alprazolam sandoz 0.25 mg Uses, Dosage, Side Effects, Precautions & Warnings
Active ingredients: Alprazolam
what is alprazolam sandoz ?
ALPRAZOLAM SANDOZ 0.25 MG: GENERAL INFORMATION
This medication is recommended in the treatment of anxiety when it is accompanied by troublesome disorders, or in the prevention and / or treatment of symptoms linked to alcohol withdrawal.
PRESENTATION (S) AVAILABLE FOR ALPRAZOLAM SANDOZ 0.25 MG
3 presentations are available for this drug:
- PVC-Aluminum blister pack (s) of 30 tablet (s)
- PVC-aluminum blister pack (s) of 60 tablet (s)
- PVC-aluminum blister pack (s) of 100 tablet (s)
|Active substance (s)||for one tablet: alprazolam (0.25 mg)|
|Pharmaceutical form||breakable tablet|
|Route (s) of administration||oral|
|Social security reimbursement rate||65%|
|Conditions of issue||available by simple prescription|
what is alprazolam sandoz medication used for and indication?
- Symptomatic treatment of severe anxiety symptoms and / or disabling.
- Prevention and treatment of delirium tremens and other manifestations of alcohol withdrawal.
alprazolam sandoz Dosage
Reserved for adults
- In all cases, treatment will be started at the lowest effective dose and the maximum dose of 4 mg / day will not be exceeded.
- In general, in adults, treatment will be started at a dosage of 0.75 mg to 1 mg per day, divided into 3 doses as follows:
- 0.25 mg in the morning and at noon, and 0.25 to 0.50 mg in the evening.
- The dosage will then be individually adjusted depending on the therapeutic response.
- The average dosage is between 1 and 2 mg per day.
- In the elderly, renal or hepatic insufficiency:
- In the elderly, renal or hepatic insufficiency: it is recommended to reduce the dosage, by half for example. The 0.25 mg dosage is more particularly suitable in these cases.
- The safety and efficacy of alprazolam have not been studied in children and adolescents below 18 years of age. Its use is not recommended in this population.
- Treatment should be as brief 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 period of dose reduction (see section 4.4).
- In some cases, it may be necessary to extend the treatment beyond the recommended periods. This assumes precise and repeated assessments of the patient’s condition.
- Prevention and treatment of delirium tremens, and other manifestations of alcohol withdrawal: brief treatment of the order of 8 to 10 days.
- Oral route.
alprazolam sandoz Contraindications
Do not use ALPRAZOLAM SANDOZ 0.25 mg, scored tablet in the following cases:
- known allergy to this class of products or to one of the components of the drug,
- severe respiratory failure,
- sleep apnea syndrome ( breathing pauses during sleep ),
- severe liver failure,
- myasthenia gravis ( disease characterized by an excessive tendency to muscle fatigue ).
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
HOW TO TAKE alprazolam sandoz?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
how does alprazolam sandoz work?
- Pharmacotherapeutic group: anxiolytics, ATC code: N05BA12 .
- Alprazolam belongs to the class of 1-4 benzodiazepines and has pharmacodynamic activity qualitatively similar to that of the other compounds of this class:
- Muscle relaxant,
- These effects are linked to a specific agonist action on a central receptor forming part of the “GABA-OMEGA macromolecular receptors” complex, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.
HOW TO STORE alprazolam sandoz?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date refers to the last day of that month.
- Store at a temperature not exceeding 25 ° C.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
alprazolam sandoz Side Effects
Like all medicines, ALPRAZOLAM SANDOZ 0.25 mg, scored tablet can cause side effects, although not everybody gets them.
They are related to the dose ingested and the individual sensitivity of the patient:
Neuro-psychiatric adverse effects .
- memory impairment (memory loss), which can occur with therapeutic doses, the risk increasing in proportion to the dose,
- behavioral disturbances, changes in consciousness, irritability, aggressiveness, agitation,
- physical and psychological dependence, even at therapeutic doses with withdrawal or rebound syndrome upon discontinuation of treatment,
- feelings of intoxication, headaches, difficulty coordinating certain movements,
- confusion, decreased alertness or even drowsiness (particularly in the elderly), insomnia, nightmares, tension,
- changes in libido.
Skin side effects
- rashes, with or without itching.
General side effects
- muscle weakness, fatigue.
Ocular side effects
- double vision.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
alprazolam sandoz Interactions
Not recommended associations
Alcohol (drink or excipient)
- Alcohol enhancement of the sedative effect of these substances. Impaired vigilance can make driving and using machines dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
- Increase in central depression. Impaired vigilance can make driving and using machines dangerous.
Associations to take into account
- It should be taken into account that many drugs or substances can add up their depressant effects on the central nervous system and contribute to reducing alertness. These are morphine derivatives (analgesics, cough suppressants and substitution treatments); neuroleptics; barbiturates; benzodiazepines, anxiolytics other than benzodiazepines (eg, meprobamate); hypnotics; sedative antidepressants; sedating H1 antihistamines; central antihypertensive drugs; baclofen and thalidomide.
- Increase in central depression. Impaired vigilance can make driving and using machines dangerous.
Opioids (including opioids)
- The combination of opioids with sedative drugs, such as benzodiazepines or related substances, such as ALPRAZOLAM SANDOZ increases the risk of sedation, respiratory depression, coma and death due to the additive effects of central nervous system depression. The dose and duration of concomitant treatment should be limited.
- Increased risk of respiratory depression, which can be fatal in the event of overdose . Barbiturates
- Increased risk of respiratory depression, which may be fatal in case of overdose.
- Increased risk of collapse with respiratory and / or cardiac arrest.
- With buprenorphine used in substitution treatment: 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 adhere to the prescribed doses.
Strong CYP3A4 inhibitors
- Possible increased sedative effect of alprazolam.
- Not applicable.
Drive and use machines
- Attention is drawn to drowsiness, lamnesia, impairment of muscle functions, decreased concentration and alertness associated with the use of this drug.
- The combination with other sedative or hypnotic drugs, and of course with alcohol, is not recommended when driving a car or using machines.
- If the duration of sleep is insufficient, the risk of impaired vigilance is further increased.
Warnings and Precautions
This drug treatment alone cannot resolve the difficulties associated with anxiety. You should seek advice from your doctor. He will show you the behaviors that can help in the fight against anxiety.
- If loss of effectiveness occurs with repeated use of the drug, do not increase the dose.
- Risk of DEPENDENCE: this treatment can lead, especially in case of prolonged use, to a state of physical and psychological dependence. Various factors seem to favor the onset of dependence:
- duration of treatment,
- history of other drug dependence or not, including alcoholic.
- Addiction can occur even in the absence of these contributing factors.
For more information, talk to your doctor or pharmacist.
- Abruptly stopping this treatment may cause the appearance of a WITHDRAWAL phenomenon. This is characterized by the appearance, in a few hours or a few days, of signs such as severe anxiety, insomnia, muscle pain, but one can also observe restlessness, irritability, headaches, numbness or tingling of the extremities, abnormal sensitivity to noise, light or physical contact, etc., etc.
The modalities for stopping treatment should be defined with your doctor.
- The very PROGRESSIVE reduction of the doses and the spacing of the catches represent the best prevention of this phenomenon of withdrawal. This period will be longer as the treatment has been prolonged.
- Despite the gradual decrease in doses, a mild REBOUND phenomenon may occur, with TRANSITIONAL reappearance of symptoms (anxiety) which had justified the initiation of treatment.
- Memory problems as well as alterations in psychomotor functions are likely to appear within hours of taking the drug.
- In some subjects, this medication may cause reactions contrary to the desired effect: insomnia, nightmares, restlessness, nervousness, euphoria or irritability, tension, changes in consciousness, or even potentially dangerous behavior (aggression towards oneself or those around them , as well as behavioral disorders and automatic acts).
If one or more of these reactions occur, contact your doctor as soon as possible.
- Benzodiazepines and related products should be used with caution in the elderly, because of the risk of drowsiness and / or muscle relaxation which can promote falls, with often serious consequences in this population.
- Due to the presence of lactose, this medicine should not be used in case of galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
Precautions for use
- Taking this medication requires reinforced medical monitoring, especially in cases of renal failure, chronic liver disease, alcoholism and respiratory failure.
- This medicine does not treat depression. In the subject presenting with depression, it should not be used alone because it would allow the depression to evolve on its own account with persistence or increased risk of suicide.
- Alcohol intake is strictly discouraged during the treatment.
- In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
PREGNANCY & BREAST-FEEDING & FERTILITY
- Numerous data from cohort studies have not demonstrated the occurrence of malformative effects during exposure to benzodiazepines during the 1st trimester of pregnancy. However, in some case-control epidemiological studies, an increased occurrence of cleft lip and palate has been observed with benzodiazepines. According to these data, the incidence of cleft lip and palate in newborns is less than 2/1000 after exposure to benzodiazepines during pregnancy, while the expected rate in the general population is 1/1000.
- When taking benzodiazepines in high doses in the 2nd and / or 3rd trimesters of pregnancy, a decrease in active fetal movements and a variability of the fetal heart rate have been described. Treatment at the end of pregnancy with benzodiazepines, even at low doses, may be responsible in the newborn for signs of impregnation such as axial hypotonia, sucking disorders leading to low weight gain. These signs are reversible, but may last 1 to 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. Moreover, a neonatal withdrawal syndrome is possible, even in the absence of signs of impregnation. It is characterized in particular by hyperexcitability, restlessness and tremors of the newborn occurring at a distance from childbirth. The time to onset depends on the elimination half-life of the drug and can be important when this is long.
- In view of these data, as a precaution, the use of alprazolam is not recommended during pregnancy, whatever the term.
- If a woman of childbearing potential is prescribed alprazolam, she should be advised of the need to contact her doctor if pregnancy is planned or started so that he or she can reassess the benefit of the treatment.
- At the end of pregnancy, if it becomes really necessary to initiate treatment with alprazolam, avoid prescribing high doses and take into account, for the monitoring of the newborn, the effects described above.
Feeding with milk
- Alprazolam is excreted in human milk at low concentrations. However, the use of this medicine during breast-feeding is not recommended.
What happens if I overdose from alprazolam sandoz?
- The vital prognosis can be threatened, especially in cases of polyintoxication involving other depressants of the central nervous system (including alcohol).
- It is important to keep in mind that multiple medication may be responsible for overdose.
- In case of massive intake, the signs of overdose are mainly manifested by CNS depression which can range from drowsiness to coma, depending on the amount ingested.
- Mild cases are manifested by drowsiness, signs of mental confusion, lethargy.
- More serious cases manifest as ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
- In the event of oral overdose prior to 1 hour, induction of vomiting should be performed if the patient is conscious or, failing that, gastric lavage with protection of the airways. After this time, administration of activated charcoal may reduce absorption.
- Particular monitoring of cardio-respiratory functions in a specialized environment is recommended.
- Administration of flumazenil may be useful for the diagnosis and / or treatment of intentional or accidental overdose of benzodiazepines.
- Antagonism by flumazenil of the effect of benzodiazepines may promote the onset of neurological disorders (convulsions), especially in patients with epilepsy.
What should I do if I miss a dose?
- Take the next dose at the usual time. Do not take a double dose to compensate the single dose you forgot to take.
What is Forms and Composition ?
- 30 scored tablets in blister packs (PVC / Aluminum).
- 60 scored tablets in blister packs (PVC / Aluminum).
- 100 scored tablets in blister packs (PVC / Aluminum).
Not all presentations may be marketed.
- ALPRAZOLAM SANDOZ 0.25 mg, scored tablet, box of 30
|Active ingredient||Breakable tablet|
|Alprazolam||0.5 mg *|
* per unit dose
Other excipients: Microcrystalline cellulose, DC microcrystalline cellulose, Pregelatinized corn starch, Magnesium stearate, Sodium docusate, Silica colloidal anhydrous, Erythrosine aluminum lake
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