FDA Label for Alprazolam

Medication Guide Section

MEDICATION GUIDE

MEDICATION GUIDE
Alprazolam (al pra' zoe lam)
Tablets, USP, C-IV

What is the most important information I should know about alprazolam tablets?

Alprazolam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens:

shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (sedation)

Do not drive or operate heavy machinery until you know how taking alprazolam tablets with opioids affects you.

Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including alprazolam tablets, which can lead to overdose and serious side effects including coma and death.

Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including alprazolam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
You can develop an addiction even if you take alprazolam tablets as prescribed by your healthcare provider.
Take alprazolam tablets exactly as your healthcare provider prescribed.
Do not share your alprazolam tablets with other people.
Keep alprazolam tablets in a safe place and away from children.

Physical dependence and withdrawal reactions. Alprazolam tablets can cause physical dependence and withdrawal reactions.

Do not suddenly stop taking alprazolam tablets. Stopping alprazolam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
Some people who suddenly stop benzodiazepines, have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Do not take more alprazolam tablets than prescribed or take alprazolam tablets for longer than prescribed.

What are alprazolam tablets?

Alprazolam tablets are 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)

Alprazolam tablets are a federal controlled substance (C-IV) because they contain alprazolam that can be abused or lead to dependence. Keep alprazolam tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
It is not known if alprazolam tablets are safe and effective in children.
Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam tablets.
It is not known if alprazolam tablets are safe and effective when used to treat anxiety disorder for longer than 4 months.
It is not known if alprazolam tablets are safe and effective when used to treat panic disorder for longer than 10 weeks.

Do not take alprazolam tablets if:

you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in alprazolam tablets. See the end of this Medication Guide for a complete list of ingredients in alprazolam tablets.
you are taking antifungal medicines including ketoconazole and itraconazole.

Before you take alprazolam tablets, tell your healthcare provider about all of your medical conditions, including if you:

have or have had depression, mood problems, or suicidal thoughts or behavior
have liver or kidney problems
have lung disease or breathing problems
are pregnant or plan to become pregnant. Alprazolam tablets may harm your unborn baby. You and your healthcare provider should decide if you should take alprazolam tablets while you are pregnant.
are breastfeeding or plan to breastfeed. Alprazolam 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 alprazolam tablets. You should not breastfeed while taking alprazolam tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking alprazolam tablets with certain other medicines can cause side effects or affect how well alprazolam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

How should I take alprazolam tablets?

See "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ALPRAZOLAM TABLETS?"
Take alprazolam tablets exactly as your healthcare provider tells you to take them. Your healthcare provider will tell you how much alprazolam tablets to take and when to take them.
If you take too much alprazolam tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of alprazolam tablets?
Alprazolam tablets may cause serious side effects, including:

See "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ALPRAZOLAM TABLETS?"
Seizures. Stopping alprazolam tablets can cause seizures and seizures that will not stop (status epilepticus).
Mania. Alprazolam tablets may cause an increase in activity and talking (hypomania and mania) in people who have depression.

Alprazolam tablets 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 alprazolam tablets affect you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam tablets may make your sleepiness or dizziness much worse.

The most common side effects of alprazolam tablets include:

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

These are not all the possible side effects of alprazolam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store alprazolam tablets?

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

General information about the safe and effective use of alprazolam tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use alprazolam tablets for a condition for which it was not prescribed.
Do not give alprazolam tablets to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about alprazolam tablets that is written for health professionals.

What are the ingredients in alprazolam tablets?
Active ingredient: alprazolam
Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake.
For more information, go to www.bpirx.com or call Breckenridge Pharmaceutical, Inc. 1-800-367-3395.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured By:
Centaur Pharmaceuticals Pvt. Ltd.
Pune – 411057, INDIA.
Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037
Revised: 04/2021

Overdosage Section

OVERDOSAGE

10.1 Clinical Experience

Manifestations of alprazolam overdosage 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. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.

10.2 Management of Overdose

In case of an overdosage, consult a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.

As in all cases of drug overdosage, 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. As with the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil may be useful in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert should be consulted prior to use.

Contraindications Section

CONTRAINDICATIONS

Alprazolam tablets are contraindicated in patients:

with known hypersensitivity to alprazolam or other benzodiazepines. Angioedema has been reported [see ADVERSE REACTIONS (6.2)].
taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see DOSAGE AND ADMINISTRATION (2.6), WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7.1)].

Dosage And Administration Section

DOSAGE AND ADMINISTRATION

2.1 Dosage in Generalized Anxiety Disorder

The recommended starting oral dosage of alprazolam tablets for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses).

Use the lowest possible effective dose and frequently assess the need for continued treatment [see WARNINGS AND PRECAUTIONS (5.2)].

2.2 Dosage in Panic Disorder

The recommended starting oral dosage of alprazolam tablets for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.

Controlled trials of alprazolam tablets in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day.

For patients receiving doses greater than 4 mg per day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.

The necessary duration of treatment for PD in patients responding to alprazolam tablets is unknown. After a period of extended freedom from panic attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena [see DOSAGE AND ADMINISTRATION (2.3)].

2.3 Discontinuation or Dosage Reduction of Alprazolam Tablets

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see WARNINGS AND PRECAUTIONS (5.3), DRUG ABUSE AND DEPENDENCE (9.3)].

Reduce the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled postmarketing discontinuation study of panic disorder patients which compared the recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

2.4 Dosage Recommendations in Geriatric Patients

In geriatric patients, the recommended starting oral dosage of alprazolam tablets is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see USE IN SPECIFIC POPULATIONS (8.5), CLINICAL PHARMACOLOGY (12.3)].

2.5 Dosage Recommendations in Patients with Hepatic Impairment

In patients with hepatic impairment, the recommended starting oral dosage of alprazolam tablets is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].

2.6 Dosage Modifications for Drug Interactions

Alprazolam tablets should be reduced to half of the recommended dosage when a patient is started on ritonavir and alprazolam together, or when ritonavir is administered to a patient treated with alprazolam. Increase the alprazolam tablets dosage to the target dose after 10 to 14 days of dosing ritonavir and alprazolam together. It is not necessary to reduce alprazolam tablets dose in patients who have been taking ritonavir for more than 10 to 14 days.

Alprazolam tablets are contraindicated with concomitant use of all strong CYP3A inhibitors, except ritonavir [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.5)].

Indications And Usage Section

INDICATIONS AND USAGE

Alprazolam tablets are indicated for the:

acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults.