All Categories
EN

Home > BLOG > Atorvastatin calcium tablet

Atorvastatin calcium tablet

December 28,2022

Pharmaceutical ingredients

This product is mainly composed of atorvastatin calcium.

Chemical name: [R-(R', R')]-2-(4- fluorophenyl)-β, δ-dihydroxy -5-(1- methyl ethyl)-3- phenyl -4-[ (aniline) carbonyl ]-1-hydrogen-pyrrole -1- calcium heptanoate trihydrate.

Molecular formula: (C33H34FN2O5)2Ca·3H2O

Molecular weight: 1209.42

Drug character

This product is a white film-coated tablet, and the film-coated tablet is white.

As a generic drug supplier in China, Feiyue Pharmaceutical can provide finished drugs such as Atorvastatin Calcium Tablets

FEIYUE recruits agents worldwide, we can provide complete registration documents.

Efficacy

1. Hypercholesterolemia: Patients with primary hypercholesterolemia, including familial hypercholesterolemia (heterozygous type) or mixed hyperlipidemia (type IIa and type IIb according to Fredrickson's classification), can be treated with this product for the increase of total cholesterol (TC), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B(ApoB) if the therapeutic effect of diet therapy and other non-drug therapy is not satisfactory. In patients with homozygous familial hypercholesterolemia, atorvastatin calcium can be combined with other lipid-lowering therapies (such as low-density lipoprotein plasma dialysis) or used alone (when there are no other treatments) to reduce total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C).

2. Coronary heart disease: coronary heart disease or coronary heart disease and other critical diseases (such as diabetes, symptomatic atherosclerotic diseases, etc.) complicated with hypercholesterolemia or mixed dyslipidemia. This product is suitable for: reducing the risk of non-fatal myocardial infarction, fatal and non-fatal stroke, vascular reconstruction, hospitalization due to congestive heart failure and angina pectoris.

Contraindications

1. Active liver diseases, which may include the continuous rise of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) in the liver with unknown causes.

2. Known allergy to any ingredient in this product.

3. Pregnancy: This product is forbidden for pregnant women or women of childbearing age who may become pregnant. Pregnant women taking this product may cause damage to the fetus. In normal pregnancy, serum total cholesterol (TC) and triglyceride (TG) levels increase, and cholesterol or cholesterol derivatives are essential substances for fetal development. Atherosclerosis is a chronic pathological process, so stopping lipid-lowering drugs during pregnancy has little effect on the long-term outcome of atherosclerosis. At present, there are not enough controlled studies about pregnant women taking atorvastatin; However, occasionally, it has been reported that intrauterine exposure to statins can cause fetal congenital abnormalities. There is no evidence of teratogenicity of atorvastatin in rat and rabbit reproductive studies. For women of childbearing age, only those who are extremely unlikely to conceive and have been informed of the potential harm can be prescribed Lipitor. Patients should stop taking drugs immediately during pregnancy, and consider the potential harm of drugs to the fetus.

4. Lactating women: Whether atorvastatin can be secreted from human milk is unknown; However, these other drugs can be secreted into milk in a small amount. Because statins may have potentially serious adverse reactions to newborns who are breast-feeding, women who take this product are forbidden to breast-feed.

adverse effect

1. Serious adverse reactions:

(1) Rhabdomyolysis and myopathy.

(2) Abnormal liver enzymes.

2. Clinical adverse reactions:

(1) The patient's condition is complicated during the implementation of clinical trials, so the incidence of adverse reactions obtained by two different drugs in clinical research cannot be directly compared, and may not reflect the incidence of adverse reactions in clinical practice.

(2) A total of 16,066 patients were enrolled in the placebo-controlled clinical trial of atorvastatin calcium tablets (atorvastatin calcium tablets n = 8,755, placebo n = 7,311, aged from 10 to 93 years, 39% of whom were women; 91% were Caucasian white, 3% were black, 2% were Asian, and 4% were other races), and the median treatment period was 53 weeks; Regardless of causality, 9.7% of patients in atorvastatin calcium group and 9.5% in placebo group stopped taking drugs due to adverse reactions. The incidence of atorvastatin calcium tablets group was higher than that of placebo group. The five most common adverse reactions were myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase (0.4%) and other liver enzymes (0.4%).

(3) Regardless of causality, the most common adverse reactions (≥2%) in placebo-controlled trial of atorvastatin calcium tablets (n=8755) with higher incidence than placebo were nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain of limbs (6.0%) and urinary tract.

(4) Other adverse reactions reported in placebo-controlled studies include:

① Whole body: unwell and feverish.

Digestive system: abdominal discomfort, belching, flatulence, hepatitis and cholestasis.

③ Musculoskeletal system: skeletal muscle pain, muscle fatigue, neck pain and joint swelling.

④ Nutrition and metabolic system: elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), abnormal liver function examination, elevated blood alkaline phosphatase, elevated creatine phosphokinase and hyperglycemia.

⑤ Nervous system: nightmare.

⑥ Respiratory system: epistaxis.

⑦ Skin and appendages: urticaria.

⑧ Special sensation: blurred vision and tinnitus.

⑨ Urogenital system: positive urine leukocytes.

3. Post-marketing report: The following adverse reactions come from the report after atorvastatin calcium tablets are approved for marketing and application. Because the post-marketing adverse reactions are reported voluntarily by patients, and the actual number of drug users is uncertain, the exact incidence of these adverse reactions cannot be calculated, and the causal relationship between these adverse reactions and drugs cannot be determined. Regardless of causality, the related adverse reactions of atorvastatin calcium tablets not listed above include: allergic reaction, angioneurotic edema, herpes zoster (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal or non-fatal liver failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease. There are occasional reports of immune-mediated necrotizing myopathy related to statin use.

4. Post-marketing monitoring of statins:

(1) In the post-marketing monitoring of statins, there are reports of hyperglycemia, impaired glucose tolerance, elevated glycated hemoglobin level, new-onset diabetes, and deterioration of blood sugar control, and some statins also have reports of hypoglycemia.

(2) There are rare reports of cognitive impairment in overseas post-marketing monitoring of statins, which are manifested as memory loss, memory decline, confusion, etc., and most of them are non-serious and reversible reactions, which can generally be recovered after drug withdrawal.

5. Children patients (aged 10-17 years) In a 26-week controlled study involving 187 boys and girls with heterozygous familial hypercholesterolemia or severe hypercholesterolemia aged 10-17 years, atorvastatin 10mg-20mg/ day (n=140, 31% were girls; 92% Caucasian white, 1.6% black, 1.6% Asian, 4.8% other race) is similar to placebo in safety and tolerance.

6. Drug overdose: There is no special treatment for this drug overdose. Once drug overdose occurs, patients should take symptomatic treatment and supportive treatment measures as needed. Because Lipitor is widely combined with plasma proteins, hemodialysis can not significantly increase the clearance of Lipitor.

Drug storage

Keep out of light and sealed.