|
| 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 © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Mar 25, 2025 16:28 HKT/SGT |
|
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards |
| Mar 25, 2025 11:21 HKT/SGT |
|
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace |
| Mar 10, 2025 19:24 HKT/SGT |
|
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time |
| Mar 5, 2025 08:09 HKT/SGT |
|
Eisai: Update on the Co-Promotion of the Oral Antifungal Agent Nailin Capsules 100mg in Japan |
| Mar 4, 2025 16:22 HKT/SGT |
|
Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer's Disease in Australia |
| Mar 3, 2025 14:41 HKT/SGT |
|
"Fatigue Recovery While You Sleep!" Eisai to Launch Designated Quasi-Drug Drink "Chocola BB Nightwell" |
| Mar 3, 2025 12:53 HKT/SGT |
|
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease |
| Feb 28, 2025 11:31 HKT/SGT |
|
Eisai Enters into License Agreement for the Development and Distribution of Fibroblast Growth Factor (FGF) Receptor Selective Tyrosine Kinase Inhibitor Tasurgratinib in Greater China Region (Mainland China, Hong Kong, Macau, and Taiwan) with SciClone |
| Feb 20, 2025 12:29 HKT/SGT |
|
Eisai Selected for "Human Capital Leaders 2024" and "Human Capital Management Gold Quality" for Second Consecutive Year, as a Company Committed to Excellent Management and Disclosure of Human Capital Initiatives |
| Feb 14, 2025 11:09 HKT/SGT |
|
Development of Prediction Model for Brain Amyloid-Beta Accumulation for Early Screening of Alzheimer's Disease |
| More news >> |
 |
|
|
|
