CLONAZEPAM tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Direct_Rx

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Seizure Disorders: 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). Panic Disorder: 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 characte

Podsumowanie produktu:

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: • Bottles of 100: NDC 43547-406-10 • Bottles of 500: NDC 43547-406-50 • Bottles of 1000: NDC 43547-406-11 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: • Bottles of 30: NDC 72189-475-30 • Bottles of 60: NDC 72189-475-60 2 mg: white, flat-faced beveled edge tablets, unscored, debossed "2532" on one side and debossed "V" on the reverse side, available as follows: • Bottles of 100: NDC 43547-408-10 • Bottles of 500: NDC 43547-408-50

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

CLONAZEPAM- CLONAZEPAM TABLET
Direct_Rx
----------
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:
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
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.
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 clonazepamtablets 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

Charakterystyka produktu

CLONAZEPAM- CLONAZEPAM TABLET
DIRECT_RX
----------
CLONAZEPAM
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
•
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
risk of
withdrawal reactions, use a gradual taper to discontinue clonazepam or
reduce the
dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).
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, clonazep