CLONAZEPAM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Major Pharmaceuticals

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 disorder (DSM-V) is characterized by recurrent unexpected pan

Resumo do produto:

Clonazepam Tablets, USP are available as: 0.5 mg: light yellow, flat-faced beveled edge tablets, scored, debossed "2530" on one side and debossed "V" on the reverse side, available as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7227-61 1 mg: light blue, flat-faced beveled edge tablets, unscored, debossed "2531" on one side and debossed "V" on the reverse side, available as follows: Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7728-61

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

CLONAZEPAM- CLONAZEPAM TABLET
Major Pharmaceuticals
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/clonazepam-tablets.pdf
Clonazepam Tablets
for oral use
What is the most important information I should know about clonazepam
tablets?
•
Clonazepam tablets are 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:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clonazepamtablets 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.
•
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.
•
You can develop an addiction even if you take clonazepam tablets as
prescribed by your healthcare
provider.
•
Take clonazepam tablets exactly as your healthcare provider
prescribed.
•
Do not share your clonazepamtablets with other people.
•
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.
•
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can cause
serious and lif

Características técnicas

CLONAZEPAM- CLONAZEPAM TABLET
MAJOR PHARMACEUTICALS
----------
CLONAZEPAM TABLETS, USP
0.5 MG, 1 MG AND 2 MG
CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Clonazepam Tablets USP, a benzodiazepine, is available as scored
tablets containing 0.5
mg of clonazepam and unscored tablets containing 1 mg or 2 mg of
clonazepam. Each
tablet also contains colloidal silicon dioxide, croscarmellose sodium,
lactose
monohydrate, magnesium stearate and microcrystalline cellulose, with
the following
colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue
#1 aluminum
lake.
Chemically, clonazepam is
5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-benzodiazepin-
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-THREATENING. TO REDUCE THE
RIS