Alprazolam

What is Alprazolam?

• Alprazolam (Xanax) is a benzodiazepine used to treat anxiety disorders and panic attacks.

Alprazolam

Alprazolam molecule ball

Alprazolam molecule spacefill

What are the uses of this medicine?

Alprazolam (Xanax) is a prescription medicine used:

• to treat anxiety disorders
• for the short-term relief of the symptoms of anxiety
• to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia)

Limitations of use:

• Xanax is a federal controlled substance (C-IV) because it contains alprazolam that can be abused or lead to dependence.
• Elderly patients are especially susceptible to dose related adverse effects when taking Xanax.
• It is not known if Xanax is safe and effective when used to treat anxiety disorder for longer than 4 months.
• It is not known if Xanax is safe and effective when used to treat panic disorder for longer than 10 weeks.

How does this medicine work?

• Alprazolam (al pra' zoe lam) is a benzodiazepine that is widely used in the therapy of anxiety and panic disorder.
• Alprazolam is a triazolobenzodiazepine agent with anxiolytic, sedative-hypnotic and anticonvulsant activities.
• Alprazolam binds to a specific site distinct from the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) binding site on the benzodiazepine-GABA-A-chloride ionophore receptor complex located in the limbic, thalamic and hypothalamic regions of the central nervous system (CNS).
• This binding causes an allosteric modification of the receptor and enhances the affinity of GABA to the receptor leading to an increase in the frequency of chloride-channel opening events.
• This leads to an increase in chloride ion conductance, neuronal hyperpolarization, inhibition of the action potential and leads to a decrease in neuronal excitability.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to alprazolam, other benzodiazepines, or any of the ingredients in Xanax.
• you are taking antifungal medicines including ketoconazole and itraconazole.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• itraconazole (Onmel, Sporanox) or ketoconazole (Nizoral)
• amiodarone (Cordarone, Nexterone, Pacerone)
• antidepressants ('mood elevators') such as desipramine (Norpramin), imipramine (Tofranil), and nefazodone
• antifungals such as fluconazole (Diflucan), posaconazole (Noxafil), or voriconazole (Vfend)
• antihistamines
• cimetidine (Tagamet)
• clarithromycin (Biaxin, in Prevpac)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• diltiazem (Cardizem, Cartia XT, Tiazac); ergotamine (Ergomar, in Cafergot, in Migergot)
• erythromycin (E.E.S., ERYC, others)
• isoniazid (Laniazid, in Rifamate, in Rifater)
• medications for mental illness and seizures
• nicardipine (Cardene); nifedipine (Adalat, Afeditab CR, Procardia)
• oral contraceptives (birth control pills)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft)
• sedatives
• sleeping pills
• tranquilizers
• St. John's wort

Is this medicine FDA approved?

• Alprazolam was approved in the United States in 1981, and currently more than 40 million prescriptions are filled yearly.
• Current indications are for anxiety and panic disorders.

How should this medicine be used?

Recommended dosage: Generalized Anxiety Disorder:

• Recommended starting oral dosage is 0.25 mg to 0.5 mg three times daily.
• Dosage may be increased, at intervals of every 3 to 4 days, to a maximum recommended daily dose of 4 mg, given in divided doses.
• Use the lowest possible effective dose and frequently assess the need for continued treatment.

Panic Disorder:

• Recommended starting oral dosage is 0.5 mg three times daily.
• The dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.
• When tapering, decrease dosage by no more than 0.5 mg every 3 days.
• Some patients may require an even slower dosage reduction.

Dosage Recommendations in Geriatric Patients:

• In geriatric patients, the recommended starting oral dosage of Xanax is 0.25 mg, given 2 or 3 times daily.
• This may be gradually increased if needed and tolerated.

Dosage Recommendations in Patients with Hepatic Impairment:

• In patients with hepatic impairment, the recommended starting oral dosage of Xanax is 0.25 mg, given 2 or 3 times daily.
• This may be gradually increased if needed and tolerated.

• Xanax should be reduced to half of the recommended dosage when a patient is started on ritonavir and Xanax together, or when ritonavir administered to a patient treated with Xanax.
• Increase the Xanax dosage to the target dose after 10 to 14 days of dosing ritonavir and Xanax together.

Administration:

• Alprazolam comes as a tablet, an extended-release tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), and a concentrated solution (liquid) to take by mouth.
• The tablet, orally disintegrating tablet, and concentrated solution usually are taken two to four times a day.
• The extended-release tablet is taken once daily, usually in the morning.
• To take the concentrated liquid, use only the dropper that came with your prescription.
• Draw into the dropper the amount prescribed for one dose.
• Squeeze the dropper contents into a liquid or semisolid food such as water, juice, soda, applesauce, or pudding.
• Stir the liquid or food gently for a few seconds.
• The concentrated liquid will blend completely with the food. Drink or eat the entire mixture immediately.
• Do not store for future use.
• Remove the orally disintegrating tablet from the bottle just before it is time for your dose. With dry hands, open the bottle, remove the tablet, and immediately place it on your tongue. The tablet will dissolve and can be swallowed with saliva. The orally disintegrating tablet can be taken with or without water.
• Swallow the extended-release tablets whole; do not chew, crush, or break them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet, an extended-release tablet, an orally disintegrating tablet, and a concentrated solution (liquid)

This medicine is available in fallowing brand namesː

• Niravam
• Xanax

What side effects can this medication cause?

The most common side effects of this medicine include:

• problems with coordination
• hypotension
• trouble saying words clearly (dysarthria)
• changes in sex drive (libido)

Alprazolam may cause serious side effects, including:

• severe drowsiness
• breathing problems (respiratory depression)
• coma and death
• Physical dependence and withdrawal reactions
• Seizures
• Mania

What special precautions should I follow?

• Xanax can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Xanax affects you.
• Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Xanax without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Xanax may make your sleepiness or dizziness much worse.
• Use of Xanax during later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate.
• Benzodiazepines may worsen depression. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients.
• Episodes of hypomania and mania have been reported in association with the use of Xanax in patients with depression.
• There have been reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with Xanax. Closely monitor patients with impaired respiratory function. If signs and symptoms of respiratory depression, hypoventilation, or apnea occur, discontinue Xanax.
• To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Xanax or reduce the dosage.
• Concomitant use of benzodiazepines, including Xanax, and opioids may result in profound sedation, respiratory depression, coma, and death. Advise both patients and caregivers about the risks of respiratory depression and sedation when Xanax is used with opioids.
• Xanax passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Xanax. You should not breastfeed while taking Xanax.
• As with most benzodiazepines, alprazolam therapy has not been associated with serum aminotransferase or alkaline phosphatase elevations, and clinically apparent liver injury from alprazolam has been reported, but is very rare.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence, confusion, impaired coordination, diminished reflexes, and coma.
• Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Respiration, pulse rate, and blood pressure should be monitored.
• General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained.
• Flumazenil may be useful in situations when an overdose with a benzodiazepine is known or suspected.
• Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment.

Can this medicine be used in pregnancy?

• Overall available data from published observational studies of pregnant women exposed to alprazolam have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates.

Can this medicine be used in children?

• Safety and effectiveness of Xanax have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: alprazolam
• Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2.

Who manufactures and distributes this medicine?

• Pharmacia & Upjohn Company LLC
• Division of Pfizer Pharmaceuticals LLC.
• Xanax® is a registered trademark of Pharmacia & Upjohn Company LLC.

What should I know about storage and disposal of this medication?

• Store Xanax at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep Xanax and all medicines out of the reach of children.

• Dailymed label info on Alprazolam
• FDA Alprazolam

Alprazolam Resources
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Benzodiazipines

• Alprazolam
• Chlordiazepoxide
• Diazepam (Oral)
• Estazolam
• Flurazepam
• Lorazepam
• Midazolam
• Oxazepam
• Quazepam
• Temazepam
• Triazolam

Anticonvulsants Drugs

• Clobazam
• Clonazepam
• Clorazepate
• Diazepam (Intravenous)

Drug class for Alprazolam

Anticonvulsants, and Benzodiazepines]