TEMAZEPAM (Page 4 of 5)

OVERDOSAGE

Manifestations of acute overdosage of temazepam capsules can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD 50 of temazepam capsules were 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits.

Treatment

If the patient is conscious, vomiting should be induced mechanically or with emetics. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension. Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicon ®) * , a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference ®**.

DOSAGE AND ADMINISTRATION

While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined.

HOW SUPPLIED

Temazepam Capsules USP

7.5 mg

Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and Mallinckrodt on the other side in red, and a blue cap imprinted “7.5 mg” twice in red.
Unit dose packages of 30 (3 x 10) NDC 68084-549-21

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

*Romazicon is the trademark of Hoffman-LaRoche Inc.
**Trademark of Medical Economics Company, Inc.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, Mallinckrodt and other brands are trademarks of a Mallinckrodt company.

© 2018 Mallinckrodt.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from SpecGx LLC. as follows:
(7.5 mg / 30 UD) NDC 68084-549-21 packaged from NDC 0406-9960

Distributed by:
American Health Packaging Columbus, OH 43217

8254921/0819A

MEDICATION GUIDE

8254921/0819A Temazepam (te-maz’ĕ-pam) Capsules, C-IV

What is the most important information I should know about temazepam capsules?

  • Temazepam capsules are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.
  • After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules. Reported activities include:
  • driving a car (“sleep-driving”)
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules.

  • Do not take temazepam capsules unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
  • Do not take more temazepam capsules than prescribed.

What are temazepam capsules?

  • Temazepam capsules are a prescription sleep medicine. Temazepam capsules are used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night.
  • Temazepam capsules are a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep temazepam capsules in a safe place to prevent misuse and abuse. Selling or giving away temazepam capsules may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • It is not known if temazepam capsules are safe and effective in children.
  • It is not known if temazepam capsules are safe and effective for use longer than 2 weeks.

Do not take temazepam capsules if you:

  • are allergic to temazepam or any of the ingredients in temazepam capsules. See the end of this Medication Guide for a complete list of ingredients in temazepam capsules.

Before you take temazepam capsules, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness or, suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have lung disease or breathing problems
  • are pregnant or plan to become pregnant. Temazepam capsules may cause birth defects or harm your unborn baby.
  • are breastfeeding, or plan to breastfeed. Temazepam capsules may pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take temazepam capsules.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking temazepam capsules with certain other medicines can cause side effects or affect how well temazepam capsules or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Do not take temazepam capsules with other medicines that can make you sleepy unless your healthcare provider tells you to.

How should I take temazepam capsules?

  • See “What is the most important information I should know about temazepam capsules?”
  • Take temazepam capsules exactly as your healthcare providers tell you to take it. Take temazepam capsules right before you get into bed.
  • Do not take temazepam capsules unless you are able to get a full night’s sleep before you must be active again.
  • If you take too much temazepam capsules or overdose, get emergency treatment right away.

What should I avoid while taking temazepam capsules?

  • Do not drive, operate machinery, do other dangerous activities or do anything that needs you to be alert until you know how temazepam capsules affects you.
  • You should not drink alcohol while you are taking temazepam capsules.

What are the possible side effects of temazepam capsules?

Temazepam capsules may cause serious side effects, including:

  • See “What is the most important information I should know about temazepam capsules?”
  • Withdrawal symptoms. You may have withdrawal symptoms if you stop taking temazepam capsules suddenly. Withdrawal symptoms can be serious and include seizures shakiness, stomach and muscle cramps, vomiting and sweating. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your healthcare provider about slowly stopping temazepam capsules to avoid withdrawal symptoms.
  • Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.
  • Abuse and dependence. Taking temazepam capsules can cause physical and psychological dependence. Physical and psychological dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • Severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help right away if you have these symptoms after taking temazepam capsules.

The most common side effects of temazepam capsules include:

  • drowsiness
  • headache
  • tiredness
  • nervousness
  • dizziness
  • nausea

You may still feel drowsy the next day after taking temazepam capsules. Do not drive or do other dangerous activities after taking temazepam capsules until you feel fully awake. These are not all the possible side effects of temazepam capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store temazepam capsules?

  • Store temazepam capsules between 68°F to 77°F (20°C to 25°C).
  • Keep temazepam capsules and all medicines out of the reach of children.

General information about the safe and effective use of temazepam capsules. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use temazepam capsules for a condition for which it was not prescribed. Do not give temazepam capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about temazepam capsules that is written for healthcare professionals.

What are the ingredients in temazepam capsules? Active Ingredient: temazepam Inactive Ingredients: gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide If you would like more information, call Mallinckrodt Inc. at 1-800-778-7898 or visit www.mallinckrodt.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Distributed by:
American Health Packaging Columbus, OH 43217

8254921/0819A

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