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네오보노정10밀리그램

네오보노정10밀리그램(보노프라잔푸마르산염)

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허가상태: 정상

허가상태는 현재 판매·유통·약국 재고를 뜻하지 않습니다.

DUR 등록 구분: 임부금기,투여기간주의. 개인별 금기 판정은 아니며 상세 조건은 공식 정보에서 확인하세요.

핵심부터 확인하세요.

표시를 누르면 설명 원문으로 이동해요.
원문에 이런 주의 주제가 있어요임신·수유어린이표시되지 않은 주의사항도 확인하세요.

성분

보노프라잔푸마르산염아래 원료약품 및 분량에서 함량 확인

표시된 함량은 원문 수록값이며, 1회 복용량을 뜻하지 않습니다.

효능·효과

어떤 증상에 사용하는 약인가요?
위궤양 치료, 미란성 위식도역류질환 치료, 미란성 위식도역류질환 치료후 유지요법, 비스테로이드성소염진통제(NSAIDs) 투여 시 위궤양 또는 십이지장궤양 재발 방지

복용법·사용법

연령, 1회 용량과 사용 간격을 확인하세요
● 위궤양 치료
성인에게 보노프라잔으로서 1회 20 mg을 1일 1회 경구투여한다. 통상 최대 8주까지 투여한다.
● 미란성 위식도역류질환의 치료 및 치료후 유지요법
치료: 성인에게 보노프라잔으로서 1회 20 mg을 1일 1회 경구투여한다. 통상 최대 4주까지 투여한다. 효과가 충분하지 않은 경우 8주까지 투여할 수 있다.
유지요법: 1회 10 mg을 1일 1회 경구투여하며, 효과가 충분하지 않은 경우 1회 20 mg을 1일 1회 경구투여할 수 있다.
● 비스테로이드성소염진통제(NSAIDs) 투여 시 위궤양 또는 십이지장궤양 재발 방지
성인에게 보노프라잔으로서 1회 10 mg을 1일 1회 경구투여한다.

복용 전 주의사항

질환·연령·임신 등 내 상황과 함께 확인하세요

1. 다음의 환자에는 투여하지 말 것

1) 이 약 또는 이 약의 구성성분에 대해 과민반응 및 그 병력이 있는 환자
2) 아타자나비어, 넬피나비어 또는 릴피비린 함유제제를 투여 중인 환자 (5. 상호작용 참조)

2. 다음의 환자에는 신중히 투여할 것

1) 신장애 환자 (6. 신장애 환자에 대한 투여 참조)
2) 간장애 환자 (7. 간장애 환자에 대한 투여 참조)
3) 고령자 (11. 고령자에 대한 투여 참조)

3. 이상반응

1) 위궤양 치료, 미란성 위식도역류질환의 치료 및 치료후 유지요법, 비스테로이드성소염진통제(NSAIDs) 투여 시 위궤양 또는 십이지장궤양 재발 방지 관련 임상시험에서 보고된 치료 중 발생 이상반응(TEAE) 중 1% 이상으로 보고된 이상반응은 표 1과 같다. 약물이상반응(ADR)은 * 표시하였으며, 표 1에 기재된 약물이상반응은 해당 이상반응이 1% 이상으로 보고된 경우이고, 표 1 아래에 기재된 약물이상반응은 해당 이상반응이 1% 미만으로 보고된 경우이다.
표 1. 임상시험에서 1% 이상으로 보고된 이상반응(약물이상반응은 * 표시)

신체 기관계 분류 (SOC)

이상사례 및 약물이상반응(*)

보노프라잔푸마르산염

10 mg

(N=719)

보노프라잔푸마르산염

20 mg

(N=1625)

위장관 장애

상복부 통증*

9 (1.3%)

13 (0.8%)

변비*

23 (3.2%)

31 (1.9%)

충치*

8 (1.1%)

9 (0.6%)

설사*

24 (3.3%)

37 (2.3%)

위용종*

15 (2.1%)

16 (1.0%)

위염*

7 (1.0%)

7 (0.4%)

구역*

7 (1.0%)

12 (0.7%)

구내염*

13 (1.8%)

9 (0.6%)

구토*

8 (1.1%)

12 (0.7%)

전신 장애 및 투여 부위 병태

말초 부종*

8 (1.1%)

15 (0.9%)

면역계 장애

계절성 알레르기

14 (1.9%)

27 (1.7%)

감염 및 기생충 감염

기관지염

19 (2.6%)

18 (1.1%)

위장염

29 (4.0%)

26 (1.6%)

인플루엔자

7 (1.0%)

10 (0.6%)

비인두염*

152 (21.1%)

190 (11.7%)

식도 칸디다증*

7 (1.0%)

14 (0.9%)

치주염

7 (1.0%)

6 (0.4%)

인두염*

20 (2.8%)

15 (0.9%)

부비동염

7 (1.0%)

2 (0.1%)

손상, 중독 및 시술 합병증

타박상

25 (3.5%)

23 (1.4%)

낙상

38 (5.3%)

30 (1.8%)

인대 염좌

9 (1.3%)

12 (0.7%)

시술 관련 출혈

9 (1.3%)

8 (0.5%)

임상 검사

알라닌 아미노 전이효소 증가*

7 (1.0%)

5 (0.3%)

혈액 크레아틴 인산 활성 효소 증가*

15 (2.1%)

29 (1.8%)

혈액 중성 지방 증가*

9 (1.3%)

19 (1.2%)

혈액 요산 증가*

7 (1.0%)

5 (0.3%)

γ-glutamyltransferase 증가*

8 (1.1%)

11 (0.7%)

근골격계 및 결합조직 장애

관절통*

8 (1.1%)

14 (0.9%)

등허리 통증*

17 (2.4%)

25 (1.5%)

골관절염

13 (1.8%)

10 (0.6%)

관절주위염

8 (1.1%)

9 (0.6%)

신경계 장애

어지러움*

15 (2.1%)

8 (0.5%)

정신 장애

불면

12 (1.7%)

11 (0.7%)

호흡기, 흉곽 및 종격 장애

알레르기성 비염*

10 (1.4%)

12 (0.7%)

상기도 염증

30 (4.2%)

36 (2.2%)

피부 및 피하조직 장애

접촉 피부염

8 (1.1%)

17 (1.0%)

습진*

14 (1.9%)

21 (1.3%)

임상시험에서 1% 미만으로 보고된 이상반응 중 약물이상반응은 다음과 같다.
- 혈액 및 림프계 장애: 빈혈*, 철결핍성 빈혈*
- 심장 장애: 대동맥판 기능 부전*, 심방세동*, 우각차단*
- 귀 및 미로 장애: 현훈*
- 내분비 장애: 아급성 갑상선염*
- 눈 장애: 각막 탈락*, 눈 건조*, 눈꺼풀 습진*, 개방각 녹내장*
- 위장관 장애: 복부 불편감*, 복부 팽창*, 하복부 통증*, 복통*, 배변 불규칙*, 맹장염*, 입술염*, 십이지장 용종*, 소장 결장염*, 상복부의 불편감*, 대변 변색*, 고창*, 기능성 위장관 장애*, 위 출혈*, 위 점막 병변*, 미란성 위염*, 출혈성 위염*, 위장음 이상*, 위식도 역류질환*, 설염*, 치핵*, 구강 감각 저하*, 장 폐쇄*, 대장 용종*, 입술 미란*, 타액선 통증*
- 전신 장애 및 투여 부위 병태: 흉통*, 안면 부종*, 병감(권태)*, 부종*, 용종*, 발열*, 갈증*
- 간담도 장애: 약물유발 간손상*, 간기능 이상*
- 감염 및 기생충 감염: 중이염*, 폐렴*, 피하 농양*, 안면 백선*
- 손상, 중독 및 시술 합병증: 근육 부상*
- 임상 검사: 아스파르트산 아미노 전이 효소 증가*, 호염구 수 증가*, 혈액 알칼리 인산 분해 효소 증가*, 혈액 빌리루빈 증가*, 혈액 콜레스테롤 증가*, 혈액 철 감소*, 혈액 철 증가*, 혈액 젖산 탈수소 효소 증가*, 혈액 마그네슘 증가*, 혈액 칼륨 증가*, 혈액 요소 증가*, 혈뇨 존재*, 호산구 수 증가*, 요당 존재*, 간 효소 증가*, 간 기능 시험 이상*, 림프구 수 감소*, 중성구 수 감소*, 중성구 수 증가*, 요단백 존재*, 신장 기능 시험 이상*, 비타민 B12 증가*, 백혈구 수 감소*, 백혈구 수 증가*
- 대사 및 영양 장애: 당뇨병*, 통풍*, 고중성지방혈증*, 고요산혈증*, 2형 당뇨병*
- 근골격 및 결합 조직 장애: 근육 쇠약*, 경부 통증*, 다발 관절염*, 회전근개 증후군*
- 양성, 악성 및 상세불명의 신생물 (낭종 및 용종 포함): 방광암*, 위 선종*, 악성 섬유성 조직구종*, 신우의 악성 신생물*
- 신경계 장애: 두통*, 감각 저하*, 말초 신경병증*, 조가비핵 출혈*, 졸림*
- 신장 및 요로 장애: 요관 결석*, 빈뇨*
- 호흡기, 흉곽 및 종격 장애: 천식*, 후두 통증*, 구인두 불편감*
- 피부 및 피하조직 장애: 혈관부종*, 피부염*, 홍반*, 점상 출혈*, 가려움 발진*, 소양증*, 전신 발진*, 발진*, 두드러기*
- 혈관 장애: 청색 발가락 증후군*, 고혈압*
2) 시판 후 관찰된 약물이상반응은 아래 표 2와 같다.
표 2. 시판 후 관찰된 약물이상반응 (빈도 불명)

신체 기관계 분류 (SOC)

약물이상반응

면역계 장애

약물 과민성 (쇼크, 아나필락시스)

두드러기

약물발진

혈액 및 림프계 이상

범혈구감소증

무과립구증

백혈구감소증

혈소판감소증

간담도계 장애

간독성

황달

피부 및 피하 조직 장애

발진

다형성 홍반

스티븐스-존슨 증후군

독성표피괴사용해

4. 일반적 주의

1) 간독성: 간손상을 포함한 간기능 이상이 임상시험에서 보고되었다. 시판 후 보고도 접수되었으며, 많은 경우 치료 시작 직후에 발생했다. 간기능 이상이 확인되었거나, 간기능 이상을 시사하는 징후나 증상이 나타난 환자에게는 이 약의 투여를 중지할 것을 권장한다.
2) 이 약의 장기투여 시, 내시경 검사와 같이 충분한 관찰을 해야 한다.
3) 미란성 위식도역류질환의 유지요법에서, 이 약은 재발∙재연을 반복하는 상태의 환자에게만 투여한다. 유지요법이 필요 없는 환자에게는 투여하지 않는다. 관해 상태가 장기간 유지되는 경우 또는 재발할 우려가 없다고 판단되는 경우 1회 20 mg에서 1회 10 mg으로의 감량 또는 휴약을 고려해야 한다.
4) 비스테로이드성소염진통제(NSAIDs) 투여 시 위궤양 또는 십이지장궤양 재발 방지에서, 이 약은 류마티스 관절염 또는 퇴행성 관절염 등에 대한 통증 관리를 위해 비스테로이드성소염진통제를 지속적으로 투여중인 환자에게 투여한다. 투여 시작 전 위궤양 또는 십이지장궤양의 병력을 확인한다.
5) 이 약의 장기투여 시 양성 위용종이 관찰되었다.
6) 이 약의 투여는 위암의 증상을 은폐할 수 있으므로, 이 약 투여 전 궤양의 악성 여부를 확인하는 것이 필요하다.
7) 복수의 관찰연구에서, 프로톤펌프억제제 치료 시 고관절, 손목 또는 척추의 골다공증 관련 골절의 위험이 증가하는 것이 보고되었다. 주로 고령이거나 다른 알려진 위험 요소가 있을 때, 특히 고용량 및 장기간(1년 이상)의 치료를 받은 환자에서 골절 위험이 증가했다.
8) 위내 pH를 높이는 약물은 클로스트리듐 디피실레(Clostridium difficile) 위장 감염의 위험 증가와 관련이 있을 수 있다. 주로 입원환자를 대상으로 한 복수의 관찰연구에서 프로톤펌프억제제를 투여받은 환자에서 클로스트리듐 디피실레에 의한 위장 감염의 위험이 증가하는 것으로 보고되었다.
9) 이 약의 투여는 Chromogranin A (CgA) 수치를 증가시킬 수 있는데, 이로 인해 신경내분비 종양의 조사에 방해가 될 수 있다. 이러한 간섭을 피하기 위해, CgA 수치를 측정하기 14일 전에 이 약의 치료를 중단해야 한다.

5. 상호작용

1) 이 약을 투여하면 위 내 pH가 높아지기 때문에, 위의 pH가 생체이용률의 중요한 결정요인인 경구제의 경우 약물흡수에 영향을 미칠 수 있다. 따라서 아타자나비어 및 넬피나비어와 같이 흡수가 위내 산성 pH에 의존하는 일부 약물의 경우, 이 약과 병용할 경우 생체이용률이 유의하게 감소되므로, 이 약과 병용하는 것이 권장되지 않는다.
2) 이 약은 주로 CYP3A4에 의해 대사되고, CYP2B6, CYP2C19 및 CYP2D6에 의해 부분적으로 대사된다. 또한, 이 약은 약한 CYP3A4 억제제로 분류된다.
3) 병용투여 금지 (이 약은 다음의 약물과 병용투여 하지 않는다.)

약물

증상

작용원리 및 위험요소

아타자나비어

아타자나비어의 효과가 감소될 수 있다.

이 약의 위산분비억제 작용에 의해, 아타자나비어의 용해도가 낮아지고, 이에 혈중 아타자나비어의 농도가 감소될 수 있다.

릴피비린

릴피비린의 효과가 감소될 수 있다.

이 약의 위산분비억제 작용에 의해, 릴피비린의 흡수가 낮아지고, 이에 혈중 릴피비린의 농도가 감소될 수 있다.

넬피나비어

넬피나비어의 효과가 감소될 수 있다.

이 약의 위산분비억제 작용에 의해, 혈중 넬피나비어의 농도가 감소될 수 있다.

4) 병용투여 주의 (이 약은 다음의 약물과 병용투여 시 주의가 필요하다.)

약물

증상

작용원리 및 위험요소

CYP3A4 억제제

  클래리트로마이신 등

이 약의 혈중농도가 증가될 수 있다.

클래리트로마이신과 병용투여 시 이 약의 혈중 농도가 증가되었다는 보고가 있다.

디곡신, 메틸디곡신

디곡신 및 메틸디곡신의 효과가 증가될 수 있다.

이 약의 위산분비억제 작용에 의해, 디곡신의 가수분해가 억제되어, 혈중 디곡신의 농도가 증가될 수 있다.

이트라코나졸,

티로신키나아제 억제제

제피티닙

닐로티닙

엘로티닙

이트라코나졸, 티로신키나아제 억제제의 효과가 감소될 수 있다.

이 약의 위산분비억제 작용에 의해, 혈중 이트라코나졸, 티로신키나아제 억제제의 농도가 감소될 수 있다.

CYP3A4에 의해 대사되는 약물

  미다졸람 등

CYP3A4에 의해 대사되는 약물의 효과가 증가될 수 있다.

이 약의 CYP3A4에 대한 약한 억제효과로 인해, CYP3A4에 의해 대사되는 약물의 대사가 억제된다.

강력하거나 중강도의 CYP3A4 유도제

  리팜피신

  에파비렌즈 등

이 약의 혈중농도가 감소될 수 있다.

CYP3A4 유도제에 의해 이 약의 대사속도가 빨라진다.

6. 신장애 환자에 대한 투여

이 약의 배설이 지연될 수 있으며, 이로 인해 이 약의 혈중 농도가 증가할 수 있으므로 신중하게 투여해야 한다.

7. 간장애 환자에 대한 투여

이 약의 대사 및 배설이 지연될 수 있으며, 이로 인해 이 약의 혈중 농도가 증가할 수 있으므로 신중하게 투여해야 한다.

8. 임산부에 대한 투여

임산부를 대상으로 한 이 약의 평가를 위한 임상시험 연구는 실시되지 않았다. 이 약은 임산부 또는 임신 가능성이 있는 여성에게는 예상되는 치료효과가 발생할 수 있는 위험보다 중요하다고 판단되는 경우가 아니라면 투여하지 않는다. 동물시험(랫트) 시 보노프라잔 최대 임상용량(40 mg/일)의 약 28배를 초과하는 노출량(AUC)에서 태아 체중 및 태반 중량의 낮은 수치, 외상 이상(항문 협착 및 꼬리의 이상) 및 내장 이상(심실중격결손 및 이상쇄골하동맥)이 관찰되었다.

9. 수유부에 대한 투여

수유부를 대상으로 한 이 약의 평가를 위한 임상시험 연구는 실시되지 않았다. 이 약의 예상되는 치료적 이득과 모유 수유의 이점을 고려하여 모유 수유를 계속할지 중단할지를 결정해야 한다. 동물시험(랫트) 시 이 약이 모유 중으로 이행하는 사실이 보고되었다. 수유부에게 이 약의 투여가 필요하다면, 이 약으로 치료하는 중에는 모유 수유를 피해야 한다.

10. 소아에 대한 투여

소아 환자를 대상으로 한 임상시험 연구는 실시되지 않았다.

11. 고령자에 대한 투여

일반적으로 고령자에서는 간기능 또는 신기능과 같은 생리기능이 저하되므로 신중하게 투여해야 한다.

12. 적용상의 주의

약물 교부 시: PTP 포장 약제는 PTP 시트에서 꺼내어 복용하도록 환자에게 지시해야 한다. PTP 시트를 삼킨 경우, 시트의 단단한 모서리가 식도 점막을 찌르고 나아가 천공을 일으켜서 종격동염 등의 심각한 합병증을 유발할 수 있다고 보고되었다.

보관 방법

약을 어떻게 보관하나요?

기밀용기, 실온(1∼30℃)보관

원료약품 및 분량 원문

총량 : 1정114.50밀리그램|성분명 : 보노프라잔푸마르산염|분량 : 13.36|단위 : 밀리그램|규격 : 별규|성분정보 : |비고 :

환자용 안내 원문

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의약품동등성시험 정보

가. 시험약 네오보노정20밀리그램(보노프라잔푸마르산염)[㈜녹십자]과 대조약 Takecab® 20밀리그램(보노프라잔푸마르산염)[Takeda Pharmaceutical Company Limited]을 2x2 교차시험으로 각 1정씩 건강한 성인에게 공복 시 단회 경구투여하여 32명의 혈중 보노프라잔을 측정한 결과, 비교평가항목치(AUCt, Cmax)를 로그변환하여 통계처리하였을 때, 기하평균비율의 90% 신뢰구간이 80.00~125.00% 이내로서 생물학적으로 동등함을 입증하였다.

구분

비교평가항목

참고평가항목

AUC0-36hr (ng·hr/mL)

Cmax

(ng/mL)

Tmax (hr)

t1/2 (hr)

대조약

Takecab® 20밀리그램

(보노프라잔푸마르산염)

[Takeda Pharmaceutical Company Limited]

179.4±53.5

23.47±6.82

1.50

(1.00~2.50)

7.60±1.18

시험약

네오보노정20밀리그램

(보노프라잔푸마르산염)

[녹십자(주)]

172.5±51.6

22.64±7.24

1.50

(1.00~4.00)

7.70±1.43

기하평균비율의 90% 신뢰구간

(기준 : 80.00~125.00%)

93.19~

100.02%

91.65~

99.96%

-

-

(AUCt, Cmax, t1/2 ; 평균값±표준편차, Tmax ; 중앙값(범위), n=32)

 

AUCt : 투약시간부터 최종혈중농도 정량시간 t까지의 혈중농도-시간곡선하면적

Cmax : 최고혈중농도

Tmax : 최고혈중농도 도달시간

t1/2 : 말단 소실 반감기

나. 의약품동등성시험기준 제7조 제2항에 따라, 네오보노정10밀리그램(보노프라잔푸마르산염)[㈜녹십자]은 대조약 네오보노정20밀리그램(보노프라잔푸마르산염)[㈜녹십자]과의 비교용출시험자료를 제출하였으며, 대조약과 용출양상이 동등하였다. 이에 따라 해당 자료로서 생물학적동등성을 입증하였다. 

어디에서 가져온 정보인가요?

출처
식품의약품안전처 품목허가정보
원문 갱신
미제공
데이터 가져온 날
2026-09-07
허가일
2026-02-26
성상
연한 노란색의 타원형 필름코팅정제
포장단위
30정/병,30정/피티피[10정/PTP x 3]
사용기간
제조일로부터 24 개월
ATC 코드
A02BC08
품목기준코드
202600582

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