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Alprazolam XR

Class
Anticonvulsants and anxiolytics
Subclass
Benzodiazepines
Substance name
ALPRAZolam XR
Brand names
Xanax XR®
Common formulations
Tablet
See also
Alprazolam (Xanax®, Niravam®)
Dosage and administration
Adults patients
Treatment of panic disorder
•
Start at: 0.5-1 mg PO daily
•
Maintenance: 3-6 mg PO daily
•
Maximum: 10 mg per day
May increase by 1 mg/day every 3 to 4 days if required.
Indications for use
Labeled indications
Adults
•
Treatment of panic disorder
Safety risks
Boxed warnings
Benzodiazepine withdrawal syndrome
•
Do not discontinue abruptly in patients taking the drug for a prolonged period. In particular, patients taking > 4 mg for more than 12 weeks are at risk for protracted withdrawal syndrome.
Drug misuse, drug abuse, benzodiazepine use disorder
•
Use extreme caution in patients taking the drug for a prolonged period.
Profound sedation, respiratory depression, coma
•
Use extreme caution in patients receiving opioids. Limit doses to the minimum required. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.
Contraindications
Hypersensitivity to alprazolam or its components or other benzodiazepines
Concomitant use of strong CYP3A inhibitors (such as ketoconazole or itraconazole), except ritonavir
Warnings and precautions
Exacerbation of depression
•
Use caution in patients with depression.
Manic episode
•
Use caution in patients with depression.
Neonatal abstinence syndrome
•
Use caution in pregnant patients because use can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, feeding difficulties).
Respiratory depression
•
Use extreme caution in patients with severe pulmonary disease. Obtain close monitoring in patients with impaired respiratory function. Discontinue alprazolam if signs and symptoms of respiratory depression, hypoventilation, or apnea occur.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery. Use caution in patients taking other CNS depressants or using alcohol.
Specific populations
Renal impairment
CrCl ≥ 10 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 10 mL/min
•
Use with caution. No dose adjustment required.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
Reduce dose. Start at dose of 0.5 mg once daily.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Consider safer alternatives. Evidence of fetal harm in humans. Monitor neonates for CNS depression and withdrawal symptoms.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Dysarthria, ↓ libido, depression, dizziness, dry mouth, fatigue, ↑ appetite, memory impairment, nasal congestion, somnolence, sedation
Common 1-10%
•
Agitation, ataxia, dyskinesia, lethargy, anxiety, arthralgia, back pain, blurred vision, chest pain, confusion, constipation, difficulty urinating, dysmenorrhea, dyspepsia, dyspnea, headache, hyperventilation, hypoesthesia, ↑ libido, insomnia, irritability, loss of appetite, malaise, muscle cramps, myalgia, nausea, nightmares, palpitations, paresthesia, restlessness, tremor, vertigo, vomiting, weakness, weight gain, weight loss, sleep apnea
Uncommon < 1%
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Cognitive impairment, dysphonia, hypotension, hypotonia, mydriasis, aggressive behavior, asthenia, dysphagia, euphoria, fever, hallucinations, hot flashes, hypersalivation, mania, nosebleed, otalgia, photophobia, rhinorrhea, skin rash, syncope, tinnitus, urinary frequency, urinary incontinence, tachycardia, urticaria
Unknown frequency
•
Angioedema, benzodiazepine withdrawal syndrome, gynecomastia, ↑ liver enzymes, ↑ serum prolactin, jaundice, neonatal abstinence syndrome, peripheral edema, galactorrhea, suicidal ideation, respiratory depression, Stevens-Johnson syndrome
Interactions
Drug(s)
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