Atorvastatin Calcium Tablets, These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS., ATORVASTATIN CALCIUM tablets, for oral administration, Initial U.S. Approval: 1996

1 INDICATIONS AND USAGE

id: 6505ba8d-e763-1441-e053-2a91aa0ae6cb
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.

2 DOSAGE AND ADMINISTRATION

id: 6505ba8d-e767-1441-e053-2a91aa0ae6cb
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

3 DOSAGE FORMS AND STRENGTHS

id: 6505ba8d-e76e-1441-e053-2a91aa0ae6cb
displayName: DOSAGE FORMS & STRENGTHS SECTION
FDA Article Code: 43678-2

White, oval, biconvex, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium.

4 CONTRAINDICATIONS

id: 6505ba8d-e76f-1441-e053-2a91aa0ae6cb
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

6 ADVERSE REACTIONS

id: 6505ba8d-e77a-1441-e053-2a91aa0ae6cb
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis and myopathy
[see
Warnings and Precautions (5.1)
] Liver enzyme abnormalities
[see Warnings and Precautions (5.2)]

7 DRUG INTERACTIONS

id: 6505ba8d-e77e-1441-e053-2a91aa0ae6cb
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole)
[see
Warnings and Precautions, Skeletal Muscle (5.1)
and

Clinical Pharmacology (12.3)
]. 

8 USE IN SPECIFIC POPULATIONS

id: 6505ba8d-e78a-1441-e053-2a91aa0ae6cb
displayName: USE IN SPECIFIC POPULATIONS SECTION
FDA Article Code: 43684-0

10 OVERDOSAGE

id: 6505ba8d-e790-1441-e053-2a91aa0ae6cb
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

There is no specific treatment for atorvastatin 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 clearance.

11 DESCRIPTION

id: 6505ba8d-e791-1441-e053-2a91aa0ae6cb
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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.   The drug substance used in atorvastatin calcium tablets is atorvastatin calcium in the form of propylene glycol solvate.  The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C
₆₆H
₆₈CaF
₂N
₄O
₁₀ * C
₃H
₈O
₂ and its molecular weight is 1231.46. Its structural formula is: Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate (vegetable source), colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.

12 CLINICAL PHARMACOLOGY

id: 6505ba8d-e792-1441-e053-2a91aa0ae6cb
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

13 NONCLINICAL TOXICOLOGY

id: 6505ba8d-e796-1441-e053-2a91aa0ae6cb
displayName: NONCLINICAL TOXICOLOGY SECTION
FDA Article Code: 43680-8

15 REFERENCES

id: 6505ba8d-e79f-1441-e053-2a91aa0ae6cb
displayName: REFERENCES SECTION
FDA Article Code: 34093-5

¹National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents,
Pediatrics. 89(3):495-501. 1992.

16 HOW SUPPLIED/STORAGE AND HANDLING

id: 6505ba8d-e7a0-1441-e053-2a91aa0ae6cb
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin. 10 mg tablets Atorvastatin calcium tablets, 10 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side.  NDC 50268-093-15  10 tablets per card, 5 cards per carton. 20 mg tablets Atorvastatin calcium tablets, 20 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side.  NDC 50268-094-15  10 tablets per card, 5 cards per carton. 40 mg tablets Atorvastatin calcium tablets, 40 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.  NDC 50268-095-15  10 tablets per card, 5 cards per carton. 80 mg tablets Atorvastatin calcium tablets, 80 mg, are available for oral administration as white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side.  NDC 50268-096-12  5 tablets per card, 4 cards per carton.

Dispensed in Unit Dose Package. For Institutional Use Only.

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight container [see USP].

17 PATIENT COUNSELING INFORMATION

id: 6505ba8d-e7a1-1441-e053-2a91aa0ae6cb
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0

Patients taking atorvastatin calcium tablets should be advised that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.  Patients should be advised about substances they should not take concomitantly with atorvastatin

[

see


Warnings and Precautions (5.1)


]

. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium tablets.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

id: 6505ba8d-e7a7-1441-e053-2a91aa0ae6cb
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 50268-093-15

Atorvastatin Calcium Tablets

10 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809315

NDC 50268-093-15

Atorvastatin Calcium Tablets

10 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809315 PHARMACIST: Dispense the enclosed Patient Information Leaflet to each patient.

*Each film-coated tablet contains atorvastatin calcium equivalent to 10 mg of atorvastatin.

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Usual Dosage: See package insert. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 11/15        AV 06/16 (P)

NDC 50268-094-15

Atorvastatin Calcium Tablets

20 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809415

NDC 50268-094-15

Atorvastatin Calcium Tablets

20 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809415

PHARMACIST: Dispense the enclosed Patient Information Leaflet to each patient.

*Each film-coated tablet contains atorvastatin calcium equivalent to 20 mg of atorvastatin.

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Usual Dosage: See package insert. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 11/15        AV 06/16 (P) NDC 50268-095-15

Atorvastatin Calcium Tablets

40 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809515

NDC 50268-095-15

Atorvastatin Calcium Tablets

40 mg*

Rx Only

50 Tablets (5 x 10) Unit Dose

5026809515 

PHARMACIST: Dispense the enclosed Patient Information Leaflet to each patient.

*Each film-coated tablet contains atorvastatin calcium equivalent to 40 mg of atorvastatin.

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Usual Dosage: See package insert. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 11/15        AV 06/16 (P) NDC 50268-096-12

Atorvastatin Calcium Tablets

80 mg*

Rx Only

20 Tablets (5 x 10) Unit Dose

5026809612

NDC 50268-096-12

Atorvastatin Calcium Tablets

80 mg*

Rx Only

20 Tablets (5 x 10) Unit Dose

5026809612

PHARMACIST: Dispense the enclosed Patient Information Leaflet to each patient.

*Each film-coated tablet contains atorvastatin calcium equivalent to 80 mg of atorvastatin.

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].

Usual Dosage: See package insert. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 AvPAK

A PRODUCT OF AvKARE

Mfg. Rev. 11/15        AV 06/16 (P)