazid) may reduce the clearance of benzodiazepines and potentiate their actions.
Known inducers of hepatic enzymes, for example, rifampicin, may increase the clearance of benzodiazepines.
Antidepressants:
Enhanced sedation or respiratory and cardiovascular depression. Diazepam plasma levels increased by concomitant fluvoxamine.
Antiepileptics:
Enhanced sedation or respiratory and cardiovascular depression. Known inducers of hepatic enzymes, for example, carbamazepine and phenytoin, may increase the clearance of benzodiazepines. Serum phenytoin levels may rise, fall or remain unaltered.
In addition, phenytoin may cause diazepam serum levels to fall. Concomitant sodium valproate may increase serum levels of diazepam, with associated drowsiness.
Antihistamines:
Enhanced sedation or respiratory and cardiovascular depression with sedative antihistamines.
Antihypertensives:
Enhanced hypotensive effect, enhanced sedative with alpha-blockers and possibly moxonidine.
Antipsychotics:
Enhanced sedation or respiratory and cardiovascular depression. Increased plasma concentrations of zotepine. Severe hypotension, collapse, respiratory depression, potentially fatal respiratory arrest and unconsciousness have been reported in a few patients on benzodiazepines and clozapine.
Caution is advised when initiating clozapine therapy in patients taking benzodiazepines.
Antivirals:
Amprenavir and ritonavir have been shown to reduce the clearance of benzodiazepines and may potentiate their actions, with risk of extreme sedation and respiratory depression – avoid concomitant use.
Anxiolytics:
Enhanced sedation or respiratory and cardiovascular depression with other anxiolytics.
Digoxin:
Reduced clearance of dogoxin.
Disulfiram:
Has been shown to reduce clearance and may potentiate actions of benzodiazepines.
Dopaminergic agents:
Diazepam may cause inhibition of levodopa.
Hypnotics:
Enhanced sedation or respiratory and cardiovascular depression.
Lofexidine:
Enhanced sedation or respiratory and cardiovascular depression.
Muscle relaxants:
Increased CNS depressant effects with baclofen and tizanidine.
Nabilone:
Enhanced sedation or respiratory and cardiovascular depression.
Nicotine:
Diazepam metabolism is accelerated by smoking.
Oral contraceptives:
Reduce the clearance of bezodiazepines and may potentiate their actions.
Sedatives:
Enhanced sedation or respiratory and cardiovascular depression.
Theophylline:
Diazepam metabolism is accelerated by theophylline.
Ulcer-healing drugs:
Cimetidine and omeprazole may reduce the clearance of benzodiazepines and potentiate their actions. 6 Pregnancy and lactation There is no evidence […]
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. Rebound 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 or sleep disturbances and restlessness. It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.
Benzodiazepines should not be given to children for anxiety without careful assessment of the need to do so. 8 Undesirable Effects). The condition occurs most often several hours after administration. To reduce the risk, where appropriate and possible, patients should be able to have an uninterrupted sleep of 7-8 hours after administration.
8 Undesirable Effects). Should they occur, use of diazepam should be discontinued. Use in patients with concomitant mental illness or addiction Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
As with other benzodiazepines, extreme caution should be used if prescribing diazepam for patients with personality disorders. The disinhibiting effects of benzodiazepines may be manifested as the precipitation of suicide in patients who show aggressive behaviour towards self and others.
The excipient benzoic acid may be mildly irritant to mucous membranes. 70mmol sodium per dose. To be taken into consideration by patients on a controlled sodium diet.