Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Amifampridine (UNII: RU4S6E2G0J) (Amifampridine - UNII:RU4S6E2G0J)
Jacobus Pharmaceutical Company,Inc
ORAL
PRESCRIPTION DRUG
RUZURGI is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. RUZURGI is contraindicated in patients with: - A history of seizures [see Warnings and Precautions (5.1)] - Hypersensitivity to amifampridine or another aminopyridine [see Warnings and Precautions (5.2)] Risk Summary There are no data on the developmental risk associated with the use of RUZURGI in pregnant women. Animal studies to assess the potential adverse effects of amifampridine on embryofetal development have not been conducted. In the US 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. Risk Summary There are no data on the presence of amifampridine or the 3-N-acetyl-amifampridine metabolite in human milk, the effects on the breastfed infant, or the effects on mi
RUZURGI (amifampridine) 10 mg functionally scored tablets are oval, white to off-white, and debossed “10 │ 110” on one side and “JACOBUS” on the other side. RUZURGI is supplied as follows: Prior to Dispensing: Store tablets in a refrigerator between 2°C to 8°C (36°F to 46°F). Keep container tightly closed with desiccant canister inside after opening. Protect from moisture and light. After Dispensing: Store tablets at 20°C to 25°C (68°F to 77°F) for up to 3 months; excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
New Drug Application
RUZURGI- AMIFAMPRIDINE TABLET Jacobus Pharmaceutical Company,Inc ---------- MEDICATION GUIDE RUZURGI® (rew-ZUR-jee) (amifampridine) tablets, for oral use Read this Medication Guide before you start taking RUZURGI 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 RUZURGI? RUZURGI can cause seizures. • You could have a seizure even if you never had a seizure before. • Do not take RUZURGI if you have ever had a seizure. Stop taking RUZURGI and call your doctor right away if you have a seizure while taking RUZURGI. What is RUZURGI? RUZURGI is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome (LEMS) in children 6 to less than 17 years of age. It is not known if RUZURGI is safe or effective in children less than 6 years of age. Do not take RUZURGI if you: • have ever had a seizure. • are allergic to amifampridine or another aminopyridine. Talk to your doctor if you are not sure. Before you take RUZURGI, tell your doctor about all of your medical conditions including if you: • are taking another aminopyridine, such as as compounded 3,4-diaminopyridine (3,4-DAP), 4- aminopyridine, or pyridostigmine. • have had a seizure. • have kidney problems. • have liver problems. • are pregnant or planning to become pregnant. It is not known if RUZURGI can harm your unborn baby. You and your doctor should decide if you will take RUZURGI while you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if RUZURGI passes into your breastmilk. Talk to your doctor about the best way to feed your baby while taking RUZURGI. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take RUZURGI? • See the detailed “Instructions for Use” on how to take and prepare a suspension of RUZURGI if your dos Pročitajte cijeli dokument
RUZURGI- AMIFAMPRIDINE TABLET JACOBUS PHARMACEUTICAL COMPANY,INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RUZURGI SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RUZURGI. RUZURGI (AMIFAMPRIDINE) TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 2018 INDICATIONS AND USAGE RUZURGI is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. (1) DOSAGE AND ADMINISTRATION Patients 6 to less than 17 years of age weighing 45 kg or more: Initial dosage is 15 mg to 30 mg daily, in divided doses Increase daily in 5 mg to 10 mg increments, divided in up to 5 doses daily Maximum single dose is 30 mg; maximum daily dosage is 100 mg (2.1) Patients 6 to less than 17 years of age weighing less than 45 kg: Initial dosage is 7.5 mg to 15 mg daily, in divided doses Increase daily in 2.5 mg to 5 mg increments, divided in up to 5 doses daily Maximum single dose is 15 mg; maximum daily dosage is 50 mg (2.1) When patients require a dosage in less than 5 mg increments, have difficulty swallowing, or require feeding tubes, a 1 mg/mL suspension can be prepared. (2.2) For patients with renal or hepatic impairment or who are known N-acetyltransferase 2 poor metabolizers, use the lowest recommended initial dosage. (2.3, 2.4, 2.5) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, functionally scored (3) CONTRAINDICATIONS History of seizures (4) Hypersensitivity to amifampridine or other aminopyridine (4) WARNINGS AND PRECAUTIONS RUZURGI can cause seizures. Consider discontinuation or dose-reduction of RUZURGI in patients who have a seizure while on treatment. (5.1) Hypersensitivity reactions: If a hypersensitivity reaction such as anaphylaxis occurs, RUZURGI should be discontinued and appropriate therapy initiated. (5.2) ADVERSE REACTIONS The most common adverse reactions (incidence at least 10% and at least 2% greater than placebo) are paresthesia/dysesthesia, abdominal pain, dyspeps Pročitajte cijeli dokument