Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties. It is indicated for short term therapy, usually not exceeding two to four weeks, as symptomatic treatment of severe, disabling or causing unacceptable stress, anxiety. The anxiety can be occurring alone or in combination with insomnia or short term psychotic, organic or psychosomatic illness.
The dosage should be individually titrated and optimized as should frequency of administration, on the basis of the individual response, severity of symptoms and any available history of precious response to psychotropic drugs.
The usual dose in normal circumstances ranges from 3 mg – 18 mg a day, administered in two or three divided doses.
Hospitalized patients may in exceptional conditions require a daily dosage of up to 60 mg in divided doses. The maximum dose of 60 mg a day should not be exceeded.
Not indicated for paediatric use.
Elderly patients and those with impaired hepatic and/or renal function require lower doses because of individual variations in sensitivity and pharmacokinetics; closes should not exceed half those normally recommended.
For all categories of patient, the lowest dose that control symptoms should be used. The use of the full dosage regime should not be prolonged beyond four weeks. Withdrawal of therapy should be done by gradual dose reduction. This may require more time the longer a patient has been on therapy, and in such cases specialist therapy may be appropriate.
Akamon tablets are for oral administration.
Intensification of therapeutic effects such as sedation, muscle weakness and profound sleep. In some cases it may be characterized by paradoxical reactions of excitation. High overdosage may result in apnoea, cardiac and respiratory depression, areflexia and coma. In general overdose of benzodiazepines usually leads to degrees of central nervous system depression ranging from drowsiness to coma.
In the management of overdose with any medicinal product it should be borne in mind that multiple agents may have been taken.
When taken with centrally acting drugs especially alcohol, the effects of overdosage are likely to be more severe and in the absence of supportive measures may prove fatal.
Following overdose with oral benzodiazepines, 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 the absorption.
The value of dialysis has not been determined. Special attention should be paid to respiratory and cardiac function in intensive care. Flumazenil could be used as antidote in emergency situations. Patients requiring such interventions should be monitored closely in hospital (see separate prescribing information). Flumazenil is not recommended in patients with epilepsy who have been treated with benzodiazepines. Antagonism in such patients may produce seizures. If excitation occurs, barbiturates should not be used.
60 months.
Store below 25ºC in the original package, in order to protect form light.
Akamon 1.5 mg tablets: Combination polyvinylchloride – aluminium blisters.
Thirty (30), forty (40) or sixty (60) tablets are contained in a card carton.
Akamon 3 mg tablets: Combination polyvinylchloride – aluminium blisters.
Forty (40), one hundred (100), five hundred (500) and one thousand (1000) tablets are contained in a card carton.
One thousand (1000) tablets are contained in securitainers.
Not all pack sizes may be marketed.
Tablets are for oral administration only.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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