Country: United States
Language: English
Source: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
REMEDYREPACK 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. Phenytoin is contraindicated in patients with: - A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . - A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.6)]. A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.6)]. - Co-administration 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. Co-administration with delavirdine because of the potential for loss of vir
Extended phenytoin sodium capsules, USP 100 mg are supplied as white opaque / light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body. They are supplied as follows: Bottles of 30: NDC 65162-212-03 Bottles of 100: NDC 65162-212-10 Bottles of 500: NDC 65162-212-50 Bottles of 1000: NDC 65162-212-11 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.
Abbreviated New Drug Application
EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE REMEDYREPACK INC. ---------- MEDICATION GUIDE Extended Phenytoin (FEN-i-toyn) Sodium Oral 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 • 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 of your body. These can be very serious and cause death. Call your Read the complete document
EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE REMEDYREPACK 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 RECENT MAJOR CHANGES Contraindications (4) 12/2016 Warnings and Precautions (5.11) 12/2016 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, USP are available as Read the complete document