Brand Name

    US Brand Name

    Gabazolamine-0.5

    Niravam

    Xanax

    Xanax XR

    Canadian Brand Name

    Alti-ALPRAZolam


    Description

    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.

    This product is available in the following dosage forms:

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

    Before Using

    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, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    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.

    • Boceprevir
    • Ceritinib
    • Clarithromycin
    • Cobicistat
    • Flumazenil
    • Idelalisib
    • Indinavir
    • Itraconazole
    • Ketoconazole
    • Lonafarnib
    • Mifepristone
    • Nefazodone
    • Nelfinavir
    • Paritaprevir
    • Posaconazole
    • Ribociclib
    • Saquinavir
    • Telaprevir
    • Telithromycin
    • Troleandomycin
    • Tucatinib
    • Voriconazole

    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.

    • Abametapir
    • Acepromazine
    • Alfentanil
    • Amiodarone
    • Amobarbital
    • Amprenavir
    • Anileridine
    • Aprepitant
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Asenapine
    • Atazanavir
    • Avacopan
    • Baclofen
    • Benperidol
    • Benzhydrocodone
    • Bromazepam
    • Bromopride
    • Buprenorphine
    • Buspirone
    • Butabarbital
    • Butalbital
    • Butorphanol
    • Calcium Oxybate
    • Cannabidiol
    • Cannabis
    • Carbamazepine
    • Carbinoxamine
    • Carisoprodol
    • Carphenazine
    • Cetirizine
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpromazine
    • Chlorzoxazone
    • Cimetidine
    • Ciprofloxacin
    • Clobazam
    • Clonazepam
    • Clorazepate

    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.

    • Fluoxetine
    • Kava
    • Rifapentine
    • Roxithromycin
    • Sertraline
    • St John's Wort
    • Theophylline

    Other Interactions

    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.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol
    • Grapefruit Juice

    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:

    • Alcohol or drug abuse or dependence, history of or
    • Depression, or history of or
    • Lung or breathing problems (eg, respiratory depression) or
    • Mania, or history of or
    • Mental health problems, or history of or
    • Seizures, or history of—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

    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. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

    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.


    Precautions

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

    Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. 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.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). 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 or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the above while you are using this medicine.

    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 change your dose or stop taking this medicine without checking first with your doctor. 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 including changes in behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, nausea or vomiting, seeing or hearing things that others do not see or hear, seizures or tremors, stomach or muscle cramps, sweating, thoughts of killing oneself, trouble concentrating, trouble sleeping, unusual movements, responses, or expressions.

    This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

    Symptoms of an overdose include: change in consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, drowsiness, hallucinations, lack of coordination, loss of consciousness, loss of strength or energy, muscle pain or weakness, shakiness and unsteady walk, sleepiness, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual excitement, nervousness, restlessness, or irritability, or unusual weakness. Call your doctor right away if you notice these symptoms.

    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.


    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
    • slurred speech
    • tiredness
    • trouble concentrating
    • trouble performing routine tasks
    • trouble sleeping
    • trouble speaking
    • unsteadiness, trembling, or other problems with muscle control or coordination
    • unusual tiredness or weakness

    Less common

    • Blurred vision
    • body aches or pain
    • burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
    • changes in behavior
    • chest tightness
    • 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 passing urine (dribbling)
    • difficulty with concentration
    • difficulty with moving
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • dry mouth
    • ear congestion
    • environment seems unreal
    • fainting
    • feeling of unreality
    • feeling warm
    • fever
    • general feeling of discomfort or illness
    • headache
    • inability to move the eyes
    • inability to sit still
    • increased blinking or spasms of the eyelid
    • irregular heartbeats
    • itching or rash
    • 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 aches, cramps, pain, stiffness, or weakness
    • nausea
    • need to keep moving
    • painful urination
    • problems with memory
    • restlessness
    • runny or stuffy nose
    • seeing, hearing, or feeling things that are not there
    • seizures
    • sense of detachment from self or body
    • shaking
    • shivering
    • sneezing
    • sore throat
    • sticking out of the tongue
    • stomach pain
    • sweating
    • swollen joints
    • talkativeness
    • 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 dullness or feeling of sluggishness
    • unusual facial expressions
    • unusually deep sleep
    • unusually long duration of sleep
    • vomiting of blood
    • 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 the 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
    • swelling
    • talking, feeling, and acting with excitement
    • thoughts of killing oneself
    • uncaring
    • unusual weak feeling
    • voice changes

    Incidence not known

    • Light-colored stools
    • upper right abdominal or stomach pain

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Agitation
    • change in consciousness
    • changes in patterns and rhythms of speech
    • confusion
    • lack of coordination
    • loss of consciousness
    • loss of strength or energy
    • shakiness and unsteady walk
    • slurred speech
    • sleepiness or unusual drowsiness
    • talkativeness
    • unsteadiness, trembling, or other problems with muscle control or coordination
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
    • unusual excitement, nervousness, restlessness, or irritability
    • unusual weak feeling

    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 the mouth
    • weight loss

    Less common

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

    Rare

    • Acid or sour stomach
    • belching
    • bigger, dilated, or enlarged pupils (black part of the 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 the eyes to sunlight
    • indigestion
    • redness of the skin
    • sensation of spinning
    • stomach discomfort or upset

    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 the 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.






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