מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)
Hikma Pharmaceuticals USA 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 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 resulted in no evidence of deve
Dalfampridine Extended-release Tablets 10 mg tablets are supplied as white to off-white, film coated oval tablets with “54 052” debossed on one side and plain on the other side. NDC 0054-0479-21 Bottle of 60 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 Hikma Pharmaceuticals USA Inc. ---------- Medication Guide MEDICATION GUIDE Dalfampridine Extended-release Tablets (dal fam’ pri deen) Rx only 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? Dalfampridine 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 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. • Do not take Dalfampridine if you have ever had a seizure. • Before taking Dalfampridine tell your doctor if you have kidney problems. • Take Dalfampridine exactly as prescribed by your doctor. See "How should I take Dalfampridine?" Stop taking Dalfampridine and call your doctor right away if you have a seizure while taking Dalfampridine. What is Dalfampridine? Dalfampridine is 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 is safe or effective in children less than 18 years of age. Who should not take Dalfampridine? Do not take Dalfampridineif you: • have ever had a seizure • have certain types of kidney problems • are allergic to dalfampridine (4-aminopyridine), the active ingredient in Dalfampridine What should I tell my doctor before taking Dalfampridine? Before you take Dalfampridine, tell your doctor if you: • have any other medical conditions • are taking compounded 4-aminopyridine (fampridine, 4-AP) • are taking any ot קרא את המסמך השלם
DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE HIKMA PHARMACEUTICALS USA 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 • • • • 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 were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS USA INC. AT 1- 800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS OCT2 Inhibitors: Concomitant use may cause an increased exposure and potential risk of seizures (7.1) USE IN SPECIFIC POPULATIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE. 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 קרא את המסמך השלם