PHENYTOIN SODIUM capsule, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tên quốc tế):

PHENYTOIN SODIUM

Thành phần:

PHENYTOIN SODIUM 100 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Extended phenytoin sodium capsules are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY). Extended phenytoin sodium capsules are contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Tóm tắt sản phẩm:

Extended Phenytoin Sodium Capsules, USP are available containing phenytoin sodium equivalent to 100 mg of phenytoin, USP. The 100 mg capsule is a hard-shell gelatin capsule with a light lavender opaque cap and white opaque body filled with one white to off-white capsule-shaped tablet. The capsule is axially printed with MYLAN over 1560 in black ink on both the cap and body. They are available as follows: NDC 0615-1343-39 blistercards of 30 capsules NDC 0615-1343-31 blistercards of 31 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. U.S. Patent No. 6,274,168 U.S. Patent No. 6,620,432 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED NOVEMBER 2009 PHNY:R10

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
EXTENDED PHENYTOIN SODIUM CAPS
DESCRIPTION
Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related
to the barbiturates in chemical
structure, but has a five-membered ring. The chemical name is
5,5-Diphenylhydantoin sodium salt,
having a molecular weight of 274.25 and having the following
structural formula and molecular
formula:
C
H N NaO
Each extended phenytoin sodium capsule, USP, for oral administration,
contains 100 mg phenytoin
sodium, USP. Each capsule also contains the following inactive
ingredients: colloidal silicon dioxide,
hydroxyethyl cellulose, magnesium oxide, magnesium stearate,
microcrystalline cellulose, povidone
and sodium lauryl sulfate. In addition, each of the empty gelatin
capsules contains the following: D&C
Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, sodium lauryl
sulfate and titanium dioxide.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol and shellac glaze.
Product_ in vivo_ performance is characterized by a slow and extended
rate of absorption with peak blood
concentrations expected in 4 to 12 hours as contrasted to prompt
phenytoin sodium capsules, USP with a
rapid rate of absorption with peak blood concentration expected in
11⁄2 to 3 hours.
Extended phenytoin sodium capsules, USP 100 mg meet _USP Dissolution
Test 2._
CLINICAL PHARMACOLOGY
Phenytoin is an antiepileptic drug which can be used in the treatment
of epilepsy. The primary site of
action appears to be the _motor cortex_ where spread of seizure
activity is inhibited. Possibly by
promoting sodium efflux from neurons, phenytoin tends to _stabilize_
the threshold against
hyperexcitability caused by excessive stimulation or environmental
changes capable of reducing
membrane sodium gradient. This includes the reduction of posttetanic
poten