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Ator 80 mg - 10 F.C. Tablets

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Medical Description

Antilipidemic Agent, HMG-CoA Reductase inhibitor used in the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular diseases.

Indication & Usage

-Heterozygous familial hypercholesterolemia: High-intensity therapy: Oral: Initial: 40 or 80 mg once daily; if 40 mg once daily is initiated and tolerated, increase to 80 mg once daily. -Homozygous familial hypercholesterolemia: High-intensity therapy: Oral: 80 mg once daily. -Primary prevention of atherosclerotic cardiovascular disease: 1-Patients without diabetes, age 40 to 75 years, and LDL-C 70 to 189 mg/dL: a-In case of patients with ASCVD 10-year risk = 5% to <7.5%: Moderate-intensity therapy: Oral: 10 to 20 mg once daily to reduce LDL-C by 30% to 49%.b-In case of patients with ASCVD 10-year risk ≥7.5% to <20%: Moderate-intensity therapy: Oral: 10 to 20 mg once daily to reduce LDL-C by 30% to 49%. c-In case of patients with ASCVD 10-year risk ≥20%: High-intensity therapy: Oral: 40 to 80 mg once daily to reduce LDL-C by ≥50%. 2-While in case of patients with diabetes: a-In case of patients with age 40 to 75 years without additional ASCVD risk factors: Moderate-intensity therapy: Oral: 10 to 20 mg once daily to reduce LDL-C by 30% to 49%, b-in case of patients with ASCVD risk >20% or multiple ASCVD risk factors: High-intensity therapy: Oral: 40 to 80 mg once daily to reduce LDL-C by ≥50%. 3-Patients with LDL-C ≥190 mg/dL and age 20 to 75 years: High-intensity therapy: Oral: 40 to 80 mg once daily to reduce LDL-C by ≥50%. -Secondary prevention in patients with established atherosclerotic cardiovascular disease: High-intensity therapy: Oral: 80 mg once daily to reduce LDL-C by ≥50%. -Pediatric dosing: see dosage and administration

Active Ingredients

Atorvastatin

Recommended Doctors

No Recommended Doctors Found

Dosage & Administration

Administer with or without food. -Pediatric dosing: -Heterozygous familial and nonfamilial hypercholesterolemia: Children 6 to <10 years of age: Limited data available: Oral: Initial: 5 mg once daily; if target LDL-C not achieved after 4 weeks, may increase incrementally by doubling dose (10 mg/day, 20 mg/day) at monthly intervals until target LDL-C; usual maximum daily dose: 40 mg/day. Children and adolescents 10 to 17 years: Oral: Initial: 10 mg once daily; if target LDL-C not achieved after 4 weeks, may increase incrementally by doubling dose (20 mg/day, 40 mg/day) at monthly intervals until target LDL-C up to a maximum daily dose: 80 mg/day.

Side Effects

-Statins are associated with increased serum transaminases and hepatotoxicity. -Statins are associated with several muscle-related effects, including: Myalgia, myopathy and rhabdomyolysis. -Diarrhea, arthralgia, nasopharyngitis, hemorrhagic stroke, diabetes mellitus, dyspepsia, nausea, urinary tract infection, increased serum transaminases, insomnia, limb pain, muscle spasm, musculoskeletal pain, myalgia and pharyngolaryngeal pain.

Safety Advice

-Should not be given to patients suffering from hypersensitivity to atorvastatin. -May cause increase in HbA1c and fasting blood glucose. -Use with caution in patients who consume large amounts of ethanol or have a history of liver disease; use is contraindicated in patients with active liver disease. -May rarely worsen or precipitate myasthenia gravis. -Statins are associated with increased serum transaminases and hepatotoxicity. -Statins are associated with several muscle-related effects, including: Myalgia, myopathy and rhabdomyolysis. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Storage

Store at room temperature.

Drug Interactions

-Amiodarone: May increase the serum concentration of Atorvastatin. -Azithromycin (Systemic): May enhance the myopathic (rhabdomyolysis) effect of Atorvastatin. -Clarithromycin: May increase the serum concentration of Atorvastatin. -Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). -Digoxin: Atorvastatin may increase the serum concentration of Digoxin. -Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). -Gemfibrozil: May enhance the myopathic (rhabdomyolysis) effect of Atorvastatin. -Grapefruit Juice: May increase the serum concentration of Atorvastatin. -Itraconazole: May increase the serum concentration of Atorvastatin. -Rifampin: May increase the serum concentration of Atorvastatin. -Spironolactone: Atorvastatin may enhance the adverse/toxic effect of Spironolactone. -St John's Wort: May decrease serum concentrations of the active metabolite(s) of HMG-CoA Reductase Inhibitors (Statins). -Ticagrelor: May increase the serum concentration of Atorvastatin. -Verapamil: Atorvastatin may increase the serum concentration of Verapamil.

Pregnancy & Lactation

-Atorvastatin is contraindicated in females who may become pregnant. Adequate contraception is recommended if an HMG-CoA reductase inhibitor is required in females of reproductive potential. Females planning a pregnancy should discontinue the HMG-CoA reductase inhibitor 1 to 2 months prior to attempting to conceive. -Use is contraindicated in breastfeeding women. It is not known if atorvastatin is present in breast milk. -Ask your physician before taking any medications during pregnancy or lactation.

Manufacture

EIPICO

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