Celontin ® (Methsuximide Capsules, USP)

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Farmea

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

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).

Volitamisolek:

New Drug Application

Infovoldik

CELONTIN- METHSUXIMIDE CAPSULE
Farmea
----------
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:
•
fever, swollen glands, or sore throat that come and go or do not go
away
•
frequent infections or an infection that does not go away
•
easy bruising
•
red or purple spots on your body
•
bleeding gums or nose bleeds
•
severe fatigue or weakness
2.
Systematic Lupus Erythematosus. Call your healthcare provider right
away if you have any of these
symptoms:
•
joint pain and swelling
•
muscle pain
•
fatigue
•
low-grade fever
•
pain in the chest that is worse with breathing
•
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:
•
thoughts about suicide or dying
•
attempts 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

Toote omadused

CELONTIN- METHSUXIMIDE CAPSULE
FARMEA
----------
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
suicidal thoughts or b