Tiginor EZ(Atorvastatin and Ezetimibe)
Therapeutic Group: Cardiovascular
Presentation
Tiginor EZ 10/10: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg and
Ezetimibe USP 10 mg.
Tiginor EZ 20/10: Each film coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 20 mg and
Ezetimibe USP 10 mg
Description
Tiginor EZ contains Atorvastatin, a 3-hydroxy-3-methyIglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and Ezetimibe, a
selective inhibitor of intestinal cholesterol and related phytosterol absorption.
Indications
Primary Hyperlipidemia: Tiginor EZ is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH): Tiginor EZ is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable
Dosage & Administration
The recommended starting dose of Tiginor EZ is 10/10 mg or 20/10 mg daily. Tiginor EZ can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 40/10 mg daily. After initiation and/or upon titration of Tiginor EZ, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.
Patients with Homozygous Familial Hypercholesterolemia: The dosage of Tiginor EZ in patients with homozygous familial
hypercholesterolemia is 40/10 mg or 80/10 mg daily. Tiginor EZ should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
Patients with Hepatic Impairment: Tiginor EZ is contraindicated in patients with active liver disease or unexplained persistent elevations in hepatic transaminase levels.
Patients with Renal Impairment: In patients with renal impairment, no dosage adjustment of Tiginor EZ is necessary.
Side Effects
Common side effects are rhabdomyolysis, myopathy, liver enzyme abnormalities, myalgia, abdominal pain, increased hepatic enzymes.
Precautions
Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin coadministered with colchicine, and caution should be exercised when prescribing Tiginor EZ with colchicine. Tiginor EZ therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis.
Liver Enzymes: It is recommended that liver enzyme tests be obtained prior to initiating therapy with Tiginor EZ and repeated as clinically indicated. If serious liver injury with symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Tiginor EZ, promptly interrupt therapy. If an alternate etiology is found, do not restart Tiginor EZ. Active liver disease or unexplained persistent transaminase elevations are contraindicated to the use of Tiginor EZ.
Endocrine Function: Cautions should be exercised if Tiginor EZ is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone and cimetidine.
Use in Pregnancy & Lactation
Use in Special Population
Pregnancy: Pregnancy Category X. Tiginor EZ is contraindicated in women who are or may become pregnant.
Nursing Mothers: Because of the potential for adverse reactions in nursing infants, women taking Tiginor EZ should not breastfeed.
Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
Geriatric Use: In geriatric patients, no dosage adjustment of Tiginor EZ is necessary
Drug Interaction
The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole). The coadministration of Tiginor EZ with cyclosporine should be avoided. Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Tiginor EZ with gemfibrozil should be avoided. The risk of skeletal muscle effects may be enhanced when Tiginor EZ is used in combination with niacin. Patients taking digoxin should be monitored appropriately. The increase in AUC values for norethindrone and ethinyl estradiol should be considered when selecting an oral contraceptive for a woman taking Tiginor EZ.
Caution should be exercised when prescribing Tiginor EZ with colchicine. If Tiginor EZ is added to warfarin, a coumarin anticoagulant, the International Normalized Ratio (INR) should be appropriately monitored.
Over Dose
No specific treatment of overdosage with Tiginor EZ can be recommended. In the event of an overdose, the patient should be
treated symptomatically, and supportive measures instituted as required
Storage
Do not store above 30° C. Keep away from light and out of the reach of children.
Commercial Pack
Tiginor EZ 10/10 tablet: Each box contains 3 blister strips of 10 tablets.
Tiginor EZ 20/10 tablet: Each box contains 3 blister strips of 10 tablets.