Alprazolam precautions

List of precautions
General Lab tests Drug/lab test interactions Carcinogenesis Mutagenesis Impairment of fertility Pregnancy Labor & delivery Nursing mothers Pediatric use Geriatric use

General
If Alprazolam is to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines. As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients. The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed. There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with Alprazolam. A decreased systemic Alprazolam elimination rate (eg, increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving Alprazolam. Episodes of hypomania and mania have been reported in association with the use of Alprazolam in patients with depression. Alprazolam has a weak uricosuric effect. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with Alprazolam. Return to top

Lab tests
Laboratory tests are not ordinarily required in otherwise healthy patients. Return to top

Drug/lab test interactions
Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test. Return to top

Carcinogenesis
No evidence of carcinogenic potential was observed during 2-year bioassay studies of Alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose). Return to top

Mutagenesis
Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay. Return to top

Impairment of fertility
Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day. Return to top

Pregnancy
Teratogenic Effects Nonteratogenic Effects Return to top
 * Pregnancy category D.
 * It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines.

Labor & delivery
Alprazolam has no established use in labor or delivery. Return to top

Nursing mothers
Benzodiazepines are known to be excreted in human milk. It should be assumed that Alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use Alprazolam. Return to top

Pediatric use
Safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established. Return to top

Geriatric use
The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma Alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of Alprazolam should be used in the elderly to preclude the development of ataxia and oversedation. Return to top