Gabazolamine-0.5 (Oral)

Alprazolam helps reduce anxiety symptoms, including anxiety linked to depression. It is also used to treat panic disorder in certain patients.

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

You can only get this medicine with a prescription from your doctor.

It is very important for your doctor to check your progress during regular visits to ensure this medicine is working properly. You may need blood and urine tests to check for any unwanted effects.

Inform your doctor if you are pregnant or planning to become pregnant. Using this medicine during late pregnancy may cause problems in your newborn baby (e.g., sedation or withdrawal symptoms). Tell your doctor immediately if your baby has any unusual sleep patterns, 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 this medicine, notify your doctor immediately.

Do not take itraconazole (Sporanox®) or ketoconazole (Nizoral®) while using this medicine. Using either of these with this medicine may increase the risk of serious side effects.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that slow down the nervous system and may cause drowsiness). Examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicines, 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, discuss it with your doctor. Some changes observed in people taking this medicine are similar to those seen in individuals who consume alcohol and then act unusually. Other changes can be more extreme, including confusion, worsening depression, hallucinations (seeing, hearing, or feeling things that are not present), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Alprazolam may cause some individuals, especially older adults, to feel drowsy, dizzy, or less alert than usual. Make sure you understand how you react to this medicine before you drive, operate machinery, or do anything else that could be dangerous if you are dizzy or not alert.

Do not change your dose or stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce your dosage before stopping completely. This can help prevent your condition from worsening and reduce the risk of withdrawal symptoms, which may include changes in behavior, feelings of discouragement, sadness or emptiness, irritability, lack of appetite, loss of interest or pleasure, nausea or vomiting, hallucinations, seizures or tremors, stomach or muscle cramps, sweating, thoughts of self-harm, trouble concentrating, sleeping difficulties, and unusual movements or expressions.

This medicine can be habit-forming. If you feel that the medicine is not as effective, do not exceed your prescribed dose. Contact your doctor for guidance.

Symptoms of an overdose include: change in consciousness, confusion, dizziness, faintness, or lightheadedness when standing 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, difficulty speaking, sleep issues, unsteadiness, trembling, or other problems with muscle control or coordination, unusual excitement, nervousness, restlessness, irritability, or unusual weakness. Call your doctor immediately if you notice these symptoms.

Do not take other medicines unless you have discussed them 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 using the medicine must be weighed against the good it will do. This is a decision you and your physician 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 drug or any other medicines. 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 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.

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 chances prior to taking this medication while breastfeeding.

Interactions with Drugs

Although certain medications should not be used together at all, in other cases two different drugs 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 medication, it is especially essential 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 drugs is not advised. Your clinician may decide not to treat you with this medicine or change some of the other medicines 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 usually not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician 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 medicine with any of the following medications may cause an increased risk of certain side effects, but using both drugs may be the best therapy for you. If both drugs 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
• Troleandomycin

Interactions with Food/Tobacco/Alcohol

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 additionally 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 normally not advised, but may be unavoidable in some cases. If used together, your physician may change the dose or how often 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 medicine. 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 medicine 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 might need medical attention.

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

More common

• Forgetfulness
• changes in speech patterns and rhythms
• clumsiness or unsteadiness
• difficulty coordinating movements
• feelings of discouragement
• drowsiness
• feeling sad or empty
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• feeling relaxed and calm
• shakiness and unsteady walking
• sleepiness
• slurred speech
• tiredness
• trouble concentrating
• trouble doing 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 identity, place, and time
• cough
• dark urine
• decreased frequency of urination
• decreased urine volume
• diarrhea
• difficulty breathing
• trouble passing urine (dribbling)
• difficulty concentrating
• difficulty moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• feeling that the environment is unreal
• fainting
• feeling detached from reality
• feeling warm
• fever
• general feeling of discomfort or illness
• headache
• inability to move the eyes
• inability to stay still
• increased blinking or spasms of the eyelid
• irregular heartbeats
• itching or rash
• joint pain
• loss of self-control
• loss of bladder control
• loss of coordination
• memory loss
• loss of voice
• mood or mental changes
• 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 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 balancing
• 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

• Out-of-control actions
• attack, assault, or force
• chest pain
• persistent ringing or buzzing or other unexplained noises in the ears
• decreased awareness or responsiveness
• deep or fast breathing with dizziness
• ear pain
• unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling jittery
• feeling unusually cold
• overall slowing of mental and physical activity
• hearing loss
• hoarseness
• lack of feelings or emotions
• loss of control of the legs
• loss of strength or energy
• nightmares
• numbness in the feet, hands, or around the mouth
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• sleep talking
• swelling
• acting with excitement
• thoughts of self-harm
• indifference
• unusual weakness
• changes in voice

Incidence not known

• Light-colored stools
• pain in the upper right abdomen or stomach

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
• 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 happen that usually do not need medical attention. These side effects might go away as your body adjusts to the medicine. Your healthcare professional may also be able to provide ways to prevent or lessen some of these side effects. Check with your healthcare 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 or abnormal ejaculation
• difficulty having a bowel movement
• inability to have or maintain an erection
• increased appetite
• increase in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• weight gain
• loss of sexual ability, desire, drive, or performance
• stopping of menstrual bleeding
• drooling
• weight loss

Less common

• Blistering, crusting, irritation, itching, or reddening of the skin
• change in taste or unusual bad taste
• cracked, dry, or scaly skin
• double vision
• feeling warm
• heavy bleeding
• changes in menstrual cycle
• pelvic pain
• redness in 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 pupils
• change in color vision
• trouble seeing at night
• feeling constant movement of self or surroundings
• feeling relaxed
• 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 excessive 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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