|
| Thursday, 19 February 2015, 16:55 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
TOKYO, Feb 19, 2015 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has received marketing and manufacturing approval in Japan for Tambocor Fine Granules 10%, a new formulation of anti-arrhythmic agent Tambocor (flecainide acetate).
Tambocor suppresses tachyarrythmia by blocking cardiac sodium channels and slowing down cardiac conduction. Approved and launched as Tambocor Tablets in Japan in 1991, the drug was originally indicated for the treatment of tachyarrythmia in adults. Determining the need to make the drug available to treat pediatric patients in Japan, the Japanese Ministry of Health, Labour and Welfare's Council for Pediatric Pharmacotherapy approved Tambocor as indicated for the treatment of tachyarrythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular tachycardia, ventricular tachycardia) in pediatric patients in May 2010.
Furthermore, Tambocor is the only sodium channel blocking agent in Japan to be approved for the treatment of tachyarrythmia in pediatric patients.
When administering Tambocor Tablets to pediatric patients, it is necessary to adjust the dosage depending on age and body surface area, which means that the tablets need to be crushed into powder for dosage adjustment. As such, there have been requests for development of a formulation that is suitable for pediatric administration. In consideration of an appropriate formulation that would meet clinical needs, Eisai developed a 10% fine granule formulation which enables precise dosage adjustment for pediatric patients and can be administered to patients who have difficulty with taking tablets. Having confirmed bioequivalence to the tablet formulation through clinical studies, Eisai submitted an application for the approval of the additional formulation in January 2014.
Pediatric arrhythmia not only causes heart palpitations, dizziness, shortness of breath and other symptoms that impact the daily lives of patients, it is also said to be one of the most common causes of sudden death among children. Regarding pediatric arrhythmia, Eisai has received approval of additional indications for pediatric patients for Tambocor Tablets in May 2010, and for the calcium channel blocking agents Vasolan Tablets 40 mg and Vasolan for intravenous injection 5 mg in May 2011. By providing a fine granule formulation that is easy to measure and administer in addition to Tambocor Tablets, Eisai will continue to make further contributions to address their needs of patients with tachyarrhythmia.
About Tambocor Fine Granules 10%
1) Product Name
Tambocor Fine Granules 10%
2) Indications, Dosage & Administration
Indications
The following conditions where other antiarrhythmic drugs cannot be used or are ineffective:
Adults: Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, ventricular tachycardia)
Children: Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular tachycardia, ventricular tachycardia)
Dosage & Administration
Adults:
- Tachyarrhythmia (paroxysmal atrial fibrillation/flutter)
The recommended starting dose is 100 mg (1 g of fine granules) of flecainide acetate per day, taken orally and divided into two equally spaced doses. The recommended dose may be increased to a maximum of 200 mg (2 g of fine granules) per day if efficacy is not achieved. It may also be decreased according to age and symptoms.
- Tachyarrhythmia (ventricular tachycardia)
The recommended starting dose is 100 mg (1 g of fine granules) of flecainide acetate per day, taken orally and divided into two equally spaced doses. The recommended dose may be increased to a maximum of 200 mg (2 g of fine granules) per day if efficacy is not achieved. It may also be decreased or increased according to age and symptoms.
Children:
- Tachyarrhythmia (paroxysmal atrial fibrillation/flutter, paroxysmal superventricular tachycardia, ventricular tachycardia)
The recommended dose for infants over six months of age, toddlers, and children is 50-100 mg/m2 (body surface area) [0.5-1 g/m2 (body surface area) of fine granules] of flecainide acetate per day, taken orally and divided into two or three equally spaced doses. The recommended dose may be adjusted according to age and symptoms, however, the maximum recommended dose is 200 mg/m2 per day [2 g/m2 of fine granules].
The recommended dose for infants under six months of age is 50 mg/m2 (body surface area) [0.5 g/m2 (body surface area) of fine granules] of flecainide acetate per day, taken orally and divided into two or three equally spaced doses. The recommended dose may be adjusted according to age and symptoms, however, the maximum recommended dose is 200 mg/m2 per day [2 g/m2 of fine granules].
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
Topic: Press release summary
Source: Eisai
Sectors: BioTech, Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Apr 18, 2024 09:53 HKT/SGT |
|
Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category) |
| Apr 17, 2024 15:17 HKT/SGT |
|
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan |
| Apr 3, 2024 15:24 HKT/SGT |
|
French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics |
| Apr 1, 2024 08:39 HKT/SGT |
|
Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA |
| Mar 29, 2024 14:51 HKT/SGT |
|
Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical |
| Mar 29, 2024 14:19 HKT/SGT |
|
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture |
| Mar 29, 2024 13:32 HKT/SGT |
|
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024 |
| Mar 21, 2024 16:36 HKT/SGT |
|
Lifenet and Eisai Co-Develop Dementia Insurance "be" |
| Mar 21, 2024 15:10 HKT/SGT |
|
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace |
| Mar 6, 2024 16:47 HKT/SGT |
|
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients |
| More news >> |
 |
|
|
|
