CLONAZEPAM- clonazepam tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Mylan Pharmaceuticals Inc.

INN (International Name):

CLONAZEPAM

구성:

CLONAZEPAM 0.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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). 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 character

제품 요약:

Clonazepam Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, round, scored tablets debossed with M on one side of the tablet and C above the score and 13 below the score on the other side. They are available as follows: NDC 0378-1910-77 bottles of 90 tablets NDC 0378-1910-01 bottles of 100 tablets NDC 0378-1910-10 bottles of 1000 tablets The 1 mg tablets are light green, round, scored tablets debossed with M on one side of the tablet and C above the score and 14 below the score on the other side. They are available as follows: NDC 0378-1912-77 bottles of 90 tablets NDC 0378-1912-01 bottles of 100 tablets NDC 0378-1912-10 bottles of 1000 tablets The 2 mg tablets are white, round, scored tablets debossed with M on one side of the tablet and C above the score and 15 below the score on the other side. They are available as follows: NDC 0378-1914-01 bottles of 100 tablets NDC 0378-1914-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Mylan Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Clonazepam Tablets, USP CIV
for oral use
(kloe naz' e pam)
What is the most important information I should know about clonazepam
tablets?
•
Clonazepam tablets are 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.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you
know how clonazepam tablets affect you.
o
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 tablets 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:
o
thoughts about suicide
or dying
o
new or worse anxiety
o
trouble sleeping
(insomnia)
o
acting on dangerous
impulses
o
attempts to commit
suicide
o
feeling agitated or
restless
o
new or worse
irritability
o
an extreme increase in
activity and talking
(mania)
o
new or worse depression
o
panic attacks
o
acting aggressive, being
angry, or violent
o
other unusual changes in
behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
o
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
o
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

제품 특성 요약

CLONAZEPAM- CLONAZEPAM TABLET
MYLAN PHARMACEUTICALS INC.
----------
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH (SEE WARNINGS AND
PRECAUTIONS).
•
•
•
DESCRIPTION
Clonazepam tablets, USP, a benzodiazepine, are available containing
0.5 mg, 1 mg or 2 mg clonazepam,
USP. The 0.5 mg tablets are yellow, round, scored tablets debossed
with M on one side of the tablet
and C above the score and 13 below the score on the other side. The 1
mg tablets are light green,
round, scored tablets debossed with M on one side of the tablet and C
above the score and 14 below the
score on the other side. The 2 mg tablets are white, round, scored
tablets debossed with M on one side
of the tablet and C above the score and 15 below the score on the
other side. Each tablet contains
anhydrous lactose, colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch (corn) and sodium lauryl sulfate. The 0.5 mg
tablets also contain D&C Yellow No.
10 Aluminum Lake and the 1 mg tablets also contain D&C Yellow No. 10
Aluminum Lake and FD&C
Blue No. 1 Aluminum Lake.
Chemically, clonazepam is
5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-benzodiazepin-2-one.
It is a
light yellow crystalline powder. It has a molecular weight of 315.72,
molecular formula of
C
H ClN 0 and the following structural formula:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE 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.
15
10
3
3
The precise mechanism by which clonazepam exerts its antiseizure and
antipanic 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.
PHARMACOKIN