Niravam (Oral)

Alprazolam is used to help with symptoms of anxiety, including anxiety that comes from depression. It is also used to treat panic disorder in some patients.

Alprazolam is a benzodiazepine. Benzodiazepines are part of a group of medicines known as central nervous system (CNS) depressants, which slow down the nervous system.

This medicine is available only with a prescription from your doctor.

It is very important for your doctor to check your progress at regular visits to ensure 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 later pregnancy may cause problems in your newborn baby (for example, sedation or withdrawal symptoms). Inform your doctor immediately if your baby has an unusual sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or does not 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 using this medicine. Taking any of them together with this medicine may increase the risk of serious side effects.

This medicine will enhance the effects of alcohol and other CNS depressants (medications that slow down the nervous system, potentially causing drowsiness). Some examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medications, prescription pain medicines 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. Consult your doctor before taking any of the above while using this medicine.

If you experience any unusual or strange thoughts or behaviors while taking alprazolam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are similar to those seen in people who drink alcohol and then behave abnormally. Other changes may be more unusual and extreme, such as confusion, worsening 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 adults, to feel drowsy, dizzy, or less alert than usual. Make sure you know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert or able to see well.

Do not change your dose or stop taking this medicine without consulting 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 risk of withdrawal symptoms, which can include 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 self-harm, 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 take more than your prescribed dose. Contact 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 walking, sleepiness, trouble 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 immediately 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.

In deciding to use a drug, the risks of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, 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 drugs. As well 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 issues that would limit the usefulness of alprazolam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, serious sleepiness, light-headedness, confusion, clumsiness, or unsteadiness) and kidney, liver, or lung issues, which may require caution and an adjustment in the dose for patients receiving this drug.

Breast Feeding

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

Interactions with Drugs

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 using this drug, it is especially critical 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 medication with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other drugs you take.

• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Flumazenil
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

Using this drug with any of the following medications is typically not advised, but may be required in some cases. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Abametapir
• Acepromazine
• Alfentanil
• Amiodarone
• Amobarbital
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Ciprofloxacin
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dantrolene
• Daridorexant
• Darunavir
• Dasabuvir
• Delavirdine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Digoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Domperidone
• Doxylamine
• Dronedarone
• Droperidol
• Elagolix
• Enflurane
• Erythromycin
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Imatinib
• Isoflurane
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Larotrectinib
• Lemborexant
• Letermovir
• Levocetirizine
• Levoketoconazole
• Levorphanol
• Lofexidine
• Lomitapide
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melperone
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrexate
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Mirtazapine
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Netupitant
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Omaveloxolone
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Palbociclib
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Piperaquine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Remifentanil
• Remimazolam
• Remoxipride
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Verapamil
• Voxelotor
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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

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

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications may as well 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 drug with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, 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 medication. Make sure you inform your doctor if you have any other medical issues, 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 since of slower removal of the medication from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Forgetfulness
• changes in speech patterns and rhythms
• clumsiness or unsteadiness
• difficulty coordinating movements
• feelings of discouragement
• drowsiness
• feeling sad or empty
• irritability
• loss of appetite
• lightheadedness
• loss of interest or pleasure
• feeling relaxed and calm
• shakiness and unsteady walking
• sleepiness
• slurred speech
• tiredness
• trouble concentrating
• difficulty completing routine tasks
• trouble sleeping
• trouble speaking
• unsteadiness, trembling, or other issues 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 sensations
• changes in behavior
• chest tightness
• chills
• clay-colored stools
• confusion about who you are, where you are, and what time it is
• cough
• dark urine
• less frequent urination
• less urine volume
• diarrhea
• difficulty breathing or shortness of breath
• difficulty in passing urine (dribbling)
• trouble concentrating
• difficulty moving
• dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• dry mouth
• ear congestion
• feeling that the environment seems unreal
• fainting
• feeling of unreality
• feeling warm
• fever
• general discomfort or illness
• headache
• inability to move the eyes
• inability to sit still
• increased blinking or eyelid spasms
• irregular heartbeats
• itching or rash
• joint pain
• lack of self-control
• loss of bladder control
• loss of coordination
• memory loss
• loss of voice
• changes in mood or mental state
• muscle aches, cramps, pain, stiffness, or weakness
• nausea
• need to keep moving
• painful urination
• memory problems
• restlessness
• runny or stuffy nose
• seeing, hearing, or feeling things that are not real
• seizures
• feeling detached from yourself or your body
• shaking
• shivering
• sneezing
• sore throat
• sticking out of the tongue
• stomach pain
• sweating
• swollen joints
• excessive talkativeness
• trouble with balance
• twitching, twisting, or uncontrolled 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 sluggishness
• unusual facial expressions
• unusually deep sleep
• unusually long sleep duration
• vomiting blood
• yellowing of the eyes or skin

Rare

• Loss of control over actions
• attack, assault, or force
• chest pain
• ongoing ringing, buzzing, or other unexplained noises in the ears
• decreased awareness or responsiveness
• rapid or deep breathing with dizziness
• ear pain
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat
• feeling jittery
• feeling unusually cold
• slowing down 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 in the feet, hands, and around the mouth
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• sleep talking
• swelling
• talking, feeling, and acting excited
• thoughts of suicide
• lack of care
• unusual weakness
• change in voice

Incidence not known

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

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

Symptoms of overdose

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

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also have ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects persist, are bothersome, or if you have 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 maintain an erection
• increased appetite
• increased sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• weight gain
• loss in sexual ability, desire, drive, or performance
• stopping of menstrual bleeding
• excessive saliva
• weight loss

Less common

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

Rare

• Acid or sour stomach
• belching
• enlarged or dilated pupils
• change in color vision
• difficulty seeing at night
• feeling of constant movement of yourself or surroundings
• feeling relaxed
• heartburn
• hives or welts
• increased sensitivity of the eyes to sunlight
• indigestion
• skin redness
• 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 tenderness 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.

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

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.

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