Thông tin sản phẩm
M\u1ed9t viên nén phóng thích kéo dài ch\u1ee9a:
\n- Ho\u1ea1t ch\u1ea5t: Natri diclofenac (natri-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate) 75mg hay 100mg.
\n- Tá d\u01b0\u1ee3c:
\n+ Lõi viên nén: Sucrose; cetyl alcohol; povidone; magnesium stearat; silic d\u1ea1ng keo khan.
\n+ V\u1ecf viên nén: Hypromellose; b\u1ed9t tan tinh khi\u1ebft; polysorbat 80; titan dioxid (E171); oxid s\u1eaft màu \u0111\u1ecf (E172), macrogol 8000, sucrose. M\u1ef1c in: carbon \u0111en, shellac, nhôm hydroxid, simethicon.
", "index": 1}, {"title": "C\u00f4ng d\u1ee5ng", "content": "", "index": 2}, {"title": "T\u00e1c d\u1ee5ng ph\u1ee5", "content": "Các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i c\u1ee7a thu\u1ed1c t\u1eeb các th\u1eed nghi\u1ec7m lâm sàng và/ho\u1eb7c t\u1ef1 phát hay trong y v\u0103n (B\u1ea3ng 1) \u0111\u01b0\u1ee3c li\u1ec7t kê theo h\u1ec7 th\u1ed1ng phân lo\u1ea1i c\u01a1 quan MedDRA. V\u1edbi m\u1ed7i lo\u1ea1i h\u1ec7 th\u1ed1ng phân lo\u1ea1i c\u01a1 quan, ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i \u0111\u01b0\u1ee3c x\u1ebfp lo\u1ea1i theo \u0111\u1ec1 m\u1ee5c v\u1ec1 t\u1ea7n su\u1ea5t, \u0111\u1ea7u tiên là các ph\u1ea3n \u1ee9ng th\u01b0\u1eddng g\u1eb7p nh\u1ea5t. Trong m\u1ed7i nhóm t\u1ea7n su\u1ea5t, ph\u1ea3n \u1ee9ng ph\u1ee5 c\u1ee7a thu\u1ed1c \u0111\u01b0\u1ee3c trình bày theo th\u1ee9 t\u1ef1 gi\u1ea3m d\u1ea7n m\u1ee9c \u0111\u1ed9 nghiêm tr\u1ecdng. Ngoài ra, các lo\u1ea1i t\u1ea7n su\u1ea5t t\u01b0\u01a1ng \u1ee9ng cho m\u1ed7i ph\u1ea3n \u1ee9ng ph\u1ee5 cu\u1ea3 thu\u1ed1c d\u1ef1a trên s\u1eed d\u1ee5ng quy \u01b0\u1edbc sau \u0111ây (CIOMS III): hay g\u1eb7p (>=1/10), th\u01b0\u1eddng g\u1eb7p (>=1/100 \u0111\u1ebfn < 1/10), ít g\u1eb7p (>=1/1000 \u0111\u1ebfn < 1/100), hi\u1ebfm g\u1eb7p (>=1/10.000, < 1/1000), r\u1ea5t hi\u1ebfm g\u1eb7p ( < 1/10.000).
\nCác ph\u1ea3n \u1ee9ng ph\u1ee5 sau \u0111ây bao g\u1ed3m c\u1ea3 nh\u1eefng báo cáo v\u1edbi Voltaren viên nén phóng thích kéo dài và/ho\u1eb7c các d\u1ea1ng bào ch\u1ebf khác c\u1ee7a diclofenac, dùng ng\u1eafn h\u1ea1n hay dài h\u1ea1n.
\nB\u1ea3ng 1. Ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i c\u1ee7a thu\u1ed1c
\n| \n Các r\u1ed1i lo\u1ea1n máu và h\u1ec7 b\u1ea1ch huy\u1ebft \n | \n|
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Gi\u1ea3m ti\u1ec3u c\u1ea7u, gi\u1ea3m b\u1ea1ch c\u1ea7u, thi\u1ebfu máu (bao g\u1ed3m c\u1ea3 thi\u1ebfu máu tan máu và thi\u1ebfu máu b\u1ea5t s\u1ea3n t\u1ee7y), m\u1ea5t b\u1ea1ch c\u1ea7u h\u1ea1t. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 h\u1ec7 mi\u1ec5n d\u1ecbch \n | \n|
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n Quá m\u1eabn c\u1ea3m, các ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7 và d\u1ea1ng ph\u1ea3n v\u1ec7 (bao g\u1ed3m c\u1ea3 h\u1ea1 huy\u1ebft áp và s\u1ed1c). \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Phù m\u1ea1ch (bao g\u1ed3m c\u1ea3 phù m\u1eb7t). \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 tâm th\u1ea7n \n | \n|
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n M\u1ea5t \u0111\u1ecbnh h\u01b0\u1edbng, tr\u1ea7m c\u1ea3m, m\u1ea5t ng\u1ee7, ác m\u1ed9ng, cáu g\u1eaft, r\u1ed1i lo\u1ea1n tâm th\u1ea7n. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 h\u1ec7 th\u1ea7n kinh \n | \n|
| \n Th\u01b0\u1eddng g\u1eb7p: \n | \n\n Nh\u1ee9c \u0111\u1ea7u, chóng m\u1eb7t. \n | \n
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n Bu\u1ed3n ng\u1ee7. \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n D\u1ecb c\u1ea3m, gi\u1ea3m trí nh\u1edb, co gi\u1eadt, lo âu, run, viêm màng não vô khu\u1ea9n, r\u1ed1i lo\u1ea1n v\u1ecb giác, tai bi\u1ebfn m\u1ea1ch máu não. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 m\u1eaft \n | \n|
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: R\u1ed1i lo\u1ea1n th\u1ecb giác, nhìn m\u1edd, song th\u1ecb. \n | \n|
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 tai và ti\u1ec1n \u0111ình \n | \n|
| \n Hay g\u1eb7p: \n | \n\n Chóng m\u1eb7t. \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Ù tai, gi\u1ea3m thính giác. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 tim \n | \n|
| \n Ít g\u1eb7p *: Nh\u1ed3i máu c\u01a1 tim, suy tim, \u0111ánh tr\u1ed1ng ng\u1ef1c, \u0111au ng\u1ef1c. \n | \n|
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 m\u1ea1ch \n | \n|
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: T\u0103ng huy\u1ebft áp, viêm m\u1ea1ch. \n | \n|
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 hô h\u1ea5p, ng\u1ef1c và trung th\u1ea5t \n | \n|
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n Hen (k\u1ec3 c\u1ea3 khó th\u1edf). \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Viêm ph\u1ed5i. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 d\u1ea1 dày ru\u1ed9t \n | \n|
| \n Hay g\u1eb7p: \n | \n\n Bu\u1ed3n nôn, nôn, tiêu ch\u1ea3y, khó tiêu, \u0111au b\u1ee5ng, \u0111\u1ea7y h\u01a1i, chán \u0103n. \n | \n
| \n Hi\u1ec3m g\u1eb7p: \n | \n\n Viêm d\u1ea1 dày, xu\u1ea5t huy\u1ebft tiêu hóa, nôn ra máu, tiêu ch\u1ea3y xu\u1ea5t huy\u1ebft, tiêu phân \u0111en, loét d\u1ea1 dày -ru\u1ed9t (có ho\u1eb7c không có ch\u1ea3y máu ho\u1eb7c th\u1ee7ng). \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Viêm \u0111\u1ea1i tràng (bao g\u1ed3m c\u1ea3 viêm \u0111\u1ea1i tràng xu\u1ea5t huy\u1ebft và t\u0103ng \u0111\u1ed9 tr\u1ea7m tr\u1ecdng c\u1ee7a viêm \u0111\u1ea1i tràng ho\u1eb7c b\u1ec7nh Crohn), táo bón, viêm mi\u1ec7ng, viêm l\u01b0\u1ee1i, r\u1ed1i lo\u1ea1n th\u1ef1c qu\u1ea3n, chít h\u1eb9p ru\u1ed9t do t\u1ea1o màng ngang lòng ru\u1ed9t, viêm t\u1ee5y. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 gan m\u1eadt \n | \n|
| \n Th\u01b0\u1eddng g\u1eb7p: \n | \n\n T\u0103ng transaminase. \n | \n
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n Viêm gan, vàng da, r\u1ed1i lo\u1ea1n \u1edf gan. \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Viêm gan b\u1ea1o phát, ho\u1ea1i t\u1eed gan, suy gan. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 da và mô d\u01b0\u1edbi da \n | \n|
| \n Th\u01b0\u1eddng g\u1eb7p: \n | \n\n Phát ban. \n | \n
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n N\u1ed5i m\u1ec1 \u0111ay. \n | \n
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Viêm da bóng n\u01b0\u1edbc, chàm, ban \u0111\u1ecf, ban \u0111\u1ecf \u0111a hình, h\u1ed9i ch\u1ee9ng Stevens-Johnson, ho\u1ea1i t\u1eed bi\u1ec3u bì nhi\u1ec5m \u0111\u1ed9c (h\u1ed9i ch\u1ee9ng Lyell), viêm da tróc v\u1ea3y, r\u1ee5ng tóc, ph\u1ea3n \u1ee9ng c\u1ea3m quang, ban xu\u1ea5t huy\u1ebft, ban xu\u1ea5t huy\u1ebft Schonlein, ng\u1ee9a. \n | \n
| \n Các r\u1ed1i lo\u1ea1n v\u1ec1 th\u1eadn-ti\u1ebft ni\u1ec7u \n | \n|
| \n R\u1ea5t hi\u1ebfm g\u1eb7p: \n | \n\n Suy th\u1eadn c\u1ea5p, huy\u1ebft ni\u1ec7u, protein ni\u1ec7u, h\u1ed9i ch\u1ee9ng th\u1eadn h\u01b0, viêm \u1ed1ng th\u1eadn- mô k\u1ebd, ho\u1ea1i t\u1eed nhú th\u1eadn. \n | \n
| \n Các r\u1ed1i lo\u1ea1n chung và tình tr\u1ea1ng t\u1ea1i ch\u1ed7 dùng thu\u1ed1c \n | \n|
| \n Hi\u1ebfm g\u1eb7p: \n | \n\n Phù n\u1ec1. \n | \n
*T\u1ec9 l\u1ec7 ph\u1ea3n ánh s\u1ed1 li\u1ec7u t\u1eeb các tr\u1ecb li\u1ec7u lâu dài v\u1edbi li\u1ec1u cao (150mg/ngày)
\nMô t\u1ea3 các ph\u1ea3n \u1ee9ng ph\u1ee5 \u0111\u01b0\u1ee3c l\u1ef1a ch\u1ecdn:
\nHuy\u1ebft kh\u1ed1i \u0111\u1ed9ng m\u1ea1ch
\nCác phân tích meta và các d\u1eef li\u1ec7u d\u1ecbch t\u1ec5 d\u01b0\u1ee3c h\u1ecdc cho th\u1ea5y m\u1ed9t nguy c\u01a1 gia t\u0103ng nh\u1ecf c\u1ee7a các bi\u1ebfn c\u1ed1 huy\u1ebft kh\u1ed1i \u0111\u1ed9ng m\u1ea1ch (ví d\u1ee5 nh\u01b0 nh\u1ed3i máu c\u01a1 tim) liên quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng Diclofenac, \u0111\u1eb7c bi\u1ec7t \u1edf li\u1ec1u cao (150mg/ngày) và trong th\u1eddi gian \u0111i\u1ec1u tr\u1ecb dài (xem ph\u1ea7n C\u1ea2NH BÁO VÀ TH\u1eacN TR\u1eccNG).
\nThông báo cho bác s\u0129 nh\u1eefng tác d\u1ee5ng ph\u1ee5 không mong mu\u1ed1n g\u1eb7p ph\u1ea3i khi s\u1eed d\u1ee5ng thu\u1ed1c.
\nC\u1ea2NH BÁO VÀ TH\u1eacN TR\u1eccNG
\n\u0110\u1ecdc k\u1ef9 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng tr\u01b0\u1edbc khi dùng. N\u1ebfu c\u1ea7n thêm thông tin, xin h\u1ecfi ý ki\u1ebfn bác s\u0129. Thu\u1ed1c này ch\u1ec9 dùng theo s\u1ef1 kê \u0111\u01a1n c\u1ee7a bác s\u0129.
\n\u1ea2nh h\u01b0\u1edfng trên \u0111\u01b0\u1eddng tiêu hóa
\nLoét, ch\u1ea3y máu ho\u1eb7c th\u1ee7ng d\u1ea1 dày ru\u1ed9t, có th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eed vong, \u0111ã \u0111\u01b0\u1ee3c báo cáo v\u1edbi t\u1ea5t c\u1ea3 các NSAlD, bao g\u1ed3m c\u1ea3 diclofenac, và có th\u1ec3 x\u1ea3y ra b\u1ea5t c\u1ee9 lúc nào trong quá trình \u0111i\u1ec1u tr\u1ecb, có ho\u1eb7c không có kèm các tri\u1ec7u ch\u1ee9ng c\u1ea3nh báo ho\u1eb7c có ti\u1ec1n s\u1eed tr\u01b0\u1edbc \u0111ó v\u1ec1 b\u1ec7nh d\u1ea1 dày ru\u1ed9t nghiêm tr\u1ecdng. Nói chung, nh\u1eefng ph\u1ea3n \u1ee9ng này mang l\u1ea1i h\u1eadu qu\u1ea3 nghiêm tr\u1ecdng h\u01a1n \u1edf ng\u01b0\u1eddi cao tu\u1ed5i. N\u1ebfu có ch\u1ea3y máu ho\u1eb7c loét d\u1ea1 dày ru\u1ed9t \u1edf b\u1ec7nh nhân dùng Voltaren thì c\u1ea7n ng\u1eebng dùng thu\u1ed1c.
\nC\u0169ng nh\u01b0 t\u1ea5t c\u1ea3 các NSAIDs khác, bao g\u1ed3m c\u1ea3 diclofenac, b\u1eaft bu\u1ed9c ph\u1ea3i giám sát ch\u1eb7t ch\u1ebd v\u1ec1 y khoa và c\u1ea7n ph\u1ea3i th\u1eadn tr\u1ecdng \u0111\u1eb7c bi\u1ec7t khi kê \u0111\u01a1n Voltoren cho nh\u1eefng b\u1ec7nh nhân có các tri\u1ec7u ch\u1ee9ng r\u1ed1i lo\u1ea1n \u1edf \u0111\u01b0\u1eddng tiêu hóa ho\u1eb7c có ti\u1ec1n s\u1eed g\u1ee3i ý v\u1ec1 loét, ch\u1ea3y máu ho\u1eb7c th\u1ee7ng d\u1ea1 dày ho\u1eb7c ru\u1ed9t (xem ph\u1ea7n PH\u1ea2N \u1ee8NG B\u1ea4T L\u1ee2I C\u1ee6A THU\u1ed0C). Nguy c\u01a1 v\u1ec1 ch\u1ea3y máu d\u1ea1 dày-ru\u1ed9t cao h\u01a1n khi t\u0103ng li\u1ec1u NSAID và \u1edf nh\u1eefng b\u1ec7nh nhân có ti\u1ec1n s\u1eed loét, \u0111\u1eb7c bi\u1ec7t n\u1ebfu \u0111ã có bi\u1ebfn ch\u1ee9ng xu\u1ea5t huy\u1ebft ho\u1eb7c th\u1ee7ng và \u1edf ng\u01b0\u1eddi cao tu\u1ed5i.
\n\u0110\u1ec3 làm gi\u1ea3m nguy c\u01a1 \u0111\u1ed9c tính \u0111\u1ed1i v\u1edbi d\u1ea1 dày - ru\u1ed9t \u1edf nh\u1eefng b\u1ec7nh nhân có ti\u1ec1n s\u1eed loét, \u0111\u1eb7c bi\u1ec7t n\u1ebfu \u0111ã có bi\u1ebfn ch\u1ee9ng xu\u1ea5t huy\u1ebft ho\u1eb7c th\u1ee7ng, và \u1edf ng\u01b0\u1eddi cao tu\u1ed5i, nên \u0111i\u1ec1u tr\u1ecb kh\u1edfi \u0111\u1ea7u và \u0111i\u1ec1u tr\u1ecb duy trì v\u1edbi li\u1ec1u th\u1ea5p nh\u1ea5t mà có hi\u1ec7u qu\u1ea3. Nên xem xét \u0111i\u1ec1u tr\u1ecb k\u1ebft h\u1ee3p các thu\u1ed1c b\u1ea3o v\u1ec7 (nh\u01b0 các ch\u1ea5t \u1ee9c ch\u1ebf b\u01a1m proton ho\u1eb7c misoprostol) \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nhân này, và \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nhân \u0111ang c\u1ea7n s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi nh\u1eefng thu\u1ed1c ch\u1ee9a acid acetylsalicylic (ASA)/aspirin li\u1ec1u th\u1ea5p ho\u1eb7c nh\u1eefng thu\u1ed1c khác có kh\u1ea3 n\u0103ng làm t\u0103ng nguy c\u01a1 \u0111\u1ed1i v\u1edbi d\u1ea1 dày-ru\u1ed9t.
\nB\u1ec7nh nhân có ti\u1ec1n s\u1eed viêm loét, xu\u1ea5t huy\u1ebft d\u1ea1 dày ru\u1ed9t, \u0111\u1eb7c bi\u1ec7t \u1edf ng\u01b0\u1eddi cao tu\u1ed5i nên báo cáo b\u1ea5t k\u1ef3 tri\u1ec7u ch\u1ee9ng b\u1ea5t th\u01b0\u1eddng nào \u1edf \u0111\u01b0\u1eddng tiêu hóa. Nên th\u1eadn tr\u1ecdng \u1edf nh\u1eefng b\u1ec7nh nhân \u0111ang dùng \u0111\u1ed3ng th\u1eddi các thu\u1ed1c có th\u1ec3 làm t\u0103ng nguy c\u01a1 loét ho\u1eb7c ch\u1ea3y máu nh\u01b0 corticosteroid dùng \u0111\u01b0\u1eddng toàn thân, thu\u1ed1c ch\u1ed1ng \u0111ông máu, thu\u1ed1c ch\u1ed1ng ti\u1ec3u c\u1ea7u ho\u1eb7c thu\u1ed1c \u1ee9c ch\u1ebf thu h\u1ed3i serotonin ch\u1ecdn l\u1ecdc (xem ph\u1ea7n T\u01af\u01a0NG TÁC THU\u1ed0C).
\nC\u1ea7n giám sát y khoa ch\u1eb7t ch\u1ebd và ph\u1ea3i th\u1eadn tr\u1ecdng \u1edf nh\u1eefng b\u1ec7nh nhân b\u1ecb viêm loét \u0111\u1ea1i tràng ho\u1eb7c b\u1ec7nh Crohn, vì tình tr\u1ea1ng c\u1ee7a h\u1ecd có th\u1ec3 n\u1eb7ng lên (xem ph\u1ea7n PH\u1ea2N \u1ee8NG B\u1ea4T L\u1ee2I C\u1ee6A THU\u1ed0C).
\nTác d\u1ee5ng trên tim m\u1ea1ch
\n\u0110i\u1ec1u tr\u1ecb v\u1edbi các thu\u1ed1c NSAID k\u1ec3 c\u1ea3 diclofenac, \u0111\u1eb7c bi\u1ec7t \u1edf li\u1ec1u cao và dài h\u1ea1n, có th\u1ec3 \u0111\u01b0\u1ee3c liên k\u1ebft v\u1edbi m\u1ed9t nguy c\u01a1 gia t\u0103ng nh\u1ecf c\u1ee7a các bi\u1ebfn c\u1ed1 huy\u1ebft kh\u1ed1i tim m\u1ea1ch nghiêm tr\u1ecdng (bao g\u1ed3m c\u1ea3 nh\u1ed3i máu c\u01a1 tim và \u0111\u1ed9t qu\u1ef5).
\nNói chung, không khuy\u1ebfn cáo s\u1eed d\u1ee5ng Voltaren cho b\u1ec7nh nhân có b\u1ec7nh lý tim m\u1ea1ch (suy tim sung huy\u1ebft, b\u1ec7nh lý thi\u1ebfu máu tim, b\u1ec7nh \u0111\u1ed9ng m\u1ea1ch ngo\u1ea1i biên) ho\u1eb7c t\u0103ng huy\u1ebft áp không ki\u1ec3m soát. N\u1ebfu c\u1ea7n, các b\u1ec7nh nhân có b\u1ec7nh lý tim m\u1ea1ch, t\u0103ng huy\u1ebft áp không ki\u1ec3m soát ho\u1eb7c có các y\u1ebfu t\u1ed1 nguy c\u01a1 tim m\u1ea1ch quan tr\u1ecdng (nh\u01b0 t\u0103ng huy\u1ebft áp, t\u0103ng lipid máu, \u0111ái tháo \u0111\u01b0\u1eddng và hút thu\u1ed1c) ch\u1ec9 nên \u0111i\u1ec1u tr\u1ecb v\u1edbi Voltaren sau khi cân nh\u1eafc c\u1ea9n th\u1eadn và \u1edf li\u1ec1u ≤100mg m\u1ed9t ngày khi \u0111i\u1ec1u tr\u1ecb liên t\u1ee5c trên 4 tu\u1ea7n.
\nVì các nguy c\u01a1 tim m\u1ea1ch c\u1ee7a Diclofenac có th\u1ec3 t\u0103ng theo li\u1ec1u và th\u1eddi gian ti\u1ebfp xúc, li\u1ec1u hàng ngày th\u1ea5p nh\u1ea5t có hi\u1ec7u qu\u1ea3 nên \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong th\u1eddi gian ng\u1eafn nh\u1ea5t có th\u1ec3. Nên \u0111\u1ecbnh k\u1ef3 \u0111ánh giá l\u1ea1i s\u1ef1 c\u1ea7n thi\u1ebft c\u1ee7a b\u1ec7nh nhân trong \u0111áp \u1ee9ng và \u0111i\u1ec1u tr\u1ecb tri\u1ec7u ch\u1ee9ng, \u0111\u1eb7c bi\u1ec7t khi \u0111i\u1ec1u tr\u1ecb liên t\u1ee5c h\u01a1n 4 tu\u1ea7n. B\u1ec7nh nhân c\u1ea7n c\u1ea3nh giác v\u1edbi nh\u1eefng d\u1ea5u hi\u1ec7u và tri\u1ec7u ch\u1ee9ng c\u1ee7a huy\u1ebft kh\u1ed1i \u0111\u1ed9ng m\u1ea1ch (nh\u01b0 \u0111au ng\u1ef1c, h\u01a1i th\u1edf ng\u1eafn (h\u1ee5t h\u01a1i), suy nh\u01b0\u1ee3c, nói khó) có th\u1ec3 xu\u1ea5t hi\u1ec7n ngoài c\u1ea3nh báo. Trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p nh\u01b0 v\u1eady, b\u1ec7nh nhân c\u1ea7n \u0111\u01b0\u1ee3c h\u01b0\u1edbng d\u1eabn t\u1edbi g\u1eb7p bác s\u0129 ngay.
\nCác tác d\u1ee5ng trên huy\u1ebft h\u1ecdc
\nKhi dùng Voltaren lâu dài, c\u0169ng nh\u01b0 các NSAID khác, c\u1ea7n ph\u1ea3i theo dõi công th\u1ee9c máu.
\nC\u0169ng nh\u01b0 v\u1edbi các NSAID khác, Voltaren có th\u1ec3 nh\u1ea5t th\u1eddi \u1ee9c ch\u1ebf s\u1ef1 k\u1ebft t\u1eadp ti\u1ec3u c\u1ea7u. C\u1ea7n theo dõi c\u1ea9n th\u1eadn nh\u1eefng b\u1ec7nh nhân có r\u1ed1i lo\u1ea1n v\u1ec1 c\u1ea7m máu.
\nTác d\u1ee5ng trên hô h\u1ea5p (hen có t\u1eeb tr\u01b0\u1edbc)
\n\u1ede các b\u1ec7nh nhân b\u1ecb hen, viêm m\u0169i d\u1ecb \u1ee9ng theo mùa, s\u01b0ng niêm m\u1ea1c m\u0169i (nh\u01b0 polyp m\u0169i), b\u1ec7nh ph\u1ed5i t\u1eafc ngh\u1ebdn m\u1ea1n tính ho\u1eb7c nhi\u1ec5m khu\u1ea9n m\u1ea1n tính \u0111\u01b0\u1eddng hô h\u1ea5p (\u0111\u1eb7c bi\u1ec7t n\u1ebfu có liên quan \u0111\u1ebfn các tri\u1ec7u ch\u1ee9ng nh\u01b0 viêm m\u0169i d\u1ecb \u1ee9ng) thì các ph\u1ea3n \u1ee9ng v\u1edbi thu\u1ed1c NSAIDs nh\u01b0 các c\u01a1n hen k\u1ecbch phát (\u0111\u01b0\u1ee3c g\u1ecdi là không dung n\u1ea1p v\u1edbi các thu\u1ed1c gi\u1ea3m \u0111au/hen do thu\u1ed1c gi\u1ea3m \u0111au), phù Quinck ho\u1eb7c mày \u0111ay, th\u01b0\u1eddng g\u1eb7p nhi\u1ec1u h\u01a1n \u1edf các b\u1ec7nh nhân khác. Do \u0111ó, c\u1ea7n \u0111\u1eb7c bi\u1ec7t th\u1eadn tr\u1ecdng v\u1edbi các b\u1ec7nh nhân nh\u01b0 v\u1eady (chu\u1ea9n b\u1ecb s\u1eb5n sàng ph\u01b0\u01a1ng ti\u1ec7n c\u1ea5p c\u1ee9u). C\u0169ng ph\u1ea3i chú ý \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi nh\u1eefng b\u1ec7nh nhân \u0111ã t\u1eebng b\u1ecb d\u1ecb \u1ee9ng v\u1edbi các ch\u1ea5t khác, nh\u01b0 ph\u1ea3n \u1ee9ng v\u1edbi da, ng\u1ee9a ho\u1eb7c mày \u0111ay.
\nTác d\u1ee5ng trên h\u1ec7 gan m\u1eadt
\nYêu c\u1ea7u giám sát y t\u1ebf ch\u1eb7t ch\u1ebd khi kê \u0111\u01a1n Voltaren cho b\u1ec7nh nhân suy gi\u1ea3m ch\u1ee9c n\u0103ng gan vì tình tr\u1ea1ng c\u1ee7a h\u1ecd có th\u1ec3 n\u1eb7ng thêm.
\nC\u0169ng nh\u01b0 v\u1edbi các NSAIDs khác, bao g\u1ed3m Diclofenac, tr\u1ecb s\u1ed1 c\u1ee7a m\u1ed9t hay nhi\u1ec1u enzym gan có th\u1ec3 t\u0103ng. Trong quá trình \u0111i\u1ec1u tr\u1ecb kéo dài v\u1edbi Voltaren (nh\u01b0 v\u1edbi d\u1ea1ng viên nén ho\u1eb7c thu\u1ed1c \u0111\u1eb7t), theo dõi th\u01b0\u1eddng xuyên ch\u1ee9c n\u0103ng gan \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh nh\u01b0 m\u1ed9t bi\u1ec7n pháp phòng ng\u1eeba. N\u1ebfu xét nghi\u1ec7m ch\u1ee9c n\u0103ng gan b\u1ea5t th\u01b0\u1eddng kéo dài ho\u1eb7c t\u1ed3i t\u1ec7 h\u01a1n, n\u1ebfu có d\u1ea5u hi\u1ec7u lâm sàng ho\u1eb7c tri\u1ec7u ch\u1ee9ng liên quan \u0111\u1ebfn b\u1ec7nh gan phát tri\u1ec3n ho\u1eb7c n\u1ebfu các bi\u1ec3u hi\u1ec7n khác xu\u1ea5t hi\u1ec7n (nh\u01b0 t\u0103ng b\u1ea1ch c\u1ea7u eosin, phát ban) nên ng\u01b0ng s\u1eed d\u1ee5ng Voltaren. Viêm gan có th\u1ec3 x\u1ea3y ra khi s\u1eed d\u1ee5ng Diclofenac mà không có tri\u1ec7u ch\u1ee9ng báo tr\u01b0\u1edbc. Th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng Voltaren cho nh\u1eefng b\u1ec7nh nhân r\u1ed1i lo\u1ea1n chuy\u1ec3n hóa Porphyrin gan vì có th\u1ec3 gây ra c\u01a1n Porphyrin c\u1ea5p.
\nPh\u1ea3n \u1ee9ng \u1edf da
\nCác ph\u1ea3n \u1ee9ng da nghiêm tr\u1ecdng, m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p b\u1ecb t\u1eed vong, bao g\u1ed3m viêm da tróc v\u1ea3y, h\u1ed9i ch\u1ee9ng Stevens-Johnson và ho\u1ea1i t\u1eed bi\u1ec3u bì nhi\u1ec5m \u0111\u1ed9c \u0111ã \u0111\u01b0\u1ee3c ghi nh\u1eadn trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p r\u1ea5t hi\u1ebfm liên quan v\u1edbi vi\u1ec7c dùng NSAID, k\u1ec3 c\u1ea3 Voltaren (xem ph\u1ea7n PH\u1ea2N \u1ee8NG B\u1ea4T L\u1ee2I C\u1ee6A THU\u1ed0C). B\u1ec7nh nhân có nguy c\u01a1 cao nh\u1ea5t v\u1ec1 các ph\u1ea3n \u1ee9ng này s\u1edbm trong ti\u1ebfn trình \u0111i\u1ec1u tr\u1ecb, kh\u1edfi phát ph\u1ea3n \u1ee9ng x\u1ea3y ra trong \u0111a s\u1ed1 tr\u01b0\u1eddng h\u1ee3p trong vòng tháng \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb. Ph\u1ea3i ng\u1eebng Voltaren khi có bi\u1ec3u hi\u1ec7n \u0111\u1ea7u tiên v\u1ec1 phát ban da, t\u1ed5n th\u01b0\u01a1ng niêm m\u1ea1c ho\u1eb7c b\u1ea5t k\u1ef3 d\u1ea5u hi\u1ec7u quá m\u1eabn nào khác.
\nC\u0169ng nh\u01b0 các NSAID khác, các ph\u1ea3n \u1ee9ng d\u1ecb \u1ee9ng k\u1ec3 c\u1ea3 ph\u1ea3n \u1ee9ng ph\u1ea3n v\u1ec7/ph\u1ea3n \u1ee9ng ki\u1ec3u ph\u1ea3n v\u1ec7 c\u0169ng có th\u1ec3 x\u1ea3y ra trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p hi\u1ebfm g\u1eb7p v\u1edbi diclofenac mà không có ti\u1ebfp xúc tr\u01b0\u1edbc \u0111ó v\u1edbi thu\u1ed1c.
\nTác d\u1ee5ng trên th\u1eadn
\n\u0110i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c NSAIDs k\u1ec3 c\u1ea3 diclofenac th\u01b0\u1eddng gây gi\u1eef d\u1ecbch và phù, nên c\u1ea7n \u0111\u1eb7c bi\u1ec7t chú ý khi dùng cho b\u1ec7nh nhân b\u1ecb t\u1ed5n th\u01b0\u01a1ng ch\u1ee9c n\u0103ng tim ho\u1eb7c th\u1eadn, có ti\u1ec1n s\u1eed b\u1ecb t\u0103ng huy\u1ebft áp, ng\u01b0\u1eddi cao tu\u1ed5i, b\u1ec7nh nhân \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb \u0111\u1ed3ng th\u1eddi v\u1edbi thu\u1ed1c l\u1ee3i ni\u1ec7u ho\u1eb7c các thu\u1ed1c \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ee9c n\u0103ng th\u1eadn, và nh\u1eefng b\u1ec7nh nhân m\u1ea5t d\u1ecbch ngoài t\u1ebf bào do b\u1ea5t c\u1ee9 nguyên nhân nào, ví d\u1ee5 tr\u01b0\u1edbc ho\u1eb7c sau nh\u1eefng ph\u1eabu thu\u1eadt l\u1edbn (xem m\u1ee5c CH\u1ed0NG CH\u1ec8 \u0110\u1ecaNH). Theo dõi ch\u1ee9c n\u0103ng th\u1eadn là bi\u1ec7n pháp phòng ng\u1eeba s\u1edbm khi dùng Voltaren trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p nh\u01b0 v\u1eady. Ng\u1eebng \u0111i\u1ec1u tr\u1ecb th\u01b0\u1eddng ph\u1ee5c h\u1ed3i l\u1ea1i \u0111\u01b0\u1ee3c tr\u1ea1ng thái tr\u01b0\u1edbc \u0111i\u1ec1u tr\u1ecb.
\nB\u1ec7nh nhân cao tu\u1ed5i
\nC\u1ea7n ph\u1ea3i th\u1eadn tr\u1ecdng \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi cao tu\u1ed5i \u0111ang có nh\u1eefng b\u1ec7nh lý n\u1ed9i khoa c\u01a1 b\u1ea3n. \u0110\u1eb7c bi\u1ec7t khuy\u1ebfn cáo dùng li\u1ec1u th\u1ea5p nh\u1ea5t có hi\u1ec7u qu\u1ea3 \u1edf b\u1ec7nh nhân già y\u1ebfu ho\u1eb7c nh\u1eefng ng\u01b0\u1eddi nh\u1eb9 cân.
\nT\u01b0\u01a1ng tác v\u1edbi NSAIDs
\nKhông nên s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi Voltaren v\u1edbi các NSAID dùng \u0111\u01b0\u1eddng toàn thân bao g\u1ed3m c\u1ea3 các ch\u1ea5t \u1ee9c ch\u1ebf ch\u1ecdn l\u1ecdc cyclooxygenase-2 \u0111\u1ec3 tránh các tác d\u1ee5ng không mong mu\u1ed1n x\u1ea3y ra (xem ph\u1ea7n T\u01af\u01a0NG TÁC THU\u1ed0C).
\nChe l\u1ea5p các d\u1ea5u hi\u1ec7u nhi\u1ec5m khu\u1ea9n
\nGi\u1ed1ng nh\u01b0 các NSAID khác, Voltaren có th\u1ec3 che l\u1ea5p nh\u1eefng d\u1ea5u hi\u1ec7u và tri\u1ec7u ch\u1ee9ng nhi\u1ec5m khu\u1ea9n do các \u0111\u1eb7c tính d\u01b0\u1ee3c l\u1ef1c h\u1ecdc c\u1ee7a nó.
\nT\u01af\u01a0NG TÁC V\u1edaI CÁC THU\u1ed0C KHÁC
\nNh\u1eefng t\u01b0\u01a1ng tác thu\u1ed1c sau \u0111ây bao g\u1ed3m c\u1ea3 nh\u1eefng tr\u01b0\u1eddng h\u1ee3p \u0111ã quan sát \u0111\u01b0\u1ee3c khi dùng Voltaren viên nén phóng thích kéo dài và/ho\u1eb7c các d\u1ea1ng bào ch\u1ebf khác c\u1ee7a diclofenac.
\nCác t\u01b0\u01a1ng tác nên \u0111\u01b0\u1ee3c xem xét
\nCh\u1ea5t \u1ee9c ch\u1ebf m\u1ea1nh CYP2C9: Th\u1eadn tr\u1ecdng \u0111\u01b0\u1ee3c khuy\u1ebfn cáo khi dùng \u0111\u1ed3ng th\u1eddi diclofenac v\u1edbi ch\u1ea5t \u1ee9c ch\u1ebf CYP2C9 m\u1ea1nh (nh\u01b0 sulfinpyrazone và voriconazole), \u0111i\u1ec1u này có th\u1ec3 gây t\u0103ng \u0111áng k\u1ec3 n\u1ed3ng \u0111\u1ed9 \u0111\u1ec9nh trong huy\u1ebft t\u01b0\u01a1ng và s\u1ef1 ph\u01a1i nhi\u1ec5m diclofenac do \u1ee9c ch\u1ebf s\u1ef1 chuy\u1ec3n hóa c\u1ee7a diclofenac.
\nLithium: N\u1ebfu \u0111\u01b0\u1ee3c dùng \u0111\u1ed3ng th\u1eddi, diclofenac có th\u1ec3 làm t\u0103ng n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a lithium. Vi\u1ec7c ki\u1ec3m soát n\u1ed3ng \u0111\u1ed9 lithium trong huy\u1ebft thanh \u0111\u01b0\u1ee3c khuy\u1ebfn cáo.
\nDigoxin: N\u1ebfu \u0111\u01b0\u1ee3c dùng \u0111\u1ed3ng th\u1eddi, diclofenac có th\u1ec3 làm t\u0103ng n\u1ed3ng \u0111\u1ed9 trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a digoxin. Vi\u1ec7c ki\u1ec3m soát n\u1ed3ng \u0111\u1ed9 digoxin trong huy\u1ebft thanh \u0111\u01b0\u1ee3c khuy\u1ebfn cáo.
\nCác thu\u1ed1c l\u1ee3i ti\u1ec3u và thu\u1ed1c ch\u1ed1ng t\u0103ng huy\u1ebft áp: Gi\u1ed1ng nh\u01b0 các NSAID khác, s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi diclofenac v\u1edbi các thu\u1ed1c l\u1ee3i ti\u1ec3u ho\u1eb7c thu\u1ed1c ch\u1ed1ng t\u0103ng huy\u1ebft áp (ví d\u1ee5 nh\u01b0 các thu\u1ed1c ch\u1eb9n beta, \u1ee9c ch\u1ebf men chuy\u1ec3n angiotensin (ACE) có th\u1ec3 làm gi\u1ea3m tác d\u1ee5ng ch\u1ed1ng t\u0103ng huy\u1ebft áp c\u1ee7a các thu\u1ed1c này. Do \u0111ó vi\u1ec7c k\u1ebft h\u1ee3p c\u1ea7n ph\u1ea3i th\u1eadn tr\u1ecdng và \u1edf nh\u1eefng b\u1ec7nh nhân này, \u0111\u1eb7c bi\u1ec7t là ng\u01b0\u1eddi già, nên ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 huy\u1ebft áp c\u1ee7a h\u1ecd. B\u1ec7nh nhân nên \u0111\u01b0\u1ee3c bù n\u01b0\u1edbc \u0111\u1ea7y \u0111\u1ee7 và c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m tra ch\u1ee9c n\u0103ng th\u1eadn sau khi b\u1eaft \u0111\u1ea7u dùng ph\u1ed1i h\u1ee3p và ki\u1ec3m tra \u0111\u1ecbnh k\u1ef3 sau \u0111ó, \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi các thu\u1ed1c l\u1ee3i ti\u1ec3u và \u1ee9c ch\u1ebf ACE do có th\u1ec3 làm t\u0103ng nguy c\u01a1 gây \u0111\u1ed9c cho th\u1eadn (xem ph\u1ea7n C\u1ea2NH BÁO VÀ TH\u1eacN TR\u1eccNG).
\nCiclosporin: Diclofenac, gi\u1ed1ng nh\u01b0 các NSAID khác, có th\u1ec3 làm t\u0103ng \u0111\u1ed9c tính \u0111\u1ed1i v\u1edbi th\u1eadn c\u1ee7a ciclosporin do tác d\u1ee5ng trên prostaglandin \u1edf th\u1eadn. Vì v\u1eady, trong tr\u01b0\u1eddng h\u1ee3p này, ph\u1ea3i dùng li\u1ec1u diclofenac th\u1ea5p h\u01a1n li\u1ec1u th\u01b0\u1eddng dùng \u1edf các b\u1ec7nh nhân không dùng Ciclosporin.
\nThu\u1ed1c gây t\u0103ng kali máu: Dùng \u0111\u1ed3ng th\u1eddi v\u1edbi thu\u1ed1c l\u1ee3i ti\u1ec3u gi\u1eef kali, ciclosporin, tacrolimus ho\u1eb7c trimethoprim có th\u1ec3 làm t\u0103ng n\u1ed3ng \u0111\u1ed9 kali trong huy\u1ebft thanh, do \u0111ó c\u1ea7n \u0111\u01b0\u1ee3c theo dõi th\u01b0\u1eddng xuyên n\u1ed3ng \u0111\u1ed9 kali huy\u1ebft thanh (xem ph\u1ea7n C\u1ea2NH BÁO VÀ TH\u1eacN TR\u1eccNG).
\nThu\u1ed1c kháng khu\u1ea9n quinolone: \u0110ã có báo cáo riêng l\u1ebb v\u1ec1 co gi\u1eadt do dùng \u0111\u1ed3ng th\u1eddi quinolone và NSAID.
\nCác t\u01b0\u01a1ng tác d\u1ef1 ki\u1ebfn \u0111\u01b0\u1ee3c xem xét
\nCác NSAID khác và corticosteroid: Dùng \u0111\u1ed3ng th\u1eddi diclofenac và các NSAID \u0111\u01b0\u1eddng toàn thân khác ho\u1eb7c corticosteroid có th\u1ec3 làm t\u0103ng t\u1ea7n su\u1ea5t b\u1ecb các tác d\u1ee5ng ph\u1ee5 trên d\u1ea1 dày ru\u1ed9t (xem ph\u1ea7n C\u1ea2NH BÁO VÀ TH\u1eacN TR\u1eccNG).
\nCác thu\u1ed1c ch\u1ed1ng \u0111ông và kháng ti\u1ec3u c\u1ea7u: C\u1ea7n th\u1eadn tr\u1ecdng do khi dùng \u0111\u1ed3ng th\u1eddi có th