CLONAZEPAM- clonazepam tablet
Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Gebrauchsinformation
(PIL)
06-05-2019
Fachinformation
(SPC)
06-05-2019
Wirkstoff:
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
Verfügbar ab:
REMEDYREPACK INC.
Verabreichungsweg:
ORAL
Verschreibungstyp:
PRESCRIPTION DRUG
Anwendungsgebiete:
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
Produktbesonderheiten:
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.
Berechtigungsstatus:
Abbreviated New Drug Application
Gebrauchsinformation
CLONAZEPAM-
clonazepam tablet
REMEDYREPACK
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 s
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Fachinformation
CLONAZEPAM- CLONAZEPAM TABLET
REMEDYREPACK 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).
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, 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
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
15
10
3
3
(GABA), the major inhibitory neurotransmitter in the central nervous
system.
PHARMACOKINETICS
Clonazepam is
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