Caduet / 確健心 - Hong Kong[香港药品]

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Caduet / 確健心

2014-02-13 13:12:59 来源: 作者: 【大中小】浏览:1129次评论:0条

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Manufacturer

Pfizer

Distributor

Hong Kong: Zuellig/Macau: The Glory Medicina

Contents

Per 5/10 mg tab Amlodipine besylate 5 mg, atorvastatin Ca 10 mg. Per 5/20 mg tab Amlodipine besylate 5 mg, atorvastatin Ca 20 mg. Per 5/40 mg tab Amlodipine besylate 5 mg, atorvastatin Ca 40 mg. Per 10/10 mg tab Amlodipine besylate 10 mg, atorvastatin Ca 10 mg. Per 10/20 mg tab Amlodipine besylate 10 mg, atorvastatin Ca 20 mg. Per 10/40 mg tab Amlodipine besylate 10 mg, atorvastatin Ca 40 mg

Indications

Patients at increased CV risk due to the presence of 2 modifiable risk factors, HTN & dyslipidemia; &/or patients w/ increased CV risk due to the presence of symptomatic CHD expressed as angina w/ an additional modifiable risk factor of dyslipidemia. Amlodipine component 1st-line treatment of HTN; 1st-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Reduce risk of hospitalization due to angina & reduce risk of coronary revascularization procedure. Atorvastatin component Adjunct to diet to treat patients w/ elevated total-cholesterol, LDL-cholesterol, apolipoprotein B & triglyceride & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & nonfamilial), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & patients w/ dysbetalipoproteinemia (Fredrickson type III) not responding adequately to diet. Reduce total-cholesterol & LDL-cholesterol in patients w/ homozygous familial hypercholesterolemia when response to diet & other nonpharmacological measures are inadequate. Prevention of CV complications: Reduce risk of fatal CHD & non-fatal MI, stroke, revascularization procedures & angina pectoris in patients w/ or w/o CV disease &/or dyslipidemia but w/ multiple risk factors for CHD; reduce risk of MI & stroke in type 2 diabetic patients w/o CHD but w/ multiple risk factors for CHD; reduce risk of non-fatal MI, fatal & non-fatal stroke, revascularization procedures, hospitalization for CHF & angina in patients w/ CHD. Adjunct to diet to reduce total-cholesterol, LDL-cholesterol & apolipoprotein B levels in boys & post-menarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia after an adequate trial of diet therapy.
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Dosage

Amlodipine/atorvastatin: 5 mg/10 mg to a max dose of 10 mg/80 mg once daily. Atorvastatin: Childn 10-17 yr Heterozygous familial hypercholesterolemia Individualized dose. Initially 10 mg/day. Max dose: 20 mg/day. Amlodipine: Patients w/ CHD Recommended dose: 5-10 mg once daily. Childn 6-17 yr HTN 2.5-5 mg once daily.
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Overdosage

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Administration

May be taken with or without food

Contraindications

Hypersensitivity to dihydropyridines. Hepatic impairment. Active liver disease or unexplained persistent elevations of serum transaminases >3x the upper limit of normal. Pregnancy (including women of childbearing potential who are not using adequate contraceptive measures), lactation.
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Special Precautions

Heart failure. Perform liver function tests before initiating treatment & periodically thereafter. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Discontinue drug if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Concomitant administration of fibric acid derivatives, erythromycin, immunosuppressants, azole antifungals or lipid-modifying doses of niacin. Monitor for unexplained muscle pain, tenderness or weakness accompanied by malaise or fever. Acute, serious condition suggestive of myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Childn <6 yr.
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Adverse Drug Reactions

Amlodipine: Headache, dizziness, somnolence, palpitations, flushing, abdominal pain, nausea, edema, fatigue. Also vasodilation, epistaxis & asthenia in childn 6-17 yr. Atorvastatin: Nasopharyngitis, hyperglycemia, pharyngolaryngeal pain, epistaxis, diarrhea, dypepsia, nausea, flatulence, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling, abnormal liver function test, increased blood CPK.
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Drug Interactions

Grapefruit or grapefruit juice. Amlodipine: Erythromycin. Ketoconazole, ritonavir; rifampicin, St. John's wort ( Hypericum perforatum). Atorvastatin: Cyclosporine, fibric acid derivatives, lipid-modifying class of niacin, clarithromycin, azole antifungals; protease inhibitors, diltiazem HCl, itraconazole, efavirenz, rifampin, antacids, colestipol, digoxin, OCs, fusidic acid.
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Pregnancy Category (US FDA)

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Description

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Mechanism of Action

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ATC Classification

C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

Presentation/Packing

Form

Packing

Photo

Caduet 5/10 mg tablet

Caduet 30's