Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)
Mylan Pharmaceuticals 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 is contraindicated in the following conditions: Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets 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% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis result
Dalfampridine Extended-Release Tablets are available containing 10 mg of dalfampridine, USP. The 10 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and DF10 on the other side. They are available as follows: NDC 0378-4504-91 bottles of 60 tablets NDC 0378-4504-80 bottles of 180 tablets NDC 0378-4504-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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
DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Dalfampridine Extended-Release Tablets (dal fam' pri deen) 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 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 Lestu allt skjalið
DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE MYLAN PHARMACEUTICALS 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 extended-release tablets are 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 51-80 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 • • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS The most common adverse events (incidence ≥ 2% and at a rate greater than the placebo rate) for dalfampridine extended-release tablets were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngea Lestu allt skjalið