CLONAZEPAM tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

REMEDYREPACK INC.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Clonazepam tablets, USP 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, USP may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect). Clonazepam tablets, USP 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, USP 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: Clin

Prehľad produktov:

Clonazepam Tablets, USP, for oral administration, are available as: 0.5 mg : Round, light yellow, bi-convex tablet, debossed “ E ” over “63” on one side and bisected on the other side and supplied as: NDC 0185-0063-01 bottles of 100 NDC 0185-0063-05 bottles of 500 NDC 0185-0063-10 bottles of 1000 0.5 mg : Round, light yellow, flat-faced beveled edge, debossed “ E ” over “63” on one side and bisected on the reverse side and supplied as: NDC 0781-8018-01 bottles of 100 NDC 0781-8018-05 bottles of 500 NDC 0781-8018-10 bottles of 1000 1 mg : Round, light blue, bi-convex tablet, debossed “ E ” over “64” on one side and bisected on the other side and supplied as: NDC 0185-0064-01 bottles of 100 NDC 0185-0064-05 bottles of 500 NDC 0185-0064-10 bottles of 1000 1 mg : Round, light blue, bi-convex tablet, debossed “ E ” over “64” on one side and plain on the reverse side and supplied as: NDC 0781-5567-01 bottles of 100 NDC 0781-5567-05 bottles of 500 NDC 0781-5567-10 bottles of 1000 2 mg : Round, white, bi-convex tablet, debossed “ E ” over “65” on one side and bisected on the other side and supplied as: NDC 0185-0065-01 bottles of 100 NDC 0185-0065-05 bottles of 500 NDC 0185-0065-10 bottles of 1000 2 mg : Round, white, bi-convex tablet, debossed “ E ” over “65” on one side and plain on the reverse side and supplied as: NDC 0781-5569-01 bottles of 100 NDC 0781-5569-05 bottles of 500 NDC 0781-5569-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

CLONAZEPAM- CLONAZEPAM TABLET
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Clonazepam Tablets, USP CIV
(kloe-NAZ-eh-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.
•
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 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:
•
thoughts about suicide or
dying
•
new or worse anxiety
•
trouble sleeping (insomnia)
•
acting on dangerous
impulses
•
attempts to commit
suicide
•
feeling agitated or restless
•
new or worse irritability
•
an extreme increase in
activity and talking
(mania)
•
new or worse depression
•
panic attacks
•
acting aggressive, being
angry, or violent
•
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, esp

Súhrn charakteristických

CLONAZEPAM- CLONAZEPAM TABLET
REMEDYREPACK INC.
----------
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 tablets, USP, for oral administration, contain 0.5 mg, 1 mg
or 2 mg clonazepam. In addition,
each tablet also contains the following inactive ingredients: corn
starch, lactose anhydrous, magnesium
stearate and microcrystalline cellulose with the following colorants:
0.5 mg - D&C yellow No. 10
aluminum lake; 1 mg - FD&C blue No. 1 aluminum lake.
Chemically, clonazepam is 5-(2-chlorophenyl)-1,
3-dihydro-7-nitro-2H-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-nitro group to
the 4-amino derivative. This
derivative can be acetylated, hydroxylated and glucuronidated.
Cytochrome P-450, including