Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Sun Pharmaceutical Industries, Inc.
PHENYTOIN SODIUM
PHENYTOIN SODIUM 200 mg
ORAL
PRESCRIPTION DRUG
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. Extended phenytoin sodium capsules are contraindicated in patients with: - A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . Reactions have included angioedema. - A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8)] . - Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as extended phenytoin sodium capsules, during pregnancy. Physicians are advised to recommend that pregn
Extended Phenytoin Sodium Capsules, USP are available containing 200 mg or 300 mg of phenytoin sodium, USP. The 200 mg capsule has a blue transparent cap and a light blue transparent body. The hard-shell gelatin capsule is filled with white to off-white powder. The capsule is printed axially with 299 in black ink on both the cap and the body. They are available as follows: Bottle of 30 with child-resistant cap...................NDC 62756-299-83 Bottle of 100 with child-resistant cap.................NDC 62756-299-88 Bottle of 100.........NDC 62756-299-08 Bottle of 500.........NDC 62756-299-13 The 300 mg capsule has a light blue transparent cap and a light blue transparent body. The hard-shell gelatin capsule is filled with white to off-white powder. The capsule is printed axially with 432 in black ink on both the cap and the body. They are available as follows: Bottle of 30 with child-resistant cap...................NDC 62756-432-83 Bottle of 100 with child-resistant cap.................NDC 62756-432-88 Bottle of 100.........NDC 62756-432-08 Bottle of 500.........NDC 62756-432-13 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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.
Abbreviated New Drug Application
Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products MEDICATION GUIDE Extended Phenytoin (FEN-i-toyn) Sodium Capsules, USP What is the most important information I should know about extended phenytoin sodium capsules? 1. Do not stop taking extended phenytoin sodium capsules without first talking to your healthcare provider. • Stopping extended phenytoin sodium 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, extended phenytoin sodium 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 • New or worse anxiety • Trouble sleeping (insomnia) • Acting on dangerous impulses • Attempts to commit suicide • Feeling agitated or restless • New or worse irritability • An extreme increase in activity and talking (mania) • New or worse depression • Panic attacks • Acting aggressive, being angry, or violent • 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. Extended phenytoin sodium 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 Lesen Sie das vollständige Dokument
PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EXTENDED PHENYTOIN SODIUM CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1953 INDICATIONS AND USAGE 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. (1) DOSAGE AND ADMINISTRATION 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 extended phenytoin sodium 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 concentration is 1 to 2 mcg/mL). (2.3) DOSAGE FORMS AND STRENGTHS Extended phenytoin sodium capsules are available as 200 mg and 300 mg extended phenytoin sodium capsules. (3) (3) CONTRAINDI Lesen Sie das vollständige Dokument