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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 indicated for the short term relief (2-4 weeks) of anxiety that is disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic and psychotic illness. The use of benzodiazepines to treat short-term anxiety is…
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). As an anxiolytic, the lowest effective dose should be employed for the shortest time possible. Dosage regimes should not exceed beyond 4 weeks and treatment should be withdrawn gradually to minimise possible withdrawal symptoms (See Special Warnings and Precautions for Use).
Please note that in patients with renal or hepatic impairment, lower doses may be sufficient (see Special Warnings and Precautions for Use). Adults: • Anxiety – one to two 15mg tablets three (or four) times daily • Insomnia associated with anxiety – In most cases, 15-25mg dose taken 1 hour before retiring.
This may be increased to a maximum of 50mg where necessary Elderly or patients who are particularly sensitive to the effects of benzodiazepines: 10-20mg three or four times daily Children: Oxazepam is not recommended for the treatment of children Method of Administration 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. 4 Special warnings and precautions). 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 † = more likely to occur in children and the elderly Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages and may lead to the patient exhibiting inappropriate behaviour.
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 is increased with higher doses and/or longer use; it is also greater in patients with a history of alcoholism or drug abuse, or in patients with significant personality disorders.
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.
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.
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.
• Hypersensitivity to benzodiazepines including Oxazepam Tablets or their components • Chronic psychosis • Phobic or obsessional states • Respiratory depression • Sleep apnoea syndrome • Myasthenia gravis • Acute pulmonary insufficiency • 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. 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. SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxazepam Tablets 15mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxazepam tablets containing oxazepam 15mg.
Oxazepam (INN, BAN) is chemically defined as 7-chloro-1,3-dihydro-3- hydroxy-5-phenyl-2H-1,4-benzodiazepine-2-one. 5mm in diameter, having flat faces with bevelled edges. A breakbar on one face and “15” on the other. 1 Therapeutic indications Oxazepam is indicated for the short term relief (2-4 weeks) of anxiety that is disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic and psychotic illness.
The use of benzodiazepines to treat short-term anxiety is considered to be inappropriate. 2 Posology and method of administration 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). As an anxiolytic, the lowest effective dose should be employed for the shortest time possible. Dosage regimes should not exceed beyond 4 weeks and treatment should be withdrawn gradually to minimise possible withdrawal symptoms (See Special Warnings and Precautions for Use).
Please note that in patients with renal or hepatic impairment, lower doses may be sufficient (see Special Warnings and Precautions for Use). Adults: • Anxiety – one to two 15mg tablets three (or four) times daily • Insomnia associated with anxiety – In most cases, […]
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.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
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). 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 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 the elderly. 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). Special patient groups Oxazepam is not intended for the primary treatment of psychotic illness or depressive disorders, and should not be used alone to treat depressed patients.
The use of benzodiazepines may have a disinhibiting effect and may release […]