Pronunciation:

al-PRA-zoe-lam

Brand Names:

• Gabazolamine-0.5
• Niravam
• Xanax
• Xanax XR
• Alti-Alprazolam

Dosage Forms:

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

Classifications:

Therapeutic—

Antianxiety

Pharmacologic—

Benzodiazepine, Short or Intermediate Acting

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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
• Carbinoxamine
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Digoxin
• Domperidone
• Ethchlorvynol
• Fentanyl
• Fluconazole
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meclizine
• 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
• Perampanel
• Rifapentine
• Ritonavir
• Roxithromycin
• Sertraline
• St John's Wort
• Telaprevir
• Theophylline
• Troleandomycin

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.

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 This Medicine:

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 This Medicine:

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.

Side Effects of This Medicine:

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 (black 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.