‘Aspirin Protect’ dosing guide likely to change to ‘before meals’

‘Aspirin Protect’ dosing guide likely to change to ‘before meals’. January. 04, 2017 07:10. by Ho-Kyeong Kim kimhk@donga.com.

Steps are being taken to change the medication guide for "Aspirin Protect tablet," which is widely used for prevention of cardiovascular diseases, to one that advises users to take before meals. Aspirin Protect tablet, which was first licensed in Korea in 2001, has thus far been recommended for medication after meals. Aspirin Protect tablet is different from Bayer Aspirin tablet, which is used as pain killer.

According to Bayer Korea on Tuesday, the company in early December made advance inquiry to the Korea Food and Drug Safety Ministry whether changing the dosing method of Aspirin Protect is possible. If a pharmaceutical company is to change the dosing method, it can only do so after winning approval from the Korea Food and Drug Safety Ministry. Hence, the state drug regulator held a central pharmaceutical affairs review committee meeting on December 16 and discussed the issue in question.

“Based on the results of consultations by the central pharmaceutical affairs review committee, we will inform Bayer Korea of the result of our advance review,” said Goh Yong-seok, a research officer at the ministry's drug license review department. If the ministry approves the request for change thereafter, the dosing method of Aspirin Protect tablet will change for the first time in 15 years.

The reason for an envisaged change to the dosing method is that "Aspirin Protect" is a tablet designed for dissolution in the gut’ that dissolves and gets absorbed in the intestine rather than the stomach. An Aspirin Protect tablet poses little risk of causing stomach disorder even if it is taken when the stomach is empty, but the possibility for the tablet to dissolve in the stomach cannot be ruled out if it is taken after consumption of meal.

“There is no change to its efficacy irrespective of whether the tablet is taken before or after meals, but we are taking steps to change the regulatory guideline to make most of the characteristics of the tablet designed for dissolution in the intestine,” said Park Hyeon-joo, manager at Bayer Korea. In Germany, consumers are recommended to take an Aspirin Protect tablet before meals.

However, consumers should use caution because the dosing method of the Bayer Aspirin tablets 100mg and 500mg, the two types of Aspirin that are widely used as pain killer at households, will not change. Consumers must only keep the daily dosage when using the Bayer Aspirin tablets, regardless of whether they take the pill before or after a meal.