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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 is recommended for short term use of approximately 2-4 weeks. As with all benzodiazepines, doctors should be aware that long term use may lead to dependence and withdrawal symptoms in certain patients. Oxazepam is indicated for the short-term treatment of anxiety that is disabling or subjecting the individual…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. 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 daily.
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.
Paediatric population:
Not recommended for children. Method of administration For oral administration.
4, and also see below), mild drowsiness*, disorientation, dreams, †nightmares, lethargy, amnesia (see below), mild excitatory effects with stimulation of effect**, numbed emotions, reduced alertness, †restlessness, †agitation, †irritability, †delusions, †rages, †psychoses, †inappropriate behaviour, behavioural adverse effects including paradoxical †aggressive outbursts, excitement, †hallucinations, confusion, uncovering of depression with suicidal tendencies***.
†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, gastro-intestinal disturbances. Hepatobiliary disorders Increased liver enzymes, jaundice. Skin and subcutaneous tissue disorders Minor diffuse skin rashes (morbilliform, urticarial and maculopapular).
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.
4 Special warnings and precautions): Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
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. Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
1. • For phobic or obsessional states. • For the treatment of chronic psychosis. • In acute pulmonary insufficiency. • Respiratory depression. • In patients with myasthenia gravis. • In patients with sleep apnoea syndrome. • In severe hepatic insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. 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. 4). Dependence When used at the appropriate recommended dosage for short term treatment of anxiety the dependence potential of oxazepam is low.
4). 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.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with oxazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
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, 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.
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. Drug withdrawal syndrome Prior to starting treatment with oxazepam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome.
A withdrawal strategy for ending treatment with oxazepam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
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. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of […]