Description
Gepirone is used to treat major depressive disorder (MDD).
This medicine is available only with your doctor's prescription.
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Dronedarone
- Idelalisib
- Indinavir
- Isocarboxazid
- Itraconazole
- Ketoconazole
- Linezolid
- Lonafarnib
- Mesoridazine
- Methylene Blue
- Mifepristone
- Nefazodone
- Nelfinavir
- Ozanimod
- Paritaprevir
- Phenelzine
- Pimozide
- Piperaquine
- Posaconazole
- Procarbazine
- Rasagiline
- Ribociclib
- Ritonavir
- Safinamide
- Saquinavir
- Selegiline
- Sparfloxacin
- Telaprevir
- Telithromycin
- Terfenadine
- Thioridazine
- Tranylcypromine
- Troleandomycin
- Tucatinib
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
- Avacopan
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Benzphetamine
- Brompheniramine
- Buprenorphine
- Buserelin
- Buspirone
- Butorphanol
- Carbamazepine
- Chloroquine
- Chlorpheniramine
- Chlorpromazine
- Cimetidine
- Ciprofloxacin
- Citalopram
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
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.
- For depression:
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
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
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.
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