Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)
Mylan Pharmaceuticals Inc.
PHENYTOIN SODIUM
PHENYTOIN SODIUM 200 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- 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 Lue koko asiakirja
PHENYTEK- EXTENDED PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE MYLAN PHARMACEUTICALS INC. ---------- 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 Lue koko asiakirja