ZARONTIN- ethosuximide solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ETHOSUXIMIDE (UNII: 5SEH9X1D1D) (ETHOSUXIMIDE - UNII:5SEH9X1D1D)

Dostopno od:

Parke-Davis Div of Pfizer Inc

INN (mednarodno ime):

ETHOSUXIMIDE

Sestava:

ETHOSUXIMIDE 250 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Zarontin is indicated for the control of absence (petit mal) epilepsy. Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

Povzetek izdelek:

Zarontin is supplied as: NDC 0071-2418-19: 1 pint amber polyethylene terephthalate (PET) bottles (polyethylene cap liner). Each 5 mL of oral solution contains 250 mg ethosuximide in a raspberry flavored base. Store at 20°–25°C (68° – 77°F); [see USP Controlled Room Temperature] Preserve in tight containers. Protect from freezing and light.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZARONTIN- ETHOSUXIMIDE SOLUTION
Parke-Davis Div of Pfizer Inc
----------
MEDICATION GUIDE
ZARONTIN, (Ză rŏn' tĭn)
(ethosuximide)
Capsules, Oral Solution
Read this Medication Guide before you start taking ZARONTIN 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
ZARONTIN, ask your healthcare provider or
pharmacist.
What is the most important information I should know about ZARONTIN?
Do not stop taking ZARONTIN without first talking to your healthcare
provider.
Stopping ZARONTIN suddenly can cause serious problems.
ZARONTIN 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.
Drug reactions that may affect different parts of the body such as
your liver, kidneys, heart, or blood
cells. You may or may not have a rash with these types of reactions.
These reactions can be very
serious and can cause death. Call your healthcare provider right away
if you have any of these
symptoms:
•
joint pain and swelling
•
muscle pain
•
fatigue, weakness
•
low-grade fever
•
pain in the chest that is worse with breathing
•
skin rash
•
swollen lymph glands
•
swelling of your face
•
yellowing of your skin or the white part of your eyes
3.
Like other antiepileptic drugs, ZARONTIN 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

Lastnosti izdelka

ZARONTIN- ETHOSUXIMIDE SOLUTION
PARKE-DAVIS DIV OF PFIZER INC
----------
ZARONTIN
(ETHOSUXIMIDE)
ORAL SOLUTION
DESCRIPTION
Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically
designated as
alpha-ethyl-alpha-methyl-succinimide, with the following structural
formula:
Each teaspoonful (5 mL), for oral administration, contains 250 mg
ethosuximide, USP.
Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C
yellow No. 6; flavor;
glycerin, USP; purified water, USP; saccharin sodium, USP; sodium
benzoate, NF;
sodium citrate, USP; sucrose, NF.
CLINICAL PHARMACOLOGY
Ethosuximide 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
Zarontin is indicated for the control of absence (petit mal) epilepsy.
CONTRAINDICATIONS
Ethosuximide 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 ethosuximide; therefore, periodic blood
counts should be
performed. Should signs and/or symptoms of infection (e.g., sore
throat, fever)
develop, blood counts should be considered at that point.
DRUG-INDUCED IMMUNE THROMBOCYTOPENIA:
Drug-induced immune thrombocytopenia (DITP) has been reported with
ethosuximide.
In the reported cases, the onset of symptoms occurred 1 to 3 weeks
after initiation of
ethosuximide; one patient had recurrence of symptoms within 1 day of a
subsequent
re-challenge with the drug. In those cases in which the platelet count
was specified, the
nadir was 2,000 and 3,000/mm . When DITP is suspected, discontinue
Zarontin,
monitor serial platelet counts, and treat as appropriate. If possible,
assess the presence
of drug-dependent an