ATORVALIQ Dosage & Rx Info | Uses, Side Effects

Atorvaliq Generic Name & Formulations

Legal Class

General Description

Atorvastatin calcium 20mg/5mL; oral susp; orange-flavor.

Pharmacological Class

HMG-CoA reductase inhibitor.

How Supplied

Oral susp—150mL

Manufacturer

CMP Pharma

Generic Availability

Mechanism of Action

Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.

Atorvaliq Indications

Indications

To reduce risk of MI, stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. To reduce risk of MI and stroke in patients with type 2 diabetes with multiple risk factors for CHD but without clinically evident CHD. To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with clinically evident CHD. Adjunct to diet to reduce LDL-C in: adults with primary hyperlipidemia; or patients aged ≥10yrs with heterozygous familial hypercholesterolemia (HeFH). Adjunct to other lipid-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in patients aged ≥10yrs with homozygous familial hypercholesterolemia (HoFH). Adjunct to diet for adults with: primary dysbetalipoproteinemia; or hypertriglyceridemia.

Atorvaliq Dosage and Administration

Adult

Take on empty stomach. Measure with calibrated oral syringe or dosing device. Initially 10–20mg once daily; if more than a 45% reduction in LDL-C is needed, may start at 40mg once daily; range 10–80mg once daily. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir ± ritonavir, elbasvir + grazoprevir, letermovir: max 20mg/day. Concomitant nelfinavir: max 40mg/day.

Children

HeFH or HoFH: <10yrs: not established. Take on empty stomach. Measure with calibrated oral syringe or dosing device. ≥10yrs: HeFH: initially 10mg/day; range 10–20mg once daily. HoFH: initially 10–20mg/day; range 10–80mg once daily. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir ± ritonavir, elbasvir + grazoprevir, letermovir: max 20mg/day. Concomitant nelfinavir: max 40mg/day.

Atorvaliq Contraindications

Contraindications

Active liver disease or decompensated cirrhosis.

Atorvaliq Boxed Warnings

Not Applicable

Atorvaliq Warnings/Precautions

Warnings/Precautions

Risk for myopathy (eg, ≥65yrs of age, uncontrolled hypothyroidism, renal impairment, higher atorvastatin dose, concomitant certain drugs including other lipid-lowering therapies). Discontinue if markedly elevated CPK levels occur or if myopathy is diagnosed or suspected. Withhold dose in patients with acute or serious condition with high risk of developing renal failure secondary to rhabdomyolysis. Discontinue if immune-mediated necrotizing myopathy is suspected. Monitor liver function prior to starting therapy and repeat as clinically indicated. Discontinue immediately if serious hepatic injury, and/or hyperbilirubinemia, or jaundice occurs. History of liver disease. Substantial alcohol ingestion. Recent stroke or TIA: increased risk of hemorrhagic stroke (with atorvastatin 80mg dose). Elderly (monitor). Pregnancy: discontinue when recognized. Nursing mothers: not recommended.

Atorvaliq Pharmacokinetics

Absorption

Absolute bioavailability of atorvastatin: ~14%.

Distribution

Plasma protein bound: ≥98%.

Metabolism

Hepatic (CYP3A4).

Elimination

Bile (primarily), renal (<2%). Half-life: ~14 hours.

Atorvaliq Interactions

Interactions

See Adult dose. Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, glecaprevir + pibrentasvir, grapefruit juice (>1.2L/day). Potentiated by inhibitors of CYP3A4 and/or transporters (eg, OATP1B1/1B3, P-gp, BCRP, MRP2, OAT2). Monitor with lopinavir + ritonavir, simeprevir, ledipasvir + sofosbuvir, other fibrates, macrolide antibiotics, azole antifungals, niacin (≥1g/day), colchicine; use lowest atorvastatin dose necessary. Potentiates serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. May be antagonized by CYP3A4 inducers (eg, rifampin); administer rifampin simultaneously to avoid decrease in plasma levels.

Atorvaliq Adverse Reactions

Adverse Reactions

Nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI; myopathy, rhabdomyolysis, elevated serum transaminases, increased HbA1c and fasting serum glucose, cognitive impairment, hypersensitivity reactions.

Atorvaliq Clinical Trials

See Literature

Atorvaliq Note