What is Alprazolam ER?

QUICK LINKS

• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

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.

Proper UseTOP

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.

DosingTOP

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 DoseTOP

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.

Use & StorageTOP

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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

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.

GeriatricTOP

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.

PregnancyTOP

Breast FeedingTOP

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.

Drug InteractionsTOP

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
• Flumazenil
• 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
• Boceprevir
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Ceritinib
• Chloral Hydrate
• Chlorzoxazone
• Clarithromycin
• Cobicistat
• Codeine
• Conivaptan
• Dantrolene
• Dasabuvir
• Digoxin
• Domperidone
• Doxylamine
• Eliglustat
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fluconazole
• Fospropofol
• Hydrocodone
• Hydromorphone
• Idelalisib
• Levorphanol
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Oxycodone
• Oxymorphone
• Pentobarbital
• Periciazine
• Phenobarbital
• Piperaquine
• Primidone
• Propofol
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Thiopental
• Tramadol
• 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
• Cimetidine
• Desipramine
• Desogestrel
• Dienogest
• Drospirenone
• Erythromycin
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fluoxetine
• Imipramine
• Kava
• Levonorgestrel
• Mestranol
• Mifepristone
• Nefazodone
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Rifapentine
• Roxithromycin
• Sertraline
• St John's Wort
• Telaprevir
• Theophylline
• Troleandomycin

Other InteractionsTOP

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.

• Grapefruit Juice

Other Medical ProblemsTOP

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 abuse, history of or
• Depression, or history of or
• Drug abuse or dependence, 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.

PrecautionsTOP

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.

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.

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 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 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, such as convulsions (seizures), stomach or muscle cramps, sweating, tremors, vomiting, or unusual behavior.

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.

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.