CLONAZEPAM tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Preferred Pharmaceuticals Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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-lIlR category of panic disorder (see Error! Hyperlink reference not valid. Error! Hyperlink reference not valid. ). 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 tablets are contraindicated in patients with the following conditions: Controlled Substance Class: Clonazepam tablets contain clonazepam, a Schedule IV controlled substance. Abuse: Clonazepam tablet 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) . 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 Error! Hyperlink reference not valid. Error! Hyperlink reference not valid. ) , 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. What is the most important information I should know about clonazepam tablets? Do not drive or operate heavy machinery until you know how taking clonazepam tablets with opioids affects you. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: How can I watch for early symptoms of suicidal thoughts and actions? Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Do not stop clonazepam tablets without first talking to a healthcare provider. What are clonazepam tablets? Clonazepam tablet is a federally controlled substance (C-IV) because it  contains clonazepam that can be  abused or lead to  dependence. Keep clonazepam tablets in a safe place to prevent misuse and  abuse. Selling  or giving  away clonazepam tablets 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 clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old. Who should not take clonazepam tablets? Do not take clonazepam tablets if you: Ask your healthcare provider if you are not sure if you have any of the problems listed above. Before you take clonazepam tablets, tell your healthcare provider if you: Tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. You and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. How should I take clonazepam tablets? What should I avoid while taking clonazepam tablets? What are the possible side effects of clonazepam tablets? See “What is the most important information I should know about clonazepam tablets?” Clonazepam tablets can also make your seizures happen more often or make them worse. Call your healthcare provider right away if your seizures get worse while taking clonazepam tablets. The most common side effects of clonazepam tablets include: These are not all the possible  side  effects of  clonazepam tablets.  Call  your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or contact Advagen Pharma Ltd, at 866-488-0312. How should I store clonazepam tablets? General Information about the safe and effective use of clonazepam tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam tablets for a condition for which it was not prescribed. Do not give clonazepam tablets to other people, even if they have the same  symptoms  that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals. For more information, contact Advagen Pharma Ltd, at 866-488-0312. What are the ingredients in clonazepam tablets? Active ingredient: clonazepam Inactive ingredients: This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Distributed by: Advagen Pharma Ltd 666 Plainsboro Road Suite 605 Plainsboro, NJ  08536, US Revision: 04/22 Repackaged By: Preferred Pharmaceuticals Inc.

Ürün özeti:

NDC 72888-152-00, bottles of 1000. Clonazepam Tablets USP, 1 mg are mottled blue, round, flat-faced, beveled edge tablet, debossed with Λ on one side and plain on the other side. They are supplied as follows:                                                                                                                                                                      67 NDC 68788-8473-2, bottles of 20. NDC 68788-8473-8, bottles of 28. NDC 68788-8473-3, bottles of 30. NDC 68788-8473-6, bottles of 60. NDC 68788-8473-9, bottles of 90. Store at 20°C to 25°C (68°F -77°F) [See USP Controlled Room Temperature]. All trademarks are the property of their respective owners. Dispense with Medication Guide available at: www.advagenpharma.com/medguide/clonazepamtablets Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India Distributed by: Advagen Pharma Ltd 666 Plainsboro Road Suite 605 Plainsboro, NJ  08536, US Revision: 09/22 Repackaged By: Preferred Pharmaceuticals Inc.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

CLONAZEPAM- CLONAZEPAM TABLET
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDECLONAZEPAM (KLOE
NAZ E PAM)
TABLET, FOR ORAL USE, C-IV
What is the most important information I should know about clonazepam
tablets?
•
Clonazepam 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 tablets with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clonazepam 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 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.
o
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can cause
serious and life-threatening side effects, including, unusual
movements, responses, or

Ürün özellikleri

CLONAZEPAM- CLONAZEPAM TABLET
PREFERRED PHARMACEUTICALS INC.
----------
CLONAZEPAM TABLETS, USP
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION, AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Clonazepam Tablets, USP, a benzodiazepine, is available as scored
tablet with debossing
Λ containing 0.5 mg of clonazepam and unscored tablets with debossing
Λ and Λ
containing 1 mg or 2 mg of clonazepam respectively. Each tablet also
contains lactose
monohydrate, polyethylene
66 67 69
glycol, microcrystalline cellulose, croscarmellose sodium and
magnesium stearate, with
the following colourants: 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow
10 Al Lake; 1 mg-
FD & C Blue 1 Al lake and FD & C Blue 2 Al lake
Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-
_2H_-1,4-benzodiazepin-
2-one. It is a light yellow crystalline powder. It has a molecular
weight of 315.72 and the
following structural formula:
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS:_
The precise mechanism by which clonazepam exerts its anti-seizure and
anti-panic
effects is unknown, although it is believed to be related to its
ability to enhance the
activity of gamma aminobutyric acid (GABA), the major inhibitory
neurotransmitter in the
central nervous system.
_PHARMACOKINETICS:_
Clonazepam is rapidly and completely absorbed after oral
administration. The absolute
bioavailability of clonazepam is about 90%. Maximum plasma
concentrations of
clonazepam are reached within 1 to 4 hours after oral administration.
Clonazepam is
approximately 85% bound to plasma proteins. Clonazepam is highly
metabolized, with
less than 2% unchanged clonazepam being excreted in the urine.
Biotransformation
occurs mainly by reduction of the 7-nitro group to the 4-amino
derivative. This derivative
can be acetylated, hydroxylated and glucuronidated. Cytochrome P-450
including
CYP3A, may play an important role in clonazepam reduction and
oxidation. The
elimination half-life of clonazepam is typically 30 to 40 hours.
Clonaze