CLONAZEPAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Clonazepam 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 may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Clonazepam 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 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Clonazepam is contraindicated in patients with the following conditions: Clonazepam is a Schedule IV controlled substance. Clonazepam 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) Physical Dependence Clonazepam 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 or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of Clonazepam and WARNINGS: Dependence and Withdrawal Reactions ). Tolerance Tolerance to clonazepam 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 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.

Ringkasan produk:

Clonazepam Tablets, USP are available as: 0.5 mg: light yellow, flat-faced beveled edge tablets, scored, debossed "2530" on one side and debossed "V" on the reverse side. NDC: 72162-1364-0: 1000 Tablets in a bottle, plastic. NDC: 72162-1364-5: 500 Tablets in a bottle, plastic. NDC: 72162-1364-1: 100 Tablets in a bottle, plastic. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

CLONAZEPAM- CLONAZEPAM TABLET
Bryant Ranch Prepack
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/clonazepam-tablets.pdf
Clonazepam Tablets
for oral use
What is the most important information I should know about clonazepam
tablets?
•Clonazepam tablets are 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:oshallow or slowed
breathingobreathing stops (which may lead to
the heart stopping)oexcessive sleepiness (sedation)Do not drive or
operate heavy machinery until you
know how taking clonazepamtablets 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.oSerious 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. oYou can
develop an addiction even if you
take clonazepam tablets as prescribed by your healthcare provider.
oTake clonazepam tablets exactly as
your healthcare provider prescribed. oDo not share your
clonazepamtablets with other people.oKeep
clonazepam tablets in a safe place and away from children.•Physical
dependence and withdrawal
reactions. Clonazepam tablets can cause physical dependence and
withdrawal reactions.oDo not suddenly
stop taking clonazepam tablets. Stopping clonazepam tablets suddenly
can cause serious and life-
threatening side effects, including,

Ciri produk

CLONAZEPAM- CLONAZEPAM TABLET
BRYANT RANCH PREPACK
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CLONAZEPAM TABLETS, USP
0.5 MG, 1 MG AND 2 MG
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,
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
and throughout treatment, assess each patient’s risk for abuse,
misuse, and
addiction (see WARNINGS). •The continued use of benzodiazepines,
including
clonazepam, 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 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 or reduce the dosage (see DOSAGE AND
ADMINISTRATION and WARNINGS).
DESCRIPTION
Clonazepam Tablets USP, a benzodiazepine, is available as scored
tablets containing 0.5
mg of clonazepam and unscored tablets containing 1 mg or 2 mg of
clonazepam. Each
tablet also contains colloidal silicon dioxide, croscarmellose sodium,
lactose
monohydrate, magnesium stearate and microcrystalline cellulose, with
the following
colorants: 0.5 mg – D&C Yellow #10 alum