Xanax XR Oral

This section provides information on the proper use of a number of products that contain alprazolam. It may not be specific to Xanax XR. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release tablet or tablet whole with a full glass of water. Do not break, crush, or chew it.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not remove the tablets from the bottle until you are ready to take it. Place the tablet immediately on the top of your tongue. It should melt quickly and be swallowed with saliva.

If you are using the oral liquid, measure the dose with a marked measuring spoon, oral syringe, or medicine cup.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For anxiety:
  • For oral dosage forms (solution, tablets, or orally disintegrating tablets):
    • Adults—At first, 0.25 to 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 mg per day.
    • Older adults—At first, 0.25 mg 2 or 3 times a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For panic disorder:
  • For oral dosage form (extended-release tablets):
    • Adults—At first, 0.5 to 1 milligram (mg) taken in the morning once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
    • Older adults—At first, 0.5 mg taken in the morning once a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage forms (solution, tablets, or orally disintegrating tablets):
    • Adults—At first, 0.5 milligram (mg) 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
    • Older adults—At first, 0.25 mg 2 or 3 times a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important to protect the orally disintegrating tablets from moisture. Remove and throw away any cotton packaging from the medicine bottle when you first use the medicine.

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 Xanax XR

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. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. 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.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

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 persists or worsens.

Xanax XR (alprazolam) is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Alprazolam affects chemicals in the brain that may become unbalanced and cause anxiety.

Xanax XR is used to treat anxiety disorders, panic disorders, and anxiety caused by depression.

Xanax XR may also be used for other purposes not listed in this medication guide.

Do not use Xanax XR if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax). This medication can cause birth defects in an unborn baby. Do not use Xanax XR if you are pregnant.

Before taking Xanax XR, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking Xanax XR. This medication can increase the effects of alcohol. Xanax XR may be habit-forming and should be used only by the person it was prescribed for. Xanax XR should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Xanax XR can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, loss of balance or coordination, feeling light-headed, fainting, and coma.

Common side effects of Xanax XR include: depression, diarrhea, drowsiness, dysarthria, headache, insomnia, memory impairment, nervousness, sedation, and tremor. Other side effects include: anxiety, ataxia, constipation, depersonalization, hyperventilation, hypoesthesia, muscle twitching, paresthesia, weight loss, decreased appetite, and decreased libido. See below for a comprehensive list of adverse effects.

Applies to alprazolam: compounding powder, oral concentrate, oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

General

The most commonly reported side effects were fatigue, tiredness, drowsiness, impaired coordination, and memory impairment.[Ref]

Psychiatric

Very common (10% or more): Irritability (33.1%), anxiety (19.2%), depression (13.9%), confusional state (10.4%),
Common (1% to 10%): Disinhibition, talkativeness, derealization, dream abnormalities, fear
Uncommon (0.1% to 1%): Anger
Frequency not reported: Hallucinations, depersonalization, aggression, hostility, abnormal thinking, withdrawal symptoms
Postmarketing reports: Hypomania, mania[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 76.8%), impaired coordination (40.1%), memory impairment (33.1%), light-headedness/dizziness (29.8%), insomnia (29.5%). headache (29.2%), cognitive disorder (28.8%), dysarthria (23.3%), abnormal involuntary movement (17.3%), somnolence, ataxia, balance disorder
Common (1% to 10%): Nervousness, syncope, akathisia, agitation, paresthesia, tinnitus, disturbance in attention, hypersomnia, lethargy
Frequency not reported: Dystonia, transient amnesia, loss of coordination, seizures, sedation, slurred speech, taste alterations, psychomotor hyperactivity, autonomic nervous system imbalance, autonomic manifestations, concentration difficulties[Ref]

Hepatic

Frequency not reported: Jaundice, elevated bilirubin, elevated hepatic enzymes, abnormal hepatic function
Postmarketing reports: Hepatitis, hepatic failure[Ref]

Respiratory

Very common (10% or more): Nasal congestion (17.4%)
Common (1% to 10%): Hyperventilation, upper respiratory infection[Ref]

Other

Very common (10% or more): Fatigue/tiredness (48.6%)
Common (1% to 10%): Weakness, felling warm, edema
Frequency not reported: Sleepiness, peripheral edema[Ref]

Ocular

Very common (10% or more): Blurred vision (21%)
Frequency not reported: Diplopia, increased intraocular pressure[Ref]

Genitourinary

Very common (10% or more): Decreased libido (14.4%), micturition difficulties (12.2%), menstrual disorders (10.4%)
Common (1% to 10%): Increased libido, change in libido, sexual dysfunction, incontinence
Uncommon (0.1% to 1%): Irregular menstruation
Frequency not reported: Urinary retention[Ref]

Gastrointestinal

Very common (10% or more): Decreased salivation (32.8%), constipation (26.2%), nausea/vomiting (22%), diarrhea (20.6%), abdominal distress (18.3%), dry mouth (14.7%)
Common (1% to 10%): Increased salivation
Frequency not reported: Gastrointestinal disorder[Ref]

Dermatologic

Very common (10% or more): Sweating (15.1%), rash (10.8%)
Common (1% to 10%): Dermatitis/allergy
Frequency not reported: Pruritus, photosensitivity reaction
Postmarketing reports: Stevens-Johnson syndrome, angioedema[Ref]

Endocrine

Postmarketing reports: Hyperprolactinemia, gynecomastia, galactorrhea[Ref]

Cardiovascular

Very common (10% or more): Tachycardia (15.4%), chest pain (10.6%)
Common (1% to 10%): Palpitations, hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Rigidity, tremor, muscular twitching, muscle tone disorders, vasomotor disturbances, muscular cramps, muscular stiffness
Frequency not reported: Musculoskeletal weakness[Ref]

Metabolic

Very common (10% or more): Increased appetite (32.7%), decreased appetite (27.8%), weight gain (27.2%), weight loss (22.6%)
Frequency not reported: Anorexia[Ref]

Some side effects of Xanax XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.