CLONAZEPAM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Advanced Rx Pharmacy of Tennessee, LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

INDICATIONS AND USAGE Seizure Disorders: 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). Panic Disorder: 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 disor

Ringkasan produk:

Clonazepam tablets USP 1 mg are blue, round, flat faced, beveled edge, debossed with “C 1” on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 80425-0135-01 Bottles of 60: NDC 80425-0135-02 Bottles of 90: NDC 80425-0135-03 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 054, India. 10 0533 3 6007149 Issued February 2021

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

CLONAZEPAM- CLONAZEPAM TABLET
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
MEDICATION GUIDE
Medication Guide
Clonazepam Tablets, USP
(kloe-NA-za-pam)
CIV
What is the most important information I should know about clonazepam
tablets?
• Clonazepam tablets is a benzodiazepine medicine. Benzodiazepines
can cause severe drowsiness, breathing
problems (respiratory depression), coma, and death when taken with
opioid medicines.
•Clonazepam tablets can make you sleepy or dizzy and can slow your
thinking and motor skills. This may get
better over time.
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how clonazepam
tablets affects you.
Clonazepam tablets may cause problems with your coordination,
especially when you are walking or picking
things up.
•Do not drink alcohol or take other drugs that may make you sleepy
or dizzy while taking clonazepam tablets
until you talk to your healthcare provider. When taken with alcohol or
drugs that cause sleepiness or
dizziness, clonazepam may make your sleepiness or dizziness worse.
Like other antiepileptic drugs, clonazepam tablets may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
thoughts about suicide or dying
attempt to commit suicide
new or worse depression
new or worse anxiety
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Suicidal thoughts

Karakteristik produk

CLONAZEPAM- CLONAZEPAM TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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CLONAZEPAM 1MG TABLETS
BOXED WARNING
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 DOSAGE AND ADMINISTRATION)
DESCRIPTION
Clonazepam, a benzodiazepine, is available as scored tablets debossed
with “1” and “2”
containing 0.5 mg of clonazepam and unscored tablets debossed with
“C 1” on 1 mg
tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of
clonazepam. Each tablet
contains anhydrous lactose, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose and starch (corn), with the following col