Anxiolytic - Antipanic Alprazolam, a triazolo 1,4 benzodiazepine analog, binds with high affinity to the GABA benzodiazepine receptor complex. Considerable evidence suggest that the central pharmacologic/therapeutic actions of alprazolam are mediated via interaction with this receptor complex. Orally administered it is readily absorbed in man with peak plasma concentrations occurring 1 to 2 hours following administration. The half life range is 6 to 20 hours following single dose administration. With multiple doses, given 3 times daily, steady state is reached within 7 days. Alprazolam and its metabolites are excreted primarily in the urine. Degradation occurs mainly by oxidation yielding the primary and secondary metabolites which are active and appear to have half-lives similar to alprazolam but are present at only low levels in the plasma. Alprazolam is 80% protein bound. Alprazolam 500 mcg (0.5 mg), administered 3 times a day for 14 days, did not affect prothrombin times or plasma warfarin levels in male volunteers administered sodium warfarin orally. Indications For the management of anxiety disorders or the short-term symptomatic relief of symptoms of excessive anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Alprazolam is indicated for the treatment of Generalized Anxiety Disorder (GAD) and is also indicated for the management of panic disorder with or without agoraphobia. Contraindications Hypersensitivity to alprazolam or other benzodiazepines. Alprazolam is also contraindicated in pregnancy, in infants and in patients with myasthenia gravis and acute narrow angle glaucoma. Warnings Alprazolam is not recommended for use in patients whose primary diagnosis is psychosis or depression. Occupational Hazards: As with other CNS depressant drugs, patients should be cautioned against activities requiring mental alertness, judgement and physical coordination such as driving or operating machinery, particularly in the early phases of treatment and until proper adjustment to side effects has been established. Alcohol and benzodiazepines should never be mixed when driving because of the unpredictable CNS depressant effects of this combination. Pregnancy: Safety in pregnancy has not been established, therefore its use is not recommended. Studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines, such as chlordiazepoxide, diazepam, and also meprobamate, during the first trimester of pregnancy. Since alprazolam is a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential. If the drug is prescribed to a woman of child bearing potential she should be warned to consult her physician regarding the discontinuation of the drug if she intends to become or suspects that she is pregnant. Lactation: Studies in rats have indicated that alprazolam and its metabolites are secreted into the milk. Therefore, nursing should not be undertaken while a patient is receiving the drug. Safety and efficacy of alprazolam in patients under the age of 18 years has not been established. Precautions Elderly and debilitated patients, or those with organic brain syndrome, have been found to be prone to the CNS depressant activity of benzodiazepines even after low doses. Manifestations include ataxia, oversedation and hypotension. Therefore, medication should be administered with caution to these patients, particularly if a drop in blood pressure might lead to cardiac complications. Initial doses should be low and increments should be made gradually, depending on the response of the patient, in order to avoid oversedation, neurological impairment and other possible adverse reactions. Alprazolam should not be administered to individuals prone to drug abuse. Caution should be observed in all patients who are considered to have potential for psychological dependence. Withdrawal symptoms have been observed after abrupt discontinuation of benzodiazepines. These include irritability, nervousness, insomnia, agitation, tremors, convulsions, diarrhea, abdominal cramps, vomiting and mental impairment. Since these symptoms may be similar to those for which the patient is being treated, it may appear that he has suffered a relapse upon discontinuation. It is suggested that alprazolam should be withdrawn gradually if the individual is suspected of having become dependent, or the drug perhaps has been used in prolonged high doses. Suicidal tendencies may be present in patients with emotional disorders, particularly when depressed and that protective measures and appropriate treatment may be necessary and should be instituted without delay. Alprazolam should not be used in patients suspected of having psychotic tendencies since excitement and other paradoxical reactions can result from the use of anxiolytic-sedatives in these patients. As with other benzodiazepines, alprazolam should not be used in individuals with physiological anxiety or normal stress of daily living but only in the presence of disabling manifestations of an appropriate pathological anxiety disorder. These drugs are not effective in patients with characterological and personality disorders or those with obsessive compulsive disorders. Alprazolam is not recommended for the management of depressive or psychotic disorders. If treatment is necessary in patients with impaired hepatic or renal function, therapy should be initiated at a very low dose and the dosage increased only to the extent that it is compatible with the degree of residual function of these organs. If alprazolam is administered for repeated cycles of therapy, periodic blood counts and liver function tests are advisable. Since benzodiazepines may occasionally exacerbate grand mal seizures, caution is required when used in epileptic patients and an adjustment may be necessary in their anticonvulsive medication. Abrupt withdrawal of alprazolam should be avoided. Benzodiazepines may potentiate or interact with effects of other CNS acting drugs such as alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antihistamines, phenothiazines, butyrophenones, MAO inhibitors, tricyclic antidepressants and anticonvulsants. Therefore, if alprazolam is to be combined with other drugs acting on the CNS, careful consideration should be given to the pharmacology of the agent involved because of the possible additive or potentiating effects. Patients should also be advised against the simultaneous use of other CNS depressant drugs and should be cautioned not to take alcohol during the administration of alprazolam. Side Effects The most frequently reported are drowsiness, coordination difficulties with dizziness. Release of hostility and other paradoxical effects such as irritability, excitability and hallucinations are known to occur with the use of benzodiazepines. Other side effects less frequently reported, listed by body systems, include the following: Neurologic: Blurred vision, headache, seizures, slurred speech, difficulty in depth perception. Psychiatric: Agitation, mental confusion, depression, irritability, nervousness, sleep disturbances, euphoria, lethargy, stupor. Gastrointestinal: Dry mouth, nausea, nonspecific gastrointestinal disturbances, vomiting. Muscle spasm, muscle weakness. Cardiovascular: Hypotension, palpitations, tachycardia. Dermatologic: Pruritus, rash. Genitourinary: Incontinence, change in libido. Hematologic: Decreased hemoglobin and hematocrit, increased and decreased WBC. Hepatic: Elevations of alkaline phosphatase, bilirubin, AST (SGOT), ALT (SGPT). Miscellaneous: Increased and decreased blood sugar levels. Overdose Symptoms: Manifested as an extension of alprazolam's pharmacologic activity. Varying degrees of CNS depressant effects such as somnolence and hypnosis can occur. Other manifestations may include muscle weakness, ataxia, dysarthria and particularly in children paradoxical excitement. In more severe cases diminished reflexes, confusion and coma may ensue. It should be remembered when treating an overdose that multiple agents may have been ingested. Fatalities with benzodiazepines rarely occur except when other drugs, alcohol or aggravating factors are involved. Treatment: Vomiting may be induced if the patient is fully awake. Vital signs should be monitored and general supportive measures should be employed as indicated. Gastric lavage should be instituted as soon as possible. I.V. fluids may be administered and an adequate airway should be maintained. Experiments in animals have indicated that cardiopulmonary collapse can occur with massive i.v. doses of alprazolam. This could be reversed with positive mechanical respiration and the i.v. infusion of levarterenol. Animal experiments with alprazolam and related compounds have suggested that hemodialysis and forced diuresis are probably of little value.
    
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