XANAX Tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Xanax 500 microgram Tablets.
Qualitative and quantitative composition
Each tablet contains 500 micrograms alprazolam. Excipient(s) with known effect: Lactose, 91.1 mg per tablet. For the full list of excipients, see section 6.1
Pharmaceutical form
Tablet. Pink, oval, biconvex tablet scored on one side and marked Upjohn 55 on the other.
Therapeutic indications
Xanax is indicated for the short-term treatment of moderate or severe anxiety states and anxiety associated with depression. It is only indicated when the disorder is severe, disabling or subjecting the ...
Posology and method of administration
Posology 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 elderly or in the presence of debilitating disease 250 micrograms ...
Contraindications
Hypersensitivity to benzodiazepines, alprazolam, or to any of the excipients listed in section 6.1. Benzodiazepines are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, ...
Special warnings and precautions for use
Renal and hepatic impairment Caution is recommended when treating patients with impaired renal function or mild to moderate hepatic insufficiency. Depression/anxiety In patients presenting with major depression ...
Interaction with other medicinal products and other forms of interaction
Opioids The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Xanax with opioids increases the risk of sedation, respiratory depression, coma and death because of additive ...
Pregnancy and lactation
Pregnancy The data concerning teratogenicity and effects on postnatal development and behavior following benzodiazepine treatment are inconsistent. A large amount of data based on cohort studies indicate ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive and use machines. If insufficient sleep occurs, the likelihood of impaired alertness may ...
Undesirable effects
Adverse events, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage. The following undesirable effects have been observed ...
Overdose
As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). In the management of overdose with any medicinal product, it ...
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. It facilitates the ...
Pharmacokinetic properties
Alprazolam is readily absorbed. Following oral administration peak concentration in the plasma occurs after 1-2 hours. The mean half-life is 12-15 hours. Repeated dosage may lead to accumulation and this ...
Preclinical safety data
Mutagenesis and Carcinogenesis Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential. Ocular Effects When rats were treated orally ...
List of excipients
Lactose Microcrystalline cellulose Colloidal anhydrous silica Maize starch Magnesium stearate Docusate sodium with sodium benzoate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Clear PVC/aluminium foil blister strips of 10 tablets, packed 6 strips to a box. Glass bottle with metal screw cap or HDPE bottle with LDPE tamper evident cap containing 100 or 1000 tablets. Not all pack ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1059
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 August 1982 Date of latest renewal: 23 January 2003
Date of revision of the text
01/2019
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