TEMAZEPAM (Page 3 of 6)

PRECAUTIONS

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 capsules are recommended as the initial dosage for such patients.

Temazepam capsules 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 capsules are 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 capsules and diphenhydramine. One case of stillbirth at term has been reported 8 hours after a pregnant patient received temazepam capsules and diphenhydramine. A cause and effect relationship has not yet been determined ( see CONTRAINDICATIONS).

Information for Patients

Advise the patient to read the FDA approved patient labeling ( Medication Guide).

Risks from Concomitant Use with Opioids

Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when temazepam capsules are used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see WARNINGS, Risks from Concomitant Use with Opioids and PRECAUTIONS, Drug Interactions).

Abuse, Misuse, and Addiction

Inform patients that the use of temazepam capsules, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug ( see WARNINGS, Abuse, Misuse, and Addiction and DRUG ABUSE AND DEPENDENCE).

Withdrawal Reactions

Inform patients that the continued use of temazepam capsules may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of temazepam capsules may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of temazepam capsules may require a slow taper ( see WARNINGS, Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE).

“Sleep-Driving” and Other Complex Behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when temazepam capsules are taken with alcohol or other central nervous system depressants ( see WARNINGS). Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events.

Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.

Pregnancy

Advise pregnant females that use of temazepam capsules late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns ( see WARNINGS, Neonatal Sedation and Withdrawal Syndromeand PRECAUTIONS, Pregnancy). Instruct patients to inform their healthcare provider if they are pregnant.

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to temazepam capsules during pregnancy ( see PRECAUTIONS, Pregnancy).

Nursing

Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed. Instruct breastfeeding patients using temazepam capsules to monitor infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs ( see PRECAUTIONS, Nursing Mothers).

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.

Drug Interactions

The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

The benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were conducted in rats at dietary temazepam doses up to 160 mg/kg/day for 24 months and in mice at dietary doses 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.

Fertility in male and female rats was not adversely affected by temazepam capsules.

No mutagenicity tests have been done with temazepam.

Pregnancy

Pregnancy Exposure Registry
There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including temazepam capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/.

Risk Summary
Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal ( see WARNINGS, Neonatal Sedation and Withdrawal Syndrome and Clinical Considerations). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects ( see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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