- 1 Important to know about Lexomil (Bromazepam) ?
- 2 Lexomil (Bromazepam) indication and Uses :
- 3 Lexomil (Bromazepam) Dosage :
- 4 How it works Lexomil (Bromazepam) :
- 5 Lexomil (Bromazepam) Side Effects :
- 6 Lexomil (Bromazepam) Warnings and Precautions :
- 7 Drive and use machines:
- 8 Lexomil (Bromazepam) and PREGNANCY / BREAST FEEDING / FERTILITY:
- 9 Pregnancy :
- 10 What should I do if I miss a dose?
- 11 What happens if I overdose from Lexomil (Bromazepam) ?
- 12 What is Forms and Composition Lexomil (Bromazepam) ?
Important to know about Lexomil (Bromazepam) ?
This medicine is recommended in the treatment of anxiety when it is accompanied by troublesome disorders, or in the prevention and / or treatment of manifestations related to alcohol withdrawal.
Lexomil (Bromazepam) indication and Uses :
– Symptomatic treatment of severe and / or disabling anxiety disorders.
– Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
Lexomil (Bromazepam) Dosage :
The use of bromazepam is not recommended in children, in the absence of study. In addition, the tablet is not a form suitable for children under 6 years (risk of mis-driving).
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
– In current practice :
In adults , the beginning of treatment, the mean daily dose of BROMAZEPAM is 6 mg per day, spread most often as follows:
. 1/4 compressed-wand morning (1.5 mg)
. 1/4 compressed-wand at noon (1.5 mg)
. 1/2 tablet-baguette at night (3 mg).
It must then be adapted individually according to the therapeutic response.
– In psychiatry :
Depending on the severity of the anxiety to be treated: in ambulatory patients, the dosage is between 6 and 18 mg; in subjects whose severity of the anxiety syndrome requires hospitalization, it is possible to prescribe higher doses, 24 or even 36 mg per day.
– In children, the elderly, the renal or hepatic insufficiency : it is recommended to reduce the dosage, by half for example.
– Treatment should be as short as possible. The indication will be reviewed regularly especially in the absence of symptoms. The overall duration of treatment should notexceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see section cautionary statements and precautions for use).
In some cases, it may be necessary to prolong the treatment beyond the recommended periods. This requires accurate and repeated assessments of the patient’s condition.
– Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal : short treatment of the order of 8 to 10 days.
How it works Lexomil (Bromazepam) :
DERIVATIVES OF BENZODIAZEPINE.
ATC code: N05BA (anxiolytics).
(N: Central Nervous System).
– The bromazepam belongs to the class of benzodiazepines 1-4 and pharmacodynamic activity qualitatively similar to that of other compounds of this class
. muscle relaxant,
These effects are linked to a specific agonist action on a central receptor belonging to the complex “GABA-OMEGA macromolecular receptors”, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.
Lexomil (Bromazepam) Side Effects :
Description of adverse effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
They are related to the ingested dose and the individual sensitivity of the patient.
Neuro-psychiatric side effects (see Warnings): Not known
· Memory problems, which can occur at therapeutic doses, the risk increases in proportion to the dose,
· Behavior disorders, changes in consciousness, irritability, aggression, agitation,
· Physical and mental dependence, even at therapeutic doses with withdrawal syndrome or rebound at discontinuation of treatment,
· Feelings of vertigo, headaches, difficulty coordinating certain movements,
· Confusion, sleepiness or alertness decline (especially in the elderly), insomnia, nightmares, tension,
· Changes in libido.
Dermal side effects: Not known
· Rash, with or without itching, urticaria.
Cardiac Undesirable Effects: Not known
· Heart failure, including cardiac arrest
Respiratory side effects: Not known
· Decreased respiratory capacity
Gastrointestinal side effects: Not known
· Nausea, vomiting, constipation
Adverse effects of kidney and urinary tract : Not known
· Unable to urinate
Ocular Adverse Reactions: Not known
· Double vision.
Adverse reactions of the immune system: Not known
· Allergies (such as swelling, redness of the skin), including severe allergic reactions (anaphylactic shock, angioedema)
General side effects: Not known
· Muscle weakness, fatigue
Treatment Complications (see Warnings): Not known
· Falls, fractures.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr
Lexomil (Bromazepam) Interactions :
Associations advised against
Alcohol enhancement of the sedative effect of benzodiazepines and the like. Impairment of alertness can make driving and using machines dangerous. Avoid taking alcoholic drinks and drugs containing alcohol.
Associations to consider
+ Other central nervous system depressants: Increased central depressant effect with morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); antipsychotics (neuroleptics); barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative antihistamines H1; central antihypertensives; anticonvulsants; baclofen; Thalidomide.
Altered alertness can make driving dangerous and the use of machinery dangerous.
In addition, for morphine derivatives (analgesics, antitussives and substitution treatments), barbiturates: increased risk of respiratory depression, which can be fatal in case of overdose, especially in the elderly.
Increased risk of respiratory depression, which can be fatal.
Carefully evaluate the benefit / risk ratio of this combination. Inform the patient of the need to respect the prescribed doses.
Increased risk of collapse with respiratory and / or cardiac arrest.
Pharmacokinetic interactions may occur when bromazepam is administered with drugs that inhibit the CYP3A4 hepatic enzyme by increasing plasma levels of bromazepam.
Caution should be exercised when concomitant administration of bromazepam with potent CYP3A4 inhibitors (eg, azole antifungals, protease inhibitors, or certain macrolides) and a significant reduction in dosage should be considered. In the case of narcotic analgesics, a potentiation of euphoria may also occur, which may lead to increased psychic dependence.
Lexomil (Bromazepam) Warnings and Precautions :
This medicine contains lactose. Its use is contraindicated in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (hereditary diseases).
The action of benzodiazepines and relatives may decrease gradually despite the use of the same dose in case of repeated administration for several weeks.
Any treatment with benzodiazepines and related drugs, especially with prolonged use, may result in a state of physical and mental dependence.
Various factors seem to favor the occurrence of dependence:
· Duration of treatment,
· History of other addictions: medication or not, including alcoholic.
Drug dependence may occur at therapeutic doses and / or in patients without individualized risk factors.
This state can lead to the cessation of treatment a withdrawal phenomenon.
Some symptoms are common and seemingly trivial: insomnia, headache, diarrhea, extreme anxiety, myalgia, tension, irritability, nervousness, confusion.
In severe cases the following symptoms may occur: hyperacusis, agitation or even confusional episode, paresthesia of the extremities, hypersensitivity to light, noise, and physical contact, depersonalization, derealization, hallucinatory phenomena, convulsions.
Withdrawal symptoms may occur within days of stopping treatment. For short-acting benzodiazepines, and especially if given at high doses, symptoms may even occur in the interval between two doses.
When using long-acting benzodiazepines, it is important to inform the patient that switching to a short-acting benzodiazepine may result in withdrawal symptoms.
The combination of several benzodiazepines may, regardless of the anxiolytic or hypnotic indication, increase the risk of drug dependence.
Cases of abuse have been reported.
REBOUND PHENOMENON / WEANING
This transient syndrome may manifest itself at the end of the treatment by the reappearance, in an accentuated form, of the symptoms of anxiety and insomnia which motivated the treatment with the benzodiazepines and allied ones. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances, and nervousness. As the risk of rebound / weaning is higher after abrupt cessation of treatment, it is recommended to gradually reduce the dosage.
AMNESIA AND ALTERATIONS OF PSYCHOMOTIC FUNCTIONS
Anterograde amnesia and alterations in psychomotor function may occur within hours of taking the drug. Therefore, to reduce the risk, patients must be sure to sleep uninterrupted sleep for several hours after taking it. The effects of amnesia may be associated with inappropriate behavior (see also section 4.8).
PSYCHIATRIC AND PARADOXAL REACTIONS
In some subjects, benzodiazepines and related products may result in a syndrome associating to varying degrees an impairment of consciousness and behavioral and memory disorders may be observed:
· Worsening of insomnia, nightmares, agitation, nervousness,
· Delusions, hallucinations, confuso-oniric state, psychotic type symptoms,
· Disinhibition with impulsiveness,
· Euphoria, irritability,
· Anterograde amnesia,
This syndrome may be accompanied by potentially dangerous disorders for the patient or for others, such as:
· Inappropriate behavior for the patient,
· Anger attacks, self- or hetero-aggressive behavior, especially if the entourage tries to hinder the patient’s activity,
· Automatic driving with post-event amnesia.
These events require the cessation of treatment. These reactions are more likely to occur in children and the elderly.
RISK OF ACCUMULATION
Benzodiazepines and related drugs (like all drugs) persist in the body for a period of about 5 half-lives.
In the elderly or with renal or hepatic insufficiency, the half-life may be considerably longer. When taken repeatedly, the drug or its metabolites reach the equilibrium plateau much later and at a much higher level. It is only after obtaining a balance plateau that it is possible to evaluate both the efficacy and the safety of the drug.
Dosage adjustment may be necessary (see section 4.2). The patient should be monitored regularly at the beginning of treatment in order to decrease the dosage and / or the frequency of administration and to prevent the occurrence of accumulation-related overdose.
Benzodiazepines and related products should be used with caution in the elderly, because of the risk of sedation and / or myorelaxant effect that may lead to falls, with often severe consequences in this population.
CONCOMITANT USE OF ALCOHOL / CNS DEPRESSANTS
Concomitant use of bromazepam with alcohol and / or CNS depressants should be avoided. This concomitant use may increase the clinical effects of bromazepam, including severe sedation and clinically relevant respiratory and / or cardiovascular depression (see section 4.5).
Precautions for use
Great caution is recommended in case of a history of alcoholism or other addictions, whether medicated or not .
AT THE SUBJECT WITH A MAJOR DEPRESSIVE EPISODE
Benzodiazepines and related drugs should not be used alone to treat depression or anxiety associated with depression. The latter may evolve on its own account with persistence or increase in suicidal risk. Bromazepam should therefore be used with caution and the duration of treatment should be limited in patients with signs and symptoms of depressive disorder or suicidal tendencies.
Benzodiazepines are not recommended for the first-line treatment of psychotic illnesses.
DURATION OF TREATMENT
The duration of treatment should be as short as possible (see section 4.2) and should not exceed 8 to 12 weeks, including the dose reduction phase. If it is necessary to prolong the treatment beyond this time, the patient’s condition must be re-evaluated. It is useful to inform the patient when initiating treatment that it will be of limited duration.
PROGRESSIVE STOPPING PROCEDURES FOR TREATMENT
They must be stated to the patient precisely.
In addition to the need for gradual decrease in doses, patients should be warned of the possibility of a rebound phenomenon, to minimize the anxiety that may arise from the symptoms related to this interruption, even progressive.
The patient should be warned of the possibly uncomfortable nature of this phase.
Even more than in adults, the benefit / risk ratio will be carefully evaluated and the duration of treatment as short as possible. No clinical studies have been conducted in children with bromazepam.
SUBJECT AGE, INSUFFICIENT RENAL AND INSUFFICIENT HEPATIC:
The risk of accumulation leads to a reduction in dosage, for example by half (see section 4.4). Benzodiazepines are contraindicated in patients with severe hepatic impairment (risk of encephalopathy).
In patients with respiratory insufficiency, the depressant effect of benzodiazepines and related substances should be taken into account (especially since anxiety and agitation may be signs of a call for a decompensation of the respiratory function which justifies the transition to intensive care unit). It is recommended to reduce the dose.
Drive and use machines:
Prevent drivers of vehicles and machinery users from the risk of drowsiness, sedation, amnesia, impaired concentration and impaired muscle function.
The combination with other sedative drugs should be discouraged or taken into account when driving or using machines ( see Interactions ).
If sleep time is insufficient, the risk of impaired alertness is further increased. This effect is increased if the patient has consumed alcohol.
Lexomil (Bromazepam) and PREGNANCY / BREAST FEEDING / FERTILITY:
Many data from cohort studies have not revealed the occurrence of malformative effects during benzodiazepine exposure during the course of 1
first trimester of pregnancy. However, in some case-control epidemiological studies, an increase in the occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns would be less than 2/1000 after exposure to benzodiazepines during pregnancy while the expected rate in the general population is 1/1000.
If benzodiazepines are taken in high doses at 2 nd and / or 3 rdtrimesters of pregnancy, a decrease in fetal active movements and a variability in fetal heart rate have been described. Treatment with benzodiazepines at the end of pregnancy, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders resulting in low weight gain. These signs are reversible, but may last 1-3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, respiratory depression or apnea, and hypothermia may occur in the newborn. In addition, a syndrome of neonatal withdrawal is possible, even in the absence of signs of impregnation. It is characterized in particular by hyperexcitability, agitation and tremulations of the newborn occurring at a distance from the delivery. The time of onset depends on the elimination half-life of the drug and may be important when it is long.
Given these data, as a precautionary measure, the use of bromazepam is not recommended during pregnancy for any term.
When prescribing bromazepam to a woman of childbearing age, she should be advised of the need to contact her doctor if a pregnancy is planned or started to re-assess the benefit of the treatment.
At the end of pregnancy, if it is really necessary to start treatment with bromazepam, avoid prescribing high doses and take into account, for the surveillance of the newborn, the effects described above.
What should I do if I miss a dose?
Take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from Lexomil (Bromazepam) ?
Immediately consult your doctor or pharmacist.
What is Forms and Composition Lexomil (Bromazepam) ?
|FORMS and PRESENTATIONS|
6 mg (white) quadrisecable baguette tablet: Tube of 30.
Hospital model: Box of 100, in blister packs.
|Bromazepam (DCI)||6 mg|
Excipients: microcrystalline cellulose, lactose (100 mg / cp), talc, magnesium stearate.