Alprazolam

Alprazolam is a prescription medication indicated for the treatment of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder), or the short-term relief of symptoms of anxiety. Generalized anxiety disorder (also anxiety) is characterized by unrealistic or excessive anxiety and worry over circumstances of life for a period of time. Anxiety or tension problems associated with the stress of everyday life usually do not require treatment with this drug. Alprazolam tablets are also indicated for the treatment of the panic disorder, with or without agoraphobia. This drug is also used as a treatment for anxiety associated with depression.

Alprazolam belongs to a class of medications called benzodiazepines. Benzodiazepines are medications that have anti-anxiety-producing properties.

This medication must be prescribed by a doctor and is available by prescription only.

This medication should not be used by patients who are pregnant. The use of this drug may affect the health of the baby.

• Patients taking this drug or other benzodiazepines should not consume alcohol.
• This drug may be habit-forming and has the potential to cause extreme dependence or abuse in some patients.
• Side effects that are most commonly associated with this drug are drowsiness and lightheadedness.
• Patients taking this drug should alert their doctors about any problems from the use of this medication and any troublesome side effects.
• Read the information leaflet that accompanies the prescription as well as every time the prescription is refilled. There may be new health information.
• Alprazolam is available under the following different brand names: Xanax, Niravam, and Xanax XR.

Dosages of Alprazolam (Xanax) Should Be Given As Follows:

Adult Dosage Forms & Strengths

Tablet: Schedule IV

• 0.25 mg
• 0.5 mg
• 1 mg
• 2 mg

Tablet, extended-release: Schedule IV

• 0.5 mg
• 1 mg
• 2 mg
• 3 mg

Tablet, orally disintegrating: Schedule IV

• 0.25 mg
• 0.5 mg
• 1 mg
• 2 mg

Oral solution: Schedule IV

• 1 mg/mL

Dosage Considerations of Alprazolam (Xanax)

Treatment of Anxiety and Anxiety Disorders

• 0.25-0.5 mg orally once every 6-8 hours
• titrate dosage to effect once every 3-4 days; not to exceed 4 mg/day

Panic Disorder Treatment (Panic and Anxiety Attacks)

Immediate-release

• 0.5 mg orally once every 8 hours; may adjust once every 3-4 days by 1 mg or less/day
• Average drug dose: 5-6 mg/day orally
• May require up to 10 mg/day orally divided once every 8 hours

Extended-release

• Dose drug 0.5-1 mg orally once/day; may adjust once every 3-4 days by 1 mg or less/day
• Average drug dose: 3-6 mg orally once/day

Treatment for Anxiety Associated With Depression

• Immediate-release: Decrease initial dose to 0.25 mg orally once every 8-12 hours
• Extended-release: 0.5 mg orally once/day

Treatment of Premenstrual Syndrome (Off-label)

• 0.25 mg orally once every 6-12 hours; initiate treatment on day 16-18 of menses (not to exceed 3-4 mg/day); taper dose over 2-3 days once menses occurs

Dosing Modifications

Renal impairment

• Use caution; not studied

Advanced hepatic impairment

• Immediate-release
  • Decrease initial dose to 0.25 mg orally once every 8-12 hours
  • Extended-release: 0.5 mg orally once/day

Not recommended for use in patients 18 years and younger.

Treatment of Geriatric Dose Panic Disorder

Immediate-release:

• Decrease the initial dose of medication to 0.25 mg orally once every 8-12 hours; may gradually increase if necessary and as tolerated; may increase every 3-4 days by 1 mg or less/day to 5-6 mg/day average dose

Extended-release:

• Start at 0.5 mg orally once/day; may gradually increase if necessary and as tolerated; may increase once every 3-4 days by 1 mg or less/day to 3-6 mg/day

Geriatric Dose Anxiety Associated With Depression

• Decrease the initial dose of medication to 0.25 mg orally once every 8-12 hours; may gradually increase if needed and as tolerated; may increase every 3-4 days by 1 mg or less/day to 1-4 mg/day

Maintenance

• 1-4 mg/day orally divided once every 8 hours

Geriatric Dosing Considerations

• Use the smallest dose of this drug to avoid ataxia and over-sedation and other undesirable side effects or symptoms
• Elderly people are especially sensitive to benzodiazepines; higher plasma levels are exhibited because of reduced clearance
• Mean half-life: 16.3 hours in healthy elderly individuals (range: 9-26.9 hours), compared with 11 hours in healthy adults (range: 6.3-15.8 hours)

Common side effects of alprazolam (Xanax) include:

• Drowsiness
• Depression
• Headache pain
• Constipation
• Diarrhea
• Dry mouth
• Impaired coordination
• Increased or decreased appetite
• Fatigue
• Memory problems
• Irritability
• Decreased salivation
• Cognitive disorders
• Insomnia
• Lightheadedness
• Fainting
• Difficulty speaking
• Nausea/vomiting
• Weight gain or weight loss
• Nasal congestion
• Decreased or increased libido
• Menstrual disorder
• Difficulty urinating
• Fast heart rate
• Confusion
• Blurred vision
• Low blood pressure (hypotension)
• Agitation/restlessness
• Dizziness
• Increased salivation
• Nervousness
• Tremor
• Talkativeness
• Incontinence

Serious adverse reactions of alprazolam (Xanax) include:

• Toxic epidermal necrolysis
• Severe allergic reaction (anaphylaxis)
• Liver failure
• Stevens-Johnson syndrome
• Gastrointestinal hemorrhage
• Laryngeal edema
• Kidney toxicity
• Liver toxicity/liver failure
• Hyperammonemia
• Agranulocytosis
• Low white blood cell count (leukopenia, neutropenia)
• Low platelet count (thrombocytopenia)
• Low red and white blood cell count and low platelet count (pancytopenia)

Side effects of alprazolam (Xanax) from postmarketing reports:

• Gastrointestinal: Liver enzyme elevations, hepatitis, liver failure
• CNS: Hypomania, mania
• Immunologic: Stevens-Johnson syndrome, skin swelling, swelling of extremities
• Endocrine: elevated blood prolactin, swelling of breast tissue in males (gynecomastia), milky nipple discharge unrelated to breastfeeding (galactorrhea)

This document does not contain all possible side effects and other serious side effects may occur. Check with your doctor for additional health information about common problems or negative side effects associated with this medicine. Patients taking this medicine should not use alcohol.

If your doctor has directed you to use this prescription medication, your doctor or pharmacist may already be aware of any possible drug interactions, health risks and side effects, and may be monitoring you for them. Do not start, stop, or change the dosage of this drug or any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of alprazolam (Xanax) include:

• itraconazole
• ketoconazole
• sodium oxybate
• tipranavir

Serious Interactions of alprazolam (Xanax) include:

• carbamazepine
• cimetidine
• clarithromycin
• erythromycin base
• erythromycin ethylsuccinate
• erythromycin lactobionate
• erythromycin stearate
• idelalisib
• itraconazole
• ivacaftor
• ketoconazole
• nefazodone
• rifabutin
• rifampin
• saquinavir
• St. John's wort
• valerian

Alprazolam (Xanax) has moderate interactions with at least 264 different drugs.

Minor interactions of alprazolam (Xanax) include:

• brimonidine
• ciprofloxacin
• esomeprazole
• eucalyptus
• fleroxacin
• gemifloxacin
• green tea
• levofloxacin
• lithium
• moxifloxacin
• norfloxacin
• ofloxacin
• omeprazole
• rifabutin
• sage
• vinpocetine
• zolpidem

This document does not contain all possible interactions of this drug with other drugs. Therefore, before using this medication, tell your doctor or pharmacist of all the medications you use. Keep a list of all your medications with you, and share the list of drugs with your doctor and pharmacist. Check with your doctor if you have health questions or concerns.

Warnings

• This medication contains alprazolam. Do not take Xanax, Niravam, or Xanax XR if you are allergic to alprazolam or any ingredients contained in this drug.
• Keep this medicine out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Documented hypersensitivity
• Acute narrow angle glaucoma
• Concomitant use with CYP3A4 inhibitors (itraconazole, ketoconazole)

Effects of Drug Abuse

• Use with caution with this medication in patients with history of drug abuse or acute alcoholism; psychological dependence (abuse or addiction) may occur with prolonged use (greater than 10 days)
• Do not stop treatment of this drug abruptly; slowly taper to discontinuation (0.5 mg once every 3 days)

Short-term Effects

• See “What Are Side Effects Associated with Using Alprazolam (Xanax)?”

Long-term Effects

• This drug may have prolonged results in obese patients when discontinued; use caution
• See “What Are Side Effects Associated with Using Alprazolam (Xanax)?”

Cautions

• Anterograde amnesia reported with benzodiazepine use
• Use caution with benzodiazepines in elderly patients
• Use caution with benzodiazepines in debilitated patients
• Use caution in severe respiratory depression
• Use caution in patients who recently received other respiratory depressants
• Use caution in patients who are at risk of falls
• Benzodiazepines may have prolonged results in obese patients when discontinued; use caution
• Not for use in acute alcohol intoxication; poses serious health risks
• Use with caution with this medication in patients with hepatic or renal impairment
• Myasthenia gravis (allowable in limited circumstances)
• Use caution with this medication in cases of respiratory disease (COPD), sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicide ideation, drug abuse
• CNS depressants may impair ability to perform hazardous tasks
• Paradoxical reactions, including hyperactive or aggressive behavior reported
• Cigarette smoking may decrease alprazolam concentration up to 50%
• Mania and hypomania episodes reported in depressed patients

Pregnancy and Lactation

• Only use alprazolam (Xanax) during pregnancy in LIFE-THREATENING emergencies when no safer drug is available
• There is positive evidence of human fetal health risk from the use of this medicine.
• Minor tranquilizers should be avoided in first trimester of pregnancy due to increased risk of congenital malformations
• Maternal use shortly before delivery is a common problem associated with floppy infant syndrome (good and consistent evidence)
• Prenatal benzodiazepine exposure slightly elevates oral cleft risk (limited or inconsistent evidence)
• Alprazolam enters breast milk and is not recommended for use while lactating