alprazolam mylan 0.25 mg Uses, Dosage, Side Effects, Precautions & Warnings
Active ingredients: Alprazolam
what is Mylan alprazolam ?
ALPRAZOLAM MYLAN 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 MYLAN 0.25 MG
4 presentations are available for this drug:
- 1 polypropylene bottle (s) of 30 tablet (s)
- 1 polypropylene bottle (s) of 100 tablet (s)
- PVC-aluminum blister pack (s) of 30 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%|
|Laboratory (s)||MYLAN SAS|
|Conditions of issue||available by simple prescription|
what is Mylan alprazolam 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.
Mylan alprazolam Dosage
Reserved for adults.
- The safety and efficacy of alprazolam have not been demonstrated in children and adolescents under 18 years of age; therefore the use of alprazolam is not recommended.
- The 0.25 mg dosage is more particularly suitable for the elderly, with renal or hepatic insufficiency.
- 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 children, the elderly, renal or hepatic insufficiency :
- it is recommended to reduce the dosage, by half for example.
- 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.
- 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.
Mylan alprazolam Contraindications
Do not take ALPRAZOLAM MYLAN 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 ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
HOW TO TAKE ALPRAZOLAM MYLAN?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
how does Mylan alprazolam work?
- The absorption of alprazolam is rapid: the Tmax is between 0.5 and 2 hours. Bioavailability is of the order of 90%.
- The volume of distribution ranges from 0.5 to 1 l / kg.
- Protein binding is close to 70%.
- The plasma elimination half-life of alprazolam is between 10 and 20 hours. Steady state plasma concentrations are reached in about 3 days.
- A concentration-effect relationship could not be established for this class of products, due to the intensity of their metabolism and the development of tolerance.
- Benzodiazepines cross the blood-brain barrier as well as in the placenta and breast milk.
Metabolism and Elimination
- The liver plays a major role in the process of metabolism of benzodiazepines, which explains the negligible percentage of unchanged alprazolam found in the urine. The main metabolite of alprazolam is hydroxy-alprazolam, with an equivalent half-life but with half the activity of the parent molecule. Inactivation occurs by glucuronidation, resulting in water-soluble substances excreted in the urine.
Populations at risk
- Elderly :
- hepatic metabolism decreases as well as total clearance with increasing steady-state concentrations and half-lives. It is important to reduce the doses.
- Renal impairment :
- an increase in the free fraction (and therefore the volume of distribution) is noted.
- Hepatic impairment :
- total clearance decreases with increased half-life.
HOW TO STORE ALPRAZOLAM MYLAN?
- 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.
- This medication should be stored in a dry place.
- 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 MYLAN Side Effects
Adverse reactions associated with alprazolam treatment in patients participating in controlled clinical studies and post-marketing experience are as follows:
Adverse effects are related to the dose ingested and the individual sensitivity of the patient.
|Organ Class System||Very common ≥ 1/10||Common ≥ 1/100 to <1/10||Uncommon ≥ 1 / 1,000 to <1/100||Rare ≥ 1 / 10,000 to <1 / 1,000||Very Rare <1 / 10,000||Not known (frequency cannot be estimated from the available data)|
|Endocrine disorders||Hyperprolactinemia *|
|Metabolism and nutrition disorders||Decreased appetite|
|Psychiatric disorders||Depression||Confusional state, change in libido, anxiety, insomnia, nervousness||Hallucination *, anger *, agitation *||Aggression *, hostile behavior *, abnormal thinking *|
|Nervous system disorders||Sedation, somnolence, ataxia, memory loss, dysarthria, dizziness, headache||Balance disturbance, coordination disorder, concentration disturbance, tremor||Anterograde amnesia||Autonomic nervous system imbalance *, dystonia *, vegetative manifestations|
|Eye disorders||Blurry vision|
|Gastrointestinal disorders||Constipation||Nausea||Vomiting||Gastrointestinal disorders *|
|Hepatobiliary disorders||Hepatitis *, abnormal liver function *, jaundice *|
|Skin and subcutaneous tissue disorders||Dermatitis*||Angioedema *, photosensitivity reaction|
|Musculoskeletal and connective tissue disorders||Muscular weakness|
|Kidney and urinary tract disorders||Incontinence*||Urinary retention*|
|Reproductive system and breast disorders||Sexual dysfunction *||Menstrual irregularity *|
|General disorders and administration site conditions||Fatigue, irritability||Peripheral edema *|
|Investigations||Weight loss, weight gain||Increased intraocular pressure *|
* Adverse effect identified after marketing.
Use, even at therapeutic doses, may promote the onset of physical dependence with withdrawal or rebound syndrome upon discontinuation of treatment. Psychic dependence can occur.
Cases of abuse with benzodiazepines have been reported.
ALPRAZOLAM MYLAN Interactions
Not recommended associations
- Alcohol enhancement of the sedative effect of benzodiazepines and related drugs. Impaired vigilance can make driving and using machines dangerous.
- Avoid taking alcoholic drinks and drugs containing alcohol.
Associations to take into account
Other central nervous system depressants:
Morphinic derivatives (analgesics, cough suppressants and substitution treatments other than buprenorphine); neuroleptics; barbiturates; other anxiolytics; hypnotics; sedative antidepressants; sedative H1 antihistamines; central antihypertensive drugs; baclofen; thalidomide, pizotifen.
Increase in central depression. Impaired vigilance can make driving and using machines dangerous.
In addition, for morphine derivatives (analgesics, cough suppressants and substitution treatments), barbiturates: increased risk of respiratory depression, which may be fatal in the event of overdose.
- Increased risk of respiratory depression, which may be fatal in case of overdose.
- 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.
- Increased risk of collapse with respiratory and // or cardiac arrest.
- Increased risk of respiratory depression, which may be fatal in case of overdose.
Drive and use machines
- Warn drivers of vehicles and users of machines of the possible risk of drowsiness.
- The combination with other sedative drugs should be discouraged or taken into account when driving a car or using machines (see section Interactions with other drugs and other forms of interactions ).
- If the duration of sleep is insufficient, the risk of impaired vigilance is further increased.
Warnings and Precautions
Risk in case of concomitant use of opioids:
- Concomitant use of ALPRAZOLAM Mylan 0.25 mg scored tablet and opioids may result in sedation, respiratory depression, coma and death.
- Because of these risks, the concomitant prescription of opioids and sedative drugs, such as benzodiazepines or other related drugs, such as ALPRAZOLAM MYLAN 0.25 mg, scored tablet should be reserved for patients for whom there is no therapeutic alternative. is possible.
- If it is decided to prescribe ALPRAZOLAM MYLAN 0.25 mg scored tablet concomitantly with opioids, the lowest effective dose should be prescribed and the duration of treatment should be as short as possible .
- Signs and symptoms of respiratory depression and sedation should be closely monitored in these patients.
- In this regard, it is strongly recommended to inform patients and their caregivers so that they are aware of these symptoms (see section Interactions with other medicinal products and other forms of interactions).
- The anxiolytic effect of benzodiazepines and related drugs may gradually decrease despite the use of the same dose when administered for several weeks.
- Any treatment with benzodiazepines and related drugs, and more particularly in the event of prolonged use, can lead to a state of physical and psychological drug dependence.
Various factors seem to favor the onset of dependence:
- duration of treatment,
- History of other drug dependencies or not, including alcoholic.
- Drug dependence can occur at therapeutic doses and / or in patients without an individualized risk factor.
- In the event of physical dependence, abrupt discontinuation of treatment may lead to withdrawal symptoms. These symptoms can be: insomnia, headache, myalgia, severe anxiety, nervous tension, restlessness, confusion, irritability. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations, epileptic seizures.
- Withdrawal symptoms may appear within days of stopping treatment. For short-acting benzodiazepines, and especially if given in high doses, symptoms may even appear in the interval between two doses.
- The combination of several benzodiazepines, regardless of the anxiolytic or hypnotic indication, may increase the risk of drug dependence.
- As the risks of withdrawal are greater when the drug is stopped suddenly, it is recommended to gradually reduce the daily dose (see section Warnings and precautions for use, Precautions for use, Duration and gradual withdrawal procedures processing).
- Cases of abuse have been reported.
- This transient syndrome, the symptoms of which initially motivated treatment with benzodiazepines, may become exacerbated upon discontinuation of treatment.
- This syndrome can be accompanied by other reactions including mood swings, anxiety and sleep disturbances and restlessness.
- As the risk of the rebound phenomenon is greater when the drug is stopped suddenly, it is recommended to gradually reduce the daily dose (see section Warnings and precautions for use “Precautions for use, Duration and methods of stopping progressive treatment ”).
Amnesia and alterations in psychomotor functions:
- Anterograde amnesia as well as alterations in psychomotor functions are likely to appear within hours of taking.
Psychiatric and paradoxical reactions:
- In some individuals, benzodiazepines and related products may cause a syndrome with varying degrees of altered consciousness, behavioral and memory disturbances.
Can be observed:
- Worsening of insomnia, nightmares, restlessness, nervousness;
- Delusions, anger, hallucinations, dream-like state, psychotic-type symptoms;
- · Disinhibition with impulsivity;
- Euphoria, irritability, aggressiveness;
- · Anterograde amnesia;
This syndrome can be accompanied by potentially dangerous disorders for the patient or for others, such as:
- Unusual behavior for the patient,
- Auto- or hetero-aggressive behavior, especially if the entourage tries to hinder the patient’s activity,
- · Automatic behavior with post-event amnesia.
- These manifestations require the cessation of treatment.
- These behavioral disorders may occur more in children and elderly patients.
Risk of accumulation:
- Benzodiazepines and related drugs (like all drugs) persist in the body for a period of the order of 5 half-lives.
- In the elderly or with renal or hepatic insufficiency, the half-life may lengthen 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 obtaining a plateau of equilibrium that it is possible to assess 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 muscle relaxant effect which can promote falls, with often serious consequences in this population.
- It is recommended to use the lowest effective dose in the elderly and / or in the weakened subject in order to avoid the occurrence of ataxia or excessive sedation (see section Dosage and method of administration).
- This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) should not take this medicine.
- This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. that it is essentially “sodium-free”.
- Sodium benzoate
- This medicine contains 0.10 mg of sodium benzoate per tablet. Increased blood bilirubin as a result of its displacement with albumin may increase the risk of neonatal jaundice which can develop into kernicterus (deposits of unconjugated bilirubin in brain tissue).
Precautions for use
The greatest caution is recommended in the event of a history of alcoholism or other drug dependence or otherwise (see section Interactions with other medicinal products and other forms of interactions).
In the subject presenting a major depressive episode:
- Benzodiazepines and related drugs should not be used alone to treat depression because they cause or increase the risk of suicide. Thus, alprazolam should be used with caution and its prescription should be supervised in patients with signs and symptoms of depressive disorder or suicidal tendencies.
Duration and methods of gradual discontinuation of treatment (see section Posology and method of administration):
- Treatment should be as brief as possible.
- At the start of treatment, it may be useful to inform the patient that the duration of treatment will be limited.
- The procedures for phasing out treatment must be clearly stated to the patient.
- In addition to the need for a gradual decrease in doses, patients should be warned of the possibility of a rebound phenomenon, in order to minimize the anxiety that could arise from the symptoms associated with this interruption, even gradual.
- The patient should be warned of the possibly uncomfortable nature of this phase.
- With prolonged use of long-acting benzodiazepines, it is important to warn against switching to a short-acting benzodiazepine as withdrawal symptoms may occur.
Elderly subject, renal insufficiency, hepatic insufficiency:
- Benzodiazepines and related products should be used with caution in patients with renal impairment or mild to moderate hepatic impairment.
- The risk of accumulation leads to reducing the dosage, for example by half (see section Posology and method of administration).
- In patients with respiratory failure, the depressant effect of benzodiazepines and related drugs should be taken into account (especially since anxiety and agitation may constitute warning signs of decompensation of respiratory function which justifies the passage in intensive care unit).
- 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.
PREGNANCY & BREAST-FEEDING
- This medicine will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant, consult your doctor, he alone can judge the need for continued treatment.
Feeding with milk
- This drug passes into breast milk: therefore, breast-feeding is not recommended.
- Ask your doctor or pharmacist for advice before taking any medicine.
What happens if I overdose from ALPRAZOLAM MYLAN?
- 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 make up for the dose you forgot to take.
What is Forms and Composition ?
- Alprazolam: 0.25 mg For a scored tablet.
- Lactose monohydrate, microcrystalline cellulose, corn starch, sodium benzoate, dioctyl ester of sodium sulfosuccinate, povidone, colloidal anhydrous silica, sodium carboxymethyl starch, magnesium stearate.
INGREDIENTS WITH KNOWN EFFECT OF ALPRAZOLAM MYLAN 0.25 MG
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