ALPRAZOLAM EXTENDED-RELEASE - ORAL

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to treat the panic and anxiety symptoms associated with panic disorder. Alprazolam belongs to a class of medications called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).

How to Use

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start taking alprazolam and each time you get a refill.

If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily in the morning.

Do not take with a high-fat meal because doing so can increase the risk of side effects.

Swallow the tablets whole.

Do not crush or chew the tablets.

Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition, age, and response to treatment.

Your dose may be gradually increased until the drug starts working well.

Follow your doctor's instructions closely to reduce the risk of side effects.

Though it helps many people, this medication may sometimes cause addiction.

This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol).

Take this medication exactly as prescribed to lower the risk of addiction.

Ask your doctor or pharmacist for more details.

When this medication is used for a long time, it may not work as well.

Talk with your doctor if this medication stops working well.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

Drowsiness, dizziness, increased saliva production, nausea, constipation, or change in sex drive/ability may occur.

If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.

Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as hallucinations, thoughts of suicide), trouble speaking, loss of coordination, trouble walking, memory problems.

Get medical help right away if you have any very serious side effects, including: yellowing eyes/skin, seizures.

A very serious allergic reaction to this drug is rare.

However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects.

If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088 or at www.

fda.

gov/medwatch.

In Canada - Call your doctor for medical advice about side effects.

You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking alprazolam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as diazepam, lorazepam); or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung/breathing problems (such as COPD, sleep apnea), liver disease, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), glaucoma.

This drug may make you dizzy or drowsy.

Alcohol or marijuana (cannabis) can make you more dizzy or drowsy.

Do not drive, use machinery, or do anything that needs alertness until you can do it safely.

Avoid alcoholic beverages.

Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness.

These side effects can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant.

You should not become pregnant while using alprazolam.

Alprazolam may harm an unborn baby.

Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding.

If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This drug passes into breast milk and may have undesirable effects on a nursing infant.

Breastfeeding is not recommended while using this drug.

Consult your doctor before breastfeeding.

Drug Interactions

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects.

This document does not contain all possible drug interactions.

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.

Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: kava, sodium oxybate.

Other medications can affect the removal of alprazolam from your body, which may affect how alprazolam works.

Examples include adagrasib, azole antifungals (such as itraconazole, ketoconazole), cimetidine, certain anti-depressants (such as fluoxetine, fluvoxamine, nefazodone), protease inhibitors (such as indinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St.

John's wort, drugs used to treat seizures (such as phenytoin), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems.

Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as diazepam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness.

Ask your pharmacist about using those products safely.

Cigarette smoking decreases blood levels of this medication.

Tell your doctor if you smoke or if you have recently stopped smoking.