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OXAZEPAM is a brand name for Oxazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the short-term relief (2-4 weeks) only of anxiety which is 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 anxiety is considered to be…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage and duration of therapy should be individualised and all patients receiving oxazepam should be carefully monitored and re-evaluated before any extension of the treatment period. Long-term chronic use is not recommended.
4). 4).
Adults:
Anxiety 15-30mg three or four times a day. Insomnia associated with anxiety generally 15-25mg one hour before retiring. This may be increased to a maximum of 50mg when necessary. Elderly patients and those who are particularly sensitive to benzodiazepines: 10-20mg three or four times a day.
Children:
Not recommended for children. Method of Administration For oral administration.
Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose. Blood and lymphatic system disorders Blood dyscrasias, leucopenia.
*** †These are more likely to occur in children and the elderly. Nervous system disorders Dizziness, light-headedness*, ataxia, vertigo, headache, syncope, slurred speech, tremor, dysarthria. Eye disorders Blurred vision, double vision.
Vascular disorders Hypotension. Gastrointestinal disorders Nausea, salivation changes, gastrointestinal disturbances. Hepatobiliary disorders Increased liver enzymes, jaundice. Skin and subcutaneous tissue disorders Minor diffuse skin rashes (morbilliform, urticarial and macropapular).
Musculoskeletal and connective tissue disorders Muscle weakness. Renal and urinary disorders Incontinence, urinary retention. Reproductive system and breast disorders Altered libido. General disorders and administration site conditions Fever, oedema, fatigue.
Injury, poisoning and procedural complications Fall. * Commonly seen in the first few days of therapy. If this becomes troublesome dosage should be reduced. ** Reported in psychiatric patients and usually occur within the first few weeks of therapy.
*** Extreme caution should therefore be exercised in prescribing benzodiazepines to patients with personality disorders. Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour.
4). Dependence When used at the appropriate recommended dosage for short term treatment of anxiety the dependence potential of oxazepam is low. However, the risk of dependence increases with higher doses and longer-term use and is further increased in patients with a history of alcoholism, drug abuse or in patients with marked personality disorders.
Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of oxazepam, these substances should either be avoided or taken in reduced dosage. Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
Dependence Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. The risk of dependence 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 significant personality disorders.
8), especially if treatment is discontinued abruptly. 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. It may be useful to inform the patient that treatment will be of limited duration and that it will be discontinued gradually.
The patient should also be made aware of the possibility of "rebound" phenomena to minimise anxiety should they occur. Abuse of benzodiazepines has been reported. 8), Benzodiazepines may be associated with an increased risk of falling especially in elderly patients.
As a result, caution should be exercised particularly when getting up at night. 2). 2) depending on the indication, but should not exceed 4 weeks for insomnia and eight to twelve weeks in case of anxiety, including tapering off process.
Extension beyond these periods should not take place without reevaluation 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.
Known hypersensitivity to benzodiazepines or any other ingredient in the tablet; phobic or obsessional states; chronic psychosis; respiratory depression, acute pulmonary insufficiency; myasthenia gravis; sleep apnoea syndrome; severe hepatic insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Withdrawal As with all benzodiazepines, withdrawal may be associated with physiological and psychological symptoms including depression, persistent tinnitus, involuntary movements, paraesthesia, perceptual changes, confusion, convulsions, muscle cramps, abdominal cramps and vomiting.
Symptoms such as anxiety, depression, headache, insomnia, tension and sweating have been reported following abrupt discontinuation of benzodiazepines and these symptoms may be difficult to distinguish from the original symptoms of anxiety.
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.
Moreover 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. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
When benzodiazepines with a long duration are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Risk from concomitant use of opioids Concomitant use of oxazepam 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 oxazepam 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. , 7-8 hours) wherever possible. Psychiatric and paradoxical reaction Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behavior and other adverse behavioral effects are known to occur when using benzodiazepines.
Should this occur, use of the medicinal product should be discontinued. They are more likely to occur in children and the elderly. 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). 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, renal impairment, muscle weakness or porphyria.
Benzodiazepines are not recommended for the primary treatment of psychotic illness or marked personality disorder. Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Also, pre-existing depression may emerge during benzodiazepine use. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Caution should be used in the treatment of patients with acute narrow-angle glaucoma.
Patients with impaired renal or hepatic function should be monitored frequently and have their dosage adjusted carefully according to response. Lower doses may be sufficient in these patients. The same precautions apply to elderly or debilitated patients and patients with chronic respiratory insufficiency.
Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes. Periodic haematologic and liver- function assessments are recommended where repeated courses of treatment are considered […]