What Is Lipirex Tablets And What It Used For All Information
Lipirex tablets available in 10mg 20mg and 40 mg form mainly contains a very useful life saving medicine named Atorvastatin Calcium Trihydrate which is a synthetic lipid lowering agent. It helps in lowering of the cholesterol levels in humans by working and limiting the synthesis the levels of cholesterol in body.
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Lipirex Tablets Uses & Indications
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increase risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholestrol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, Iipirex (Atorvastatin) can be started simultaneously with diet.
Use For Prevention of Cardiovascular Disease in Adults
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease,
Lipirex tablets Atorvastatin 10 mg 20 mg 40 mg mainly used for the treatment of symptoms like
- Reduce the risk of myocardial infarction
- Reduce the risk of stroke
- Reduce the risk for revascularization procedures and angina
In adults patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, it is indicated to:
- Reduce the risk of non-fatal myocardial infarction
- Reduce the risk of fatal and non-fatal stroke
- Reduce the risk for revascularization procedures
- Reduce the risk of hospitalization for CHF
- Reduce the risk of angina
Hyperlipidemia
Lipirex (atorvastatin) is also used for
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types lla and lib);
- As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (Fredrickson Type IV);
- For the treatment of adult patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
- To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
- As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following finding are present:
a. LDL-C remains > 190 mg/dL or
b. LDL-C remains > 160 mg/dL and:
- there is a positive family history of premature cardiovascular disease or
- two or more other CVD risk factor and present in the pediatric patient
Limitations of Use
It has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
Lipirex Atorvastatin Tablets Dosage & Administration
Dosage For Hyperlipidemia and Mixed Dyslipidemia
The recommended starting dose of Lipirex is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) maybe started at 40 mg once daily. On the other it can administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of the medicine should individualized according to patient characteristics such as goal of therapy and response. After initiation and / or upon titration of this medicine, lipid levels should be analyzed within 2 to 4weeks and dosage adjusted accordingly.
Dose For Heterozygous familial hypercholesterolemia in pediatric patients (10 years to 17 years of age)
The recommended starting dose of Lipirex (atorvastatin) is 10 mg/day. Meanwhile the usual dose range is 10 to 20 mg orally once daily. Doses should be individualized according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more.
Homozygous Familial Hypercholesterolemia Dosage
The dosage of the medeicine in patients with HoFH is 10 to 80mg daily. Moreover it should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
Concomitant lipid-lowering therapy Dosage
This medicine may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.
Dosage in patients does not affect the plasma concentration nor LDL-C reduction of this medication. Thus, dosage adjustment in patients with renal dysfunction is not necessary.
Dosage in patients taking cyclosporine, clarithromycin, itraconazole, or certain protease inhibitors
In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor glecaprevir plus pibrentasvir or letermovir when co-administered with cyclosporine, therapy with this medicine should be avoided. Moreover the patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing it and the lowest dose necessary employed.
On the other hand, in patients taking clarithromycin, itraconazole, elbasvir plus grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, draunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, or letermovir, therapy with this medication should be limited to 20mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of it is employed. In patients taking the HIV protease inhibitors nelfinavir or the hepatitis C protease inhibitors boceprevir, therapy with It should be limited to 40mg, and appropriate clinical assessment is recommended to ensure the lowest dose necessary of the medicine is employed. Similarly the patients taking the HIV protease inhibitor nelfinavir therapy with it should be limited to 40mg.
Contraindications Details
- Active liver disease or unexplained elevations of hepatic transaminase levels.
- Hypersensitivity to any component of this medication.
- Generally it contraindicated for use in pregnant women since safety in pregnant women has not women established. And also no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol. So it may cause fetal harm when administered to a pregnancy in recognized.
- Its not known whether this medicine excreted into human milk. However, a small amount of another drug in this class does pass into breast milk. Because of the potential for serious adverse reactions in a nursing infant, women that breastfeeding not recommended treatment with atorvastatin.
Lipirex Tablets Atorvastatin 10MG 20MG 40MG Side Effects
The reported adverse events are
- rhabdomyolysis
- myopathy
- alanine aminotransferase increase
- myalgia
- diarrhea
- arthralgia
- abdominal pain
- nausea
- nasopharyngitis
- dyspepsia
- increased hepatic enzymes (increased ALT, increased AST)
- musculoskeletal pain
- muscle weakness
- muscle spasm
- pain in extremity
- urinary tract infection
- insomnia and pharyngeolaryngeal pain
The additional reported adverse reactions are
- malaisa
- pyrexia
- abdominal discomfort
- flatulence
- hepatitis
- cholestasis
- musculoskeletal pain
- muscle fatigue
- muscle spasms
- neck pain
- joint swelling
- abnormal liver function test
- hyperglycemia
- nightmare
- epistaxis
- urticaria
- vision blurred
- tinnitus
- white blood cells urine positive
- anaphylaxis
- angioneurotic edema
- bullous rashes (including erythema multiforme
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- myositis
- tendon rupture
- fatal and non-fatal hepatic failure
- dizziness
- depression
- peripheral neuropathy
- pancreatitis
- interstitial lung disease
- immune mediated necrotizing myopathy
- autoimmune myopathy
- proximal muscle weakness
- back pain
- anorexia
- chest pain
- hypoglycemia
- malaise
- peripheral edema
- weight gain
- gynecomastia
- hearing loss
- cognitive impairment
- memory loss
- forgetfulness
- amnesia
- memory impairment
- confusion
Drug Interactions Information
Drug Interactions that may increase the Risk of Myopathy and Rhabdomyolysis with LIPITOR
It is a substrate of CYP3A4 and transporters (e.g.,OATP1B1/1B3, P-gp, or BCRP). The plasma levels can be significantly increase with concomitant administration of inhibitors of CYP3A4 and transporters.
Special Populations Instructions
Use In Pregnancy
It generally contraindicated for use in pregnant women since safety in pregnant women has not yet established. As well as no apparent benefit of lipid lowering drugs during pregnancy also known till now. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis of other biologically active substances derived from cholesterol. It may cause fatal harm when administered to a pregnant women. So it should discontinued as soon as pregnancy recognized. Limited published data on the use of this medication insufficient to determine a drug-associated risk of major congenital malformations or miscarriage.
Use For Nursing Mothers
This medicine contraindicated during breastfeeding. No available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Its not known whether this medication present in human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise women that breastfeeding not recommended during treatment with Lipirex (atorvastatin).
Females and Males of Reproductive Potential Contraception
Atorvastatin may cause fatal harm when administered to a pregnant women. Advise females of reproductive potential to use effective contraception during treatment with it.
Pediatric Use
Heterozygous Familial Hypercholesterolemia (HeFH)
The safety and effectiveness of this product have established in pediatric patients, 10 years to 17 years of age, with HeFH as an adjunct to diet to reduce total cholesterol, LDL-C and apo B levels when, after an adequate trial of diet therapy, the following may present:
- LDL-C > 190mg/dL, or
- LDL-C > 160mg/dL and
- a positive family history of FH, or premature CVD in a first, or second-degree relative, or
- two or more other CVD risk factors are present.
Advise post monarchal girls of contraception recommendations, if appropriate for the patient. The long-term efficacy of atorvastatin therapy initiated in childhood to reduce morbidity and mortality in adulthood has not yet established. The safety and efficacy of the drug have not established in pediatric patients younger than 10 years of age with HeFH.
Homozygous Familial Hypercholesterolemia (HeFH)
Clinical efficacy of this medication with dosages up to 80mg/day has yet evaluated.
Geriatric Use
No overall differences in safety or effectiveness also observed between these old age and younger population. Since advanced age (>65 years) a predisposing factor for myopathy, Lipirex (atorvastatin) should prescribed with caution in the elderly.
Hepatic Impairment
Generally the medicine contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels.
Overdosage Symptoms & Treatment
There is no specific treatment for Lipirex (atorvastatin) overdosage. In the event of an overdose, the patient should treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis not expected to significantly enhance atorvastatin clearance.
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