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TEMAZEPAM is a brand name for Temazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indicated for: 1) The short-term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme stress, especially for those patients in whom the persistence of a hypnotic effect would be undesirable. 2) The premedication before minor surgical and investigative procedures particularly…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks). 4). Extension of use should not take place without further clinical evaluation.
When treatment is started the patient should be informed that • treatment will be of limited duration • the dosage will be progressively decreased • there is the possibility of rebound phenomena. Patients who have received benzodiazepines for a long time may require an extended withdrawal period.
The recommended doses are as follows:
Insomnia Adults 10-20mg at bedtime. A dose of 20mg will be found satisfactory for most patients. In extreme cases this may be increased to 30-40mg in patients who do not respond to the lower dose. Elderly or debilitated or those with cerebrovascular disease or hepatic or renal impairment 5mg at bedtime.
This may be increased to 10mg or to 20mg in extreme cases. Premedication Adults The normal dose is 20-40mg, half an hour to one hour before the procedure. It is recommended that patients should be accompanied home after medication with Temazepam prior to surgical or investigative procedures.
Elderly and patients suffering from cerebrovascular disease Dosage should be reduced to possibly half the normal adult dose (10-20 mg, one hour before the procedure). In general hypnotics should be avoided in the elderly as they are at risk of becoming ataxic and confused.
This may lead to falls and injury. Paediatric population Temazepam tablets are not recommended for use in children. The safety and efficacy in children less than 18 years old has not been established. Method of Administration For oral administration.
At the start of treatment patients may suffer from drowsiness and light- headedness the next day; confusion and ataxia (especially in the elderly); amnesia may occur and dependence. Reduced alertness, dizziness, fatigue, muscle weakness, numbed emotions, double vision, respiratory depression or slurred speech.
These will normally disappear with continued treatment. More rarely, headache, vertigo, hypotension, salivation changes, visual disturbances, dysarthria, tremor, incontinence, urinary retention, blood disorders, jaundice, vivid dreams/ nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastrointestinal disturbances may occur.
Severe anaphylactic and anaphylactoid reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving temazepam. Pre-existing depression may be unmasked during treatment with temazepam. Blood dyscrasias and increased liver enzymes have also been reported to occur occasionally.
If any of these effects do occur, treatment should be discontinued. Other effects, including delusions, hallucinations, psychoses, irritability and restlessness, agitation, aggressiveness, nightmares and rages or other inappropriate behaviour and other adverse behavioural effects have also been reported to occur.
They are more likely to occur in children and the elderly. If any of these effects occur, treatment should be discontinued. 4). Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see Warnings and precautions).
Psychological dependence may occur. Abuse of benzodiazepines has been reported. 4) 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.
The cause for insomnia should be determined prior to the use of temazepam, and it should not be used for first line treatment of psychotic illness. Severe anaphylactic and anaphylactoid reactions, including rare fatal cases of anaphylaxis, have been reported in patients receiving temazepam.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam. When temazepam is used for pre-medication, patients should be accompanied home afterwards.
2) depending on the indication, but should not exceed 4 weeks for insomnia, including 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 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 minimizing anxiety over such symptoms should they occur while temazepam is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action such as temazepam, withdrawal phenomena can become manifest between doses, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. 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.
1. • Acute pulmonary insufficiency; severe respiratory depression, sleep apnoea (risk of further respiratory depression) or CNS depression • Acute narrow angle glaucoma (due to anticholinergic effects of temazepam) • Phobic or obsessional states; chronic psychosis (paradoxical reactions may occur.
Inadequate evidence of safety and efficacy) • Mild anxiety states • Severe hepatic insufficiency (may precipitate encephalopathy. Elimination half-life of temazepam may be prolonged) • Neuromuscular respiratory weakness including myasthenia gravis (condition may be exacerbated) • Breast-feeding • Children aged 18 years or under • Temazepam should not be used alone in depression or anxiety with depression (may precipitate suicide).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
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 temazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with temazepam, 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 temazepam 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.
Rebound symptoms Symptoms including insomnia and anxiety may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. 2). Amnesia Anterograde amnesia may occur, most often several hours after ingestion.
8). Insufficient sleep may adversely […]