ATORVASTATIN CALCIUM- atorvastatin calcium tablet 
Direct_Rx

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ATORVASTATIN CALCIUM

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE FORMS & STRENGTHS SECTION

Atorvastatin calcium tablets of 10 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘121’on other side.

Atorvastatin calcium tablets of 20 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘122’ on other side.

Atorvastatin calcium tablets of 40 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed ‘RDY’ on one side and ‘123’ on other side.

CONTRAINDICATIONS SECTION

WARNINGS AND PRECAUTIONS SECTION

ADVERSE REACTIONS SECTION

DRUG INTERACTIONS SECTION

USE IN SPECIFIC POPULATIONS SECTION

OVERDOSAGE SECTION

There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.

DESCRIPTION SECTION

Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:

structure

Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below.

Atorvastatin calcium tablets for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.

CLINICAL PHARMACOLOGY SECTION

NONCLINICAL TOXICOLOGY SECTION

CLINICAL STUDIES SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-258(NDC:55111-122)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 68401960MK)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLENE CHLORIDE (UNII: 588X2YUY0A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
Product Characteristics
Colorwhite (whit to off white) Scoreno score
ShapeCAPSULESize12mm
FlavorImprint Code RDY;122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-258-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/19/2019
2NDC:61919-258-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09165001/01/2015
Labeler - Direct_Rx (079254320)
Registrant - Direct_Rx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
Direct_Rx079254320repack(61919-258)

Revised: 10/2019
Document Id: 948f52bf-7c1d-d757-e053-2a95a90ab43b
Set id: 33b2b42d-60b1-47df-9df9-9965e13ece9f
Version: 4
Effective Time: 20191010
 
Direct_Rx