CLONAZEPAM tablet, orally disintegrating

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Alembic Pharmaceuticals Limited

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Seizure Disorders: Clonazepam orally disintegrating tablet 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 orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam orally disintegrating tablet 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 orally disintegrating tablets was established in two

Vörulýsing:

Clonazepam orally disintegrating tablets, USP are available as follows: 0.125 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 523’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters  of 6 tablets each             NDC 46708-364-06 0.25 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 524’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 46708-365-06 0.5 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 525’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 46708-366-06 1 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 526’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 46708-367-06 2 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 527’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 46708-368-06 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].     Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal 389350, Gujarat, India. Revised: 12/2018 

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Alembic Pharmaceuticals Limited
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MEDICATION GUIDE
Clonazepam (kloe NAZ e pam)
Orally Disintegrating Tablets, USP C-IV
What is the most important information I should know about clonazepam
orally disintegrating tablets?
· Do not stop taking clonazepam orally disintegrating tablets without
first talking to your healthcare
provider. Stopping clonazepam orally disintegrating tablets suddenly
can cause serious side effects.
· Clonazepam orally disintegrating tablet is a benzodiazepine
medicine. Benzodiazepines can cause
severe drowsiness, breathing problems (respiratory depression), coma,
and death when taken with opioid
medicines.
· Clonazepam orally disintegrating 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 orally disintegrating tablets affects you.
•
Clonazepam orally disintegrating 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
orally disintegrating tablets until you talk to your healthcare
provider. When taken with alcohol or drugs that
cause sleepiness or dizziness, clonazepam orally disintegrating
tablets may make your sleepiness or dizziness
worse.
· Like other antiepileptic drugs, clonazepam orally disintegrating
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
· attempts to commit suicide · new or worse depression
· new or worse anxiety
· feeling agitated or restless
· panic attacks
· trouble sleeping (insomnia)
· new or worse irritability
· acting aggressive, being angry,
or violent
· acting on dangerous impulses ·
an extreme increase in
activity an

Vara einkenni

CLONAZEPAM - CLONAZEPAM TABLET, ORALLY DISINTEGRATING
ALEMBIC PHARMACEUTICALS LIMITED
----------
CLONAZEPAM ORALLY DISINTEGRATING TABLETS, USP
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, USP a benzodiazepine, is available as an orally
disintegrating tablet
containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP.
Each orally
disintegrating tablet also contains sorbitol, aspartame, sodium lauryl
sulfate,
crospovidone, mannitol, colloidal silicon dioxide, talc and magnesium
stearate.
Chemically, clonazepam, USP is
5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-­
benzodiazepin-2-one. It is a light yellow 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. Convulsions produced
in rodents by
pentylenetetrazol or, to a lesser extent, electrical stimulation are
antagonized, as are
convulsions produced by photic stimulation in susceptible baboons. A
taming effect in
aggressive primates, muscle weakness and hypnosis are also produced.
In humans,
clonazepam is capable of suppressing the spike and wave discharge in
absence seizures
(petit mal) and decreasing the frequency, amplitude, duration and
spread of discharge in
minor motor seizures.
_PHARMACOKINETICS: _Clonazepam is rapidly and completely absorbed
after oral
administration.