Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Phenytoin Sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5)
Taro Pharmaceuticals U.S.A., Inc.
Phenytoin Sodium
Phenytoin Sodium 100 mg
ORAL
PRESCRIPTION DRUG
Extended phenytoin sodium capsules, USP 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 pr
Extended Phenytoin Sodium Capsules USP, 100 mg are hard gelatin capsules No. 3 with an opaque orange body and cap, imprinted "TARO PHN 100" in black ink. They are available in: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.
Abbreviated New Drug Application
Taro Pharmaceuticals U.S.A., Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2023 5200710 0923 14 Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides MEDICATION GUIDE Extended Phenytoin (fen´ i toin) Sodium Capsules 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 • 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. Extended phenytoin sodium capsules can cause a type of serious allergic reaction tha Přečtěte si celý dokument
PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE TARO PHARMACEUTICALS U.S.A., 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 mg/kg/day 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 mcg/mL to 20 mcg/mL (unbound phenytoin concentration is 1 mcg/mL to 2 mcg/mL). (2.3) DOSAGE FORMS AND STRENGTHS Extended phenytoin sodium capsules are available as 100 mg extended phenytoin sodium capsules. (3) CONT Přečtěte si celý dokument