Atonamis

Atonamis

atorvastatin

Manufacturer:

Prime Pharmaceuticals

Distributor:

AGlobal Care
Full Prescribing Info
Contents
Atorvastatin calcium.
Description
Each film-coated tablet contains: Atorvastatin (as calcium) 10 mg, Atorvastatin (as calcium) 20 mg.
Indications/Uses
Atorvastatin is indicated for the reduction of total cholesterol and Low Density Lipoprotein (LDL) cholesterol in patients with homozygous familial hypercholesterolemia when responses to diet and other nonpharmacological measures are inadequate. Prevention of cardiovascular disease.
In adult patients without clinically evident coronary heart disease such as age, smoking, hypertension, low High Density Lipoprotein Cholesterol (HDL-C) or a family history of early heart disease, atorvastatin is indicated to: Reduce the risk of myocardial infarction.
Reduce the risk of stroke.
Reduce the risk for revascularization procedures and angina.
In 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, atorvastatin is indicated to: Reduce the risk of myocardial infarction.
Reduce the risk of stroke.
Dosage/Direction for Use
The dosage range is 10 to 80 mg once daily. Doses may be given any time of the day with or without food.
Starting and maintenance dosage should be individualized according to baseline LDL-C levels, the goal of the therapy and patient response.
After initiation and/or titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.
Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia.
The majority of the patients are controlled with 10 mg Atorvastatin once a day. A therapeutic response is evident within two weeks and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia: Most patients responded to 10 mg of Atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).
Use in Patients with Renal Insufficiency: Renal disease has no influence on the plasma concentrations or on the LDL-C reduction with atorvastatin.
Thus, no adjustment or the dose is required.
Contraindications
Atorvastatin is indicated in patients who have: Hypersensitivity to any component of this medication.
Active liver disease or unexplained persistent elevation of serum transaminases exceeding three times the upper limit of normal.
Women who are or may become pregnant.
Nursing mothers.
Special Precautions
Atorvastatin can cause an elevation in transaminase. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol, have renal or hepatic impairment or failure, aged 65 years or older, and those which suffer from hypothyroidism. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of atorvastatin.
Adverse Reactions
Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient.
Most frequent adverse effects associated with atorvastatin therapy: headache, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence.
Musculoskeletal and connective tissue disorders: rhabdomyolysis, arthralgia, rupture of tendon.
Hepatic: elevated liver enzyme, liver failure.
Immunologic: systemic lupus erythematosus.
Neurologic: hemmorhagic cerebral infarction.
Dermatologic: dermatomyositis.
Drug Interactions
The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid and derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4.
Atorvastatin is metabolized by cytochrome P450 3A4. Concomitant administration of atorvastatin with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of atorvastatin. The extent of interaction and potentiation of effects depend on the variability of effect on CYP3A4.
Clarithromycin: Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin 80 mg with clarithromycin (500 mg twice daily) compared to that of atorvastatin alone. Therefore, in patients taking clarithromycin, caution should be used when the atorvastatin dose exceeds 20 mg.
Combination of Protease Inhibitors: Atorvastatin AUC was significantly increased with concomitant administration or atorvastatin with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of atorvastatin alone.
Therefore, in patients taking the HIV protease inhibitor tipranavir plus ritonavir, or the hepatitis C protease inhibitor telaprevir, concomitant use of atorvastatin should be avoided. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary should be used. In patients taking HIV protease inhibitors saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, the dose of atorvastatin should not exceed 20 mg and should be used with caution.
Itraconazole: Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin 40 mg and itraconazole 200 mg.
Therefore in patients taking itraconazole, caution should be used when the atorvastatin dose exceeds 20 mg.
Grapefruit Juice: Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption (>1.2 liters per day).
Cyclosporine: Atorvastatin and atorvastatin-metabolites are substrates of the OATP181 transporter. Inhibitors of the OATP181 (e.g. cyclosporine) can increase the bioavailabilty of atorvastatin.
Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin 10 mg and cyclosporine 5.2 mg/kg/day compared to that of atorvastatin alone. The co-administration of atorvastatin with cyclosporine should be avoided.
Gemfibrozil: Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are co-administered with gemfibrozil, concomitant administration of atorvastatin with gemfibrozil should be avoided.
Other Fibrates: Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, atorvastatin should be administered with caution when used concomitantly with other fibrates.
Niacin: The risk of skeletal muscle effects may be enhanced when atorvastatin is used in combination with niacin; a reduction in atorvastatin dosage should be considered in this setting.
Rifampin or other inducers of Cytochrome P450 3A4: Concomitant administration of atorvastatin with inducers of cytochrome P450 3A4 (e.g. ofavirenz, rifampin) can lead to variable reductions in plasma concentrations of atorvastatin. Due to the dual interaction mechanism of rifampin, simultaneous co·administration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.
Digoxin:
When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.
Oral Contraceptives: Co-administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol. These increases should be considered when selecting and oral contraceptive for a woman taking atorvastatin.
Warfarin: Atorvastatin had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.
Colchicine: Case of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine.
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 (telaprevir), therapy with atorvastatin should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Tab 10 mg x 100's. 20 mg x 100's.
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