Temazepam (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Temazepam capsules contain temazepam, a Schedule IV controlled substance.

Abuse

Temazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders ( see WARNINGS, Abuse, Misuse, and Addiction).

The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

Dependence

Physical Dependence

Temazepam may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use ( see WARNINGS, Dependence and Withdrawal Reactions).

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage ( see DOSAGE and ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepamand WARNINGS, Dependence and Withdrawal Reactions).

Acute Withdrawal Signs and Symptoms

Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.

Protracted Withdrawal Syndrome

Protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.

Tolerance

Tolerance to temazepam may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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 LD 50 of temazepam was 1,963 mg/kg in mice, 1,833 mg/kg in rats, and greater than 2,400 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, 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 be obtained from a certified Regional Poison Control Center.

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.

Discontinuation or Dosage Reduction of Temazepam

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly ( see WARNINGS, Dependence and Withdrawal Reactionsand DRUG ABUSE AND DEPENDENCE: Dependence).

Temazepam capsules, USP are available as follows:

15 mg — Each #3 capsule with green opaque cap and white opaque body, imprinted with 1 076 in black ink on both cap and body contains 15 mg of temazepam, USP. Capsules are supplied in

NDC: 70518-2487-00

NDC: 70518-2487-01

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

MEDICATION GUIDE

Temazepam (tem az’ e pam) Capsules CIV

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 (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens:
    • shallow or slowed breathing
    • breathing stops (which may lead to the heart stopping)
    • excessive sleepiness (sedation)

    Do not drive or operate heavy machinery until you know how taking temazepam capsules and opioids affect you.

    • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including temazepam capsules which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including temazepam capsules. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • You can develop an addiction even if you take temazepam capsules as prescribed by your healthcare provider
    • Take temazepam capsules exactly as your healthcare provider prescribed.
    • Do not share your temazepam capsules with other people.
    • Keep temazepam capsules in a safe place and away from children.
  • Physical dependence and withdrawal reactions. Temazepam capsules can cause physical dependence and withdrawal reactions.
    • Do not suddenly stop taking temazepam capsules. Stopping temazepam capsules suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
    • Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
    • Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
    • Do not take more temazepam capsules than prescribed or take temazepam capsules for longer than prescribed.
  • 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.

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 (CIV) because they contain temazepam that 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 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 many temazepam capsules or overdose, get emergency treatment right away.

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?”
  • Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.
  • 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.
  • Temazepam capsules can make you sleepy or dizzy and can slow your thinking and motor skills.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how temazepam capsules affect you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking temazepam capsules talking to your healthcare provider. When taken with alcohol or other drugs that cause sleepiness or dizziness, temazepam capsules may make your sleepiness or dizziness much worse.

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 at room temperature 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. For more information, call Teva at 1-888-838-2872.

What are the ingredients in temazepam capsules?

Active Ingredient: temazepam

Inactive Ingredients: corn starch, colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. In addition, the 15 mg capsule also contains: D&C yellow #10, FD&C green #3, FD&C yellow #6 (Sunset Yellow). The imprinting ink, common for both strengths, contains: black iron oxide, D&C yellow #10 aluminum lake, FD&C blue#1 brilliant blue FCF aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, shellac and may contain propylene glycol.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. B 10/2021

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Temazepam

GENERIC: Temazepam

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-2487-0

NDC: 70518-2487-1

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 16 mm

IMPRINT: R;076

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

  • TEMAZEPAM 15mg in 1

INACTIVE INGREDIENT(S):

  • STARCH, CORN
  • FD&C RED NO. 40
  • INDIGOTINDISULFONATE SODIUM
  • FD&C BLUE NO. 2–ALUMINUM LAKE
  • FD&C BLUE NO. 1 ALUMINUM LAKE
  • D&C YELLOW NO. 10 ALUMINUM LAKE
  • FERROSOFERRIC OXIDE
  • FD&C YELLOW NO. 6
  • PROPYLENE GLYCOL
  • D&C YELLOW NO. 10
  • TITANIUM DIOXIDE
  • SODIUM LAURYL SULFATE
  • MICROCRYSTALLINE CELLULOSE 102
  • MAGNESIUM STEARATE
  • GELATIN, UNSPECIFIED
  • SILICON DIOXIDE
  • SHELLAC
  • FD&C GREEN NO. 3
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
TEMAZEPAM
temazepam capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2487(NDC:0228-2076)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TEMAZEPAM (TEMAZEPAM) TEMAZEPAM 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
SHELLAC
PROPYLENE GLYCOL
Product Characteristics
Color white (opaque) , green (opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code R;076
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2487-0 100 POUCH in 1 BOX contains a POUCH (70518-2487-1)
1 NDC:70518-2487-1 1 CAPSULE in 1 POUCH This package is contained within the BOX (70518-2487-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071620 12/16/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 04/2022 REMEDYREPACK INC.

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