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.
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 ®**.
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.
Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and
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, and other brands are trademarks of a Mallinckrodt company.
© 2018 Mallinckrodt.
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
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8254921/0819A Temazepam (te-maz’ĕ-pam) Capsules, C-IV
What is the most important information I should know about temazepam capsules?
Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules.
What are temazepam capsules?
Do not take temazepam capsules if you:
Before you take temazepam capsules, tell your healthcare provider about all of your medical conditions, including if you:
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?
What should I avoid while taking temazepam capsules?
What are the possible side effects of temazepam capsules?
Temazepam capsules may cause serious side effects, including:
The most common side effects of temazepam capsules include:
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?
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
American Health Packaging Columbus, OH 43217
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