Gepirone (Oral route)

Pronunciation:

je-PYE-rone

Brand Names:

Exxua

Warnings:

Oral route(Tablet, Extended Release)

Warning: Suicidal Thoughts and BehaviorsAntidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Gepirone is not approved for use in pediatric patients .

Classifications:

Pharmacologic—

Serotonin Receptor Agonist, 5-HT1

Uses of This Medicine:

Gepirone is used to treat major depressive disorder (MDD).

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 gepirone 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 gepirone in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults 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 risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

Bepridil
Boceprevir
Ceritinib
Cisapride
Clarithromycin
Cobicistat
Conivaptan
Dronedarone
Idelalisib
Indinavir
Isocarboxazid
Itraconazole
Ketoconazole
Linezolid
Lonafarnib
Mesoridazine
Methylene Blue
Mifepristone
Nefazodone
Nelfinavir
Ozanimod
Phenelzine
Pimozide
Piperaquine
Posaconazole
Procarbazine
Rasagiline
Ribociclib
Ritonavir
Safinamide
Saquinavir
Selegiline
Sparfloxacin
Telaprevir
Telithromycin
Terfenadine
Thioridazine
Tranylcypromine
Troleandomycin
Tucatinib
Voriconazole
Ziprasidone

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.

Adagrasib
Alfentanil
Alfuzosin
Almotriptan
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Amphetamine
Amprenavir
Anagrelide
Anileridine
Apalutamide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Benzhydrocodone
Benzphetamine
Brompheniramine
Buprenorphine
Buserelin
Buspirone
Butorphanol
Carbamazepine
Chloroquine
Chlorpheniramine
Chlorpromazine
Cimetidine
Ciprofloxacin
Citalopram
Clofazimine
Clomipramine
Clozapine
Cocaine
Codeine
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desvenlafaxine
Deutetrabenazine
Dextroamphetamine
Dextromethorphan
Dibenzepin
Difenoxin
Dihydrocodeine
Diltiazem
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Duloxetine
Duvelisib
Ebastine
Efavirenz
Eletriptan
Encorafenib
Entrectinib
Enzalutamide
Eribulin
Erythromycin
Escitalopram
Ethylmorphine
Etrasimod
Famotidine
Felbamate
Fenfluramine
Fentanyl
Fexinidazole
Fingolimod
Flecainide
Fluconazole
Fluoxetine
Fluvoxamine
Formoterol
Fosamprenavir
Foscarnet
Fosnetupitant
Fosphenytoin
Frovatriptan
Galantamine
Gatifloxacin
Gemifloxacin
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Ibutilide
Iloperidone
Imatinib
Imipramine
Inotuzumab Ozogamicin
Ivabradine
Ivosidenib
Ketobemidone
Lapatinib
Lasmiditan
Lefamulin
Lenvatinib
Letermovir
Leuprolide
Levofloxacin
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lorcaserin
Lumacaftor
Lumefantrine
Macimorelin
Mefloquine
Melitracen
Meperidine
Methadone
Methamphetamine
Methotrimeprazine
Metronidazole
Milnacipran
Mirtazapine
Mitotane
Mizolastine
Mobocertinib
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nalbuphine
Naratriptan
Netupitant
Nicomorphine
Nilotinib
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Osilodrostat
Osimertinib
Oxaliplatin
Oxycodone
Oxymorphone
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Papaverine
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Perphenazine
Phenytoin
Pimavanserin
Pipamperone
Piritramide
Pitolisant
Ponesimod
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Remifentanil
Rifampin
Rifapentine
Risperidone
Rizatriptan
Schisandra sphenanthera
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sufentanil
Sulpiride
Sultopride
Sumatriptan
Sunitinib
Tacrolimus
Tamoxifen
Tapentadol
Telavancin
Tetrabenazine
Tianeptine
Tilidine
Tolterodine
Toremifene
Tramadol
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Tryptophan
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Vorinostat
Vortioxetine
Voxelotor
Zolmitriptan
Zotepine
Zuclopenthixol

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.

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 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:

Bipolar disorder, or risk of or
Electrolyte problems (eg, low magnesium or potassium in the blood), history of or
Heart attack, recent or
Heart disease or
Heart failure or
Heart rhythm problems or
High blood pressure, uncontrolled or
Hypothyroidism (underactive thyroid), uncontrolled or
Mania or hypomania, history of—Use with caution. May make these conditions worse.

Kidney disease or
Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Heart rhythm problem (eg, QT prolongation) or
Liver disease, severe—Should not be used in patients with these conditions.

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.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Take this medicine with food at the same time each day.

Swallow the extended-release tablet whole. Do not split, crush, or chew it.

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 oral dosage form (extended-release tablets):
- For depression:
  - Adults—At first, 18.2 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 72.6 mg per day.
  - 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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to allow for changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or plan to become pregnant. Using this medicine during the last 3 months of pregnancy can harm your unborn baby. Tell your doctor right away if you become pregnant or if you think you may be pregnant while using this medicine.

Gepirone may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including linezolid (Zyvox®) or methylene blue injection within the past 14 days.

This medicine can cause a change in heart rhythm called QT prolongation. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Call your doctor right away if you have any of these symptoms or any questions.

This medicine may cause a condition called serotonin syndrome when used together with some medicines (eg, SSRIs, TCAs). Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.

Do not suddenly 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.

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: Body aches or pain; chills; cough; ear congestion; fever; headache; loss of voice; sneezing; sore throat; stuffy or runny nose; trouble breathing; unusual tiredness or weakness

Less common: Bloating or swelling of the face, arms, hands, lower legs, or feet; confusion; delusions; dementia; rapid weight gain; tingling of the hands or feet; unusual weight gain or loss

Rare: Anxiety; dry mouth; fast, irregular, pounding, or racing heartbeat or pulse; hyperventilation; irritability; nervousness; restlessness; shaking; trouble sleeping; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known: Actions that are out of control; diarrhea; difficulty swallowing; fainting; irregular heartbeat; nervousness; overactive reflexes; poor coordination; shivering; skin itching, rash, or redness; sweating; swelling of the face, throat, or tongue; talking, feeling, and acting with excitement; talking or acting with excitement you cannot control; thoughts or attempts at killing oneself; trembling or shaking; twitching

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: Acid or sour stomach; belching; dizziness; feeling sleepy or tired; heartburn; indigestion; nausea; stomach discomfort, upset, or pain

Less common: Breast tenderness; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; increase appetite; muscle aches

Rare: Feeling jittery

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.

Last Updated: 4/24/2024

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