国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
AMLODIPINE BESYLATE EQV AMLODIPINE (EXTRA-GRANULAR INGREDIENTS); ATORVASTATIN CALCIUM EQV ATORVASTATIN (ATORVASTATIN GRANULATION)
VIATRIS PRIVATE LIMITED
C10BX03
5 MG
TABLET, FILM COATED
AMLODIPINE BESYLATE EQV AMLODIPINE (EXTRA-GRANULAR INGREDIENTS) 5 MG; ATORVASTATIN CALCIUM EQV ATORVASTATIN (ATORVASTATIN GRANULATION) 20 MG
ORAL
Prescription Only
Pfizer Manufacturing Deutschland GmbH
ACTIVE
2005-03-10
CADUET TABLETS 1. TRADE NAME(S) OF THE MEDICINAL PRODUCT CADUET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: amlodipine besylate, atorvastatin calcium. The tablets for oral administration contain amlodipine besylate and atorvastatin calcium equivalent to 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg amlodipine/atorvastatin dosage strengths, respectively. 3. PHARMACEUTICAL FORM Film-coated Tablets. Caduet tablets 5 mg/10 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 051 on the other side. Caduet tablets 5 mg/20 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 052 on the other side. Caduet tablets 5 mg/40 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 054 on the other side. Caduet tablets 5 mg/80 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 058 on the other side. Caduet tablets 10 mg/10 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 101 on the other side. Caduet tablets 10 mg/20 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 102 on the other side. Caduet tablets 10 mg/40 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 104 on the other side. Caduet tablets 10 mg/80 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 108 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is a 阅读完整的文件
Page 1 of 34 CADUET ® TABLETS 1. TRADE NAME OF THE MEDICINAL PRODUCT CADUET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: amlodipine besylate, atorvastatin calcium. The tablets for oral administration contain amlodipine besylate and atorvastatin calcium equivalent to 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg, and 10 mg/40 mg amlodipine/atorvastatin dosage strengths, respectively. 3. PHARMACEUTICAL FORM Film-coated Tablets. Caduet tablets 5 mg/10 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 051 on the other side. Caduet tablets 5 mg/20 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 052 on the other side. Caduet tablets 5 mg/40 mg are white, oval shape, debossed with “Pfizer” on one side and CDT 054 on the other side. Caduet tablets 10 mg/10 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 101 on the other side. Caduet tablets 10 mg/20 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 102 on the other side. Caduet tablets 10 mg/40 mg are blue, oval shape, debossed with “Pfizer” on one side and CDT 104 on the other side. Not all presentations may be marketed. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The amlodipine/atorvastatin combination product (henceforth in this document termed “amlodipine/atorvastatin”) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate: AMLODIPINE _HYPERTENSION_ The amlodipine component is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure (BP) in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of the amlodipine component of amlodipine/atorvastatin, in the same manner as they would benefit from the addition of amlodipine alone. Page 2 of 34 _CORONARY ARTERY DISEASE_ Chronic Stable Angina Amlodipine is indicated for the symp 阅读完整的文件