1. Name Of The Medicinal Product
Temazepam Tablets 20mg
2. Qualitative And Quantitative Composition
Temazepam Tablets 20mg:
Each tablet contains: 20mg temazepam BP
3. Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the short-term treatment of insomnia in cases where it is severe, disabling or subjecting the individual to extreme distress. Temazepam is also indicated for pre-operative medication prior to minor surgery or other similar procedures.
4.2 Posology And Method Of Administration
Route of administration: oral
Treatment to be given
• under close medical supervision
• at the lowest effective dose
• for the shortest possible duration (not exceeding 4 weeks)
Treatment should be tapered off gradually (see section 4.4)
Extension of use should not take place without further clinical evaluation
Chronic use not recommended (little is known of the long term safety and efficacy: potential for dependence – see section 4.4).
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
The recommended doses are as follows:
Insomnia:
Adults - 10-20mg at bedtime. In extreme cases this may be increased to 30-40mg.
Elderly or debilitated or those with 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, one hour before the procedure.
Elderly - 10-20mg, one hour before the procedure.
Children - temazepam tablets are not recommended for use in children.
4.3 Contraindications
• Hypersensitivity to benzodiazepines or to any of the other ingredients
• Acute pulmonary insufficiency, respiratory depression, sleep apnoea (risk of further respiratory depression)
• Obsessional states (inadequate evidence of safety and efficacy).
• Severe hepatic insufficiency (may precipitate encephalopathy)
• Neuromuscular respiratory weakness including myasthenia gravis
• Breast-feeding
Temazepam should not be used alone in depression or anxiety with depression (may precipitate suicide)
4.4 Special Warnings And Precautions For Use
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.
When temazepam is used for pre-medication, patients should be accompanied home afterwards.
Tolerance
Loss of efficacy to the hypnotic effects may develop after repeated use for a few weeks.
Dependence
The risk of dependence (physical or psychological) increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse, or in patients with a marked personality disorder. Therefore
• regular monitoring of such patients is essential
• routine repeat prescriptions should be avoided
• treatment should be withdrawn gradually
Withdrawal effects
The duration of treatment should be as short as possible (see section 4.2).
If physical dependence has developed, abrupt termination of treatment results in withdrawal symptoms. These include headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood changes. In severe cases the following may occur: a feeling of unreality or of being separated from the body, depersonalisation, confusional states, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures. Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.
Rebound symptoms
Symptoms including insomnia and anxiety may occur on withdrawal of treatment. As this is greater after abrupt discontinuation, the dose should be decreased gradually (see section 4.2).
Amnesia
Anterograde amnesia may occur, most often several hours after ingestion. To reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see also section 4.8). Insufficient sleep may adversely affect the ability to drive/operate machinery etc (see section 4.7).
Bereavement/loss
Psychological adjustment may be inhibited by benzodiazepines
Psychiatric and `paradoxical`reactions
Reactions such as restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects can occur. These reactions are more likely in children and the elderly, and extreme caution should be used in prescribing benzodiazepines to patients with personality disorders. Should they occur, treatment should be discontinued.
Specific Patient Groups
Patients with depression
Temazepam should not be used alone to treat depression or anxiety associated with depression as suicide may be precipitated in such patients.
Patients with a history of alcohol & drug abuse
Temazepam should be used with extreme caution in patients with a history of alcohol or drug abuse (risk of abuse/dependence).
Patients with phobias and/or chronic psychoses
Temazepam is not recommended (inadequate evidence of efficacy and safety)
Pregnant women
Avoid regular use in pregnant women (risk of neonatal withdrawal symptoms); use only if clear indication such as seizure control (high doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression) (see also section 4.6).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Not recommended
Alcohol: Temazepam should not be used together with alcohol (enhanced sedative effects: effect the ability to drive or operate machinery).
Sodium oxybate: avoid concomitant use (enhanced effects of sodium oxybate)
Take into account
Centrally acting drugs: Enhancement of the central depressive effect may occur if temazepam is combined with drugs such as neuroleptics, antipsychotics, tranquillisers, antidepressants, hypnotics, analgesics, anaesthetics, barbiturates and sedative antihistamines. The elderly may require special supervision.
Anti-epileptic drugs: When used concurrently, side effects and toxicity may be more evident, particularly with hydantoins (eg phenytoin) and/or barbiturates. This requires extra care in adjusting dosage in the initial stages of treatment.
Narcotic analgesics: Enhancement of the euphoria may lead to increased psychological dependence.
Other drugs enhancing the sedative effect of chlordiazepoxide: cisapride, lofexidine, nabilone, disulfiram and the muscle-relaxants baclofen and tizanidine.
Compound that affect hepatic enzymes (particularly cytochrome P450):
• inhibitors (eg cimetidine; ritonavir; fluvoxamine) reduce clearance and may potentiate the action of benzodiazepines
• inducers (eg rifampicin) may increase clearance of benzodiazepines
Antihypertensives, vasodilators & diuretics: Enhanced hypotensive effect with ACE-inhibitors, alpha-blockers, angiotensin-II receptor antagonists, calcium channel blockers adrenergic neurone blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside and diuretics
Dopaminergics: possible antagonism of the effect of levodopa.
Theophylline: possible reduced effects of temazepam
4.6 Pregnancy And Lactation
Avoid regular use (risk of neonatal withdrawal symptoms); use only if clear indication such as seizure control (high doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression)
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.
If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.
4.7 Effects On Ability To Drive And Use Machines
Patients should be advised that sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, they should not drive or to use machines, or take part in other activities where this would put themselves or others at risk. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Concurrent medication may increase these effects (see section 4.5).
4.8 Undesirable Effects
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 or double vision. 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.
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, psychoses, hallucinations, irritability and restlessness, aggressiveness and rages or other inappropriate behaviour have also been reported to occur, predominantly in elderly patients. If any of these effects occur, treatment should be discontinued.
4.9 Overdose
Benzodiazepines potentiate the effects of other CNS depressants including alcohol.
Features
Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually lasts a few hours but in the elderly may be more protracted and cyclical. Respiratory depression is more serious in those with severe obstructive airways disease. Patients who are asymptomatic at 4 hours are unlikely to develop symptoms.
Management
• Maintain clear airway and adequate ventilation, if indicated
• The value of gastric decontaminants is uncertain. Consider activated charcoal (50 g for an adult: 1g/Kg for a child) within 1 hour of ingestion if more than 1 mg/Kg has been taken provided the patient is not too drowsy.
• Gastric lavage – unnecessary if only benzodiazepine taken
• Supportive measures as indicated by the patient´s clinical condition
• Rarely flumazenil may used as an antidote, however it has a short half-life (about 1 hour). It should not be used in mixed overdoses or as a “diagnostic test”.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Temazepam is known to have hypnotic/sedative and anxiolytic properties. It therefore results in anxiolysis, muscle relaxation and central nervous system sedation. It has been suggested that a close molecular association between the sites and action for gamma-aminobutyric acid (GABA) and benzodiazepines and potentiation of GABA may be responsible for these effects.
Other neurotransmitters may also be affected.
5.2 Pharmacokinetic Properties
Temazepam is readily and almost completely absorbed from the gastro-intestinal tract and has been reported to be relatively extensively bound to plasma proteins (75-95%). Peak plasma concentrations are reached approximately one hour after dosing. The majority of a dose of temazepam is metabolised to inactive glucuronides, which are then excreted in the urine.
5.3 Preclinical Safety Data
Not relevant.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose monohydrate, maize starch, pregelled starch, sodium starch glycollate, microcrystalline cellulose and magnesium stearate.
6.2 Incompatibilities
Not known.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Store at or below 25°C in a dry place. Protect from light.
6.5 Nature And Contents Of Container
Packs of 28, 30, 56, 60, 84, 100, 168, 200, 250 and 500 tablets.
Polypropylene plastic tablet container, with tamper evident lid.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park,
Frimley, Camberley, Surrey,
GU16 7SR,
United Kingdom
8. Marketing Authorisation Number(S)
PL 4416/0270
9. Date Of First Authorisation/Renewal Of The Authorisation
3 February 1997
10. Date Of Revision Of The Text
05/01/2012
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