CLONAZEPAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

ATLANTIC BIOLOGICALS CORP.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 d

Resumen del producto:

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: NDC 17856-0834-01 (100 TABLETS) Clonazepam tablets USP 2 mg are white to off white, round, flat faced, beveled edge tablets debossed with “C 2” on one side and plain on the other. They are supplied as follows: NDC 17856-0835-01 (100 TABLETS) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP.  20101 N.E 16TH PLACE  MIAMI, FL 33179   

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ATLANTIC BIOLOGICALS CORP.
----------
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 or acti

Ficha técnica

CLONAZEPAM- CLONAZEPAM TABLET
ATLANTIC BIOLOGICALS CORP.
----------
CLONAZEPAM TABLETS, USP
CIV
RX ONLY
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).
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.
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 colorants: 0.5 mg-
FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 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
and the following structural
formula:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS :
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.
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-nit