How to Use Restoril?
Sleep disturbances can be an indication of an underlying physical and/or mental disorder. Therefore, you should not start temazepam until you have been thoroughly evaluated by a doctor. The medication is meant to be taken for the short-term treatment of insomnia, or about 7 to 14 days. If symptoms persist, this could be an indication of a more serious problem.As people get older their sleep patterns often change naturally, and may include difficulty falling asleep and repeated nightly awakenings. If you fit this description, talk to your doctor about ways to improve your sleep without medications, such as avoiding caffeine, getting regular exercise, and other good sleep habits.
Restoril Effects
There are some known side effects of temazepam. While infrequent, the drug can sometimes cause short-term memory loss, so it’s important to have at least 7 or 8 hours to sleep after taking a dose of Restoril. To reduce the risk of dizziness or falling, get up slowly from a sitting or lying position after taking the drug. Taking temazepam could leave you feeling sleepy all day. If this happens, your dose may need to be adjusted.Some people using the drug have engaged in activity like driving, eating, making phone calls, having sex, or sleep walking, without having any memory of doing so. If this happens, talk with your doctor about a different treatment option.
In addition, the medication might not work as well after long periods of use.
Rarely, taking temazepam for insomnia can lead to addiction, especially if you have abused alcohol or drugs in the past. Taking the medication as prescribed will reduce the likelihood of addiction
INDICATIONS AND USAGE
Restoril™ (temazepam) Capsules USP (CIV) are indicated for the short-term treatment of insomnia (generally 7 to 10 days).
Restoril™ (temazepam) Capsules USP (CIV) are indicated for the short-term treatment of insomnia (generally 7 to 10 days).
This information is intended for U.S. healthcare professionals only.
IMPORTANT RISK INFORMATION
- See more at: http://www2.mallinckrodt.com/Templates/Pages/productdetail.aspx?id=1734#sthash.2WRs0oQg.dpufINDICATIONS AND USAGE
CONTRAINDICATIONS
Restoril is contraindicated in pregnant women or women who may become pregnant due to an increased risk of congenital malformations as well as risk of neonatal CNS depression.
WARNINGS AND PRECAUTIONSRestoril is contraindicated in pregnant women or women who may become pregnant due to an increased risk of congenital malformations as well as risk of neonatal CNS depression.
- Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
- Behavioral changes may occur with use including aggressiveness and extroversion, bizarre behavior, agitation, hallucinations, and depersonalization.
- 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 Restoril capsules are recommended as the initial dosage for such patients.
- Complex behaviors, such as sleep-driving, sleep-walking, etc. may occur with Restoril capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with Restoril capsules appear to increase the risk of such behaviors, as does the use of Restoril capsules at doses exceeding the maximum recommended dose.
- Withdrawal symptoms have occurred after the abrupt discontinuation of benzodiazepines.
- Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Restoril capsules.
- Restoril capsules should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression.
- Additive effects can occur when Restoril is combined with other drugs having known hypnotic properties or CNS-depressant effects.
- Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.
- Serious adverse reactions include complex behaviors (e.g. sleep-driving, aggressiveness) and angioedema involving the tongue, glottis or larynx, hallucinations, and agitation.
- Common adverse reactions include drowsiness and headache.
- Pregnancy category X. Contraindicated in pregnancy.
- Safety and effectiveness in pediatric patients have not been established.
Restoril™ (temazepam) Capsules USP (CIV) are indicated for the short-term treatment of insomnia (generally 7 to 10 days).
This information is intended for U.S. healthcare professionals only.
IMPORTANT RISK INFORMATION
- See more at: http://www2.mallinckrodt.com/Templates/Pages/productdetail.aspx?id=1734#sthash.2WRs0oQg.dpuf
CONTRAINDICATIONS
Restoril is contraindicated in pregnant women or women who may become pregnant due to an increased risk of congenital malformations as well as risk of neonatal CNS depression.
WARNINGS AND PRECAUTIONSRestoril is contraindicated in pregnant women or women who may become pregnant due to an increased risk of congenital malformations as well as risk of neonatal CNS depression.
- Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a decision to initiate symptomatic treatment of insomnia should only be made after the patient has been carefully evaluated. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
- Behavioral changes may occur with use including aggressiveness and extroversion, bizarre behavior, agitation, hallucinations, and depersonalization.
- 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 Restoril capsules are recommended as the initial dosage for such patients.
- Complex behaviors, such as sleep-driving, sleep-walking, etc. may occur with Restoril capsules alone at therapeutic doses, the use of alcohol and other CNS depressants with Restoril capsules appear to increase the risk of such behaviors, as does the use of Restoril capsules at doses exceeding the maximum recommended dose.
- Withdrawal symptoms have occurred after the abrupt discontinuation of benzodiazepines.
- Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Restoril capsules.
- Restoril capsules should be administered with caution in severely depressed patients or those in whom there is any evidence of latent depression.
- Additive effects can occur when Restoril is combined with other drugs having known hypnotic properties or CNS-depressant effects.
- Abnormal liver function tests as well as blood dyscrasias have been reported with benzodiazepines.
- Serious adverse reactions include complex behaviors (e.g. sleep-driving, aggressiveness) and angioedema involving the tongue, glottis or larynx, hallucinations, and agitation.
- Common adverse reactions include drowsiness and headache.
- Pregnancy category X. Contraindicated in pregnancy.
- Safety and effectiveness in pediatric patients have not been established.
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