· Symptomatic treatment of anxious, severe and / or debilitating manifestations

· Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal

The use of alprazolam is not recommended in children, in the absence of study. In addition, the tablet is not a suitable form for children under the age of 6 (risk of misleading).


The 0.25 mg dosage is more suitable for the elderly, renal or hepatic impairment

Dose

In all cases, treatment will be initiated at the lowest effective dose and the maximum dose of 4 mg / day will not be exceeded.
Generally, in adults, treatment will be started at the dosage of 0.75 mg to 1 mg per day divided into 3 doses in the following manner
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· 0.25 mg in the morning and at noon and 0.25 to 0.50 mg in the evening.
The dosage will then be adjusted individually according to the therapeutic response.
In children, the subject, elderly, renal or hepatic insufficiency: it is recommended to decrease the dosage, by half for example.
Duration

Treatment should be as short as possible. The indication will be re-evaluated 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 Warnings and Precautions for Use). >

In some cases it may be necessary to prolong treatment beyond the recommended periods. This requires accurate and repeated assessments of the condition of the patient.

Prevention and treatment of delirium tremens and other manifestations of withdrawal, alcoholic: short processing on the order of 8 to 10 days

Scored tablet.

ANXIOLYTICS

ATC code: N05BA12

(N: nervous system, central)

Alprazolam belongs to the class of 1-4 benzodiazepines and has pharmacodynamic activity, qualitatively similar to that of other compounds, of this class
· Myorelaxante

· Anxiolytic

· Sedative

· Hypnotic

· Anticonvulsant

· Amnesiante.

These effects are related to, specific agonist action on a central receiver part of the complex "receptors, GABA-OMEGA macromolecular", also, called BZ1 and BZ2 and modulating the opening of the canal. Chlorine

Prevent the drivers of vehicles and users from the possible risk of drowsiness

The combination with other medicines should be discouraged or taken into account in case of driving, automobile or machine use (see section Interactions with other medicines and other forms of interactions Other drugs and other forms of interactions)

If the duration of sleep is insufficient, the risk of altering vigilance is increased.

This medicinal product should never be used in the following situations

· Hypersensitivity to the active ingredient or to any of the other ingredients

· Severe respiratory failure

· Sleep apnea syndrome

· Severe, acute or chronic liver disease (risk of occurrence of encephalopathy)

· Myasthenia.

Warnings

Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

PHARMACOLOGICAL TOLERANCE

The anxiolytic effect of benzodiazepines and related drugs may be decreased progressively despite the use of the same dose and if administered for several weeks

DEPENDENCY

Any treatment with benzodiazepines and related drugs, and more particularly in cases of prolonged use, may lead to a state of drug dependence, both physical and psychological.

Various factors seem to favor the occurrence of dependence

· Duration of treatment

· Dose

· History of other addictions, medicinal or not, including alcoholic.

Drug dependence may occur at therapeutic doses and / or in patients without an individualized risk factor

On cessation of treatment, this condition may lead to a withdrawal phenomenon.

Some symptoms are frequent and seem trivial: insomnia, headache, severe anxiety, myalgia, muscle tension, irritability.
Symptoms of withdrawal may occur within a few days after discontinuation of therapy, and for short-acting benzodiazepines, especially if given at high doses, symptoms may even occur in The interval that separates two takes.

The combination of several benzodiazepines may, whatever the indication, anxiolytic or hypnotic, increase the risk of drug dependence.


REBOND PHENOMENON

This transient syndrome may manifest itself in the form of an exacerbation of anxiety which had motivated benzodiazepine and related treatment.


Anterograde amnesia, as well as alterations of the psychomotor functions, are liable to appear within hours of taking.

BEHAVIORAL DISORDERS

In some subjects, benzodiazepines and related products may cause a syndrome associating degrees, alterations in the state of consciousness and behavioral and memory disorders

Can be observed

· Aggravation of insomnia, nightmares, agitation, nervousness

· Delusions, hallucinations, state, confuso-onirique, symptoms of psychotic type

· Disinhibition with impulsivity

· Euphoria, irritability

· Anterograde amnesia

· Suggestibility.

This syndrome may be accompanied by disorders that are potentially dangerous to the patient or to others, such as
· Unusual behavior for the patient

· Self or hetero-aggressive behavior, especially if the entourage tries to hinder the patient's activity

· Automatic behavior with amnesia, post-event.

These manifestations require the cessation of treatment.

RISK OF ACCUMULATION

Benzodiazepines and related drugs (like all medicines) persist in the body for a period of about 5 half-lives (see section 5.2). >

In elderly or patients with renal or hepatic impairment, the half-life may increase considerably. When taken repeatedly, the drug or its metabolites reach the equilibrium plateau, much later and at a much higher level. It is only after achieving an equilibrium plateau that it is possible to evaluate both the efficacy and safety of the drug.
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Dosage adjustment may be necessary (see section 4.2 Posology and method of administration)

SUBJECT AGE

Benzodiazepines and related products should be used with caution, in the elderly, because of the risk of sedation and / or muscle relaxant which may lead to falls, with often serious consequences in this population. >

Precautions for use

Extreme caution is advised in case of a history of alcoholism, or other dependencies, medicated or not, (see section Interactions with other drugs and other forms of interactions). >

IN THE SUBJECT HAVING AN EPISODE: MAJOR DEPRESSIVE

Benzodiazepines and related drugs should not be prescribed alone because they allow depression to evolve on its own account with persistence or increase in suicidal risk

METHODS OF PROGRESSIVE STOPPING OF TREATMENT

They must be stated to the patient in a precise manner

In addition to the necessity of gradually decreasing doses, patients should be warned of the possibility of a rebound phenomenon in order to minimize the anxiety that might arise from the symptoms related to this even progressive break. Code>
The patient should be warned of the possible uncomfortable nature of this phase
CHILD

More than in adults, the benefit / risk ratio will be scrupulously evaluated and the duration of treatment as short as possible. No clinical studies have been conducted in children with alprazolam.

SUBJECT AGE, RENAL INSUFFICIENT, HEPATIC INSUFFICANT

The risk of accumulation leads to a reduction in the dosage, for example by half (see Warnings).

RESPIRATORY INSUFFICIENT

In the inadequate respiratory system, consideration should be given to the depressant effect of benzodiazepines and related compounds (especially as anxiety and agitation may constitute signs of decompensation of function Respiratory that justifies the passage in intensive care unit.

Associations, deprecated

+ Alcohol

Enhancement by alcohol of the sedative effect of benzodiazepines and related compounds

The alteration of alertness may make dangerous the driving of vehicles and the use of machinery.

Avoid drinking alcoholic beverages and medicines containing alcohol

Associations, to be taken into account

+ Other; Central Nervous System; morphine derivatives (analgesics, antitussives and substitution treatment other than, buprenorphine), neuroleptics, barbiturates, other; anxiolytics, hypnotics, sedative antidepressants, sedative H1 antihistamines, central antihypertensives, baclofen, thalidomide, pizotifen .

Increased depression, central. The alteration of alertness can make dangerous the driving of vehicles and the use of machines.

In addition, for derivatives, opioids (painkillers, cough medicine and treatments; substitution), barbiturates: increased risk of, respiratory depression, which may be fatal case; overdose

+ Buprenorphine

Increased risk of respiratory depression, which can be fatal

Carefully evaluate the benefit / risk ratio of this association. Inform the patient of the need to comply with the doses prescribed.

Not applicable.

The prognosis may be, threatened, particularly in cases of multiple agents; involving other central nervous system depressants;. Central (including alcohol)

In the case of massive intake, signs of overdose are predominantly depressed, the CNS may range from somnolence to coma, depending on the amount ingested. >
Mild cases are manifested by signs of mental confusion, lethargy.

.
In case of prior oral overdose, vomiting will be induced at 1 hour, if the patient is conscious or, if not, gastric lavage with airway protection. Past, this time the administration of activated charcoal can reduce absorption.
The administration of flumazenil may be useful for the diagnosis and / or treatment of an intentional or accidental overdose of benzodiazepines.
Flumazenil antagonism of the effect of benzodiazepines may favor the development of neurological disorders (seizures), especially in the patient, epileptic.
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Pregnancy

To date, no malformation is attributed to exposure to benzodiazepines during the first trimester of pregnancy.
If benzodiazepines; in high doses to the 2 nd and / or; 3 rd trimesters of pregnancy decreased; fetal active movements and rhythm variability fetal heart were described



Treatment in late pregnancy by; benzodiazepine even at low doses, may, be responsible in the newborn signs; impregnation such axial qu'hypotonie, the disorder; suction resulting in poor weight gain. These signs are reversible but may last 1 to 3 weeks, depending on the half-life of the prescribed benzodiazepine. A high doses, reversible respiratory depression or apnea, and hypothermia may occur in the newborn. Furthermore, a neonatal withdrawal syndrome is possible even in the absence of signs of impregnation. It is characterized, in particular, by hyperexcitability, agitation and tremulousness, of the newborn occurring at a distance from childbirth .; The time of occurrence depends on the half-life, elimination of the drug and may be important When this one is long.

In view of these data, the use of alprazolam is possible during pregnancy whatever the term, in strict accordance with indications and dosages.
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At the end of pregnancy, if alprazolam treatment is necessary, avoid high-dose prescribing and take into account effects described above for monitoring the newborn. Br>

Breastfeeding

The use of this medication during lactation is not recommended.
They are related to the ingested dose, the individual sensitivity of the patient.

neuropsychiatric adverse effects (see section, warnings and precautions for use)

· Anterograde amnesia, which can occur at therapeutic doses, the risk increasing proportionally, at the dose

· Behavioral disturbances, changes in consciousness, irritability, aggression, agitation

· Physical and psychic dependence, even at doses, therapeutics with withdrawal or rebound syndrome, cessation of treatment

· Sensations, headache, ataxia

Confusion, decreased alertness or drowsiness (particularly in the elderly), insomnia, nightmares, tension

· Libido changes.

Skin Adverse Events

· Skin rashes, pruriginous or not

General Adverse Reactions

· Muscle hypotonia, asthenia.

Ocular adverse effects

· Diplopia.

· Symptomatic treatment of anxious, severe and / or debilitating symptoms · Prevention and treatment of delirium tremens and other symptoms of alcohol withdrawal