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EUHYPNOS 10mg capsules: opaque, ivory coloured, oval, No. 4 size, soft gelatine capsule, containing a clear, colourless, viscous liquid. Each capsule contains 10mg temazepam.
EUHYPNOS 20mg capsules: opaque, ivory coloured, oval, No. 7.5 size, soft gelatine capsule, marked E20 in either black or red printing, containing a clear, colourless, viscous liquid. Each capsule contains 20mg temazepam.
In animal studies temazepam showed typical benzodiazepine activity with sedative hypnotic, muscle relaxant and anticonvulsant effects. In sleep laboratory studies in man temazepam reduced the time of sleep onset, prolonged total sleep time and decreased the number of awakenings, compared to baseline.
EUHYPNOS is rapidly and almost completely absorbed in the fasting state. Plasma levels of temazepam reach 80% of peak in approximately 20 minutes, with peak levels at about 50 minutes after ingestion. Radioactive studies show wide distribution throughout the body. About 95% is bound by plasma protein. Temazepam is extensively and rapidly metabolised in the liver by conjugation with glucuronic acid. There are no long-acting metabolites. EUHYPNOS is predominantly excreted in the urine as its glucuronide derivative. It has a short half-life. The elimination half-life after evening administration has been shown to be 5.3 hours compared to about 8.4 hours after morning administration. This has been attributed to circadian variation.
During repeated night time administration there was no significant difference between the elimination after the first and seventh doses. Long-term therapy does not appear to be associated with medicine accumulation or induction of liver enzymes.
Adjunctive therapy in the short-term management of insomnia in adults.
In general benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks). Continuous long-term use of EUHYPNOS is not recommended.
10 to 30mg orally, half an hour before retiring. Doses should generally start at the 10mg level and the dose should be carefully titrated for each individual, particularly for elderly patients. Dosage may be increased to a maximum of 30mg. Most patients will respond to a dose of 20mg.
Geriatric patients generally respond to small doses (see Precautions ).
EUHYPNOS is not approved for patients under 16 years, as safety and efficacy has not been demonstrated in this group.
Patients with impaired hepatic or renal function should be treated with caution.
Patients should be warned that temazepam, like all benzodiazepines, may impair the mental or physical abilities, required on the following day, to cope with potentially hazardous tasks such as driving, operating machinery, or being a pedestrian.
In sleep laboratory studies doses of 10 and 20mg did not significantly affect morning performance. However, the 30mg dose produced impairment of psychomotor performance in the morning following night administration.
Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage while EUHYPNOS is being taken.
Following the use of EUHYPNOS, withdrawal from the medication should be gradual. As with other sedatives/hypnotics, when treatment is suddenly withdrawn, a temporary increase in sleep disturbance can occur after use of EUHYPNOS. There is evidence that tolerance develops to the sedative effects of benzodiazepines within as little as 2 weeks administration.
Temazepam is not recommended as a primary therapy for depressed or psychotic patients. In patients with depression accompanying anxiety, suicidal tendencies may be present and adequate precautions should be taken. Benzodiazepines may increase depression in some patients and may cause deterioration in severely disturbed schizophrenics with confusion and withdrawal.
For these patients the dose of temazepam should be limited to the smallest effective amount to preclude possible ataxia, giddiness or oversedation which could increase the possibility of accidental falls.
With benzodiazepines, hypotension occurs only on rare occasions, however, this should be borne in mind when prescribing for patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly the case in the elderly patient.
Prescribe with care for patients with potential for medicine abuse, or for those patients whose histories suggest that they may increase the dose on their own initiative.
The use of benzodiazepines may lead to physical or psychological dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of benzodiazepines.
Patients who have been on benzodiazepines for some time, particularly at high dosage, should not have the treatment terminated abruptly as this has resulted in withdrawal symptoms including: convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, nervousness and insomnia. The withdrawal symptoms experienced are more serious and more common in patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt cessation of benzodiazepines taken continuously at therapeutic levels. Patients should be advised to consult with their physician before either increasing the dose or abruptly discontinuing this medication. A gradual termination of treatment should be considered to avoid the occurrence of withdrawal symptoms.
When used in persons with convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in standard and anticonvulsant medication. Abrupt withdrawal in such cases may also be associated with a temporary increase in the frequency and/or severity of the seizures (see Interactions ).
These are suggested for patients on long-term therapy as temazepam may produce abnormalities in blood counts, hepatic and renal function tests.
Temazepam is inactivated by extensive conjugation with glucuronic acid in the liver. Special care is needed as impairment of hepatic function may require a reduction of dose or a decision not to prescribe. Impairment of performance the next day may necessitate discontinuing the therapy.
As renal excretion is the major route of elimination for temazepam, significant renal impairment is likely to cause accumulation. For these patients doses should be low and therapy initiated with caution.
Usually anterograde, but extending sometimes to the period before administration, amnesia has been frequently reported after parenteral dosage with benzodiazepines. As amnesia has also been reported following oral doses of benzodiazepines, the possibility of its occurrence should be kept in mind.
The medicine should be discontinued if paradoxical reactions such as acute rage, stimulation or excitement occur. These reactions have been reported with other benzodiazepines.
Caution should be used in the treatment of acute narrow angle glaucoma (because of atropine-like side effects).
Temazepam should not be indicated in chronic obstructive airways disease with incipient respiratory failure. In patients with chronic obstructive pulmonary disease benzodiazepines can cause increased arterial carbon dioxide tension and decreased oxygen tension.
Caution should be used in patients with this condition as the muscle weakness experienced could be increased during temazepam therapy.
Temazepam is not approved for use in patients under 16 years of age as safety and efficacy have not been established in this age group. Benzodiazepines may impair mental alertness in children.
Benzodiazepines cross the placenta and may cause hypotonia, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration of high doses in connection with delivery should, therefore, be avoided. Withdrawal symptoms in newborn infants have been reported with this class of medicines.
The use of benzodiazepines during the first trimester of pregnancy should almost always be avoided. If the medicine is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the medicine if she intends to become, or suspects that she is, pregnant.
The use of benzodiazepines during the last phase of pregnancy or at delivery may require ventilation of the infant at birth.
The use of temazepam should be avoided in pregnant women receiving antihistamines.
Temazepam, together with its metabolites, like other benzodiazepines is likely to be excreted in breast milk. Benzodiazepines generally show increased toxicity in neonates, therefore, EUHYPNOS is not recommended for nursing mothers.
Headache (3 to 5%), vertigo (3%) and dizziness (2%) have been reported.
Biochemical abnormalities (elevated serum alkaline phosphatase, AST, BUN, bilirubin, proteinuria, neutrophil leucocytosis); palpitation and tachycardia; macular rash, pruritis; nausea (1%); gastrointestinal upset and dyspepsia (1%), vomiting; tremor, leg cramps, sciatica, depression (1%), muzziness (1%), weakness (1%), vivid dreams (1%), dry mouth (1%), loss of taste, irritability, confusion, disorientation, faintness, blurred vision and breathlessness, In a sleep laboratory study rebound insomnia and increased anxiety followed discontinuation of temazepam. If hypersensitivity or paradoxical reactions such as hyperexcitability, increased anxiety, hallucinations, increased muscle spasticity, insomnia, rage or sleep disturbances occur, temazepam should be discontinued.
Patients should be warned about reduced tolerance to alcohol, and that the sedative effects of temazepam may be increased by other medicines, e.g. tricyclic antidepressants, barbiturates, narcotics, phenothiazines, antihistamines and anaesthetics.
The anticholinergic effects of other medicines such as atropine, antihistamines and antidepressants may be potentiated.
Benzodiazepines do not interact with coumarin anticoagulants and it appears safe to prescribe them for patients on long-term anticoagulant therapy without adjustment of dosage.
Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or the anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together, and that serum level monitoring of the anticonvulsant may need to be monitored more frequently.
Overdosage symptoms seen with benzodiazepines include extreme drowsiness, somnolence, ataxia, confusion, impaired vision, depressed reflexes and coma. Cardiovascular and respiratory depression may occur, especially if interactions with other CNS depressant medicines occur. The possibility of multiple medicine ingestion should always be considered, as additive toxicity is possible.
If vomiting has not occurred it should be induced early after ingestion of the medicine. Immediate gastric lavage is recommended. Careful observation, with general supportive measures and frequent monitoring of vital signs, is indicated. In extreme cases where there is evidence of progressive deterioration with conservative management, haemoperfusion through an activate charcoal column could be considered. The value of haemodialysis or peritoneal dialysis is unknown.
Store below 25°C. Protect from moisture.
Controlled Drug C5
EUHYPNOS 10mg capsules are available in plastic bottles of 100 capsules.
EUHYPNOS 20mg capsules are available in plastic bottles of 100 capsules.
Temazepam is a member of the benzodiazepine group of medicines. It is the 3-hydroxy metabolite of diazepam formed as an intermediate in the minor metabolism of diazepam to oxazepam.
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Auckland
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31 October 2003