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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: Short-term management of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. For premedication prior to minor surgery or other related procedures.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults including the elderly Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. 4). Treatment should be given for the shortest possible duration Insomnia Dosage should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation.
Treatment 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, of four weeks. The tapering-off process should be tailored to the individual. 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.
The product should be taken on retiring or up to 30 minutes before going to bed. Adults: 10-20 mg. In exceptional circumstances the dose may be increased to 30-40 mg. Elderly: 10 mg. In exceptional circumstances the dose may be increased to 20 mg.
Premedication Adults:
The usual dose is 20-40 mg, 30 to 60 minutes before procedure.
Elderly:
Elderly patients are likely to respond to smaller doses, possibly half the normal adult dose or less. Patients should be accompanied home when temazepam has been used as a premedicant prior to surgery or other procedures on a day attendance basis.
Paediatric population The safety and efficacy of temazepam in children and adolescents less than 18 years of age has not been established and as such is not recommended for use. Patients with hepatic impairment Patients with impaired liver function should have a reduced dose.
Method of administration For oral use.
The undesirable effects of temazepam are reported by organ system and frequency. The frequencies are represented as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
The following terminologies have been used to classify the occurrence of adverse reactions, as applicable: System Organ Class Frequency Undesirable effects Rare • Blood disordersBlood and lymphatic system disorders Not known • Thrombocytopenia, agranulocytosis, pancytopenia System Organ Class Frequency Undesirable effects Immune system disorders Not known • Anaphylactic reaction, anaphylactoid reaction, hypersensitivity Endocrine disorders Not known • Inappropriate antidiuretic hormone secretion (SIADH) Metabolism and nutrition disorders Not known • Hyponatraemia Common • Depression (pre-existing depression may be unmasked during benzodiazepine use) Uncommon • Libido disorder, erectile dysfunction, orgasm abnormal, emotional disorder Psychiatric disorders Not known • Suicide attempt, suicidal ideation • Restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, hostility, disturbance in sexual arousal, anger, sleep disorder, insomnia, drug dependence, psychotic disorder, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines.
4). • Numbed emotions (this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration) • Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
4). Very common • Sedation Common • Ataxia, confusional state, dizziness,drowsiness Uncommon • Slow response to stimuli, disturbance in attention Nervous system disorders Not known • Coma, extrapyramidal disorder, convulsion, amnesia, tremor, vertigo, dysarthria, reduced alertness, impaired concentration, headache, sleep disturbance/restless sleep.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of temazepam and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Maneo tablets concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur with using benzodiazepines.
They are more likely to occur in the elderly. Should this occur, use of the drug should be discontinued. Amnesia Benzodiazepines may induce anterograde amnesia at therapeutic dosages, with the risk increasing at high dosages. The condition occurs most often several hours after ingesting the product, and therefore patients should ensure that they will be able to have an uninterrupted sleep of 7 - 8 hours.
Amnesia effects may be associated with inappropriate behaviour. 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 Myasthenia gravis Severe respiratory insufficiency Sleep apnoea syndrome Severe hepatic insufficiency Use in children and adolescents.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration. Eye disorders Not known • Visual impairment, including diplopia and vision blurred (this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration) Rare • HypotensionVascular disorders Not known • Blood pressure decreased System Organ Class Frequency Undesirable effects Respiratory, thoracic and mediastinal disorders Not known • Respiratory depression, apnoea, sleep apnoea syndrome exacerbated, obstructive pulmonary disease exacerbated (the extent of respiratory depression with benzodiazepines is dose dependent, with more severe depression occurring with high doses) Uncommon • NauseaGastrointestinal disorders Not known • Dryness of the mouth • Gastrointestinal disturbances • Constipation Hepatobiliary disorders Not known • Jaundice, blood bilirubin increased, transaminases increased, blood alkaline phosphatase increased Skin and subcutaneous tissue disorders Not known • Alopecia, skin reactions Musculoskeletal and connective tissue disorders Not known • Muscle weakness (this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration).
Due to the myorelaxant effect there is a risk of falls and consequently fractures in the elderly. 4 Special warnings and precautions). Investigations Rare • Abnormal liver function tests Withdrawal reactions The risk of withdrawal or rebound phenomena is greater after abrupt discontinuation of treatment.
It is recommended that the dosage is decreased gradually. Use (even at therapeutic doses) of benzodiazepines may lead to the development of physical and psychological dependence. Once physical dependence has occurred, abrupt termination of treatment will be accompanied by withdrawal symptoms or rebound phenomenon.
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.
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. Abuse has also been reported. 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 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 hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety, sleep disturbances and restlessness.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage is decreased gradually.
Duration of treatment and […]