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Uses Buspirone HCl (Generic Buspar) is an antianxiety agent, or a psychotropic drug with anxiolytic properties which belongs chemically to the class of compounds known as the azaspirodecanediones. Buspirone is used for short-term symptomatic relief of excessive anxiety in patients with generalized anxiety disorder (psychoneurotic disorder). Buspirone is also used to treat the symptoms of premenstrual syndrome. Talk to your doctor about the possible risks of using this drug for your condition. How to use Take Buspirone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Continue to take buspirone even if you feel well. Do not stop taking buspirone without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will decrease your dose gradually. This drug must be taken regularly for a few weeks before its full effect is felt. Precautions Buspirone is contraindicated in patients with severe hepatic or severe renal impairment. The occurrence of elevated blood pressure in patients receiving both buspirone and a MAO inhibitor has been reported. Therefore, it is recommended that buspirone should not be used concomitantly with a MAO inhibitor. Pregnancy and Lactation: The safety of buspirone during pregnancy and lactation has not been established and, therefore, it should not be used in women of childbearing potential or nursing mothers, unless, in the opinion of the physician, the potential benefits to the patient outweigh the possible hazards to the fetus. Buspirone and its metabolites are excreted in milk in rats. The extent of excretion in human milk has not yet been determined. Side Effects The most common adverse reactions encountered with buspirone are dizziness, headache, drowsiness and nausea. During premarketing clinical trials, approximately 10% of the patients discontinued treatment due to an adverse event. Adverse reactions reported include the following. CNS: Dizziness, headache, drowsiness, lightheadedness, insomnia, fatigue, nervousness, decreased concentration, excitement, depression, confusion, nightmares/vivid dreams, anger/hostility. Infrequently (less than 1%) depersonalization, noise intolerance, euphoria/feeling high, dissociative reaction, fear, loss of interest, dysphoria, hallucinations, seizures, suicidal thoughts. Rarely, slurred speech, claustrophobia, cold intolerance, stupor, psychosis. Neurologic: Paresthesia, weakness, incoordination, tremor, numbness. Infrequently, muscle cramps and spasms, rigid/stiff muscles, involuntary movements, akathisia, slowed reaction time. Rarely, tingling of limbs, stiff neck, rigidity of jaw, ataxia. Autonomic: Dry mouth, sweating/clamminess, blurred vision, constipation. Infrequently, urinary frequency, retention and burning, flushing. Cardiovascular: Tachycardia, chest pain, palpitations. Infrequently, syncope, hypotension, hypertension. Rarely, congestive heart failure, cerebrovascular accident, myocardial infarction, cardiomyopathy, bradycardia, EKG change. Gastrointestinal: Nausea, gastrointestinal distress, diarrhea, vomiting. Infrequently, flatulence, increased appetite, anorexia, hypersalivation, rectal bleeding, irritable colon. Rarely, burning tongue. Respiratory: Nasal congestion. Infrequently, shortness of breath, chest congestion, difficulty breathing, hyperventilation. Rarely, epistaxis. Endocrine: Infrequently, decreased and increased libido, weight gain, weight loss, menstrual irregularity/breakthrough bleeding. Rarely, delayed ejaculation, impotence, galactorrhea, amenorrhea, thyroid abnormality. Allergic or Toxic: Skin rash, sore throat. Infrequently, edema/facial edema, pruritus, chills/fever. Rarely, photophobia, erythema, flu-like symptoms. Clinical Laboratory: Infrequently, increases in liver enzymes. Rarely, eosinophilia, leukopenia, thrombocytopenia. Miscellaneous: Tinnitus, muscle aches/pains. Infrequently, redness/itching of eyes, altered taste/smell, roaring sensation in head, malaise, easy bruising, dry skin, arthralgia, blisters, hair loss. Rarely, acne, thinning of nails, sore eyes, inner ear abnormality, pressure on eyes, nocturia, enuresis, hiccups, voice loss, alcohol abuse. Post Introduction Clinical Experience: Post-marketing experience in the US has shown an adverse experience profile similar to that given above. Additional reports have included rare occurrences of allergic reaction, cogwheel rigidity, dystonic reaction, ecchymosis, emotional lability and tunnel vision. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone treatment has not been determined. Storage Store Buspirone as indicated on the label.
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