Generic Name: alprazolam (Oral route)

al-PRA-zoe-lam

Commonly used brand name(s)

In the U.S.

• Gabazolamine-0.5
• Niravam
• Xanax
• Xanax XR

In Canada

• Alti-Alprazolam

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Solution
• Tablet, Extended Release

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Xanax

Alprazolam is used to relieve symptoms of anxiety, including anxiety caused by depression. It is also used to treat panic disorder in some patients.

Alprazolam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using Xanax

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alprazolam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alprazolam in the elderly. However, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of alprazolam. Elderly patients may require a lower dose to help reduce unwanted effects.

Pregnancy

Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Delavirdine
• Indinavir
• Itraconazole
• Ketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amobarbital
• Anileridine
• Aprobarbital
• Boceprevir
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Digoxin
• Domperidone
• Ethchlorvynol
• Fentanyl
• Fluconazole
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Primidone
• Propoxyphene
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Voriconazole
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Aprepitant
• Carbamazepine
• Cimetidine
• Clarithromycin
• Desipramine
• Desogestrel
• Dienogest
• Drospirenone
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fluoxetine
• Fosaprepitant
• Imipramine
• Kava
• Levonorgestrel
• Medroxyprogesterone Acetate
• Mestranol
• Mifepristone
• Nefazodone
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Rifapentine
• Ritonavir
• Roxithromycin
• Sertraline
• St John's Wort
• Telaprevir
• Theophylline
• Troleandomycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Epilepsy or history of seizures or
• Lung disease—Use with caution. May make these conditions worse.

• Glaucoma, acute narrow angle—Should not be used in patients with this condition.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of alprazolam

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

Swallow the extended-release 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 solution, measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

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) three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 4 mg a day.
    • Older adults—At first, 0.25 milligram (mg) two or three times a day. Your doctor may increase your dose if 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 if needed. However, the dose is usually not more than 10 mg a day.
    • Older adults—At first, 0.5 milligram (mg) taken in the morning once a day. Your doctor may increase your dose if 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) three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 10 mg a day.
    • Older adults—At first, 0.25 milligram (mg) two or three times a day. Your doctor may increase your dose if 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.

Precautions While Using Xanax

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not take itraconazole (Sporanox®) or ketoconazole (Nizoral®) while you are using this medicine. Using any of them together with this medicine may increase the chance of serious side effects.

If you develop any unusual and strange thoughts or behavior while you are taking alprazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Alprazolam may cause some people, especially older persons, to become drowsy, dizzy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, sweating, tremors, vomiting, or unusual behavior.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Xanax Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Being forgetful
• changes in patterns and rhythms of speech
• clumsiness or unsteadiness
• difficulty with coordination
• discouragement
• drowsiness
• feeling sad or empty
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• relaxed and calm
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• tiredness
• trouble concentrating
• trouble in speaking
• trouble performing routine tasks
• trouble sleeping
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

Less common

• Abdominal or stomach pain
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
• changes in behavior
• chills
• clay-colored stools
• confusion about identity, place, and time
• cough
• dark urine
• decrease in frequency of urination
• decrease in urine volume
• diarrhea
• difficult or labored breathing
• difficulty in moving
• difficulty in passing urine (dribbling)
• difficulty with concentration
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• dry mouth
• ear congestion
• environment seems unreal
• fainting
• fear or nervousness
• feeling of unreality
• feeling warm
• fever
• general feeling of discomfort or illness
• headache
• hyperventilation
• inability to move eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• irregular heartbeats
• itching
• joint pain
• lack or loss of self-control
• loss of bladder control
• loss of coordination
• loss of memory
• loss of voice
• mood or mental changes
• muscle aching or cramping
• muscle pain or stiffness
• muscle weakness
• nasal congestion
• nausea
• need to keep moving
• painful urination
• problems with memory
• rash
• restlessness
• runny nose
• seeing, hearing, or feeling things that are not there
• seizures
• sense of detachment from self or body
• shaking
• shivering
• shortness of breath
• sneezing
• sore throat
• sticking out of the tongue
• sweating
• swollen joints
• talkativeness
• tightness in the chest
• trouble in breathing, speaking, or swallowing
• trouble with balance
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unpleasant breath odor
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual facial expressions
• unusually deep sleep
• unusually long duration of sleep
• vomiting of blood
• wheezing
• yellow eyes or skin

Rare

• Actions that are out of control
• attack, assault, or force
• chest pain
• continuing ringing or buzzing or other unexplained noise in ears
• decreased awareness or responsiveness
• deep or fast breathing with dizziness
• ear pain
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling jittery
• feeling unusually cold
• generalized slowing of mental and physical activity
• hearing loss
• hoarseness
• lack of feeling or emotion
• loss of control of the legs
• loss of strength or energy
• nightmares
• numbness of the feet, hands, and around mouth
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• sleep talking
• sleeplessness
• swelling
• talking, feeling, and acting with excitement
• thoughts of killing oneself
• unable to sleep
• uncaring
• unusual weak feeling
• voice changes

Incidence not known

• General tiredness and weakness
• light-colored stools
• stomach pain, continuing
• upper right abdominal pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Absent, missed, or irregular menstrual periods
• decreased appetite
• decreased interest in sexual intercourse
• decreased sexual performance or desire abnormal ejaculation
• difficulty having a bowel movement (stool)
• inability to have or keep an erection
• increased appetite
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased weight
• loss in sexual ability, desire, drive, or performance
• stopping of menstrual bleeding
• watering of mouth
• weight loss

Less common

• Abdominal bloating and cramping
• blistering, crusting, irritation, itching, or reddening of the skin
• change in taste bad unusual or unpleasant (after) taste
• cracked, dry, or scaly skin
• cramps
• double vision
• feeling of warmth
• heavy bleeding
• menstrual changes
• pain
• pelvic pain
• redness of the face, neck, arms, and occasionally, upper chest
• seeing double
• sudden sweating
• unexplained runny nose or sneezing

Rare

• Acid or sour stomach
• belching
• bigger, dilated, or enlarged pupils ( part of eye)
• change in color vision
• difficulty seeing at night
• feeling of constant movement of self or surroundings
• feeling of relaxation
• heartburn
• hives or welts
• increased sensitivity of eyes to sunlight
• indigestion
• redness of skin
• runny nose
• sensation of spinning
• stomach discomfort, upset, or pain
• stuffy nose

Incidence not known

• Blistering, peeling, or loosening of the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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Generic name: ALPRAZOLAM 0.25mg
Dosage form: tablet

See also:

• Xanax XR tablet, extended release

Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

Xanax Side Effects

General

Suicide

As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients.

Mania

Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression.

Uricosuric Effect

Alprazolam has a weak uricosuric effect. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with XANAX.

Use In Patients With Concomitant Illness

It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients (see DOSAGE AND ADMINISTRATION). The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed. There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with XANAX. A decreased systemic alprazolam elimination rate (e.g., increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving XANAX (see CLINICAL PHARMACOLOGY).

Information For Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risks From Concomitant Use With Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see DRUG INTERACTIONS).

Abuse, Misuse, And Addiction

Inform patients that the use of XANAX, even at recommended dosages, exposes users to risks of abuse misuse and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS -Abuse, Misuse, and Addiction and Drug Abuse And Dependence).

Withdrawal Reactions

Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of XANAX may require a slow taper (see WARNINGS -Drug Abuse And Dependence and Drug Abuse And Dependence).

Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines.

Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication. Inform your physician if you are nursing.

Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.

Laboratory Tests

Laboratory tests are not ordinarily required in otherwise healthy patients. However, when treatment is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable in keeping with good medical practice.

Drug/Laboratory Test Interactions

Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No evidence of carcinogenic potential was observed during 2-year bioassay studies of alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose).

Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay.

Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category D

(see WARNINGS section).

Nonteratogenic Effects

It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines.

Labor And Delivery

XANAX has no established use in labor or delivery.

Nursing Mothers

Benzodiazepines are known to be excreted in human milk. It should be assumed that alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use XANAX.

Pediatric Use

Safety and effectiveness of XANAX in individuals below 18 years of age have not been established.

Geriatric Use

The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of XANAX should be used in the elderly to preclude the development of ataxia and oversedation (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).