Ứng dụng Nhà thuốc Upharma
Nhà thuốc Upharma
Thuốc Viacoram Tab 7mg/5mg điều trị tăng huyết áp (Hộp 30 viên)
Thuốc Viacoram Tab 7mg/5mg điều trị tăng huyết áp (Hộp 30 viên)

Thuốc Viacoram Tab 7mg/5mg điều trị tăng huyết áp (Hộp 30 viên)

Thương hiệu
Công dụng
Điều trị tăng huyết áp vô căn ở người lớn.
Dạng bào chế
Viên nén
Thành phần chính
Perindopril arginine, Amlodipin
Xuất xứ
Pháp
Số đăng ký
VN3-47-18
Thông tin sản phẩm

Thông tin sản phẩm

[{"title": "Th\u00e0nh ph\u1ea7n", "content": "

Thành ph\u1ea7n d\u01b0\u1ee3c ch\u1ea5t:

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Viacoram 7mg/5mg: M\u1ed7i viên nén ch\u1ee9a 4,756 mg perindopril t\u01b0\u01a1ng \u1ee9ng v\u1edbi 7 mg perindopril arginin và 6,935 mg amlodipin besilat t\u01b0\u01a1ng \u1ee9ng v\u1edbi 5 mg amlodipine.

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Thành ph\u1ea7n tá d\u01b0\u1ee3c:

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Lactose monohydrate, cellulose vi tinh th\u1ec3 (E460), silica d\u1ea1ng keo khan (E551), magie stearat (E470B).

", "index": 1}, {"title": "C\u00f4ng d\u1ee5ng", "content": "", "index": 2}, {"title": "T\u00e1c d\u1ee5ng ph\u1ee5", "content": "
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Tóm t\u1eaft d\u1eef li\u1ec7u v\u1ec1 \u0111\u1ed9 an toàn:

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D\u1eef li\u1ec7u v\u1ec1 \u0111\u1ed9 an toàn c\u1ee7a Viacoram \u0111ã \u0111\u01b0\u1ee3c \u0111ánh giá trong m\u1ed9t nghiên c\u1ee9u 6 tháng có \u0111\u1ed1i ch\u1ee9ng bao g\u1ed3m 1771 b\u1ec7nh nhân, trong \u0111ó 887 b\u1ec7nh nhân dùng Viacoram, m\u1ed9t nghiên c\u1ee9u 6 tu\u1ea7n có \u0111\u1ed1i ch\u1ee9ng bao g\u1ed3m 837 b\u1ec7nh nhân, trong \u0111ó 279 b\u1ec7nh nhân dùng Viacoram và m\u1ed9t nghiên c\u1ee9u 8 tu\u1ea7n có \u0111\u1ed1i ch\u1ee9ng placebo bao g\u1ed3m 1581 b\u1ec7nh nhân, trong \u0111ó 249 b\u1ec7nh nhân dùng Viacoram.

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Trong các nghiên c\u1ee9u lâm sàng này, không có các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i \u0111áng k\u1ec3 \u0111\u01b0\u1ee3c ghi nh\u1eadn khi k\u1ebft h\u1ee3p, so v\u1edbi các tác d\u1ee5ng b\u1ea5t l\u1ee3i \u0111ã \u0111\u01b0\u1ee3c bi\u1ebft \u0111\u1ebfn c\u1ee7a t\u1eebng thành ph\u1ea7n riêng l\u1ebb.

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Các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i d\u01b0\u1edbi \u0111ây \u0111\u01b0\u1ee3c ghi nh\u1eadn th\u01b0\u1eddng xuyên nh\u1ea5t trong các th\u1eed nghi\u1ec7m lâm sàng: chóng m\u1eb7t, ho và phù. Các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i tr\u01b0\u1edbc \u0111ây \u0111ã \u0111\u01b0\u1ee3c ghi nh\u1eadn trong các th\u1eed nghi\u1ec7m lâm sàng và/ho\u1eb7c sau khi \u0111\u01b0a thu\u1ed1c ra th\u1ecb tr\u01b0\u1eddng v\u1edbi t\u1eebng thành ph\u1ea7n \u0111\u01a1n l\u1ebb c\u1ee7a Viacoram (perindopril và amlodipin) \u0111\u01b0\u1ee3c li\u1ec7t kê trong b\u1ea3ng d\u01b0\u1edbi dây do chúng có th\u1ec3 x\u1ea3y ra v\u1edbi li\u1ec1u k\u1ebft h\u1ee3p c\u1ed1 \u0111\u1ecbnh.

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B\u1ea3ng li\u1ec7t kê các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i:

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Các tác d\u1ee5ng b\u1ea5t l\u1ee3i d\u01b0\u1edbi \u0111ây \u0111ã \u0111\u01b0\u1ee3c ghi nh\u1eadn trong quá trình \u0111i\u1ec1u tr\u1ecb b\u1eb1ng VIACORAM, perindopril ho\u1eb7c amlodipin \u0111\u01a1n \u0111\u1ed9c và \u0111\u01b0\u1ee3c s\u1eafp x\u1ebfp theo phân lo\u1ea1i MedDRA theo h\u1ec7 c\u01a1 quan và theo t\u1ea7n su\u1ea5t nh\u01b0 sau:

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R\u1ea5t ph\u1ed5 bi\u1ebfn (≥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 (≥1/10000 \u0111\u1ebfn <1/1000); r\u1ea5t hi\u1ebfm g\u1eb7p (<1/10000); ch\u01b0a bi\u1ebft rõ (không \u01b0\u1edbc tính \u0111\u01b0\u1ee3c t\u1eeb các d\u1eef li\u1ec7u hi\u1ec7n có).

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
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MedDRA

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Phân lo\u1ea1i theo h\u1ec7 c\u01a1 quan

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Tác d\u1ee5ng không mong mu\u1ed1n

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T\u1ea7n su\u1ea5t

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VIACORAM

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(Perindopril/

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Amlodipin)

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Amlodipin

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Perindopril

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Nhi\u1ec5m khu\u1ea9n và nhi\u1ec5m ký sinh

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Viêm m\u0169i

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Ít g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n máu và h\u1ec7 b\u1ea1ch huy\u1ebft

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T\u0103ng b\u1ea1ch c\u1ea7u \u01b0a eosin

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Ít g\u1eb7p*

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Gi\u1ea3m b\u1ea1ch c\u1ea7u/ gi\u1ea3m b\u1ea1ch c\u1ea7u trung tính

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R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p

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M\u1ea5t b\u1ea1ch c\u1ea7u h\u1ea1t ho\u1eb7c gi\u1ea3m toàn th\u1ec3 huy\u1ebft c\u1ea7u

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R\u1ea5t hi\u1ebfm g\u1eb7p

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Gi\u1ea3m ti\u1ec3u c\u1ea7u

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R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p

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Thi\u1ebfu máu tan huy\u1ebft trên b\u1ec7nh nhân thi\u1ebfu h\u1ee5t b\u1ea9m sinh G-6PDH

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R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n h\u1ec7 mi\u1ec5n d\u1ecbch

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Quá m\u1eabn

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R\u1ea5t hi\u1ebfm g\u1eb7p

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Ít g\u1eb7p

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R\u1ed1i lo\u1ea1n n\u1ed9i ti\u1ebft

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H\u1ed9i ch\u1ee9ng bài ti\u1ebft hormone ch\u1ed1ng I\u1ee3i ti\u1ec3u không phù h\u1ee3p (SIADH)

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Ch\u01b0a bi\u1ebft rõ

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R\u1ed1i lo\u1ea1n chuy\u1ec3n hóa và dinh d\u01b0\u1ee1ng

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T\u0103ng kali máu

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Ít g\u1eb7p

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Ít g\u1eb7p*

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T\u0103ng glucose máu

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Ít g\u1eb7p\n

R\u1ea5t hi\u1ebfm g\u1eb7p

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H\u1ea1 natri máu

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Ít g\u1eb7p*

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H\u1ea1 glucose máu

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Ít g\u1eb7p*

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R\u1ed1i lo\u1ea1n tâm th\u1ea7n

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Thay \u0111\u1ed5i tâm tr\u1ea1ng (bao g\u1ed3m c\u1ea3 lo âu)

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Ít g\u1eb7p

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Ít g\u1eb7p

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M\u1ea5t ng\u1ee7

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Ít g\u1eb7p

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Tr\u1ea7m c\u1ea3m

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Ít g\u1eb7p

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R\u1ed1i lo\u1ea1n gi\u1ea5c ng\u1ee7

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Ít g\u1eb7p

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Tr\u1ea1ng thái l\u1eabn l\u1ed9n

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Hi\u1ebfm g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n h\u1ec7 th\u1ea7n kinhChóng m\u1eb7t (\u0111\u1eb7c bi\u1ec7t trong giai \u0111o\u1ea1n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb)Th\u01b0\u1eddng g\u1eb7p\n

Th\u01b0\u1eddng g\u1eb7p

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Th\u01b0\u1eddng

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g\u1eb7p

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\u0110au \u0111\u1ea7u (\u0111\u1eb7c bi\u1ec7t trong giai \u0111o\u1ea1n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb) \n

Th\u01b0\u1eddng g\u1eb7p

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Th\u01b0\u1eddng g\u1eb7p
Bu\u1ed3n ng\u1ee7 (\u0111\u1eb7c bi\u1ec7t trong giai \u0111o\u1ea1n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb) Th\u01b0\u1eddng g\u1eb7pÍt g\u1eb7p*
R\u1ed1i lo\u1ea1n v\u1ecb giác Ít g\u1eb7p\n

Th\u01b0\u1eddng g\u1eb7p

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D\u1ecb c\u1ea3m Ít g\u1eb7p\n

Th\u01b0\u1eddng g\u1eb7p

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Ng\u1ea5t x\u1ec9u Ít g\u1eb7pÍt g\u1eb7p*
Gi\u1ea3m c\u1ea3m giác Ít g\u1eb7p 
Run Ít g\u1eb7p 
T\u0103ng tr\u01b0\u01a1ng l\u1ef1c c\u01a1 \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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B\u1ec7nh lý th\u1ea7n kinh ngo\u1ea1i biên \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Tai bi\u1ebfn m\u1ea1ch máu não có th\u1ec3 gây ra b\u1edfi vi\u1ec7c h\u1ea1 huy\u1ebft áp quá m\u1ee9c \u1edb nh\u1eefng b\u1ec7nh nhân có nguy c\u01a1 cao \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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H\u1ed9i ch\u1ee9ng ngo\u1ea1i tháp Ch\u01b0a bi\u1ebft rõ 
R\u1ed1i lo\u1ea1n trên m\u1eaftSuy gi\u1ea3m th\u1ecb giác \n

Th\u01b0\u1eddng g\u1eb7p

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Th\u01b0\u1eddng g\u1eb7p
Ch\u1ee9ng nhìn \u0111ôi Th\u01b0\u1eddng g\u1eb7p 
R\u1ed1i lo\u1ea1n tai và mê \u0111\u1ea1oÙ tai Ít g\u1eb7p\n

Th\u01b0\u1eddng g\u1eb7p

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Chóng m\u1eb7t  Th\u01b0\u1eddng g\u1eb7p
R\u1ed1i lo\u1ea1n trên tim\u0110ánh tr\u1ed1ng ng\u1ef1c Th\u01b0\u1eddng g\u1eb7pÍt g\u1eb7p
Nh\u1ecbp tim nhanh  Ít g\u1eb7p*
\u0110au th\u1eaft ng\u1ef1c  \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Nh\u1ed3i máu c\u01a1 tim, có th\u1ec3 gây ra b\u1edfi vi\u1ec7c h\u1ea1 huy\u1ebft áp quá m\u1ee9c \u1edf nh\u1eefng b\u1ec7nh nhân có nguy c\u01a1 cao R\u1ea5t hi\u1ebfm g\u1eb7pR\u1ea5t hi\u1ebfm g\u1eb7p
Lo\u1ea1n nh\u1ecbp (bao g\u1ed3m nh\u1ecbp tim ch\u1eadm, nh\u1ecbp nhanh th\u1ea5t và rung nh\u0129) Ít g\u1eb7pR\u1ea5t hi\u1ebfm g\u1eb7p
R\u1ed1i lo\u1ea1n m\u1ea1ch\u0110\u1ecf b\u1eebng m\u1eb7t Th\u01b0\u1eddng g\u1eb7p 
H\u1ea1 huy\u1ebft áp (và các tác d\u1ee5ng liên quan \u0111\u1ebfn h\u1ea1 huy\u1ebft áp) Ít g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
 Viêm m\u1ea1ch\n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Ít g\u1eb7p* 
R\u1ed1i lo\u1ea1n hô h\u1ea5p, l\u1ed3ng ng\u1ef1c và trung th\u1ea5tHoTh\u01b0\u1eddng g\u1eb7pÍt g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Khó th\u1edf \n

Th\u01b0\u1eddng g\u1eb7p

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Th\u01b0\u1eddng g\u1eb7p

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Co th\u1eaft ph\u1ebf qu\u1ea3n  Ít g\u1eb7p
Viêm ph\u1ed5i t\u0103ng b\u1ea1ch c\u1ea7u \u01b0a eosin  \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n tiêu hóa\u0110au b\u1ee5ng Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Bu\u1ed3n nôn Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Nôn Ít g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Khó tiêu Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Tiêu ch\u1ea3y Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
Táo bón Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
R\u1ed1i lo\u1ea1n tiêu hóa Th\u01b0\u1eddng g\u1eb7p 
Khô mi\u1ec7ng Ít g\u1eb7pÍt g\u1eb7p
T\u0103ng s\u1ea3n n\u01b0\u1edbu \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Viêm t\u1ee5y \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p
Viêm d\u1ea1 dày R\u1ea5t hi\u1ebfm g\u1eb7p 
R\u1ed1i lo\u1ea1n gan m\u1eadtViêm gan, vàng da \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Viêm gan ly gi\u1ea3i t\u1ebf bào ho\u1eb7c viêm gan \u1ee9 m\u1eadt \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n da và mô du\u1edbi daNg\u1ee9a Ít g\u1eb7p 
T\u0103ng ti\u1ebft m\u1ed3 hôi Ít g\u1eb7pÍt g\u1eb7p
R\u1ee5ng tóc Ít g\u1eb7p 
Ban xu\u1ea5t huy\u1ebft Ít g\u1eb7p 
\u0110\u1ed5i màu da Ít g\u1eb7p 
B\u1ec7nh bóng n\u01b0\u1edbc  Ít g\u1eb7p*
Phù m\u1eb7t, \u0111\u1ea7u chi, môi, niêm m\u1ea1c, l\u01b0\u1ee1i, thanh môn và/ho\u1eb7c thanh qu\u1ea3n R\u1ea5t hi\u1ebfm g\u1eb7pÍt g\u1eb7p
M\u1ec1 \u0111ay Ít g\u1eb7pÍt g\u1eb7p
Ph\u1ea3n \u1ee9ng m\u1eabn c\u1ea3m v\u1edbi ánh sáng \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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Ít g\u1eb7p*
H\u1ed3ng ban \u0111a d\u1ea1ngÍt g\u1eb7p\n

R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ea5t hi\u1ebfm g\u1eb7p
Phù Quinck R\u1ea5t hi\u1ebfm g\u1eb7p 
H\u1ed9i ch\u1ee9ng Stevens-Johnson R\u1ea5t hi\u1ebfm g\u1eb7p 
Viêm da tróc v\u1ea9y R\u1ea5t hi\u1ebfm g\u1eb7p 
R\u1ed1i lo\u1ea1n c\u01a1 x\u01b0\u01a1ng và mô liên k\u1ebft\u0110au l\u01b0ng Ít g\u1eb7p 
S\u01b0ng m\u1eaft cá chân Th\u01b0\u1eddng g\u1eb7p 
Chu\u1ed9t rút Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
\u0110au kh\u1edbp \u0111au c\u01a1 Ít g\u1eb7pÍt g\u1eb7p*
R\u1ed1i lo\u1ea1n ti\u1ebft ni\u1ec7uR\u1ed1i lo\u1ea1n ti\u1ec3u ti\u1ec7n, ti\u1ec3u \u0111êm, t\u0103ng s\u1ed1 l\u1ea7n \u0111i ti\u1ec3u Ít g\u1eb7p 
Suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn  Ít g\u1eb7p
Suy th\u1eadn c\u1ea5p  \n

R\u1ea5t hi\u1ebfm g\u1eb7p

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R\u1ed1i lo\u1ea1n h\u1ec7 sinh s\u1ea3n và tuy\u1ebfn vúR\u1ed1i lo\u1ea1n c\u01b0\u01a1ng Ít g\u1eb7pÍt g\u1eb7p
N\u1eef hóa tuy\u1ebfn vú Ít g\u1eb7p 
R\u1ed1i lo\u1ea1n chung và t\u1ea1i v\u1ecb trí \u0111\u01b0a thu\u1ed1cPhù ngo\u1ea1i viTh\u01b0\u1eddng g\u1eb7p Ít g\u1eb7p
Phù R\u1ea5t ph\u1ed5 bi\u1ebfn 
M\u1ec7t m\u1ecfiÍt g\u1eb7pTh\u01b0\u1eddng g\u1eb7p 
Suy nh\u01b0\u1ee3c Th\u01b0\u1eddng g\u1eb7pTh\u01b0\u1eddng g\u1eb7p
\u0110au ng\u1ef1c Ít g\u1eb7pÍt g\u1eb7p*
\u1ed0m m\u1ec7t Ít g\u1eb7pÍt g\u1eb7p*
\u0110au Ít g\u1eb7p 
Các xét nghi\u1ec7m\n

T\u0103ng cân, gi\u1ea3m cân

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 Ít g\u1eb7p 
T\u0103ng ure máu  Ít g\u1eb7p*
T\u0103ng creatinin máu  Ít g\u1eb7p*
T\u0103ng bilirubin máu  Hi\u1ebfm g\u1eb7p
T\u0103ng men gan R\u1ea5t hi\u1ebfm g\u1eb7pHi\u1ebfm g\u1eb7p
Gi\u1ea3m haemoglobin và gi\u1ea3m haematocrit  R\u1ea5t hi\u1ebfm g\u1eb7p
Ch\u1ea5n th\u01b0\u01a1ng, ng\u1ed9 \u0111\u1ed9c và các bi\u1ebfn ch\u1ee9ngNgã  Ít g\u1eb7p*
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* T\u1ea7n su\u1ea5t xu\u1ea5t hi\u1ec7n các bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i \u0111\u01b0\u1ee3c tính toán t\u1eeb các th\u1eed nghi\u1ec7m lâm sàng t\u1eeb các báo cáo t\u1ef1 phát.

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Thông tin b\u1ed5 sung v\u1ec1 dang k\u1ebft h\u01a1p perindopril/amlodipin:

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M\u1ed9t nghiên c\u1ee9u lâm sàng ng\u1eabu nhiên, mù \u0111ôi, có \u0111\u1ed1i ch\u1ee9ng placebo th\u1ef1c hi\u1ec7n trong vòng 8 tu\u1ea7n \u0111ã ghi nh\u1eadn phù ngo\u1ea1i biên, m\u1ed9t ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i \u0111ã \u0111\u01b0\u1ee3c quan sát th\u1ea5y c\u1ee7a amlodipin, có t\u1ef7 l\u1ec7 th\u1ea5p h\u01a1n \u1edf b\u1ec7nh nhân dùng d\u1ea1ng ph\u1ed1i h\u1ee3p perindopril 3,5 mg/amlodipin 2,5 mg so v\u1edbi \u1edf b\u1ec7nh nhân dùng amlodipin 5 mg \u0111\u01a1n \u0111\u1ed9c (t\u01b0\u01a1ng \u1ee9ng 1,6% và 4,9%).

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Báo cáo vê các ph\u1ea3n \u1ee9ng có h\u1ea1i nghi ng\u1edd:

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Các ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i b\u1ecb nghi ng\u1edd \u0111\u01b0\u1ee3c báo cáo sau khi thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p phép là r\u1ea5t quan tr\u1ecdng. Báo cáo này cho phép ti\u1ebfp t\u1ee5c theo dõi cân b\u1eb1ng gi\u1eefa l\u1ee3i ích/nguy c\u01a1 c\u1ee7a thu\u1ed1c. Các nhân viên y t\u1ebf \u0111\u01b0\u1ee3c yêu c\u1ea7u báo cáo b\u1ea5t c\u1ee9 ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i nghi ng\u1edd nào v\u1ec1 h\u1ec7 th\u1ed1ng báo cáo qu\u1ed1c gia.

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T\u01b0\u01a1ng tác v\u1edbi các thu\u1ed1c khác\n

Các d\u1eef li\u1ec7u nghiên c\u1ee9u lâm sàng \u0111ã cho th\u1ea5y phong b\u1ebf kép h\u1ec7 renin-angiotensin-aldosteron (RAAS) b\u1eb1ng cách s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n, thu\u1ed1c \u1ee9c ch\u1ebf th\u1ee5 th\u1ec3 angiotensin II ho\u1eb7c aliskiren có liên quan t\u1edbi t\u1ea7n su\u1ea5t cao h\u01a1n c\u1ee7a các bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i nh\u01b0 h\u1ea1 huy\u1ebft áp, t\u0103ng kali máu và suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn (bao g\u1ed3m suy th\u1eadn c\u1ea5p) khi so sánh v\u1edbi vi\u1ec7c s\u1eed d\u1ee5ng \u0111\u01a1n tr\u1ecb li\u1ec7u thu\u1ed1c tác \u0111\u1ed9ng lên h\u1ec7 RAAS.

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Các thu\u1ed1c gây t\u0103ng kali máu:

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M\u1ed9t s\u1ed1 thu\u1ed1c ho\u1eb7c các nhóm thu\u1ed1c \u0111i\u1ec1u tr\u1ecb có th\u1ec3 làm gia t\u0103ng nguy c\u01a1 t\u0103ng kali máu: aliskiren, mu\u1ed1i kali, các thu\u1ed1c l\u1ee3i ti\u1ec3u gi\u1eef kali, các thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n, các thu\u1ed1c kháng th\u1ee5 th\u1ec3 angiotensin II, các thu\u1ed1c kháng viêm phi steroid, heparin, các thu\u1ed1c \u1ee9c ch\u1ebf mi\u1ec5n d\u1ecbch nh\u01b0 ciclosporin ho\u1eb7c tacrolimus, trimethoprim và d\u1ea1ng ph\u1ed1i h\u1ee3p li\u1ec1u v\u1edbi sulfamethoxazol (Co-trimoxazole). K\u1ebft h\u1ee3p Viacoram v\u1edbi các thu\u1ed1c này làm t\u0103ng nguy c\u01a1 t\u0103ng kali máu.

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Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi:

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Aliskiren:

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Trên b\u1ec7nh nhân \u0111ái tháo \u0111\u01b0\u1eddng ho\u1eb7c suy gi\u1ea3m ch\u1ee9c n\u0103ng th\u1eadn, nguy c\u01a1 t\u0103ng kali máu, ch\u1ee9c n\u0103ng th\u1eadn x\u1ea5u \u0111i và t\u1ef7 l\u1ec7 m\u1eafc các b\u1ec7nh tim m\u1ea1ch và t\u1eed vong do các b\u1ec7nh tim m\u1ea1ch t\u0103ng lên.

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\u0110i\u1ec1u tri ngoài c\u01a1 th\u1ec3:

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\u0110i\u1ec1u tr\u1ecb ngoài c\u01a1 th\u1ec3 d\u1eabn \u0111\u1ebfn s\u1ef1 ti\u1ebfp xúc c\u1ee7a máu v\u1edbi các b\u1ec1 m\u1eb7t tích \u0111i\u1ec7n âm nh\u01b0 th\u1ea9m tách ho\u1eb7c l\u1ecdc máu v\u1edbi màng l\u1ecdc t\u1ed1c \u0111\u1ed9 cao (ví d\u1ee5 màng polyacrylonitril) và l\u1ecdc lo\u1ea1i lipoprotein t\u1ef7 tr\u1ecdng th\u1ea5p v\u1edbi dextran sulphate có nguy c\u01a1 làm t\u0103ng các ph\u1ea3n \u1ee9ng quá m\u1eabn. N\u1ebfu nh\u1eefng \u0111i\u1ec1u tr\u1ecb này \u0111\u01b0\u1ee3c yêu c\u1ea7u, c\u1ea7n cân nh\u1eafc s\u1eed d\u1ee5ng lo\u1ea1i màng th\u1ea9m tách khác ho\u1eb7c m\u1ed9t thu\u1ed1c ch\u1ed1ng t\u0103ng huy\u1ebft áp nhóm khác.

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Không khuy\u1ebfn cáo dùng \u0111\u1ed3ng th\u1eddi:

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Estramutine:

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Nguy c\u01a1 t\u0103ng các tác d\u1ee5ng b\u1ea5t l\u1ee3i nh\u01b0 phù m\u1ea1ch th\u1ea7n kinh

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Các thu\u1ed1c \u1ee9c ch\u1ebf mTOR (nh\u01b0 sirolimus, everolimus, temsirolimus):

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B\u1ec7nh nhân \u0111i\u1ec1u tr\u1ecb k\u1ebft h\u1ee3p v\u1edbi các thu\u1ed1c \u1ee9c ch\u1ebf mTOR có th\u1ec3 t\u0103ng nguy c\u01a1 b\u1ecb phù m\u1ea1ch.

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Các thu\u1ed1c l\u1ee3i ti\u1ec3u gi\u1eef kali (nh\u01b0 triamteren, amilorid, kali (các dang mu\u1ed1i):

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T\u0103ng kali máu (n\u1eb7ng có th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eed vong), \u0111\u1eb7c bi\u1ec7t khi k\u1ebft h\u1ee3p v\u1edbi suy th\u1eadn (hi\u1ec7u \u1ee9ng c\u1ed9ng h\u1ee3p t\u0103ng kali máu). Không \u0111\u01b0\u1ee3c k\u1ebft h\u1ee3p các thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n v\u1edbi các h\u1ee3p ch\u1ea5t làm t\u0103ng kali máu, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p b\u1ecb h\u1ea1 kali máu.

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Không khuy\u1ebfn cáo ph\u1ed1i h\u1ee3p Viacoram v\u1edbi các thu\u1ed1c trên. N\u1ebfu ph\u1ea3i s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi, nên ph\u1ed1i h\u1ee3p m\u1ed9t cách th\u1eadn tr\u1ecdng và theo dõi th\u01b0\u1eddng xuyên n\u1ed3ng \u0111\u1ed9 kali huy\u1ebft thanh. S\u1eed d\u1ee5ng spironolacton trong suy tim, xem d\u01b0\u1edbi \u0111ây.

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Lithi

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T\u0103ng có h\u1ed3i ph\u1ee5c n\u1ed3ng \u0111\u1ed9 lithi huy\u1ebft thanh và \u0111\u1ed9c tính \u0111ã \u0111\u01b0\u1ee3c ghi nh\u1eadn khi dùng \u0111\u1ed3ng th\u1eddi lithi v\u1edbi các thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n. Không khuy\u1ebfn cáo s\u1eed d\u1ee5ng Viacoram cùng lithi, nh\u01b0ng n\u1ebfu c\u1ea7n thi\u1ebft ph\u1ea3i ph\u1ed1i h\u1ee3p, nên theo dõi ch\u1eb7t n\u1ed3ng \u0111\u1ed9 lithi huy\u1ebft thanh.

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Dantrolen (truy\u1ec1n t\u0129nh m\u1ea1ch):

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Trên \u0111\u1ed9ng v\u1eadt, rung th\u1ea5t và tr\u1ee5y tim m\u1ea1ch d\u1eabn \u0111\u1ebfn t\u1eed vong \u0111ã \u0111\u01b0\u1ee3c ghi nh\u1eadn liên quan \u0111\u1ebfn t\u0103ng kali máu khi k\u1ebft h\u1ee3p verapamil và dantrolen truy\u1ec1n t\u0129nh m\u1ea1ch. Do nguy c\u01a1 t\u0103ng kali máu, khuy\u1ebfn cáo không dùng \u0111\u1ed3ng th\u1eddi Viacoram có ch\u1ee9a amlodipin, m\u1ed9t thu\u1ed1c ch\u1eb9n kênh canxi v\u1edbi dantrolen trên b\u1ec7nh nhân có kh\u1ea3 n\u0103ng t\u0103ng thân nhi\u1ec7t ác tính và trong \u0111i\u1ec1u tr\u1ecb t\u0103ng thân nhi\u1ec7t ác tính.

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\u0110\u1eb7c bi\u1ec7t th\u1eadn tr\u1ecdng khi s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi:

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Các thu\u1ed1c ch\u1ed1ng \u0111ái tháo \u0111\u01b0\u1eddng (insulin, các thu\u1ed1c h\u1ea1 glucose huy\u1ebft \u0111\u01b0\u1eddng u\u1ed1ng):

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Các nghiên c\u1ee9u d\u1ecbch t\u1ec5 h\u1ecdc cho th\u1ea5y s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi các thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n và các thu\u1ed1c ch\u1ed1ng \u0111ái tháo \u0111\u01b0\u1eddng (insulin, các thu\u1ed1c h\u1ea1 glucose huy\u1ebft \u0111\u01b0\u1eddng u\u1ed1ng) có th\u1ec3 gây nguy c\u01a1 h\u1ea1 glucose máu do làm t\u0103ng tác d\u1ee5ng h\u1ea1 glucose c\u1ee7a thu\u1ed1c. Hi\u1ec7n t\u01b0\u1ee3ng này xu\u1ea5t hi\u1ec7n ph\u1ed5 bi\u1ebfn h\u01a1n trong các tu\u1ea7n \u0111\u1ea7u khi ph\u1ed1i h\u1ee3p thu\u1ed1c và trên b\u1ec7nh nhân suy th\u1eadn.

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Baclofen:

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T\u0103ng tác d\u1ee5ng h\u1ea1 huy\u1ebft áp. Theo dõi huy\u1ebft áp và \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u thu\u1ed1c h\u1ea1 huy\u1ebft áp n\u1ebfu c\u1ea7n thi\u1ebft.

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Thu\u1ed1c l\u1ee3i ti\u1ec3u không gi\u1eef kali:

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B\u1ec7nh nhân \u0111ang dùng thu\u1ed1c l\u1ee3i ti\u1ec3u, \u0111\u1eb7c bi\u1ec7t b\u1ec7nh nhân có gi\u1ea3m th\u1ec3 tích tu\u1ea7n hoàn và/ho\u1eb7c m\u1ea5t mu\u1ed1i, có th\u1ec3 g\u1eb7p hi\u1ec7n t\u01b0\u1ee3ng huy\u1ebft áp gi\u1ea3m quá m\u1ee9c sau khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n. Kh\u1ea3 n\u0103ng h\u1ea1 huy\u1ebft áp có th\u1ec3 gi\u1ea3m b\u1eb1ng cách ng\u1eebng dùng thu\u1ed1c l\u1ee3i ti\u1ec3u, t\u0103ng th\u1ec3 tích tu\u1ea7n hoàn ho\u1eb7c l\u01b0\u1ee3ng mu\u1ed1i s\u1eed d\u1ee5ng tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Viacoram.

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Trong t\u0103ng huy\u1ebft áp \u0111\u1ed9ng m\u1ea1ch, n\u1ebfu \u0111i\u1ec1u tr\u1ecb b\u1eb1ng các thu\u1ed1c l\u1ee3i ti\u1ec3u tr\u01b0\u1edbc \u0111ó gây gi\u1ea3m th\u1ec3 tích tu\u1ea7n hoàn ho\u1eb7c m\u1ea5t mu\u1ed1i, nên ng\u1eebng dùng thu\u1ed1c l\u1ee3i ti\u1ec3u tr\u01b0\u1edbc khi b\u1eaft \u0111\u1ea7u dùng Viacoram. Sau \u0111ó có th\u1ec3 dùng l\u1ea1i thu\u1ed1c l\u1ee3i ti\u1ec3u không gi\u1eef kali.

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C\u1ea7n theo dõi ch\u1ee9c n\u0103ng th\u1eadn (n\u1ed3ng \u0111\u1ed9 creatinin) trong vài tu\u1ea7n \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Viacoram.

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Thu\u1ed1c l\u1ee3i ti\u1ec3u gi\u1eef kali (eplerenon, spironolacton):

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Tr\u01b0\u1eddng h\u1ee3p dùng eplerenon ho\u1eb7c spironolacton trong kho\u1ea3ng li\u1ec1u t\u1eeb 12,5 mg \u0111\u1ebfn 50 mg/ngày và dùng li\u1ec1u th\u1ea5p thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n:

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Trong \u0111i\u1ec1u tr\u1ecb suy tim \u0111\u1ed9 ll-IV (phân lo\u1ea1i NYHA) v\u1edbi phân su\u1ea5t t\u1ed1ng máu < 40%, b\u1ec7nh nhân tr\u01b0\u1edbc \u0111ây \u0111ã \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng các thu\u1ed1c \u1ee9c ch\u1ebf men chuy\u1ec3n và các thu\u1ed1c l\u1ee3i ti\u1ec3u quai, nguy c\u01a1 t\u0103ng kali máu, có th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eed vong, \u0111\u1eb7c bi\u1ec7t trong tr\u01b0\u1eddng h\u1ee3p không tuân th\u1ee7 các khuy\u1ebfn cáo kê \u0111\u01a1n khi ph\u1ed1i h\u1ee3p các thu\u1ed1c này.

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Tr\u01b0\u1edbc khi k\u1ebft h\u1ee3p thu\u1ed1c, b\u1ec7nh nhân ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m tra không có t\u0103ng kali máu và suy th\u1eadn.

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Khuy\u1ebfn cáo th