ALIP (Atorvastatin 10 mg Tablets / 20 mg Tablets/ 40 mg Tablets)
(Atorvastatin Calcium IP equivalent to Atorvastatin 20 mg)
Each film coated tablets contains:
(Atorvastatin Calcium IP equivalent to Atorvastatin 40 mg)
Tablet for Oral Use
Atorvastatin is a statin medication and a competitive inhibitor of
the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A)
reductase, which catalyzes the conversion of HMG-CoA to
mevalonate, an early rate-limiting step in cholesterol biosynthesis.
Atorvastatin acts primarily in the liver, where decreased hepatic
cholesterol concentrations stimulate the upregulation of hepatic
low-density lipoprotein (LDL) receptors, which increases hepatic
uptake of LDL. Atorvastatin also reduces Very-Low-Density
Lipoprotein-Cholesterol (VLDL-C), serum triglycerides (TG) and
Intermediate Density Lipoproteins (IDL), as well as the number of
apolipoprotein B (apo B) containing particles, but increases High-
Density Lipoprotein Cholesterol (HDL-C).
Absorption: Atorvastatin is rapidly absorbed after oral
administration with a peak plasma concentration at 1 to 2
hours. The bioavailability is low at 14% due to extensive first-
pass metabolism. Administration of Atorvastatin with food
results in prolonged Tmax and a reduction in Cmax and AUC.
Distribution: The reported volume of distribution of
Atorvastatin is of 380 L.
Plasma Binding: Atorvastatin is highly bound to plasma
proteins and over 98% of the administered dose is found in a
Metabolism &Excretion: Atorvastatin is highly metabolized
primarily by Cytochrome P450 3A4 in the intestine and liver.
Atorvastatin and its metabolites are mainly eliminated in the
bile without enterohepatic recirculation. The renal elimination
of atorvastatin is very minimal and represents less than 1% of
the eliminated dose.
Half Life: The half-life of Atorvastatin is 14 hours while the half-
life of its metabolites can reach up to 30 hours.
- Adults with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia
- Primary dysbetalipoproteinemia
- Homozygous familial hypercholesterolemia
- Pediatric patients with heterozygous familial hypercholesterolemia (after failing dietary modifications)
Common adverse effects: arthralgia, dyspepsia, diarrhea, nausea, nasopharyngitis, insomnia, urinary tract infection, and pain in extremities. Myopathies have occurred in patients taking Atorvastatin, including muscle aches, muscle tenderness, or muscle weakness, with elevated creatinine phosphokinase
DOSAGE AND ADMINISTRATION:
Primary hypercholesterolemia and mixed dyslipidemia
10-20 mg PO once a Day initially
Maintenance: 10-80 mg PO once a Day
Adjunct to diet for elevated TG levels
10 mg PO once a Day initially
Maintenance: 10-80 mg PO once a Day maintenance
Maintenance: 10-80 mg PO once a Day
Homozygous familial hypercholesterolemia
10-80 mg PO once a Day
Cardiovascular Disease Prevention: 10-80 mg PO once a Day
CONTRAINDICATIONS: Hypersensitivity to Atorvastatin, Active liver disease or unexplained transaminase elevation, Pregnancy and breastfeeding.
WARNINGS AND PRECAUTIONS:
Patients starting atorvastatin should have liver function tests and a lipid panel performed
Use of Atorvastatin during pregnancy is not suggested
Pregnancy Category: X. There are reports of congenital anomalies
Drug Interaction: Bile acid sequestrant: Administer atorvastatin/ezetimibe ≥2 hr before or ≥4 hr after administering bile acid sequestrant
Cyclosporine, tipranavir plus ritonavir, gemfibrozil: Avoid coadministration with atorvastatin (increased risk of rhabdomyolysis)
Lopinavir plus ritonavir: Use lowest dose of atorvastatin necessary
Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir: Do not exceed atorvastatin dose of 20 mg/day
Nelfinavir: Do not exceed atorvastatin dose of 40 mg/day