CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

Product summary:

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: NDC: 60760-273-60 BOTTLES OF 60 Clonazepam tablets USP 1 mg are blue, round, flat faced, beveled edge, debossed with “C 1” on one side and plain on the other. They are supplied as follows: NDC: 60760-300-30 bottle of 30 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No. : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 7744 1 626035 Issued October, 2010.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

St Marys Medical Park Pharmacy
----------
Medication Guide
Clonazepam Tablets, USP
CIV
Read this Medication Guide before you start taking clonazepam tablets
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
Clonazepam tablets can cause serious side effects. Because stopping
clonazepam tablets suddenly can
also cause serious problems, do not stop taking clonazepam tablets
without talking to your healthcare
provider first.
What is the most important information I should know about clonazepam
tablets?
Do not stop taking clonazepam tablets without first talking to your
healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems.
Clonazepam tablets can cause serious side effects, including:
1.
Clonazepam tablets can slow your thinking and motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know
how clonazepam tablets affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clonazepam 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.
2.
Like other antiepileptic drugs, clonazepam tablets may cause suicidal
thoughts or actions in a very
small number of people, about 1 in 500.
Call a 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
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicida

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
CLONAZEPAM TABLETS, USP
CIV
RX ONLY,
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
Clonazepam should not be used in patients with a history of
sensitivity to
benzodiazepines, nor in patients with clinical or biochemical evidence
of significant liver
disease. It may be used in patients with open angle glaucoma who are
receiving
appropriate therapy but is contraindicated in acute narrow angle
glaucoma.
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
The adverse experiences for clonazepam are provided separately for
patients with
seizure disorders and with panic disorder.
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Clonazepam is available as a tablet. The tablets should be
administered with water by
swallowing the tablet whole.
HOW SUPPLIED
Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled
edge, scored,
debossed with “1” and “2” on one side and plain on other. They
are supplied as follows:
NDC: 60760-273-60 BOTTLES OF 60
Clonazepam tablets USP 1 mg are blue, round, flat faced, beveled edge,
debossed with
“C 1” on one side and plain on the other. They are supplied as
follows:
NDC: 60760-300-30 bottle of 30
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to
86°F). [See USP
Controlled Room Temperature].
MANUFACTURED FOR:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
MANUFACTURED BY:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.
10 7744 1 626035
Issued October, 2010.
MEDICATION GUIDE
CLONAZEPAM TABLETS, USP
CIV
Read this Medication Guide before you start taking clonazepam tablets
and each time
you get a refill. There may be new information. This information does
not take the place
of talking to your healthcare provider about your medical condition or
treatment.
Clonazepam tablets can cause serious side effects. Because stopping
clonazepam
tablets sudden