CLONAZEPAM tablet, orally disintegrating

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Par Pharmaceutical, Inc.

INN (International Name):

CLONAZEPAM

রচনা:

CLONAZEPAM 0.125 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clonazepam orally disintegrating tablet is 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 orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Clonazepam orally disintegrating tablet is 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 orally disintegrating tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR 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 orally disintegrating 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 orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Clonazepam orally disintegrating tablets are 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). Clonazepam is a Schedule IV controlled substance. Clonazepam orally disintegrating 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 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). Physical Dependence Clonazepam orally disintegrating 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 orally disintegrating tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of Clonazepam orally disintegrating 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 orally disintegrating 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 orally disintegrating 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.

পণ্য সারাংশ:

Clonazepam Orally Disintegrating Tablets USP, 0.125 mg are white, round, flat-faced, beveled edge tablets, debossed with “K5” and is available in a blister package of 60 (6 tablets/blister card, 10 blister cards/carton), NDC 49884-306-02. Clonazepam Orally Disintegrating Tablets USP, 0.25 mg are white, round, flat-faced, beveled edge tablets, debossed with “K6” and is available in a blister package of 60 (6 tablets/blister card, 10 blister cards/carton), NDC 49884-307-02. Clonazepam Orally Disintegrating Tablets USP, 0.5 mg are white, round, flat-faced, beveled edge tablets, debossed with “K7” and is available in a blister package of 60 (6 tablets/blister card, 10 blister cards/carton), NDC 49884-308-02. Clonazepam Orally Disintegrating Tablets USP, 1 mg are white, round, flat-faced, beveled edge tablets, debossed with “K8” and is available in a blister package of 60 (6 tablets/blister card, 10 blister cards/carton), NDC 49884-309-02. Clonazepam Orally Disintegrating Tablets USP, 2 mg are white, round, flat-faced, beveled edge tablets, debossed with “K9” and is available in a blister package of 60 (6 tablets/blister card, 10 blister cards/carton), NDC 49884-310-02. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx only Dist by:  Par Pharmaceutical  Cranbury, NJ 08512 U.S.A. Revised:11/2022

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

CLONAZEPAM- CLONAZEPAM TABLET, ORALLY DISINTEGRATING
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
CLONAZEPAM (kloe NAZ e pam)
Orally Disintegrating Tablet (ODT), C-IV
What is the most important information I should know about clonazepam
orally disintegrating tablets?
•
Clonazepam orally disintegrating tablet is 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 orally disintegrating
tablets with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and
addiction with benzodiazepines, including clonazepam orally
disintegrating tablet, 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 orally disintegrating
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 orally
disintegrating tablets exactly as
prescribed by your healthcare provider.
•
Take clonazepam orally disintegrating tablets exactly as your
healthcare provider prescribed.
•
Do not share your clonazepam orally disintegrating tablets with other
people.
•
Keep clonazepam orally disintegrating tablets in a safe place and away
from children.
•
Physical dependence and withdrawal reactions. Clonazepam orally
d

পণ্য বৈশিষ্ট্য

CLONAZEPAM- CLONAZEPAM TABLET, ORALLY DISINTEGRATING
PAR PHARMACEUTICAL, INC.
----------
CLONAZEPAM ORALLY DISINTEGRATING TABLETS, USP
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 IN 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 ORALLY DISINTEGRATING
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 ORALLY DISINTEGRATING TABLETS AND THROUGHOUT
TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND
ADDICTION (SEE WARNINGS)_._
_ _THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM ORALLY
DISINTEGRATING 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 ORALLY
DISINTEGRATING 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 ORALLY DISINTEGRATING TABLETS OR REDUCE THE DOSAGE (SEE
DOSAGE AND ADMINISTRATION AND WARNINGS)_._
DESCRIPTION
Clonazepam Orally Disintegrating Tablets, USP, a benzodiazepine, is
available as an orally
disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2
mg clonazepam.
Each orally disintegrating tablet co