Alprazolam


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Short-term management of anxiety In patients with moderate or severe anxiety states, or anxiety associated with depression: As conventional tab, orally-disintegrating tab, oral solution: 0.25-0.5 mg tid, may be increased if as necessary every 3-4 days to a total of 3 or 4 mg/day. Treatment duration: 8-12 weeks, including a tapering off process. Panic disorder with or without agoraphobia As conventional tab, orally-disintegrating tab, oral solution: Initially, 0.5 mg tid, may be increased in increments of not more than 1 mg/day every 3-4 days; if required, doses of up to 10 mg/day may be used. As extended-release tab: Initial: 0.5-1 mg once daily, may be increased in increments of not more than 1 mg/day every 3-4 days; doses of up to 3-6 mg/day may be used.
Administration
May be taken with or without food. Side effects eg sleepiness/drowsiness may be reduced if taken immediately after meals.
Contraindications
Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, acute narrow-angle glaucoma. Severe hepatic impairment. Concomitant use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole).
Special Precautions
Patients with depression, suicidal tendencies, psychiatric or personality disorder, respiratory disease, history of drug abuse or acute alcoholism. Patients who are debilitated, obese, smoker, or at risk of falls. Concomitant use with opioids. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Elderly. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, sedation, amnesia, impaired concentration or muscle function, if affected, do not drive or operate machinery. Monitoring Parameters Monitor CV and respiratory status.
Adverse Reactions
Significant: Suicidal ideation, CNS depression, anterograde amnesia, psychiatric and paradoxical reactions, interdose symptoms (e.g. early morning anxiety, breakthrough anxiety), sleep-related activities (e.g. sleep-driving, cooking, eating or making phone calls while asleep), tolerance, abuse, psychological and physical dependence; rebound or withdrawal symptoms including seizures. Cardiac disorders: Palpitations, chest pain. Endocrine disorders: Hyperprolactinaemia. Eye disorders: Blurred vision. Gastrointestinal disorders: Constipation, dry mouth, nausea, vomiting, increased salivation. General disorders and administration site conditions:Ataxia, lethargy, fatigue, irritability. Hepatobiliary disorders: Jaundice, abnormal hepatic function, hepatitis. Investigations: Weight increased or decreased, increased intraocular pressure. Metabolism and nutrition disorders: Decreased or increased appetite. Musculoskeletal and connective tissue disorders: Muscle weakness, arthralgia, myalgia. Nervous system disorders: Sedation, somnolence, headache, dizziness, memory impairment, balance disorder, abnormal coordination, tremor. Psychiatric disorders: Depression, insomnia, confusional state, anxiety, disorientation, nervousness, dysarthria, disturbance in attention, hypersomnia, decreased or increased libido. Renal and urinary disorders: Incontinence, difficulty in micturition. Reproductive system and breast disorders: Sexual dysfunction, irregular menstruation. Respiratory, thoracic and mediastinal disorders: Nasal congestion, dyspnoea, rhinitis. Skin and subcutaneous tissue disorders: Dermatitis, rash, pruritus. Vascular disorders: Hypotension.
Drug Interactions
Enhanced CNS depressant effects with other anxiolytics or sedatives, antipsychotics (neuroleptics), hypnotics, antidepressants, narcotic analgesics, antiepileptic drugs, anaesthetics, sedative antihistamines. Increased plasma concentrations with CYP3A4 inhibitors (e.g. nefazodone, fluvoxamine, cimetidine, fluoxetine, propoxyphene, oral contraceptives, sertraline, paroxetine, diltiazem, isoniazid, macrolide antibiotics such as erythromycin, clarithromycin, troleandomycin). May enhance metabolism with CYP3A4 inducers (e.g. ritonavir, carbamazepine). May increase plasma concentrations of digoxin.
CIMS Class
ATC Classification
N05BA12 - alprazolam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Disclaimer: This information is independently developed by CIMS based on alprazolam from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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