CLONAZEPAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)

可用日期:

Golden State Medical Supply, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Seizure Disorders: Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder: Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Clonazepam is contraindicated in patients with the following conditions: - History of sensitivity to benzodiazepines - Clinical or biochemical evidence of significant liver disease - Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy). receiving appropriate therapy). Controlled Substance : Clonazepam contains clonazepam, a Schedule IV controlled substance . Abuse: Clonazepam tablets 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 health care 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 Clonazepam tablets 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 clonazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of clonazepam tablets and 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 associated 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 clonazepam tablets 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 clonazepam tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. Following the short-term treatment of patients with panic disorder in Studies 1 and 2 (see CLINICAL PHARMACOLOGY: Clinical Trials ), patients were gradually withdrawn during a 7- week downward-titration (discontinuance) period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.

產品總結:

Clonazepam tablets USP, 0.5 mg are available as yellow, round, flat beveled, tablets. Scored and debossed with "832" above the score on one side, debossed with "TEVA" on the other side. Packaged in bottles of 100 (NDC 51407-524-01) with a child-resistant closure, in bottles of 500 (NDC 51407-524-05) with a child-resistant closure, in bottles of 120 (NDC 51407-524-12) with a child-resistant closure, in bottles of 15 (NDC 51407-524-15) with a child-resistant closure, in bottles of 30 (NDC 51407-524-30) with a child-resistant closure, in bottles of 45 (NDC 51407-524-45) with a child-resistant closure, in bottles of 150 (NDC 51407-524-51) with a child-resistant closure, in bottles of 60 (NDC 51407-524-60) with a child-resistant closure, and in bottles of 90 (NDC 51407-524-90) with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. Y 4/2023 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

授权状态:

Abbreviated New Drug Application

资料单张

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Clonazepam (kloe naz’e pam) Tablets CIV
for oral use
What is the most important information I should know about clonazepam
tablets?
•
Clonazepam tablets 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
clonazepam tablets and opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including clonazepam
tablets, 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
clonazepam tablets. 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 clonazepam tablets as
prescribed by your healthcare provider.
•
Take clonazepam tablets exactly as your healthcare provider
prescribed.
•
Do not share your clonazepam tablets with other people.
•
Keep clonazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clonazepam tablets can
cause physical dependence and withdrawal reactions.
•
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can cause serious and life-th

产品特点

CLONAZEPAM- CLONAZEPAM TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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CLONAZEPAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND
DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE WARNINGS
AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM TABLETS, EXPOSES
USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CLONAZEPAM TABLETS
AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS) _._
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM TABLETS,
MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF CLONAZEPAM TABLETS AFTER CONTINUED USE MAY PRECIPITATE
ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE
THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
CLONAZEPAM TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND
ADMINISTRATION AND WARNINGS).
DESCRIPTION
Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg
of clonazepam USP,
a benzodiazepine. Each tablet also contains corn starch, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, and povidone.
Clonazepam tablets USP,
0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets
USP, 1 mg
contain Yellow D&C N