Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)
Actavis Pharma, Inc.
ORAL
PRESCRIPTION DRUG
Dalfampridine extended-release tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)]. The use of dalfampridine is contraindicated in the following conditions: - History of seizure [see Warnings and Precautions (5.1)] - Moderate or severe renal impairment (CrCl ≤50 mL/min) [see Warnings and Precautions (5.2)] - History of hypersensitivity to dalfampridine or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4)] Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% an
Dalfampridine extended-release tablets, 10 mg are film-coated, white to off-white, biconvex, oval shaped, unscored tablets. The tablets are identified by a debossed code “WPI ” on one side and “2533 ” on the other side and are available as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE Actavis Pharma, Inc. ---------- MEDICATION GUIDE Dalfampridine (dal fam′ pri deen) Extended-Release Tablets Read this Medication Guide before you start taking dalfampridine extended-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about dalfampridine extended-release tablets? Dalfampridine extended-release tablets can cause seizures. • You could have a seizure even if you never had a seizure before. • Your chance of having a seizure is higher if you take too much dalfampridine extended-release tablets or if your kidneys have a mild decrease of function, which is common after age 50. • Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking dalfampridine extended-release tablets. • Do not take dalfampridine extended-release tablets if you have ever had a seizure. • Before taking dalfampridine extended-release tablets tell your doctor if you have kidney problems. • Take dalfampridine extended-release tablets exactly as prescribed by your doctor. See “How should I take dalfampridine extended-release tablets?” Stop taking dalfampridine extended-release tablets and call your doctor right away if you have a seizure while taking dalfampridine extended-release tablets. What are dalfampridine extended-release tablets? Dalfampridine extended-release tablets are a prescription medicine used to help improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking speed. It is not known if dalfampridine extended-release tablets are safe or effective in children less than 18 years of age. Who should not take dalfampridine extended-release tablets? Do not take dalfampridine extended-release tablets if you: • have ever had a seizure • have certain typ Прочитајте комплетан документ
DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DALFAMPRIDINE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DALFAMPRIDINE EXTENDED-RELEASE TABLETS. DALFAMPRIDINE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2010 INDICATIONS AND USAGE Dalfampridine is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed (1, 14). DOSAGE AND ADMINISTRATION The maximum recommended dosage is 10 mg twice daily (approximately 12 hours apart). There is no evidence of additional benefit with doses greater than 10 mg twice daily. Adverse reactions, including seizures, were more frequent at higher doses. (2.1) Take with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve (2.2) Patients should not take double or extra doses if they miss a dose. (2.2) Estimated creatinine clearance (CrCl) should be known before initiating treatment with dalfampridine extended-release tablets. In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablets may reach plasma levels associated with a greater risk of seizures, and the potential benefits of dalfampridine extended-release tablets should be carefully considered against the risk of seizures in these patients (2.3, 5.2, 8.6) DOSAGE FORMS AND STRENGTHS 10 mg tablets (3) CONTRAINDICATIONS History of seizure (4) Moderate or severe renal impairment (CrCl≤50 mL/min) (4) History of hypersensitivity to dalfampridine or 4-aminopyridine (4) WARNINGS AND PRECAUTIONS Dalfampridine can cause seizures; the risk of seizures increases with increasing dalfampridine doses; discontinue dalfampridine and do not restart if a seizure occurs (5.1) Avoid concomitant use with other forms of 4-aminopyridine (4AP, fampridine), since the active in Прочитајте комплетан документ