PHENYTEK- extended phenytoin sodium capsule, extended release PHENYTEK- phenytoin sodium capsule, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

Предлага се от:

Mylan Pharmaceuticals Inc.

INN (Международно Name):

PHENYTOIN SODIUM

Композиция:

PHENYTOIN SODIUM 200 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

PHENYTEK® capsules (extended phenytoin sodium capsules) are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. PHENYTEK® capsules are contraindicated in patients with: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as PHENYTEK® capsules, during pregnancy. Physicians are advised to recommend that pregnant patients taking PHENYTEK® capsules enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is associated with an incre

Каталог на резюме:

PHENYTEK® CAPSULES (extended phenytoin sodium capsules, USP) are available containing 200 mg or 300 mg of phenytoin sodium, USP. The 200 mg capsules have a dark blue opaque cap and a blue opaque body. The hard-shell gelatin capsules are filled with two white to off-white round tablets. The capsules are rectified radial printed with BERTEK over 670 in black ink on both the cap and the body. They are available as follows: NDC 0378-2670-93 bottles of 30 capsules NDC 0378-2670-01 bottles of 100 capsules The 300 mg capsules have a blue opaque cap and a blue opaque body. The hard-shell gelatin capsules are filled with three white to off-white round tablets. The capsules are rectified radial printed with BERTEK over 750 in black ink on both the cap and the body. They are available as follows: NDC 0378-3750-93 bottles of 30 capsules NDC 0378-3750-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
PHENYTEK® CAPSULES
(extended phenytoin sodium capsules)
(fen′ i toin soe′ dee um)
What is the most important information I should know about PHENYTEK®
CAPSULES?
1. Do not stop taking PHENYTEK® CAPSULES without first talking to
your healthcare provider.
•
Stopping PHENYTEK® CAPSULES suddenly can cause serious problems.
•
Stopping a seizure medicine suddenly can cause you to have seizures
more often or seizures that
will not stop (status epilepticus).
2. Like other antiepileptic drugs, PHENYTEK® CAPSULES 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
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
3. PHENYTEK® CAPSULES can cause a type of serious allergic reaction
that may affect different parts
of the body such as your liver, kidneys, blood, heart, skin or other
parts of your body. These can be very
serious and cause death. Call your healthcare provider right away if
you have any or all of these
symptoms:
•
Fever
�

Данни за продукта

PHENYTEK- EXTENDED PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYTEK CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYTEK
CAPSULES.
PHENYTEK
CAPSULES (EXTENDED PHENYTOIN SODIUM CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
PHENYTEK
CAPSULES are indicated for the treatment of tonic-clonic (grand mal)
and psychomotor
(temporal lobe) seizures and prevention and treatment of seizures
occurring during or following
neurosurgery. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
PHENYTEK capsules are available as 200 mg or 300 mg extended phenytoin
sodium capsules. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
®
®
®
®
Adult starting dose in patients who have received no previous
treatment is one 100 mg extended
phenytoin sodium capsule three times a day, with dose adjustments as
necessary. For most adults,
the satisfactory maintenance dose will be one capsule three to four
times a day. An increase, up to
two capsules three times a day may be made, if necessary. (2.1)
Adult once-a-day dose: If seizure control is established with divided
doses of three 100 mg extended
phenytoin sodium capsules daily, once-a-day dosage with 300 mg
PHENYTEK
capsules may be
considered. (2.1)
®
Adult loading dose: reserved for patients in a clinic or hospital
setting who require rapid steady-state
serum levels and where intravenous administration is not desired.
Refer to full prescribing information.
(2.1)
Pediatric starting dose is 5 mg/kg/day in two to three equally divided
doses, with dosage adjustments
as necessary, up to a maximum of 300 mg daily. Maintenance dosage is 4
to 8 mg/kg/day. (2.2)
Serum blood level determinations may be necessary for optimal dosage
adjustments—the clinically
effective serum total concentration is 10 to 20 mcg/mL (unbound
phenytoin concen