Alprazolam

Name: Alprazolam

How should this medicine be used?

Alprazolam comes as a tablet, an extended-release tablet, an orally disintegrating tablet (tablet that dissolves quickly in the mouth), and a concentrated solution (liquid) to take by mouth. The tablet, orally disintegrating tablet, and concentrated solution usually are taken two to four times a day. The extended-release tablet is taken once daily, usually in the morning. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alprazolam exactly as directed.

To take the concentrated liquid, use only the dropper that came with your prescription. Draw into the dropper the amount prescribed for one dose. Squeeze the dropper contents into a liquid or semisolid food such as water, juice, soda, applesauce, or pudding. Stir the liquid or food gently for a few seconds. The concentrated liquid will blend completely with the food. Drink or eat the entire mixture immediately. Do not store for future use.

Remove the orally disintegrating tablet from the bottle just before it is time for your dose. With dry hands, open the bottle, remove the tablet, and immediately place it on your tongue. The tablet will dissolve and can be swallowed with saliva. The orally disintegrating tablet can be taken with or without water.

Swallow the extended-release tablets whole; do not chew, crush, or break them.

Your doctor will probably start you on a low dose of alprazolam and gradually increase your dose, not more than once every 3 or 4 days.

Alprazolam can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor . Do not stop taking alprazolam or decrease your dose without talking to your doctor. If you suddenly stop taking alprazolam you may experience withdrawal symptoms such as seizures; shaking of a part of your body that you cannot control; headache; blurred vision; increased sensitivity to noise or light; change in sense of smell; sweating; difficulty falling asleep or staying asleep; difficulty concentrating; nervousness; depression; irritability; aggressive behavior; muscle twitching or cramps; diarrhea; vomiting; pain, burning, numbness, or tingling in the hands or feet; a decrease in appetite; or weight loss. Your doctor will probably decrease your dose gradually.

Which drugs or supplements interact with medication?

  • Ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone (Serzone), cimetidine (Tagamet), and fluvoxamine (Luvox) increase concentrations in the blood of alprazolam and therefore may increase the side effects of alprazolam.
  • Alprazolam interacts with alcohol and medications (for example, barbiturates, and narcotics) that suppress activity in the brain by suppressing activity more and causing sedation.
  • Carbamazepine and rifampin reduce the effect of alprazolam by increasing metabolism and elimination of alprazolam in the liver.

Patient information

To assure safe and effective use of XANAX XR, the physician should provide the patient with the following guidance.

  1. 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.
  2. 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.
  3. Inform your physician if you are nursing.
  4. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
  5. Do not increase the dose even if you think the medication "does not work anymore" without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence.
  6. Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur.
  7. Some patients may find it very difficult to discontinue treatment with XANAX XR due to severe emotional and physical dependence. Discontinuation symptoms, including possible seizures, may occur following discontinuation from any dose, but the risk may be increased with extended use at doses greater than 4 mg/day, especially if discontinuation is too abrupt. It is important that you seek advice from your physician to discontinue treatment in a careful and safe manner. Proper discontinuation will help to decrease the possibility of withdrawal reactions that can range from mild reactions to severe reactions such as seizure.

Alprazolam and Pregnancy

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Alprazolam falls into category D. Alprazolam passes to the baby and may cause harm to the unborn baby. In addition, the baby may be born with respiratory and other problems if the mother uses alprazolam while pregnant. However, this medication may sometimes still help human mothers and their babies more than it might cause harm.

Alprazolam Dosage

Take alprazolam exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of alprazolam must be individualized.

Anxiety Disorders and Transient Symptoms of Anxiety:

Starting dose: 0.25 to 0.5 mg given three times daily. The dose may be increased to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be used and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

Panic Disorder:

  • Immediate release tablets: The successful treatment of many panic disorder patients may require doses greater than 4 mg daily. Treatment may be started at a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days. Slower titration may be needed. To lessen the possibility of symptoms between doses, you may be prescribed to take alprazolam 3 or 4 times a day.
  • Extended release tablets: The recommended total daily dose ranges between 3 to 6 mg/day. 

Dosing in special populations:

In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated.

Other Requirements

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). 

 

Overdosage

Clinical Experience

Manifestations of Alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. Death has been reported in association with overdoses of Alprazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including Alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.

The acute oral LD50 in rats is 331 mg/kg to 2171 mg/kg. Other experiments in animals have indicated that cardiopulmonary collapse can occur following massive intravenous doses of Alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human dose of 10 mg/day). Animals could be resuscitated with positive mechanical ventilation and the intravenous infusion of norepinephrine bitartrate.

Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage.

General Treatment of Overdose

Overdosage reports with Alprazolam tablets are limited. As in all cases of drug overdosage, respiration, pulse rate, and blood pressure should be monitored. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. If hypotension occurs, it may be combated by the use of vasopressors. Dialysis is of limited value. As with the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS and PRECAUTIONS should be consulted prior to use.

How is Alprazolam Supplied

Alprazolam tablets, USP are supplied as follows:

0.25 mg Each white, round tablet imprinted with on one side and 027 and bisect on the other contains 0.25 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2027-10), 500 (NDC 0228-2027-50), and 1000 (NDC 0228-2027-96).

0.5 mg Each peach, round tablet imprinted with on one side and 029 and bisect on the other contains 0.5 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2029-10), 500 (NDC 0228-2029-50), and 1000 (NDC 0228-2029-96).

1 mg Each blue, round tablet imprinted with on one side and 031 and bisect on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2031-10), 500 (NDC 0228-2031-50), and 1000 (NDC 0228-2031-96).

2 mg Each yellow, rectangle shaped, flat faced, beveled edge tablet imprinted with and 039 on one side and multi-scored on both sides contains 2 mg of Alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2039-10).

Dispense in tight, light-resistant containers as defined in the USP.

Keep container tightly closed.

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

ANIMAL STUDIES

When rats were treated with Alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

Manufactured by:
Actavis Elizabeth LLC
Elizabeth, NJ 07207 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

40-9170

Revised July 2017

Off Label Uses

Anxiety (children)

Data from a study evaluating a limited number of children (8 to 17 years of age) with overanxious disorder or avoidant disorders suggest that alprazolam may be beneficial for the treatment of anxiety as an improvement in clinical global ratings from baseline was seen, but no difference from placebo was seen [Simeon 1992]. In another study, children (7 to 16 years of age) with cancer who underwent scheduled, periodic, stressful events such as bone marrow aspirations and spinal taps, alprazolam was shown to be safe and useful for these types of procedures [Pfefferbaum 1987]. Additional data may be necessary to further define the role of alprazolam when treating children with this condition.

Contraindications

Hypersensitivity to alprazolam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); acute narrow-angle glaucoma; concurrent use with ketoconazole, itraconazole, or other potent CYP3A4 inhibitors.

Dosing Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use caution.

Dietary Considerations

Extended release tablet should be taken once daily in the morning. Orally-disintegrating tablets may contain phenylalanine.

What is alprazolam (niravam, xanax, xanax xr)?

Alprazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Alprazolam affects chemicals in the brain that may become unbalanced and cause anxiety.

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

Alprazolam may also be used for purposes not listed in this medication guide.

  • Anxiety
  • Phobias

What is alprazolam (niravam, xanax, xanax xr)?

Alprazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Alprazolam affects chemicals in the brain that may become unbalanced and cause anxiety.

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

Alprazolam may also be used for purposes not listed in this medication guide.

What is alprazolam?

Alprazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). It affects chemicals in the brain that may be unbalanced in people with anxiety.

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

Alprazolam may also be used for purposes not listed in this medication guide.

Important information

You should not use alprazolam if you have narrow-angle glaucoma, if you also take itraconazole or ketoconazole, or if you are allergic to alprazolam or similar medicines (Valium, Ativan, Tranxene, and others).

Do not use alprazolam if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.

Alprazolam may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death.

Do not drink alcohol while taking alprazolam. This medication can increase the effects of alcohol. This medicine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

How should I take alprazolam?

Take alprazolam exactly as prescribed by your doctor. Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in treating your symptoms.

Alprazolam may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Do not swallow the orally disintegrating tablet whole. Allow it to dissolve in your mouth without chewing.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if this medicine seems to stop working as well in treating your panic or anxiety symptoms.

Do not stop using alprazolam suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using alprazolam.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Alprazolam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of alprazolam can be fatal. Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, loss of balance or coordination, feeling light-headed, and fainting.

For the Consumer

Applies to alprazolam: oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

Along with its needed effects, alprazolam 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 while taking alprazolam:

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 performing routine tasks
  • trouble sleeping
  • trouble speaking
  • 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 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
  • fear or nervousness
  • feeling of unreality
  • feeling warm
  • fever
  • general feeling of discomfort or illness
  • headache
  • hyperventilation
  • 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 aching or cramping
  • muscle pain or stiffness
  • muscle weakness
  • nasal congestion
  • nausea
  • need to keep moving
  • painful urination
  • problems with memory
  • restlessness
  • runny 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
  • sweating
  • swollen joints
  • talkativeness
  • tightness in the chest
  • 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
  • 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
  • General tiredness and weakness
  • light-colored stools
  • stomach pain, continuing
  • upper right abdominal or stomach pain

Some side effects of alprazolam 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
  • Abdominal or 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 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
  • 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 the breasts

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