Colostat 10 - Tablet Atorvastatin - 10mg 10 Tablet(s) / Strip The Ibn Sina Pharmaceutical Ind. Ltd. Introduction: Colostat 10 belongs to a group of medicines called statins. It is used to lower cholesterol and to reduce the risk of heart disease. Cholesterol is a fatty substance that builds up in your blood vessels and causes narrowing, which may lead to a heart attack or stroke. Colostat 10 is a widely prescribed medicine and is regarded as safe for long-term use when taken as per doctor's advice. It can be taken with a meal or on an empty stomach. You can take it at any time of the day but try to take it at the same time... Uses of Colostat 10: High cholesterolPrevention of heart attack Side effects of Colostat 10: ConstipationHeadacheMuscle pain How to use Colostat 10: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Colostat 10 may be taken with or without food, but it is better to take it at a fixed time. How Colostat 10 works: Colostat 10 is a lipid-lowering medication (statin). It works by blocking an enzyme (HMG-CoA-reductase) that is required in the body to make cholesterol. It thus lowers "bad" cholesterol (LDL) and triglycerides, raising the level of "good" cholesterol (HDL). What if you forget to take Colostat 10?: If you miss a dose of Colostat 10, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses within 12 hour. Indication: Oral Mixed dyslipidaemia, Heterozygous familial hypercholesterolaemia, Nonfamilial hypercholesterolaemia Adult: Initially, 10 or 20 mg once daily, may be adjusted at 4-wk interval. May initiate 40 mg once daily in patients who require >45% reduction in LDL-cholesterol. Max: 80 mg/day. Elderly: No dosage adjustment needed. Administration: May increase risk of myopathy and rhabdomyolysis w/ CYP3A4 potent inhibitor (e.g. HIV or HCV protease inhibitors, itraconazole, clarithromycin), fenofibrate, colchicines, fixed combination of lopinavir/ritonavir. May decrease plasma concentration w/ CYP3A4 inducer (e.g. rifampicin, efavirenz). May significantly increase AUC and peak plasma concentration of digoxin. Increased AUC for norethindrone and ethinyl estradiol. Potentially Fatal: Increased risk of myopathy or rhabdomyolysis w/ ciclosporin, gemfibrozil, telaprevir, tipranavir. Adult Dose: Patients who consume substantial quantities of alcohol. History of liver disease. Patients with risk factors for myopathy or rhabdomyolysis. Hypothyroidism should be properly managed prior to starting statin therapy. Children <10 yr. Premenarcheal females. Lactation: Because of the potential for adverse reactions in nursing infants, women taking this drug should not breastfeed; contraindicated in nursing mothers. Renal Dose: 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. Contraindication: Oral Mixed dyslipidaemia, Heterozygous familial hypercholesterolaemia, Nonfamilial hypercholesterolaemia Child: Heterozygous familial hypercholesterolaemia: 10-17 yr 10 mg once daily, may increase at intervals of at least 4 wk to max 20 mg/day. Mode of Action: 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. Precaution: Primary hypercholesterolemia (heterozygous familial and nonfamilial), Mixed Dyslipidemia, Homozygous familial hypercholesterolemia, Hypertriglyceridemia, Familial hypercholesterolemia, Cardiovascular event prevention, Primary dysbetalipoproteinemia Side Effect: Renal Insufficiency: Renal disease does not affect the plasma concentrations or LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary. Pregnancy Category Note: >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. Interaction: Hypersensitivity, active liver disease or unexplained persistent elevations of serum transaminase, porphyria, pregnancy, lactation.