Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
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 process, of four weeks.
Halcion should be taken just before going to bed. The usual dose is 250 micrograms (0.25 mg) at night. Dosage should be adjusted on the basis of the individual patient response to achieve effect without overdosage. The lowest effective dose should be used. In patients previously untreated with hypnotics, initial dosage should be 125 micrograms (0.125 mg). A maximum dose of 250 micrograms (0.25 mg) should not be exceeded because of risk of unacceptable CNS adverse effects.
Patients with renal impairment may be administered triazolam in the usual dose range; as appropriate.
Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy.
In the elderly, debilitated or patients with impaired hepatic function initial dosage should be 125 micrograms (0.125 mg) to decrease the possibility of development of over sedation, dizziness, or impaired coordination. It is seldom necessary to exceed that dose. A maximum dose of 250 micrograms (0.25 mg) should not be exceeded. In other adults the recommended dose is 0.25 mg (see section 4.4).
Triazolam is not recommended for use in children and adolescents below the age of 18 years due to insufficient data on safety and efficacy.
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.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Symptoms of overdose with triazolam are extensions of its pharmacological action and include drowsiness, slurred speech, motor in coordination, coma, and respiratory depression. Serious sequelae are rare unless other drugs and/or ethanol are concomitantly ingested. In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. Treatment of overdosage is primarily supportive of respiratory and cardiovascular function. The value of dialysis has not been determined. Flumazenil may be used as an adjunct to the management of respiratory and cardiovascular function associated with overdose.
Following overdose with any medicinal product, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption.
4 years.
Do not store above 25°C. Keep the blister in the outer carton. Store in the original package.
PVC/AL foil blister strips: pack sizes: 7, 10 and 30 tablets.
Not all pack sizes may be marketed.
No special requirements.
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