Vastor 10 Tablet

Vastor 10 Tablet is used for: Primary hypercholesterolemia (heterozygous familial and nonfamilial), Mixed Dyslipidemia, Homozygous familial hypercholesterolemia, Hypertriglyceridemia, Familial hypercholesterolemia, Cardiovascular event prevention, Primary dysbetalipoproteinemia

Adult: Hyperlipidemias Adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C homozygous familial hypercholesterolemia (HoFH) As an adjunct to diet for treatment of primary dysbetalipoproteinemia or hypertriglyceridemia Adjunct to diet to reduce LDL-C in Primary hyperlipidemia Heterozygous familial hypercholesterolemia (HeFH) Oral Tablet The recommended starting dosage is 10 or 20 mg once daily; the dosage range is 10 mg to 80 mg once daily. Patients requiring LDL-C reduction >45% may start at 40 mg once daily. Cardiovascular Disease Prevention Reduce risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD), but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD, but without clinically evident CHD Non-fatal MI, Fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adults with clinically evident CHD Oral Tablet The recommended starting dosage is 10 or 20 mg once daily; the dosage range is 10 mg to 80 mg once daily. Patients requiring LDL-C reduction >45% may start at 40 mg once daily.

Oral Child: Heterozygous Familial Hypercholesterolemia Indicated as an adjunct to diet to reduce LDL-C in in patients aged >10 years with heterozygous familial hypercholesterolemia (HeFH) <10 years: Safety and efficacy not established >10 years: 10 mg PO once daily initially; titrate at 4-week intervals; not to exceed 20 mg PO once daily. Homozygous Familial Hypercholesterolemia Indicated as an adjunct to other LCL-C lowering therapies, or alone if such treatment are unavailable, to reduce LCL-C in patients aged >10 years with homozygous familial hypercholesterolemia (HoFH) <10 years: Safety and efficacy not established >10 years: 10-20 mg PO once daily initially Dosage range: 10-80 mg once daily.

Renal impairment Renal impairment does not affect atorvastatin plasma concentrations, therefore, there is no dosage adjustment Renal impairment is a risk factor for myopathy and rhabdomyolysis Monitor all patients with renal impairment for development of myopathy

Atorvastatin can be administered as a single dose at any time of the day, with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.

Hypersensitivity to atorvastatin Acute liver failure or decompensated cirrhosis

• Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher Atorvastatin dosage. Discontinue Atorvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Atorvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing Atorvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. • Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue Atorvastatin if IMNM is suspected. • Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue Atorvastatin

Pregnancy Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females; discontinue therapy as soon as pregnancy is recognized Treatment of hyperlipidemia is not generally necessary during pregnancy; atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations; published data from prospective and retrospective observational cohort studies with use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage Contraception Females of reproductive potential: Use effective contraception during treatment Animal data In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m2); in rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses greater than or equal to 6 times the MRHD Lactation There is no available information on effects of drug on breastfed infant or on milk production Unknown whether is present in human milk; it has been shown that drugs in this class pass into human milk and atorvastatin is present in rat milk Studies in rats have shown that atorvastatin and/or its metabolites are present in the breast milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk; this drug decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to breastfed infant Because of potential for serious adverse reactions in a breastfed infant, based on mechanism of action, advise patients that breastfeeding is not recommended during therapy

Risk of myopathy: Increased by coadministration with fibrates, cyclosporine, macrolides, inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (eg, breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis; concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir not recommended. Cases of myopathy/rhabdomyolysis reported with atorvastatin coadministered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir; consider if benefit of use of these products outweighs increased risk of myopathy and rhabdomyolysis. Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with Atorvastatin. Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive. Digoxin: May increase digoxin plasma levels; monitor patients appropriately. Potentially Fatal: Increased risk of myopathy or rhabdomyolysis w/ ciclosporin, gemfibrozil, telaprevir, tipranavir. Contraindicated (6) cyclosporine gemfibrozil lonafarnib pazopanib red yeast rice tipranavir

Side effects of Atorvastatin : >10% Diarrhea (5-14%),Nasopharyngitis (4-13%),Arthralgia (4-12%) 1-10% Insomnia (1-5%),Urinary tract infection (4-8%),Nausea (4-7%),Dyspepsia (3-6%),Increased transaminases (2-3%),Muscle spasms (2-5%),Musculoskeletal pain (2-5%),Myalgia (3-8%),Limb pain (3-8%),Pharyngolaryngeal pain (1-4%) Frequency Not Defined Angina,Syncope,Dyspnea,Myopathy,Anaphylaxis,Stevens-Johnson syndrome,Myositis Potentially Fatal: Thrombocytopenia. Rhabdomyolysis with acute renal failure.

Atorvastatin competitively inhibits HMG-CoA reductase, the enzyme that catalyses the conversion of HMG-CoA to mevalonate. This results in the induction of the LDL receptors and stimulation of LDL catabolism, leading to lowered LDL-cholesterol levels.

Vastor 10 10mg Tablet manufactured by Ad-din Pharmaceuticals Ltd.. Its generic name is Atorvastatin. Vastor 10 is availble in Bangladesh. Farmaco BD drug index information on Vastor 10 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.