Temazepam (Page 3 of 4)

DRUG ABUSE AND DEPENDENCE

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Temazepam is a controlled substance in Schedule IV.

Abuse and Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. As with any hypnotic, caution must be exercised in administering temazepam to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeated prescriptions without adequate medical supervision.

OVERDOSAGE

Manifestations of acute overdosage of temazepam 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 LD50 of temazepam was 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 References®**.

DOSAGE & 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

15 mg

Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink.

Bottle of 100 NDC 17856-0148-1

Dispense in a well-closed, light-resistant container with a child-resistant closure.

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

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

Distributed by:

Atlantic Biologicals Corp.

20101 N.E 16th place

Miami, FL 33179

MEDICATION GUIDE

TEMAZEPAM Capsules, USP CIV (temazepam)

Read the Medication Guide that comes with TEMAZEPAM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about TEMAZEPAM?

After taking TEMAZEPAM, 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. Reported activities include:

· driving a car (“sleep-driving”)

· making and eating food

· talking on the phone

· having sex

· sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking TEMAZEPAM.

Important:

1. Take TEMAZEPAM exactly as prescribed

· Do not take more TEMAZEPAM than prescribed.

· Take TEMAZEPAM right before you get in bed, not sooner.

2. Do not take TEMAZEPAM if you:

· drink alcohol

· take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take TEMAZEPAM with your other medicines

· cannot get a full night’s sleep

What is TEMAZEPAM?

TEMAZEPAM is a sedative-hypnotic (sleep) medicine.

TEMAZEPAM is 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

· waking up often during the night

TEMAZEPAM is not for children.

TEMAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away TEMAZEPAM may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.


Who should not take TEMAZEPAM?

Do not take TEMAZEPAM if you are pregnant or planning to become pregnant. TEMAZEPAM may cause birth defects or harm a fetus (unborn baby).

TEMAZEPAM may not be right for you. Before starting TEMAZEPAM, tell your doctor about all of your health 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 kidney or liver disease

· have a lung disease or breathing problems

· are breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take TEMAZEPAM with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take TEMAZEPAM?

· Take TEMAZEPAM exactly as prescribed. Do not take more TEMAZEPAM than prescribed for you.

· Take TEMAZEPAM right before you get into bed.

· Do not take TEMAZEPAM unless you are able to get a full night’s sleep before you must be active again.

· Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.

· If you take too much TEMAZEPAM or overdose, call your doctor or poison control center right away, or get emergency treatment.


What are the possible side effects of TEMAZEPAM?

Possible serious side effects of TEMAZEPAM include:

· getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about TEMAZEPAM?”)

· abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.

· memory loss

· anxiety

· severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking TEMAZEPAM.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using TEMAZEPAM.

The most common side effects of TEMAZEPAM are:

· drowsiness

· headache

· tiredness

· nervousness

· dizziness

· nausea

· “hangover” feeling the day after taking TEMAZEPAM

· You may still feel drowsy the next day after taking TEMAZEPAM. Do not drive or do other dangerous activities after taking TEMAZEPAM until you feel fully awake.

· You may have withdrawal symptoms if you stop taking TEMAZEPAM suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your doctor to check if you need to stop TEMAZEPAM slowly.

These are not all the side effects of TEMAZEPAM. Ask your doctor or pharmacist for more information.

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?

· Store TEMAZEPAM at room temperature, 68° to 77°F (20° to 25°C).

· Keep TEMAZEPAM and all medicines out of reach of children.

General Information about TEMAZEPAM

· Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

· Do not use TEMAZEPAM for a condition for which it was not prescribed.

· Do not share TEMAZEPAM with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about TEMAZEPAM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about TEMAZEPAM that is written for healthcare professionals.

What are the ingredients in TEMAZEPAM?

7.5mg, 15mg, 22.5mg and 30mg Capsules

Active Ingredient: temazepam USP

7.5 mg Capsules

Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide.

May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.

15 mg Capsules

Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide.

May also include: sodium lauryl sulfate. Imprinting ink may

contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.

22.5 mg Capsules

Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.

May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.

30 mg Capsules

Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide.

May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.

Distributed by:

Atlantic Biologicals Corp.

Miami, FL 33179

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