Buspar

Buspirone is used to treat certain anxiety disorders or to relieve the symptoms of anxiety. However, Buspirone usually is not used for anxiety or tension caused by the stress of everyday life.

It is not known exactly how Buspirone works to relieve the symptoms of anxiety.

Buspirone is thought to work by decreasing the amount and actions of a chemical known as serotonin in certain parts of the brain.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms: 15 and 30 mg tablets.

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 population

Appropriate studies on the relationship of age to the effects of buspirone have not been performed in the pediatric population. However, no pediatric-specific problems have been documented to date.

Geriatric population

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buspirone in the elderly.

Pregnancy and Lactation: Category B

No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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.

• Isocarboxazid
• Linezolid
• Phenelzine
• Tranylcypromine

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.

• Almotriptan Amitriptyline Amoxapine
• Bromazepam Buprenorphine
• Carbinoxamine Ceritinib Clorgyline Clozapine
• Dabrafenib Desvenlafaxine Dolasetron
• Fentanyl Flibanserin
• Granisetron
• Hydrocodone Hydromorphone Hydroxytryptophan
• Idelalisib Iproniazid
• Levomilnacipran Lorcaserin Lumacaftor
• Meclizine Meperidine Methadone Methylene Blue Mirtazapine Moclobemide Morphine Morphine Sulfate Liposome
• Nialamide Nilotinib
• Oxycodone Oxymorphone
• Palonosetron Pargyline Piperaquine Procarbazine
• Safinamide Selegiline Sodium Oxybate Suvorexant
• Tapentadol Toloxatone Tramadol Trazodone
• Vilazodone Vortioxetine
• Ziprasidone 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.

• Diltiazem
• Erythromycin
• Fluoxetine
• Ginkgo
• Haloperidol
• Itraconazole
• Nefazodone
• Rifampin
• St John's Wort
• Verapamil

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 may cause an increased risk of certain side effects 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:

• Kidney disease or Liver disease: Effects may be increased because of slower removal of the medicine from the body.

Take Buspirone 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. To do so may increase the chance of unwanted effects. This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food, but take it the same way each time. Do not eat grapefruit or drink grapefruit juice while you are taking this medicine. After you begin taking buspirone, 1 to 2 weeks may pass before you begin to feel the effects of 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.

Oral dosage form (tablets)

For anxiety:

• Adults: At first, 7.5 mg two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg a 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.

If you will be using buspirone regularly for a long time, your doctor should check your progress at regular visits to make sure the medicine is working properly and does not cause unwanted effects.

Do not take buspirone if you are also taking a drug with monoamine oxidase (MAO) inhibitor activity (e.g., isocarboxazid [MarplanВ®], phenelzine [NardilВ®], selegiline [EldeprylВ®], or tranylcypromine [ParnateВ®]). If you do, you may develop extremely high blood pressure.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Buspirone may cause some people to become dizzy, lightheaded, drowsy, 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. Avoid drinking alcoholic beverages while you are using this medicine.

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 taking before stopping it completely. This is to decrease the chance of having withdrawal symptoms such as increased anxiety, burning or tingling feelings, confusion, dizziness, headache, irritability, nausea, nervousness, muscle cramps, sweating, trouble with sleeping, or unusual tiredness or weakness. If you think you or someone else may have taken an overdose of buspirone, get emergency help at once.

Symptoms of an overdose are dizziness or lightheadedness, severe drowsiness or loss of consciousness, stomach upset, including nausea or vomiting, or very small pupils of the eyes. 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.

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:

Rare:

• Chest pain
• Confusion
• Fast or pounding heartbeat
• Fever
• Incoordination
• Mental depression
• Muscle weakness
• Numbness, tingling, pain, or weakness in the hands or feet
• Skin rash or hives
• Sore throat
• Stiffness of the arms or legs
• Uncontrolled movements of the body

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

• Dizziness or lightheadedness especially when getting up from a sitting or lying position suddenly
• Drowsiness (severe)
• Loss of consciousness
• Nausea or vomiting
• Stomach upset
• Very small pupils of the eyes

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:

• Restlessness
• Nervousness, or unusual excitement

Less common or rare:

• Blurred vision
• Clamminess or sweating
• Decreased concentration
• Diarrhea
• Drowsiness
• Dryness of the mouth
• Muscle pain, spasms, cramps, or stiffness
• Ringing in the ears
• Trouble with sleeping
• Nightmares, or vivid dreams
• Unusual tiredness or weakness

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.