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Basic Drug Info
Drug Name:Buspirone Hydrochloride
Manufacturer:ETHEX
Other Info:

1.

American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders– III, American Psychiatric Association, May 1980.____________________Synthroid® is the registered trademark of Abbott Laboratories.



Clinical Trials:


Indications and Usage

Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.

Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD).

Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms.

The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months.

Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience.The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia.

However, mild depressive symptoms are common in GAD.The effectiveness of buspirone in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials.

There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD.

However, in a study of long-term use, 264 patients were treated with buspirone for 1 year without ill effect.

Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Feeling jittery --

Trembling --

Myalgia -- Myalgia: Pain or aching in a muscle or muscles.

Fatigability --

Muscle twitch -- The occurrence of a single contraction or a series of contractions of a muscle.

Agitation -- A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions.

Pounding heart --

Common Cold -- A catarrhal disorder of the upper respiratory tract, which may be viral or a mixed infection. It generally involves a runny nose, nasal congestion, and sneezing.

Xerostomia -- Decreased salivary flow.

Dizziness -- An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness.

Lightheadedness --

Pins and needles --

Upset stomach --

Diarrhea -- An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.

Sensory Discomfort -- A feeling of mental or physical uneasiness, pain, or distress.

Pallor -- A clinical manifestation consisting of an unnatural paleness of the skin.

Sleeplessness -- Difficulty in going to sleep or getting enough sleep.

Contraindications
Warnings

The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard.

There have been reports of the occurrence of elevated blood pressure when buspirone has been added to a regimen including an MAOI.

Therefore, it is recommended that buspirone not be used concomitantly with an MAOI.Because buspirone has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
Branded Drugs
The following US Branded drugs contain Buspirone Hydrochloride


BUSPAR -- BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE


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