Lorazepam precautions

You don't need to be Editor-In-Chief to add or edit content to WikiDoc. You can begin to add to or edit text on this WikiDoc page by clicking on the edit button at the top of this page. Next enter or edit the information that you would like to appear here. Once you are done editing, scroll down and click the Save page button at the bottom of the page.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

List of precautions

Pre-existing depression

Respiratory depression

Physical and psychological dependence

Suicide

Impaired renal and hepatic function

Upper GI disease

Pediatric

Carcinogenesis and mutagenesis

Pregnancy

Nursing mothers

Geriatric

---

Pre-existing depression

Pre-existing depression may emerge or worsen during use of benzodiazepines including Lorazepam. Lorazepam) is not recommended for use in patients with a primary depressive disorder or psychosis.. Return to top

Respiratory depression

Use of benzodiazepines, including Lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression. Lorazepam should be used with caution in patients with compromised respiratory function (e.g. COPD, sleep apnea syndrome). Return to top

Physical and psychological dependence

The use of benzodiazepines, including Lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when Lorazepam is used at the appropriate dose for short-term treatment. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Lorazepam or other psychotropic agents. Return to top

Suicide

In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy. Return to top

Impaired renal and hepatic function

The usual precautions for treating patients with impaired renal and hepatic function should be observed. As with all benzodiazepines, the use of Lorazepam may worsen hepatic encephalopathy; therefore, Lorazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy. Dosage for patients with severe hepatic insufficiency should be adjusted carefully according to patient response; lower doses may be sufficient in such patients. Return to top

Upper GI disease

Esophageal dilation occurred in rats treated with Lorazepam for more than one year at 6 mg/kg/day. The no-effect dose was 1.25 mg/kg/day (approximately 6 times the maximum human therapeutic dose of 10 mg per day). The effect was reversible only when the treatment was withdrawn within two months of first observation of the phenomenon. The clinical significance of this is unknown. However, use of Lorazepam for prolonged periods and in geriatric patients requires caution, and there should be frequent monitoring for symptoms of upper G.I. disease. Return to top

Pediatric

Safety and effectiveness of Lorazepam in children of less than 12 years has not been established. Paradoxical reactions have been occasionally reported during benzodiazepine use in children. Return to top

Carcinogenesis and mutagenesis

No evidence of carcinogenic potential emerged in rats during an 18-month study with Lorazepam. No studies regarding mutagenesis have been performed. Return to top

Pregnancy

an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because the use of these drugs is rarely a matter of urgency, the use of Lorazepam during this period should be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.
In humans, blood levels obtained from umbilical cord blood indicate placental transfer of Lorazepam and Lorazepam glucuronide. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery. Return to top

Nursing mothers

Lorazepam has been detected in human breast milk; therefore, it should not be administered to breast-feeding women, unless the expected benefit to the woman outweighs the potential risk to the infant. Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines. Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability). Return to top

Geriatric

Clinical studies of Lorazepam generally were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects; however, the incidence of sedation and unsteadiness was observed to increase with age. Age does not appear to have a significant effect on Lorazepam kinetics. Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, and lower doses may be sufficient in these patients. Paradoxical reactions also occasionally occur in elderly patients. Return to top

---

The content of this page is taken from the FDA package insert for this drug and should not be edited.