Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, 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. The overall duration of treatment generally should not be more than 8–12 weeks, including a tapering off process.
These amounts are general recommendations, and dosage should be individually determined. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free.
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 with special expertise.
The lowest dose which can control symptoms should be used.
The optimum dosage and frequency of administration of Lexotan should be based on the individual patient, the severity of symptoms and previous psychotropic drug history.
The usual dosage in general practice is from 3 mg to 18 mg daily in divided doses.
In exceptional circumstances, in hospitalised patients, up to the maximum daily dosage of 60 mg in divided doses, may be given.
A reduction in dose for elderly patients is recommended. Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate.
Elderly patients require lower doses because of individual variations in sensitivity and pharmacokinetics; doses should not exceed half those normally recommended (see section 5.2).
Patients with severe hepatic impairment should not be treated with Lexotan tablets (see section 4.3 Contra-indications).
Patients with mild or moderate impaired hepatic and/or renal function require the lowest dose possible because of individual variations in sensitivity and pharmacokinetics.
With the elderly and patients with impaired renal and/or hepatic function, it is advisable to review treatment regularly and to discontinue use as soon as possible.
Lexotan should not be used in children less than 12 years of age. The safety and efficacy of Lexotan in children less than 12 years has not been established. Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of bromazepam is seldom life-threatening if the drug is taken alone, but may lead to slurred speech areflexia, apnea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease.
Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects.
Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure.
If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off.
Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil (Anexate), for further information on the correct use of this drug.
PVDC blister packs: 5 year shelf life.
HDPE bottles: 5 year shelf life.
PVC blister packs: 5 year shelf life.
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
PVDC blister packs of 4, 10, 20, 60 or 100 tablets.
HDPE bottles of 100 tablets.
PVC blister packs of 30 tablets.
Not all pack sizes may be marketed.
The release of pharmaceuticals in the environment should be minimized.
Medicines should not be disposed of via wastewater and disposal through household waste should be avoided.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
