CELONTIN- methsuximide capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

METHSUXIMIDE (UNII: 0G76K8X6C0) (METHSUXIMIDE - UNII:0G76K8X6C0)

Հասանելի է:

Parke-Davis Div of Pfizer Inc

INN (Միջազգային անվանումը):

METHSUXIMIDE

Կազմը:

METHSUXIMIDE 300 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs. Methsuximide should not be used in patients with a history of hypersensitivity to succinimides.

Ապրանքի ամփոփագիր:

N 0071-0525-24 (P-D 525)–Celontin Capsules, #1 capsule each containing 300 mg methsuximide; bottles of 100. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Protect from excessive heat 40°C (104°F).

Լիազորման կարգավիճակը:

New Drug Application

Տեղեկատվական թերթիկ

CELONTIN- METHSUXIMIDE CAPSULE
Parke-Davis Div of Pfizer Inc
----------
MEDICATION GUIDE
CELONTIN (Suh lŏn' tĭn)
(methsuximide)
Capsules
Read this Medication Guide before you start taking CELONTIN 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. If you have any questions about
CELONTIN, ask your healthcare provider or
pharmacist.
What is the most important information I should know about CELONTIN?
Do not stop taking CELONTIN without first talking to your healthcare
provider. Stopping CELONTIN
suddenly can cause serious problems.
CELONTIN can cause serious side effects, including:
1.
Rare but serious blood problems that may be life-threatening. Call
your healthcare provider right away
if you have:
o
fever, swollen glands, or sore throat that come and go or do not go
away
o
frequent infections or an infection that does not go away
o
easy bruising
o
red or purple spots on your body
o
bleeding gums or nose bleeds
o
severe fatigue or weakness
2.
Systematic Lupus Erythematosus. Call your healthcare provider right
away if you have any of these
symptoms:
o
joint pain and swelling
o
muscle pain
o
fatigue
o
low-grade fever
o
pain in the chest that is worse with breathing
o
unexplained skin rash
3.
Like other antiepileptic drugs, CELONTIN 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:
o
thoughts about suicide or dying
o
attempts to commit suicide
o
new or worse depression
o
new or worse anxiety
o
feeling agitated or restless
o
panic attacks
o
trouble sleeping (insomnia)
o
new or worse irritability
o
acting aggressive, being angry, or violent
o
acting on dangerous impulses
o
an extreme increase in activity and talking (mania)
o
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and

Ապրանքի հատկությունները

CELONTIN- METHSUXIMIDE CAPSULE
PARKE-DAVIS DIV OF PFIZER INC
----------
CELONTIN
(METHSUXIMIDE CAPSULES, USP)
DESCRIPTION
Celontin (methsuximide) is an anticonvulsant succinimide, chemically
designated as N,2-
Dimethyl-2-phenylsuccinimide, with the following structural formula:
Each Celontin capsule contains 300 mg methsuximide, USP. Also contains
starch, NF.
The capsule contains colloidal silicon dioxide, NF; D&C yellow No. 10;
FD&C yellow No. 6;
gelatin, NF; and sodium lauryl sulfate, NF.
CLINICAL PHARMACOLOGY
Methsuximide suppresses the paroxysmal three cycle per second spike
and wave
activity associated with lapses of consciousness which is common in
absence (petit mal)
seizures. The frequency of epileptiform attacks is reduced, apparently
by depression of
the motor cortex and elevation of the threshold of the central nervous
system to
convulsive stimuli.
INDICATIONS AND USAGE
Celontin is indicated for the control of absence (petit mal) seizures
that are refractory to
other drugs.
CONTRAINDICATIONS
Methsuximide should not be used in patients with a history of
hypersensitivity to
succinimides.
WARNINGS
BLOOD DYSCRASIAS
®
Blood dyscrasias, including some with fatal outcome, have been
reported to be
associated with the use of succinimides; therefore, periodic blood
counts should be
performed. Should signs and/or symptoms of infection (eg, sore throat,
fever) develop,
blood counts should be considered at that point.
EFFECTS ON LIVER
It has been reported that succinimides have produced morphological and
functional
changes in animal liver. For this reason, methsuximide should be
administered with
extreme caution to patients with known liver or renal disease.
Periodic urinalysis and liver
function studies are advised for all patients receiving the drug.
SYSTEMIC LUPUS ERYTHEMATOSUS
Cases of systemic lupus erythematosus have been reported with the use
of
succinimides. The physician should be alert to this possibility.
SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including Celontin, increase the risk of