Temazepam precautions

List of precautions
General Laboratory tests Carcinogenesis Mutagenesis Impairment of fertility Pregnancy Nursing mothers Pediatric use

General
Since the risk of the development of oversedation, dizziness, confusion, and/or ataxia increases substantially with larger doses of benzodiazepines in elderly and debilitated patients, 7.5 mg of Temazepam is recommended as the initial dosage for such patients. Temazepam should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression; it should be recognized that suicidal tendencies may be present and protective measures may be necessary. The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. If Temazepam is to be combined with other drugs having known hypnotic properties or CNS-depressant effects, consideration should be given to potential additive effects. The possibility of a synergistic effect exists with the co-administration of Temazepam and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received Temazepam and diphenhydramine. A cause and effect relationship has not yet been determined. Return to top

Laboratory tests
The usual precautions should be observed in patients with impaired renal or hepatic function and in patients with chronic pulmonary insufficiency. Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines. Return to top

Carcinogenesis
Carcinogenicity studies were conducted in rats at dietary Temazepam doses up to 160 mg/kg/day for 24 months and in mice at dietary dose of 160 mg/kg/day for 18 months. No evidence of carcinogenicity was observed although hyperplastic liver nodules were observed in female mice exposed to the highest dose. The clinical significance of this finding is not known. Return to top

Mutagenesis
No mutagenicity tests have been done with Temazepam. Return to top

Impairment of fertility
Fertility in male and female rats was not adversely affected by Temazepam. Return to top

Pregnancy

 * Pregnancy Category X.
 * Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.
 * Reproduction studies in animals with Temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. Return to top

Nursing mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Temazepam is administered to a nursing woman. Return to top

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