TOVAST 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia and mixed dyslipidemia; hypertriglyceridemia; primary dysbetalipoproteinemia; heterozygous and homozygous familial hypercholesterolemia; and prevention of cardiovascular events in at‑risk patients (including those with type 2 diabetes plus risk factors).

Off-Label Uses

No universally accepted off-label indication; some evidence-based but non-label uses include NAFLD/NASH risk modification and peri-procedural/anti-inflammatory applications, but these are not standard approved indications.

Dosage & Administration

Dosing by Condition

Adults: primary hypercholesterolemia/mixed dyslipidemia or hypertriglyceridemia: 10-20 mg once daily initially (range 10-80 mg daily); homozygous familial hypercholesterolemia: 10-80 mg once daily (often as adjunct to other lipid-lowering therapy); ASCVD risk reduction: 10-80 mg once daily depending on required intensity. Pediatrics (HeFH, ≥10 years): 10 mg once daily, max 20 mg/day.

Initial Dose

10-20 mg once daily

Maintenance Dose

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

Maximum Dose

80 mg once daily

Children's Dosage

For Heterozygous Familial Hypercholesterolemia in patients 10 years and older: start with 10mg daily, with a maximum recommended dose of 20mg daily.

Dose Adjustment Notes

Adjust dose based on LDL-C response at intervals of ≥4 weeks; no adjustment needed in renal impairment; contraindicated in active liver disease and avoid/use caution in hepatic impairment; reduce/hold if myopathy/rhabdomyolysis is suspected.

How to Take

Swallow tablet whole with water. Can be taken at any time of day, with or without food. Take at the same time each day for consistency.

Side Effects

Common Side Effects

Nasopharyngitis, myalgia, arthralgia, diarrhea, nausea/dyspepsia, headache; less commonly elevated liver enzymes and urinary tract infection.

Side Effect Frequency

Common (≥1% to <10%): nasopharyngitis, myalgia, arthralgia, diarrhea, nausea, headache; Uncommon (<1%): elevations in hepatic transaminases, rash/pruritus; Rare/very rare: myopathy/rhabdomyolysis, hepatitis, pancreatitis, peripheral neuropathy, angioedema, immune‑mediated necrotizing myopathy.

Safety & Warnings

Contraindications

Contraindicated in: active liver disease or unexplained persistent elevations of hepatic transaminases; pregnancy; breastfeeding; hypersensitivity to atorvastatin/excipients; concomitant use with glecaprevir/pibrentasvir; and (per many references) avoid/contraindicated with cyclosporine due to markedly increased exposure and myopathy risk.

Warnings & Precautions

Key warnings/precautions: assess liver enzymes before initiation and thereafter when clinically indicated; counsel/monitor for muscle symptoms and stop/evaluate if myopathy/rhabdomyolysis suspected (risk higher with interacting drugs, older age, renal impairment, hypothyroidism); avoid systemic fusidic acid and manage major CYP3A4 interactions; use caution with history of liver disease or heavy alcohol use; may increase blood glucose/HbA1c; discontinue and treat if serious hypersensitivity occurs.

Age Restriction

Pediatric use: approved for heterozygous familial hypercholesterolemia (HeFH) in children/adolescents aged 10-17 years; not established/approved for <10 years, and other indications generally lack pediatric approval.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major/clinically important interactions include: strong CYP3A4 inhibitors (e.g., clarithromycin, azole antifungals, HIV protease inhibitors/cobicistat) and cyclosporine (↑ atorvastatin exposure → myopathy/rhabdo risk); systemic fusidic acid (avoid-rhabdomyolysis risk); fibrates (especially gemfibrozil) and high-dose niacin (↑ myopathy risk); colchicine (↑ myopathy risk); grapefruit juice in large amounts (↑ levels); warfarin (may affect INR); digoxin (↑ digoxin levels); oral contraceptives (↑ ethinyl estradiol/norethindrone); antacids may slightly reduce atorvastatin concentrations.

Interaction Severity

MAJOR/AVOID: cyclosporine; glecaprevir/pibrentasvir; tipranavir/ritonavir and other strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, many HIV protease inhibitors) due to markedly increased atorvastatin exposure and myopathy/rhabdomyolysis risk. MODERATE: gemfibrozil and other fibrates, niacin (high dose), colchicine (additive myotoxicity); warfarin (may alter INR); digoxin and oral contraceptives (increased levels). MINOR: aluminum/magnesium antacids (reduced atorvastatin levels, usually not clinically significant); grapefruit juice in small amounts.

Food Interaction

May be taken with or without food; avoid or limit grapefruit juice-especially large quantities (e.g., >1 liter/day)-due to increased atorvastatin exposure via CYP3A4 inhibition.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

For Heterozygous Familial Hypercholesterolemia in patients 10 years and older: start with 10mg daily, with a maximum recommended dose of 20mg daily.

Elderly

Standard adult dosing; elderly patients (≥65 years) are at higher risk of myopathy - use lowest effective dose and monitor for muscle symptoms

Kidney Impairment

No renal dose adjustment required; however, severe renal impairment increases susceptibility to statin-associated myopathy, so monitor for muscle symptoms/CK when clinically indicated.

Liver Impairment

Active liver disease or unexplained persistent transaminase elevations: contraindicated; chronic stable liver disease/mild-moderate hepatic impairment: use with caution at the lowest effective dose with monitoring; severe hepatic impairment/decompensated cirrhosis (e.g., Child-Pugh C): avoid/contraindicated.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C (store below 30°C).

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose (e.g., next day), skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without prescriber advice; stopping is not physiologically dangerous/withdrawal-forming, but LDL will rise and cardiovascular risk reduction is lost.

Overdose

No specific antidote; manage with symptomatic/supportive care (consider decontamination if early/appropriate), monitor for myopathy/rhabdomyolysis and hepatotoxicity; hemodialysis is unlikely to be effective due to high protein binding-seek urgent medical care/poison center guidance.

Patient Counseling

Take 1 tablet once daily at the same time, with or without food; swallow whole. Avoid/limit large amounts of grapefruit juice. Report unexplained muscle pain/weakness or dark urine promptly. Avoid in pregnancy and breastfeeding; use effective contraception if applicable. Limit alcohol and attend follow-up lipid testing (and liver tests if symptoms). Inform clinicians/pharmacists before starting new medicines.

Monitoring Requirements

Lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; ALT/AST at baseline and thereafter only if clinically indicated; CK only if muscle symptoms or high-risk features; consider periodic glucose/HbA1c in patients at risk for diabetes.

Pharmacology

Mechanism of Action

Competitive inhibition of HMG‑CoA reductase reduces hepatic cholesterol synthesis, upregulates hepatic LDL receptors, and increases clearance of circulating LDL cholesterol.

Onset of Action

LDL-lowering begins within ~1-2 weeks after initiation or dose adjustment; near-maximal effect by ~4 weeks.

Duration of Effect

With continued once-daily therapy, LDL-lowering is maintained; the pharmacodynamic HMG‑CoA reductase inhibitory effect supports 24-hour dosing (once daily). Lipid response is typically reassessed after ~2-4 weeks, with near-maximal effect by ~4 weeks.

Half-Life

Parent atorvastatin t1/2 ≈ 14 hours; half-life of HMG‑CoA reductase inhibitory activity ≈ 20-30 hours (due to active metabolites).

Bioavailability

Approximately 14% (absolute oral bioavailability); systemic availability for HMG‑CoA reductase inhibitory activity is ~30%.

Metabolism

Extensively hepatic metabolism primarily via CYP3A4 to active ortho‑ and parahydroxylated metabolites and various beta‑oxidation products.

Excretion

Primarily biliary/fecal elimination after hepatic metabolism; <2% excreted in urine.

Protein Binding

≥98% (highly protein bound).

Product Information

Available Dosage Forms

Film-coated tablet (oral), 20 mg; blister pack of 30 tablets.

Composition per Dose

Each film-coated tablet: 20 mg atorvastatin as atorvastatin calcium

Generic Availability

Yes

OTC Alternatives

No OTC medication is a direct substitute for atorvastatin; lifestyle measures and OTC supplements (e.g., plant sterols/stanols, soluble fiber) may modestly lower LDL but are not equivalent.

Lipid Target

Both

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