CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: Clinical Trials ). Panic disorder

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLONAZEPAM- clonazepam tablet
Sandoz 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. Taking
benzodiazepines with opioid medicines,
alcohol, or other central nervous system (CNS) depressants (including
street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma, and
death. Get emergency help right
away if any of the following happens:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clonazepam tablets and opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clonazepam tablets, which can lead to
overdose and serious side effects
including coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including clonazepam tablets. These serious
side effects may also
include delirium, paranoia, suicidal thoughts or actions, seizures,
and difficulty breathing. Call
your healthcare provider or go to the nearest hospital emergency room
right away if you get any
of these serious side effects.
o
You can develop an addiction even if you take clonazepam tablets as
prescribed by your
healthcare provider.
o
Take clonazepam tablets exactly as your healthcare provider
prescribed.
o
Do not share your clonazepam tablets with other people.
o
Keep clonazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clonazepam tablets can
cause physical dependence and
withdrawal reactions.
o
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can cause
serious and life-threatening side effects, including, unusual
movements, responses, or
expressions, seizures, sudden and severe

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
SANDOZ INC
----------
CLONAZEPAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
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:
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM, EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CLONAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM, MAY
LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF CLONAZEPAM AFTER CONTINUED USE MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THRE