4. Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended. Xanax should not be used to treat short-term mild anxiety, such as anxiety or tension associated with the stress of everyday life. Paediatric population: Safety and efficacy of alprazolam have not been established in children and adolescents below the age of 18 years; therefore use of alprazolam is not recommended. Benzodiazepines are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. It is recommended that the patient be reassessed at the end of no longer than 4 weeks' treatment and the need for continued treatment established, especially in case the patient is symptom free. Therefore alprazolam should be used with caution and the prescription size should be limited in patients with signs and symptoms of a depressive disorder or suicidal tendencies. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse (see section 4.5). The usual dosage is stated below; in the few patients who require higher doses, the dosage should be increased cautiously to avoid adverse effects. If side-effects occur, the dose should be lowered. Treatment should always be tapered off gradually. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days. Pharmaceutical form White, oval, biconvex tablets containing 250 microgram (0.25 mg) alprazolam, scored on one side and marked "Upjohn 29" on the other. A lower dose is also recommended for patients with chronic respiratory insufficiency due to risk of respiratory depression. It is advisable to review treatment regularly and to discontinue use as soon as possible. Some patients may require an even slower dosage reduction. Each tablet also contains 96 mg lactose monohydrate. Should longer term treatment be necessary, then intermittent treatment may be considered to minimize the risk of dependence. As with all benzodiazepines, physicians should be aware that long-term use might lead to dependence in certain patients. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those so treated, or those with a history of chronic alcoholism. It is recommended that general principle of using the lowest effective dose to be followed in elderly and /or debilitated patients to preclude development of ataxia or over-sedation (see section 4.2). During discontinuation of alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. For the full list of excipients, see section 6.1 3. The elderly or in the presence of debilitating disease: 250 micrograms (0.25 mg) two to three times daily to be gradually increased if needed and tolerated. As the efficacy of Xanax in depression and in phobic or obsessional states has yet to be established, specific treatment may have to be considered. 4.4 Special warnings and precautions for use Caution is recommended when treating patients with impaired renal function or mild to moderate hepatic insufficiency. 4.2 Posology and method of administration Treatment should be as short as possible. The lowest dose which can control symptoms should be used. The overall duration of treatment should not be more than 8-12 weeks, including a tapering off process. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status with special expertise. It is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. In patients presenting with major depression or anxiety associated with depression benzodiazepines and benzodiazepine-like agents should not be prescribed alone to treat depression as they may precipitate or increase the risk of suicide. Clinical particulars 4.1 Therapeutic indications Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. 4.3 Contraindications Alprazolam is contraindicated in patients with known hypersensitivity to benzodiazepines, alprazolam, or to any of the excipents listed in section 6.1. Anxiety: 250 micrograms (0.25 mg) to 500 micrograms (0.5 mg) three times daily, increasing if required to a total of 3 mg daily. The optimum dosage of Xanax should be based upon the severity of the symptoms and individual patient response. Dependence. (see section 4.4) There is a reduced clearance of the drug and, as with other benzodiazepines, an increased sensitivity to the drug in elderly patients. Dosage should be reassessed at intervals of no more than 4 weeks.
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Dependence. Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. Patients who have borderline personality disorder, a prior history of violent or aggressive behaviour, or alcohol or substance abuse may be at risk of such events. They are more likely to occur in children and the elderly. In many of the spontaneous case reports of adverse behavioural effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Instances of irritability, hostility and intrusive thoughts have been reported during discontinuance of alprazolam in patients with post-traumatic stress disorder. They may be quite severe with this product.
Psychiatric and paradoxical reactions. Pre-existing depression may be unmasked during benzodiazepine use.
Xanax Tablets 250 micrograms & 500 micrograms (PIL).
Alprazolam should not be used during pregnancy unless the clinical condition of the woman requires treatment with alprazolam. The data concerning teratogenicity and effects on postnatal development and behavior following benzodiazepine treatment are inconsistent. At high doses, respiratory depression or apnoea and hypothermia in newborn may appear. When treatment has to be administered for medical reasons during the last part of pregnancy, even at low doses, floppy infant syndrome such as axial hypotonia, sucking troubles leading to a poor weight gain may be observed. If alprazolam treatment is necessary during last part of pregnancy, high doses should be avoided and withdrawal symptoms and/or floppy infant syndrome should be monitored in newborn. If alprazolam is used during pregnancy, or of the patient becomes pregnant while taking alprazolam, the patient should be apprised of the potential hazard to the foetus. Breast-feeding. However, some early case-control epidemiological studies have found a twofold increased risk of oral clefts. These signs are reversible but they may last from 1 up to 3 weeks, according to the half life of the product. Moreover, neonatal withdrawal symptoms with hyperexcitability, agitation and tremor may be observed a few days after birth, even if no floppy infant syndrome is observed. The apparition of withdrawal symptoms after birth depends on the half life of the substance. Benzodiazepine treatment at high dose, during the second and/or the third trimester of pregnancy, has revealed a decrease of fetal active movements and a variability of foetal cardiac rhythm. A large amount of data based on cohort studies indicate that first trimester exposure to benzodiazepine is not associated with an increase in the risk of major malformation.
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It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. Amnesia. Extension beyond these periods should not take place without re-evaluation of the situation. When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. The duration of treatment should be as short as possible (see section 4.2) depending on the indication, but should not exceed eight to twelve weeks including tapering off process. There are indications, that in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. They are more likely to occur in children and the elderly. Should this occur, use of the medicinal product should be discontinued. Tolerance.
Alprazolam is excreted in breast milk at low level. These can range from mild dysphoria and insomnia to a major syndrome, which may include abdominal and muscle cramps, vomiting, sweating, tremor and convulsions. The following undesirable effects have been observed and reported during treatment with alprazolam with the following frequencies: 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 (cannot be estimated from the available data). If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see section 4.5). When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive • Do not drive until you know how the medicine affects you • It is an offence to drive while under the influence of this medicine • However, you would not be committing an offence (called 'statutory defence') if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and o It was not affecting your ability to drive safely 4.8 Undesirable effects Adverse events, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. However, alprazolam is not recommended during breast-feeding. This medicine can impair cognitive function and can affect a patient's ability to drive safely. MedDRA System Organ Class Frequency Undesirable Effects Endocrine disorders Uncommon Hyperprolactinaemia Metabolism and nutrition disorders Common Decreased appetite Psychiatric disorders Common Confusional state, depression, disorientation, libido decreased Uncommon Anxiety, insomnia, nervousness, hypomania, mania (see section 4.4), hallucination, anger, aggression, hostility, agitation, libido disorder, thinking abnormal, psychomotor hyperactivity Nervous system disorders Very common Sedation, somnolence Common Ataxia, balance disorder, coordination abnormal, memory impairment, dysarthria, disturbance in attention, hypersomnia, lethargy, dizziness, headache Uncommon Amnesia, tremor, dystonia Not Known Autonomic nervous system imbalance Eye disorders Common Vision blurred Gastrointestinal disorders Common Constipation, dry mouth, nausea Uncommon Gastrointestinal disorder Hepatobiliary disorders Uncommon Hepatitis, hepatic function abnormal, jaundice Skin and subcutaneous tissue disorders Uncommon Dermatitis Not Known Angioedema, photosensitivity reaction Musculoskeletal and connective tissue disorders Uncommon Muscular weakness Renal and urinary disorders Uncommon Incontinence, urinary retention Reproductive system and breast disorders Uncommon Sexual dysfunction, menstruation irregular General disorders and administration site conditions Common Fatigue, irritability Not Known Peripheral oedema Investigations Uncommon Change in weight, intraocular pressure increased Withdrawal symptoms have occurred following rapid decrease or abrupt discontinuance of benzodiazepines including alprazolam. In addition, withdrawal seizures have occurred upon rapid decrease or abrupt discontinuation of therapy with alprazolam. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. 4.7 Effects on ability to drive and use machines Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or use machines. Amnesia. These effects are potentiated by alcohol (see section 4.5). Patients should be cautioned about operating motor vehicles or engaging in other dangerous activities while taking Xanax.
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Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. In severe cases the following symptoms may occur: derealization, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Some patients may require even slower dosage reduction. It is suggested that the daily dosage of alprazolam be decreased by no more that 0.5 mg every three days. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol and drug abuse. Pharmacodependency may occur at therapeutic doses and/or in patients with no individualised risk factor. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually by no more than 0.5 mg every three days. Some patients may require an even slower dose reduction. (see section 4.2) Duration of treatment. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability and insomnia. Cases of abuse have also been reported. There is an increased risk of pharmacodependency with the combined use of several benzodiazepines regardless of the anxiolytic or hypnotic indication. (see section 4.2) During discontinuation of alprazolam treatment, the dosage should be reduced slowly in keeping with good medical practice. Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. Withdrawal symptoms: Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
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The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours. Benzodiazepines may induce anterograde amnesia. (see section 4.8) Psychiatric and paradoxical reactions.
POM - Prescription Only Medicine.
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see section 4.4). Psychic dependence may occur. Abuse of benzodiazepines has been reported. Reporting of suspected adverse reactions.
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Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression. This interaction will require a dose-adjustment or discontinuation of alprazolam. Pharmacokinetic interactions can occur when alprazolam is administered along with drugs that interfere with its metabolism. Based on the degree of interaction and the type of data available, the following recommendations are made: • The co-administration of alprazolam with ketoconazole, itraconazole, or other azole-type antifungals is not recommended. CYP3A Inhibitors Compounds that inhibit certain hepatic enzymes (particularly cytochrome P450 3A4) may increase the concentration of alprazolam and enhance its activity. However, upon extended exposure to ritonavir, CYP3A induction offset this inhibition. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. ritonavir) and alprazolam are complex and time dependent. Alprazolam should be used with caution when combined with CNS depressants. Patients who receive alprazolam and digoxin should therefore be monitored for signs and symptoms related to digoxin toxicity. • Caution is recommended when alprazolam is co-administered with fluoxetine, propoxyphene, oral contraceptives, sertraline, diltiazem, or macrolide antibiotics such as erythromycin, clarithromycin and troleandomycin. Digoxin Increased digoxin concentrations have been reported when alprazolam was given, especially in elderly (>65 years of age). Interactions involving HIV protease inhibitors (e.g. Fertility, pregnancy and lactation Pregnancy. 4.5 Interaction with other medicinal products and other forms of interaction Benzodiazepines produce an additive effect when co-administered with alcohol or other CNS depressants. Concomitant intake with alcohol is not recommended. CYP3A4 Inducers Since alprazolam is metabolized by CYP3A4, inducers of this enzyme may enhance the metabolism of alprazolam. 4.6. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Short term, low doses of ritonavir resulted in a large impairment of alprazolam clearance, prolonged its elimination half-life and enhanced clinical effects. Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines. Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Caution and consideration of dose reduction is recommended when alprazolam is co-administered with nefazodone, fluvoxamine and cimetidine. • The co-administration of nefazodone or fluvoxamine increases the AUC of alprazolam by approximay 2-fold. In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychic dependence. Data from clinical studies with alprazolam, in-vitro studies with alprazolam and clinical studies with drugs metabolised similarly to alprazolam provide evidence for varying degrees of interaction and possible interaction with alprazolam for a number of drugs.
Date of revision of the text 07/2014 Ref XX 9_0 Company contact details Pfizer Limited Address Ramsgate Road, Sandwich, Kent, CT13 9NJ. 6.4 Special precautions for storage Do not store above 25°C. When rats were treated orally with alprazolam for 2 years, a tendency for a dose related increase in the number of cataracts (females) and corneal vascularization (males) was observed. Following overdose with oral benzodiazepines, vomiting may be induced (within 1 hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. In the management of overdose with any medicinal product, it should be borne in mind that multiple agents have been taken. It facilitates the inhibitory neurotransmitter action of gamma-aminobutyric acid, which mediates both pre- and post synaptic inhibition in the central nervous system (CNS). In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. 6.5 Nature and contents of container Clear PVC/aluminium foil blister strips of 10 tablets, packed 6 strips to a box. 5.3 Preclinical safety data Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential. Marketing authorisation number(s) PL 00057/1058 9. 6.3 Shelf life 5 years. 7. The mean half-life is 12 - 15 hours. Not all pack sizes may be marketed. Repeated dosage may lead to accumulation and this should be borne in mind in elderly patients and those with impaired renal or hepatic function. Glass bottle with metal screw cap or HDPE bottle with LDPE tamper evident cap containing 100 or 1000 tablets. It allows continued monitoring of the benefit/risk balance of the medicinal product. Marketing authorisation holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom 8. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Reporting suspected adverse reactions after authorisation of the medicinal product is important. 5.2 Pharmacokinetic properties Alprazolam is readily absorbed. 6.6 Special precautions for disposal and other handling No special requirements. Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. Alprazolam and its metabolites are excreted primarily in the urine. Date of first authorisation/renewal of the authorisation 27 August 1982/23 January 2003 10. Bottle pack only: Store in the original container. Flumazenil may be useful as an antidote. 6. These lesions did not appear until after 11 months of treatment. 5. Pharmaceutical particulars 6.1 List of excipients Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Maize starch Magnesium stearate Docusate sodium with sodium benzoate. In fertility studies, treatment of male rats at high doses prior to mating resulted in a decrease in the percentage of dams conceiving. In vitro alprazolam is bound (80%) to human serum protein. Following oral administration peak concentration in the plasma occurs after 1 - 2 hours. Blister pack: Keep container in the outer carton. 4.9 Overdose As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). In reproductive toxicity studies administration of alprazolam in rats and rabbits is associated at very high doses with developmental delay and an increased incidence of fetal death and skeletal malformations. 6.2 Incompatibilities Not applicable. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Benzodiazepine derivatives, ATC code: N05BA12 Alprazolam, like other benzodiazepines, has a high affinity for the benzodiazepine binding site in the brain.
Xanax 250 microgram Tablets 2. Excipients with known effect:. Qualitative and quantitative composition Alprazolam 250 micrograms.
Amnesic effects may be associated with inappropriate behaviour. Anterograde amnesia may occur at therapeutic dosages, the risk increasing at higher dosages. Depression. (see section 4.4).
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Xanax tablets 250