TOVAST 40/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia; homozygous familial hypercholesterolemia; and to reduce risk of cardiovascular events (e.g., MI, stroke, revascularization, angina) in at-risk patients.

Off-Label Uses

No routine/endorsed off-label use to list for this product; proposed uses (e.g., NAFLD, contrast nephropathy prevention, anti-inflammatory indications) have inconsistent evidence and are not guideline-endorsed indications for atorvastatin.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: 10-20 mg once daily initially (may start 40 mg if >45% LDL-C reduction needed), range 10-80 mg daily; Homozygous familial hypercholesterolemia: 10-80 mg once daily (often as adjunct to other lipid-lowering therapy); Hypertriglyceridemia/dysbetalipoproteinemia: 10-80 mg once daily; Cardiovascular risk reduction: intensity-based dosing (e.g., 40-80 mg for high-intensity when indicated; otherwise 10-20 mg for moderate-intensity).

Initial Dose

10-20mg once daily. [8, 9]

Maintenance Dose

10-80 mg once daily, adjusted at intervals of 4 weeks or more based on lipid response

Maximum Dose

80mg once daily. [1, 8]

Children's Dosage

For heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged ≥10 years: Initial 10 mg orally once daily; usual range 10-20 mg once daily; maximum 20 mg/day.

Dose Adjustment Notes

Individualize and titrate at intervals of about 2-4 weeks based on LDL-C response/tolerability; no adjustment is needed in renal impairment; avoid use in active liver disease and use caution in hepatic impairment; limit/avoid with strong CYP3A4 inhibitors and other myopathy-risk drugs (may require lower dose or temporary interruption).

Side Effects

Common Side Effects

Nasopharyngitis, diarrhea, dyspepsia/nausea, arthralgia, myalgia, and urinary tract infection (among the more commonly reported).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to atorvastatin/excipients; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy; breastfeeding.

Warnings & Precautions

Key warnings/precautions: assess liver enzymes before initiation and if symptoms of liver injury occur; counsel to report unexplained muscle pain/weakness and check CK when indicated; myopathy risk increases with higher doses and interacting drugs (CYP3A4 inhibitors, cyclosporine, fibrates/niacin, colchicine) and in older age/renal impairment; may increase blood glucose/HbA1c; use caution with history of liver disease or heavy alcohol use.

Age Restriction

Adults: indicated. Pediatric use: approved only for heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged ≥10 years; safety/efficacy not established for patients <10 years or for other lipid indications in patients <18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically important interactions include: strong/moderate CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, HIV protease inhibitors; grapefruit juice in large amounts) ↑ atorvastatin exposure/myopathy risk; cyclosporine ↑ exposure (avoid/very low max dose per labeling); fibrates (esp. gemfibrozil) and niacin (lipid-lowering doses) ↑ myopathy risk; colchicine ↑ myopathy risk; digoxin levels may increase; warfarin effect may be potentiated (monitor INR); rifampin can reduce exposure (timing matters); antacids can slightly reduce levels.

Interaction Severity

MAJOR: Cyclosporine; strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors/cobicistat); hepatitis C regimens such as glecaprevir/pibrentasvir (often contraindicated/avoid) - markedly increased atorvastatin exposure and myopathy/rhabdomyolysis risk. MODERATE: Gemfibrozil/other fibrates and niacin (↑ myopathy risk), colchicine (↑ myopathy risk), grapefruit (↑ exposure). MINOR/monitor: Warfarin (INR changes-monitor), digoxin (↑ levels-monitor), antacids (↓ atorvastatin levels).

Food Interaction

May be taken with or without food; avoid or limit grapefruit/grapefruit juice (especially large quantities) due to CYP3A4 inhibition increasing atorvastatin exposure and myopathy risk.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

For heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged ≥10 years: Initial 10 mg orally once daily; usual range 10-20 mg once daily; maximum 20 mg/day.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but elderly patients may be at higher risk of myopathy - monitor accordingly

Liver Impairment

No specific dose adjustment is recommended for mild hepatic impairment, but use with caution and monitor; contraindicated in active liver disease or unexplained persistent transaminase elevations (and generally avoid in decompensated hepatic disease).

Storage & Patient Advice

Storage Conditions

Do not store above 30°C; keep in original packaging (blister) to protect from moisture/light.

Stopping the Medicine

Do not stop atorvastatin without consulting the prescriber; stopping will allow LDL-C to rise and may increase cardiovascular risk over time.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG-CoA reductase in the liver, reducing cholesterol synthesis and upregulating hepatic LDL receptors to increase clearance of circulating LDL-C.

Onset of Action

LDL-C lowering begins within ~1-2 weeks, with near-maximal effect by ~4 weeks.

Duration of Effect

With continued once-daily dosing, LDL-C lowering is maintained throughout the dosing interval (24 hours) and persists as long as therapy is continued. After discontinuation, lipid levels gradually return toward baseline over several weeks.

Half-Life

Atorvastatin: ~14 hours; HMG‑CoA reductase inhibitory activity (active metabolites): ~20-30 hours.

Bioavailability

Approximately 14% (absolute oral bioavailability).

Excretion

Primarily biliary/fecal after hepatic metabolism; renal excretion is minimal (about <2% in urine).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

Both

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