- 1 Important to know about Lysanxia (Prazepam ) ?
- 2 Lysanxia (Prazepam ) indication and Uses :
- 3 Lysanxia (Prazepam ) Dosage :
- 4 Lysanxia (Prazepam ) Side Effects :
- 5 Lysanxia (Prazepam ) Interactions :
- 6 Lysanxia (Prazepam ) Warnings and Precautions :
- 7 Drive and use machines:
- 8 Lysanxia (Prazepam ) and PREGNANCY / BREAST FEEDING / FERTILITY:
- 9 What should I do if I miss a dose?
- 10 What happens if I overdose from Lysanxia (Prazepam ) ?
- 11 What is Forms and Composition Lysanxia (Prazepam )?
Important to know about Lysanxia (Prazepam ) ?
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.
Lysanxia (Prazepam ) indication and Uses :
– Symptomatic treatment of severe and / or disabling anxiety disorders.
– Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
Lysanxia (Prazepam ) Dosage :
The use of prazepam is not recommended in children. In addition, the tablet is not a form suitable for children under 6 years (risk of mis-driving).
– Dose :
In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.
. The usual dosage in adults is 10 to 30 mg daily divided into several doses during the day. In psychiatry: 20 to 60 mg a day.
. In children, the elderly, the renal failure or the hepatic insufficiency : it is recommended to reduce the dosage, by half for example.
– Duration :
. The 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 not exceed 8 to 12 weeks for the majority of patients, including the dose reduction period (see section on warnings 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 Lysanxia (Prazepam ) :
ATC Code: N05BA11.
(N: central nervous system) .
– The prazepam 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.
Lysanxia (Prazepam ) Side 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 Precautions for use, special warnings)
· Memory problems ( memory lapses), which can occur at therapeutic doses, the risk increases in proportion to the dose;
· Behavioral disturbances, 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 divinity, headaches, difficulty coordinating certain movements;
· Confusion, decreased alertness or drowsiness (particularly in the elderly), insomnia, nightmares, tension;
· Changes in libido.
Cutaneous adverse effects
· Rash, with or without itching.
General side effects
· Muscle weakness, fatigue
Ocular adverse effects
· Double vision.
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
By reporting side effects, you can help provide more information on the safety of the medicine.
Lysanxia (Prazepam ) Interactions :
.ASSOCIATION DECONSEILLEE :
Increase by alcohol sedative effect of benzodiazepines and related. Impairment of alertness can make driving and using machines dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.
ASSOCIATIONS TO BE CONSIDERED :
– Other central nervous system depressants: morphine derivatives (analgesics, antitussives and substitution treatments other than buprenorphine); neuroleptics; barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative antihistamines H1; central antihypertensives; others: baclofen; thalidomide; pizotifen.
Increase of the central depression. Impairment of alertness can make driving and using machines 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.
– Buprenorphine : 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.
Lysanxia (Prazepam ) Warnings and Precautions :
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
The anxiolytic effect of benzodiazepines and related substances may decrease gradually despite the use of the same dose when administered 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 drug addictions, 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, severe anxiety, myalgia, muscle tension, irritability.
Other symptoms are more rare: agitation or even confusional episode, paresthesia of the extremities, hyperreactivity 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. This is not expected with prazepam because of its long half-life (see section 5.2).
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.
This transient syndrome may manifest itself as an exacerbation of the anxiety that motivated treatment with benzodiazepines and the like.
AMNESIA AND ALTERATIONS OF PSYCHOMOTIC FUNCTIONS
Anterograde amnesia and alterations of the psychomotor functions are likely to appear in the hours following the taking.
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:
Can be observed:
· Worsening of insomnia, nightmares, agitation, nervousness;
· Delusions, hallucinations, confuso-oniric state, psychotic type symptoms;
· Disinhibition with impulsivity;
· Euphoria, irritability;
· Anterograde amnesia;
This syndrome may be accompanied by potentially dangerous disorders for the patient or for others, such as:
· Unusual behavior for the patient;
· Self- or hetero-aggressive behavior, especially if the family is trying to interfere with the patient’s activity;
· Automatic driving with post-event amnesia.
These events require the cessation of treatment.
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.
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.
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 prescribed alone as they allow depression to progress on its own account with persistence or increased suicidal risk.
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. The use of prazepam is not recommended in children.
SUBJECT AGE, INSUFFICIENT RENAL OR INSUFFICIENT HEPATIC
The risk of accumulation leads to a reduction in dosage, for example by half (see section 4.4 Warnings).
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).
Drive and use machines:
Prevent drivers of vehicles and machine users from the risk of drowsiness.
Combination with other sedating medicinal products should be discouraged or taken into account when driving or using machines .
If sleep time is insufficient, the risk of impaired alertness is further increased.
Lysanxia (Prazepam ) and PREGNANCY / BREAST FEEDING / FERTILITY:
To date, no ill effects are attributed to benzodiazepine exposure during the first trimester of pregnancy.
In the case of taking high dose benzodiazepines in the 2nd and / or 3rd trimesters of pregnancy, a decrease in fetal active movements and fetal heart rate variability has been described.
Treatment at the end of pregnancy with benzodiazepine, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders resulting in poor weight gain. These signs are reversible, but may last 1-3 weeks depending on the half-life of the prescribed benzodiazepine. At high doses, reversible respiratory depression or apnea, and reversible 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 childbirth. The delay of occurrence depends on the half-life of Given these data, the use of prazepam is conceivable during pregnancy whatever the term, in strict compliance with indications and dosages.At the end of pregnancy, if prazepam treatment is necessary, avoid prescribing high doses and consider the previously described effects for monitoring the newborn.
The use of this medicine during breast-feeding is not recommended.
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 single dose you forgot to take.
What happens if I overdose from Lysanxia (Prazepam ) ?
Immediately consult your doctor or pharmacist.
What is Forms and Composition Lysanxia (Prazepam )?
Prazepam: 10,000 mg
For a tablet.
Lactose monohydrate, microcrystalline cellulose, corn starch, magnesium stearate, indigo aluminum lake at 13%, anhydrous colloidal silica.