Ezetimibe Tablets for Primary Hypercholesterolemia
ACTIONS and INDICATIONS
Primary hypercholesterolemia
As adjunctive therapy other than diet control, this product can be used alone or in combination with HMG-CoA reductase inhibitors (statins) for the treatment of primary (heterozygous familial or non-familial) hypercholesterolemia, which can reduce total Cholesterol (TC), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB).
Homozygous familial hypercholesterolemia (HoFH)
This product is combined with statins to be used as an adjunct to other lipid-lowering therapies (such as LDL-C plasmapheresis) or to reduce TC and LDL-C levels in HoFH patients when other lipid-lowering therapies are ineffective.
Homozygous glutenemia (or phytosterolemia)
This product is used as an adjunct to dietary control to reduce the levels of sitosterol and phytosterols in patients with homozygous familial streptocolemia.
INGREDIENTS
Ezetimibe.
PROPERTIES
White tablets.
Spec.
10mg*10 tablets/box.
USAGE AND DOSAGE
Patients should adhere to a proper low-fat diet during the treatment of this product.
The recommended dose of this product is once daily,10mg each time, can be taken alone or in combination with statins. This product can be taken at any time of the day and can be taken on an empty stomach or at the same time with food.
Application of drugs in elderly patients
Older patients do not need to adjust the dose.
Application of drugs in children
Children and adolescents over 10 years of age: no need to adjust the dose.
Children under 10 years old: This product is not recommended.
Drugs for patients with impaired liver function
Patients with mild hepatic impairment do not need to adjust the dose (Child-Pugh score at 5 or 6) (see [Pharmacokinetics]).
Drugs for patients with impaired renal function
Patients with impaired renal function do not need to adjust the dose.
Combined with a bile acid chelating agent
This product should be taken more than 2 hours before taking the bile acid chelating agent or more than 4 hours after taking it.
ADVERSE REACTION
In a clinical study of 8 to 14 weeks, 3551 patients were treated with 10 mg of this product alone or in combination with statins or with fenofibrate. The results showed that patients were generally well tolerated and had mild adverse reactions. It was transient, and the overall incidence of side effects was similar to placebo, and the trial termination rate of the trial group due to adverse reactions was comparable to that of the placebo group.
Commonly used in patients who received this product alone (n=1691), patients who were combined with statins (n=1675), or patients who were used in combination with fenofibrate (n=185) (≥1/100, 3 times the upper limit of normal) (95% confidence interval) was 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) (adjusted according to treatment). The corresponding incidence of cholecystectomy was 0.6% (0.0, 3.1) and 1.7% (0.6, 4.0), respectively (see note). In this study, the number of patients treated with ezetimibe or fenofibrate alone or in combination was not sufficient to assess the risk of gallbladder disease. In this study, there was no increase in CPK in all treatment groups > normal value The upper limit is 10 times.
Laboratory indicators:
In the controlled clinical study of this product alone, this product (0.5%) and placebo (0.3%) caused a similar increase in transaminase (ALT and / or AST ≥ 3 times the upper limit of normal). In the combined application of this product and statin, the incidence of elevated transaminases in patients with this product and statins was 1.3%, and the incidence of statin alone was 0.4%. However, this elevated transaminase has no clinical manifestations and is not associated with cholestasis and falls to normal after discontinuation or continued treatment.
The increase in CPK (≥10 times the upper limit of normal) caused by the use of this product alone or in combination with statins is similar to the use of placebo or statin alone.
Adverse reactions reported after the product was marketed (ignoring causality evaluation): allergic reactions, including immediate allergic reactions, angioedema, rash and urticaria; joint pain; myalgia; increased CPK; increased liver transaminase; hepatitis; Reduction; pancreatitis; vomiting; dizziness; paresthesia; depression; gallstones; cholecystitis; myopathy/rhabdomyolysis is very rare..
CONSTRAINDICATION
Those who are allergic to any of the ingredients in this product.
Active liver disease, or patients with unexplained elevated serum transaminases.
All HMG-CoA reductase inhibitors are restricted for use in pregnant and lactating women. When this product is combined with such drugs in women with potential for delivery, refer to the HMG-CoA Reductase Inhibitor Product Specification (see Pregnancy and Lactating Women)..
PRECAUTION
When this product is used in combination with statins or fenofibrate, please refer to the instruction manual for the statin and or fenofibrate.
Liver enzyme
In a controlled study of this product in combination with statins, serum transaminase was found to be persistently elevated (≥ 3 times the upper limit of normal values). Therefore, when this product is combined with statins, liver function tests should be performed before treatment, and the product specifications of statins should be referred to.
Skeletal muscle
In clinical studies, this product caused no increase in myopathy and rhabdomyolysis compared to the control group (placebo or statin alone). Myopathy and rhabdomyolysis are known adverse effects of statins and other lipid-lowering drugs. The incidence of CPK greater than 10 times the upper limit of normal value was 0.2%, the incidence of placebo was 0.1%, the incidence of this product combined with statin was 0.1%, and the incidence of statin alone was 0.4%. After the product is marketed, cases of myopathy and rhabdomyolysis have been reported (whether myopathy and rhabdomyolysis are related to drugs). Most patients with rhabdomyolysis are taking statins before taking this product. However, when this product is used alone and when it is combined with a drug known to increase the risk of rhabdomyolysis, cases of rhabdomyolysis are rarely reported. All patients should be informed of the risk of myopathy when starting treatment with this product, and be told to promptly report any unexplained myalgia, tenderness or weakness. If the patient is diagnosed with or suspected of myopathy, discontinue this product and any statin that is being used. The onset of symptoms and myocardial phosphokinase (CPK) levels >10ULN indicate myopathy.
Hepatic insufficiency
In view of the fact that the long-term application of ezetimibe to patients with moderate or severe hepatic insufficiency is not clear, it is not recommended to use this product (see [Pharmacokinetics]).
Bet
At present, the safety and effectiveness of this product in combination with other fibrates other than Norbert have not been established, so the combination of these two drugs (except fenofibrate) is not recommended.
Cyclosporine
This product should be used with caution during the use of cyclosporine. For patients receiving this combination with cyclosporine, cyclosporine concentration should be monitored.
Anticoagulant
If this product is combined with warfarin and other coumarin anticoagulants or fluorinated diketones, the international normalized ratio (INR) should be properly monitored.
DRUG INTERACTIONS
If use with the other drugs at the same time may occur drug interactions,details please consult your physician or pharmacist.
VALIDITY
24 months.
STORAGE
Preserve in tightly closed containers,stored in a cool and dry place.
APPROVAL NUMBER
State medical permitment number.H20160181.
Manufactured
MSDInternationalGmbH(SingaporeBranch)
Tips: part of the goods frequent replacement of packaging, sometimes goods and pictures are not exactly the same, please refer to the goods you receive.
