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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: Oxazepam tablets are indicated for the short-term relief (2-4 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 psychosomatic, organic or psychotic illness. The use of Oxazepam to treat short-term ‘mild’…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology All patients taking oxazepam should be carefully monitored and routine repeat prescriptions should be avoided. Patients who have taken benzodiazepines for a long time may require an extended withdrawal period during which doses are reduced.
Long-term chronic use is not recommended.
Adults Severe anxiety:
The recommended dosage is 15-30mg three or four times daily. Insomnia associated with anxiety Most patients need a dose of 15-25mg but some patients may need up to 50mg. The dose should be taken one hour before retiring. Elderly patients and those who are particularly sensitive to benzodiazepines The recommended dosage is 10-20mg three or four times daily.
Children Oxazepam is not recommended for the treatment of anxiety or insomnia in children. Treatment of anxiety should not be continued beyond 8-12 weeks including a tapering off period. Treatment of insomnia should be as short as possible.
Generally, the duration of treatment varies from a few days to two weeks with a maximum, including tapering off process of four weeks. In all cases, the dosage of Oxazepam should be titrated according to the needs of the individual patient and the lowest effective dose necessary to control symptoms should be used for the shortest possible time.
The maximum dose should not be exceeded. 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. Method of administration For oral administration only.
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.
* 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. 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. Withdrawal 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.
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. Therefore, benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
Once physical dependence has developed, abrupt discontinuation of benzodiazepines may be associated with physiological and psychological symptoms of withdrawal including extreme anxiety, headache, muscle pain, insomnia, 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 enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that dosage be decreased gradually. 2) depending on the indication, but should not exceed 4 weeks for insomnia and eight to twelve weeks in case of anxiety, including a 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 it will be of limited duration and explain precisely how the dosage will be progressively decreased.
1. Myasthenia gravis, hypersensitivity to benzodiazepines, phobic or obsessional states, chronic psychosis, respiratory depression, acute pulmonary insufficiency, 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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Other symptoms such as depression, persistent tinnitus, involuntary movements, paraesthesia, perceptual changes, confusion, convulsions, abdominal and muscle cramps and vomiting may be characteristic of benzodiazepine withdrawal syndrome.
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 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. Psychiatric and paradoxical reaction Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural 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 elderly. Amnesia Benzodiazepines may induce anterograde amnesia. 8). Specific patient groups Benzodiazepines should not be used alone to treat depression or anxiety associated with depression.
Benzodiazepines are not recommended for the primary treatment of psychotic illness or marked personality disorder. Suicide may be precipitated in patients who are depressed and aggressive behaviour toward self and others may be precipitated.
A lower dose is 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 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). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
2 Posology and method of administration). Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly. Thyroid disease An increase in oxazepam dose or frequency may be necessary in patients with hyperthyroidism due to increased clearance and shorter half-life of oxazepam.
A decrease in oxazepam dose may be necessary in patients with hypothyroidism. Loss or bereavement In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
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).