Colestop

Colestop

atorvastatin

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
Adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-C, Apo B, & triglycerides in adults, adolescents & childn ≥10 yr w/ primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa & IIb of the Fredrickson classification) when response to diet & other nonpharmacological measures is inadequate. Reduction of total-C & LDL-C in adults w/ HoFH as adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable. Prevention of CV events in adult patients estimated to have a high risk for a 1st CV event, as adjunct to correction of other risk factors.
Dosage/Direction for Use
Usual starting dose: 10 mg once daily, adjust dose at ≥4 wk intervals. Max: 80 mg once daily. Adult Primary hypercholesterolaemia & combined (mixed) hyperlipidaemia 10 mg once daily. Heterozygous familial hypercholesterolaemia Initially 10 mg daily, adjust every 4 wk to 40 mg daily. Thereafter, increase dose to max 80 mg daily or combine a bile acid sequestrant w/ 40 mg atorvastatin once daily. HoFH 10-80 mg daily. Prevention of CV disease 10 mg daily. Paed population ≥10 yr Heterozygous familial hypercholesterolaemia Initially 10 mg daily, may be increased at ≥4 wk intervals to 80 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevation of serum transaminases exceeding 3 times the ULN. Patients treated w/ hepatitis C antivirals glecaprevir/pibrentasvir. Women of child-bearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Perform LFTs prior to treatment & thereafter when clinically indicated. Patients who develop any signs or symptoms suggestive of liver injury should have LFTs performed. Caution in patients who consume substantial quantities of alcohol &/or have a history of liver disease. Risk of hemorrhagic stroke in patients initiated on atorvastatin 80 mg, particularly in patients w/ prior hemorrhagic stroke or lacunar infarct. In rare occasions, may affect skeletal muscle causing myalgia, myositis, & myopathy that may progress to rhabdomyolysis. Caution in patients w/ pre-disposing factors for rhabdomyolysis. Discontinue if clinically significant elevation of creatine kinase levels (>10 times ULN) occur, or if rhabdomyolysis is diagnosed or suspected. Discontinue in case of ILD. Statins as a class may raise blood glucose; patients at risk (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m2, raised triglycerides, HTN) should be monitored both clinically & biochemically. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Women of child-bearing potential should use appropriate contraceptive measures during treatment. Not indicated in childn <10 yr.
Adverse Reactions
Nasopharyngitis; allergic reactions; hyperglycaemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhoea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain; abnormal LFT, increased blood creatine kinase.
Drug Interactions
Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, some antivirals for HCV [eg, elbasvir/grazoprevir], & HIV PIs including ritonavir, lopinavir, atazanavir, indinavir, darunavir); moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil, fluconazole); transport protein inhibitors (eg, ciclosporin, letermovir). Reduced plasma conc w/ CYP3A4 inducers (eg, efavirenz, rifampin, St. John's wort). Increased risk of muscle related events w/ gemfibrozil/fibric acid derivatives; ezetimibe; fusidic acid; colchicine. Lower plasma conc of atorvastatin & its active metabolites w/ colestipol, but greater lipid effects when co-administered. Slightly increased conc of digoxin. Increased plasma conc of norethindrone & ethinyl oestradiol. Small decrease in prothrombin time w/ warfarin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Colestop FC tab 10 mg
Packing/Price
30's
Form
Colestop FC tab 20 mg
Packing/Price
30's
Form
Colestop FC tab 40 mg
Packing/Price
30's
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