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Basic Drug Info
Drug Name:ALPRAZOLAM
Manufacturer:ALPHAPHARM PTY. LTD.
Other Info:

Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma.

Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines.

In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.The acute oral LD50 in rats is 331 to 2171 mg/kg.

Other experiments in animals have indicated that cardiopulmonary collapse can occur following massive intravenous doses of alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human dose of 10 mg/day).

Animals could be resuscitated with positive mechanical ventilation and the intravenous infusion of norepinephrine bitartrate.Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage.



Clinical Trials:


Indications and Usage

Alprazolam is also indicated for the treatment of panic disorder, with our without agoraphobia.Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings or unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to four months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit.

The physician should periodically reassess the usefulness of the drug for the individual patient.
PANIC DISORDER 1 --

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

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Trembling --

Chest Pain -- Pressure, burning, or numbness in the chest.

Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Lightheadedness --

Numbness --

Chills -- The sudden sensation of being cold. It may be accompanied by SHIVERING.

Hot flushes -- A sudden, temporary onset of body warmth, flushing, and sweating (often associated with menopause).

Menopausal hot flushes -- A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed)

Contraindications

Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.

Alprazolam may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.Alprazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see WARNINGS and PRECAUTIONS - Drug Interactions).
Open Angle Glaucoma -- Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.

Angle Closure Glaucoma -- A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber.

Warnings
Other drugs possibly affecting alprazolam metabolism by inhibition of CYP3A are discussed in the PRECAUTIONS section (see PRECAUTIONS - Drug Interactions).
Branded Drugs
The following US Branded drugs contain ALPRAZOLAM


XANAX XR -- PHARMACIA AND UPJOHN

NIRAVAM -- SCHWARZ PHARMA INC

XANAX -- PHARMACIA AND UPJOHN CO


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