What Are the Most Common Side Effects of Pravastatin?

Pravastatin sodium tablets, hyperlipidemia, familial hypercholesterolemia.

Drug Name: Pravastatin sodium tablets
Drug type: Occupational injury medical insurance

Hanyu Pinyin: Pu Fa Ta Ting Na Pian
Use classification: Lipid-lowering drugs

Ingredients for Pravastatin Sodium Tablets

The main ingredient of this product is pravastatin sodium, and its chemical name is: {1S- [1 ( ^{S *} , ^{S *} ), 2, 6, 8 (R *), 8a]}-1,2,6, 7,8,8a-hexahydro-, , 6-trihydroxy-2-methyl-8- (2-methyl-1-oxobutoxy) -1-naphthoheptanoic acid monosodium salt.

Chemical Structure:

Molecular formula: C ₂₃ H ₃₅ NaO ₇

Properties of Pravastatin Sodium Tablets

This product is a light red tablet.

Indications for Pravastatin Sodium Tablets

Hyperlipidemia, familial hypercholesterolemia.

Pravastatin sodium tablets specifications

(1) 10 mg, (2) 20 mg, and (3) 40 mg.

Dosage of pravastatin sodium tablets

The starting dose for adults is 10 to 20 mg, once a day, before bedtime. Should increase and decrease with age and symptoms, the maximum daily dose of 40 mg.

Adverse effects of pravastatin sodium tablets

Of the 11,224 cases, 329 (2.93%, this item includes side effects that cannot be calculated). Side effects (including abnormal clinical test values) occurred, mainly rash (0.11%), diarrhea (0.08%), stomach Discomfort (0.07%), etc.
1. Major adverse reactions (incidence rate unknown)
1) Rhabdomyolysis: rhabdomyolysis characterized by muscle pain, fatigue, increased CPK, and increased myoglobin in blood and urine, followed by severe renal damage such as acute renal failure. If such symptoms occur, Withdraw immediately.
2) Hepatic dysfunction: Hepatic dysfunction may occur with jaundice, significant AST and ALT increase, so attention should be paid to observation. In this case, the drug should be stopped immediately and given appropriate treatment.
3) Thrombocytopenia: Thrombocytopenia may occur, so you should pay attention to observation and take appropriate treatment preparations. (Reports of thrombocytopenia with symptoms of purpura and subcutaneous bleeding).
4) Myopathy: There have been reports of myopathy.
5) Peripheral nerve disorders: There have been reports of peripheral nerve disorders.
6) Allergic symptoms: There have been reports of allergic symptoms such as lupus-like syndrome and vasculitis.
2. Other adverse reactions

Pravastatin sodium taboo

Patients with a history of allergies to this product or any of its ingredients.

Precastatin sodium tablets precautions

1. Similar to other HMG-CoA reductase inhibitors, this product may increase alkaline phosphatase and transaminase levels. It is recommended that liver function should be measured before treatment, before dose adjustment or other needs. This product is contraindicated in patients with active liver disease or persistently elevated aminotransferases of unknown origin. Caution should be used in patients with recent liver disease, suggestive of liver disease (for example, unexplained persistent transaminase elevation, jaundice), and alcoholism. For these patients, it is advisable to start with the minimum recommended dose and gradually adjust to an effective therapeutic dose, which requires close observation. During treatment, patients with elevated transaminase or liver disease symptoms or signs need re-examination of liver function until liver function returns to normal. If AST or ALT continues to exceed the upper limit of three times or more, the product is discontinued.
2. This product rarely causes rhabdomyolysis with acute renal failure secondary to myoglobinuria, which can cause uncomplicated myalgia. Myopathy is characterized by muscle tenderness or weakness in the joints, and creatine phosphokinase (CPK) rises more than 10 times the normal upper limit. Patients with diffuse myalgia, muscle tenderness or weakness, and / or significantly elevated CPK, need to consider the possibility of myopathy. Report any muscle pain, tenderness, or muscle weakness, especially with weakness or fever, to your doctor immediately. If CPK is significantly elevated, myopathy is suspected or confirmed, discontinue this product. If the patient develops acute or severe acute renal failure secondary to rhabdomyolysis, such as sepsis, hypotension, major surgery, trauma; severe metabolic, endocrine diseases, electrolyte disorders; uncontrolled epilepsy, etc., pause Use this product. When this product is used in combination with clofibrates, there may be clinically abnormal renal function, so it can only be applied when clinically necessary.
3. The following patients should be used with caution:
Patients with severe liver damage or previous history.
Patients with severe renal impairment or previous history.
(3) Patients who are taking fibrates (benzabate, etc.), immunosuppressants (cyclosporine, etc.), and niacin.

Pravastatin sodium tablets for pregnant and lactating women

1. The safety of medication during pregnancy has not been established, so pregnant women or women who may become pregnant should only be given when the benefits of treatment outweigh the risks.
2. Breastfeeding women should avoid medication and should stop breastfeeding as a last resort.

Pravastatin sodium tablets for children

The safety of pediatric medication has not been established.

Pravastatin sodium tablets for elderly

Elderly patients should consider the possibility of lowering renal function at an advanced age, and renal function should be checked regularly to observe the patient's symptoms and be administered with caution.

Pravastatin sodium tablets drug interactions

It has been confirmed in vivo and in vitro experiments that this product is not metabolized by cytochrome P ₄₅₀ 3A4, so it will not have a significant interaction with other drugs metabolized by the cytochrome P ₄₅₀ system (such as phenytoin, quinidine, etc.) Will obviously interact with cytochrome P ₄₅₀ 3A4 inhibitors (such as diltiazem, itraconazole, ketoconazole, erythromycin, etc.).
Warfarin: The simultaneous use of warfarin and pravastatin sodium 40mg has no effect on prothrombin time.
Cimetidine: There is no difference between 0-12 hour AUC for pravastatin sodium when used alone or in combination with cimetidine. The AUC of pravastatin sodium alone or the combination of pravastatin sodium and cimetidine was significantly different from the AUC of pravastatin sodium combined with antacids.
Digoxin: 0.2 mg digoxin combined with 20 mg pravastatin sodium for 9 days, the bioavailability of digoxin has not changed; the AUC of pravastatin has an increasing trend, but the combined bioavailability of pravastatin and its metabolites Nothing has changed.
Cyclosporine: To date, there are some clinical data on the combination of cyclosporine and pravastatin sodium (up to 20 mg). These data do not show that the concentration of cyclosporine will be affected by pravastatin.
Gefitezil: clinical trials found that the combination of pravastatin sodium and gemfibrezil increased the incidence of CPK and discontinuation due to musculoskeletal symptoms, compared with placebo control group, gemfezil group alone, Compared with the pravastatin sodium group alone, there was an increasing trend, and the urinary excretion and protein binding of pravastatin decreased. It is recommended not to use pravastatin sodium in combination with gemfibrozil. Others: There is no significant difference in pharmacokinetics with aspirin, antacids (1 hour after taking this product), cimetidine, and niacin. There is no obvious drug interaction with diuretics, antihypertensive drugs, digitalis, angiotensin-converting enzyme inhibitors, calcium channel blockers, -receptor blockers and nitroglycerin.

Pravastatin sodium tablets overdose

So far in reports of overdose of pravastatin, no obvious clinical symptoms and related clinical laboratory abnormalities have been seen. If overdose occurs, systemic treatment should be performed and supportive monitoring methods established as required.

Pharmacology and toxicology of pravastatin sodium tablets

1. Pharmacological effect This product is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, which selectively acts on the liver and small intestine of major organs that synthesize cholesterol, and rapidly and strongly lowers serum Cholesterol value improves serum lipids.
This product exerts its lipid-lowering effect through two aspects. The first is the reversible inhibition of HMG-CoA reductase activity, which reduces the amount of cholesterol in cells to a certain extent, leading to an increase in the number of low-density lipoprotein (LDL) receptors on the cell surface, thereby strengthening the receptor-mediated Catabolic metabolism of low density lipoprotein cholesterol (LDL-C) and clearance of LDL-C in the blood. Second, it inhibits the production of LDL-C by inhibiting the synthesis of very low density lipoprotein cholesterol (VLDL-C) in the liver, the precursor of LDL-C.
Studies show that elevated total cholesterol (TC), LDL-C, and apolipoprotein B (Apo B) can promote the formation of atherosclerosis in the human body; at the same time, reduce high-density lipoprotein cholesterol (HDL-C) and its transport complex Apolipoprotein A (Apo A) levels are also associated with atherosclerosis. Cardiovascular morbidity and mortality increase with increasing total cholesterol levels and decrease with increasing HDL levels. Although elevated triglyceride levels are often accompanied by low HDL levels, they are not an independent risk factor for coronary heart disease. The effect of simply increasing HDL or reducing triglycerides on the incidence or mortality of coronary artery disease and cardiovascular disease is still inconclusive. In healthy volunteers and patients with hypercholesterolemia, TC can be reduced after treatment with this product. , LDL and Apo B, and reduce VLDL and triglycerides, increase HDL and Apo A, the effect of other independent factors such as Lp (a), fibrinogen and other coronary heart disease is not clear. Clinical studies have shown that this product can reduce the incidence and mortality of cardiovascular disease in patients with varying degrees of cholesterol.
2. Toxicological effects SD rats were given pravastatin sodium (mixed with 10, 30, 100 mg / kg / day, 24 months) in the experiment, the 100 mg / kg / day administration group (the maximum clinical dose of 250 The liver tumors in male mice were more obvious than in the control group, but not in female mice.
In dogs given pravastatin sodium (12.5, 50, 200 mg / kg / day, 5 weeks, orally and 12.5, 50, 200 mg / kg / day, 13 weeks, orally), the 100 mg / kg / day group was seen Cerebral microvascular exudative bleeding.

Pharmacokinetics of Pravastatin Sodium Tablets

1. Absorption, distribution and metabolism: This product is a water-soluble HMG-CoA reductase inhibitor. It is mainly absorbed from the duodenum and absorbed quickly after oral administration. It is distributed at high concentrations in the liver and small intestine where cholesterol biosynthesis is strong. The distribution of organs such as the brain, adrenal glands, and genitals is extremely low. The maximum blood concentration is reached within 1-2 hours after administration of this product, and the blood concentration increases with the increase of the dose. The half-life is about 1.5 hours, the distribution volume is 830.0L, the serum protein binding rate is 53.1%, and the AUC is 14.0 ± 3.9ng × hr / mL. This product is mainly metabolized by the liver, but not by cytochrome P ₄₅₀ 3A4. Analysis of steady-state AUCs, C _max, and C _min suggest that this product (pravastatin) is taken once daily or twice daily in the body. No accumulation.
2. Excretion: This product is cleared through the liver and kidney channels: excretion is mainly in feces (more than 80%), and excretion in urine is 2% to 13%. So patients with renal or liver dysfunction can be cleared by compensatory changes in the excretion pathway.

Pravastatin Sodium Tablets Storage

Shaded and sealed.

Packaging of Pravastatin Sodium Tablets

Aluminum plastic packaging, plus aluminum foil bag, 7 pieces / box.

Validity of Pravastatin Sodium Tablets

36 months.

Pravastatin sodium tablets

National Drug Standard YBH00802004

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