ATORVA 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) and mixed dyslipidemia; treatment of hypertriglyceridemia; treatment of primary dysbetalipoproteinemia; adjunctive therapy for homozygous familial hypercholesterolemia; prevention of cardiovascular events in patients at risk (primary and secondary prevention).

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: 10-20 mg once daily initially, adjust to 10-80 mg once daily; hypertriglyceridemia: 10-80 mg once daily; primary dysbetalipoproteinemia: 10-80 mg once daily; heterozygous familial hypercholesterolemia: 10-80 mg once daily; homozygous familial hypercholesterolemia: 10-80 mg once daily (often as adjunct to other lipid-lowering therapies); cardiovascular risk reduction: 10-80 mg once daily depending on required intensity.

Initial Dose

10-20mg once daily. [5, 23]

Maintenance Dose

10-80 mg once daily, adjusted at 4-week intervals based on lipid response

Maximum Dose

80mg once daily. [1, 23]

Children's Dosage

For children aged 10 years and older with heterozygous familial hypercholesterolemia, the recommended starting dose is 10mg once daily, with a usual range of 10-20mg once daily.

Dose Adjustment Notes

Titrate at intervals of 2-4 weeks (or longer) based on LDL-C response; no adjustment is required in renal impairment; avoid/use caution in hepatic impairment and contraindicated in active liver disease; clinically important interaction-based limits apply (e.g., with cyclosporine avoid or use the lowest possible dose with close monitoring; with strong CYP3A4 inhibitors reduce dose/avoid and monitor for myopathy).

How to Take

Take once daily at any time of day, but at the same time each day. Swallow tablet whole with water. Can be taken with or without food. [1, 10, 13]

Side Effects

Common Side Effects

Nasopharyngitis, arthralgia, diarrhea, pain in extremity, urinary tract infection, dyspepsia, nausea, myalgia, muscle spasms, insomnia, headache

Safety & Warnings

Warnings & Precautions

Assess for myopathy risk and counsel to report muscle symptoms; check liver enzymes before initiation and if clinically indicated thereafter; use caution with interacting drugs and in patients with renal impairment, hypothyroidism, advanced age, or heavy alcohol use; monitor glycemia in at-risk patients due to small diabetes risk.

Age Restriction

Approved for pediatric use in children ≥10 years (for heterozygous familial hypercholesterolemia); not indicated <10 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major interactions include strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors), cyclosporine, grapefruit juice (large amounts), and myopathy-risk combinations (gemfibrozil/other fibrates, niacin at lipid-lowering doses, colchicine); additional clinically relevant interactions include rifampin (reduced exposure), warfarin (monitor INR), digoxin (may increase levels), and some oral contraceptives (may increase hormone exposure).

Food Interaction

May be taken with or without food; avoid excessive grapefruit juice (clinically significant interaction risk increases with large quantities, e.g., >1 liter/day).

Special Populations

Children

For children aged 10 years and older with heterozygous familial hypercholesterolemia, the recommended starting dose is 10mg once daily, with a usual range of 10-20mg once daily.

Elderly

Standard adult dosing; no dose adjustment required based on age alone. Use with caution due to increased risk of myopathy in elderly patients.

Storage & Patient Advice

Stopping the Medicine

Do not stop atorvastatin without consulting a healthcare professional; stopping can cause LDL-C to rise and increase cardiovascular risk.

Pharmacology

Mechanism of Action

Selective competitive inhibition of HMG-CoA reductase reduces hepatic cholesterol synthesis, upregulates LDL receptors, and increases LDL clearance, lowering LDL-C and triglycerides with modest HDL-C increase.

Onset of Action

LDL-C reduction is typically seen within ~1-2 weeks, with near-maximal effect by ~4 weeks after initiation or dose change.

Duration of Effect

Once-daily dosing provides ~24-hour LDL-lowering coverage; lipid-lowering effect persists beyond a single dose, with near-maximal LDL-C reduction achieved by ~4 weeks after initiation or dose change.

Half-Life

Approximately 14 hours for the parent drug; 20-30 hours for HMG-CoA reductase inhibitory activity due to active metabolites. [1, 27, 30]

Bioavailability

Approximately 12-14% (low absolute bioavailability due to extensive first-pass metabolism).

Excretion

Primarily eliminated via bile/feces; <2% excreted in urine.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10 mg atorvastatin as atorvastatin calcium

OTC Alternatives

No OTC alternative

Lipid Target

Both

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