Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)
Sun Pharmaceutical Industries, 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 extended-release tablets are 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 recognize
Dalfampridine extended-release tablets, 10 mg are white to off-white, round, biconvex, beveled edged, film-coated tablets imprinted with “429” in black ink on one side and plain on the other side. They are available as: Bottles of 60 with Child-resistant Cap ………….….. NDC 62756-429-86 Store dalfampridine extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products 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 many 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 prescription medicines 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 Baca dokumen lengkapnya
DALFAMPRIDINE - DALFAMPRIDINE TABLET, EXTENDED RELEASE SUN PHARMACEUTICAL INDUSTRIES, 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 extended-release tablets or 4-aminopyridine (4) WARNINGS AND PRECAUTIONS Dalfampridine extended-release tablets can cause seizures; the risk of seizures increases with increasing dalfampridine extended-release tablets doses; discontinue dalfampridine extended-release tablets and do not restart if a seizure occurs ( Baca dokumen lengkapnya