Drug Catalog - Product Detail
ATORVASTATIN CALCIUM 40MG TB 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42571-0174-90 | MICRO LABORATORIES | 90 | 40MG | TABLET |
PACKAGE FILES
Generic Name
ATORVASTATIN CALCIUM
Substance Name
ATORVASTATIN CALCIUM TRIHYDRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA205945
Description
11 DESCRIPTION Atorvastatin calcium is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1Hpyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C 33 H 34 FN 2 O 5 ) 2 Ca•3H 2 O and its molecular weight is 1209.42. Its structural formula is: Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is insoluble to very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and soluble to freely soluble in methanol. Atorvastatin calcium tablets for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablets are coated with opadry white YS-1-7040 which contains hypromellose, polyethylene glycol, talc, titanium dioxide. atorvastatin-str.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin calcium tablets are supplied as follows: Atorvastatin Calcium Tablets 10 mg: White to off-white, oval shaped, film-coated tablet, debossed with “I” on one side and “90” on the other side. They are available as follows. Bottles of 30 NDC 42571-172-30 Bottles of 90 NDC 42571-172-90 Bottles of 1000 NDC 42571-172-10 Carton of 10x10 Unit-dose Tablets NDC 42571-172-11 Atorvastatin Calcium Tablets 20 mg: White to off-white, oval shaped, film-coated tablet, debossed with “I” on one side and “91” on the other side. They are available as follows. Bottles of 30 NDC 42571-173-30 Bottles of 90 NDC 42571-173-90 Bottles of 1000 NDC 42571-173-10 Carton of 10x10 Unit-dose Tablets NDC 42571-173-11 Atorvastatin Calcium Tablets 40 mg: White to off-white, oval shaped, film-coated tablet, debossed with “I” on one side and “92” on the other side. They are available as follows. Bottles of 30 NDC 42571-174-30 Bottles of 90 NDC 42571-174-90 Bottles of 1000 NDC 42571-174-10 Carton of 10x10 Unit-dose Tablets NDC 42571-174-11 Atorvastatin Calcium Tablets 80 mg: White to off-white, oval shaped, film-coated tablet, debossed with “I” on one side and “93” on the other side. They are available as follows. Bottles of 30 NDC 42571-175-30 Bottles of 90 NDC 42571-175-90 Bottles of 1000 NDC 42571-175-10 Carton of 5x10 Unit-dose Tablets NDC 42571-175-24 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food ( 2.1 ). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust dosage if necessary ( 2.1 ). Adults ( 2.2 ): Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily. Patients requiring LDL-C reduction >45% may start at 40 mg once daily. Pediatric Patients Aged 10 Years of Age and Older with HeFH : Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily ( 2.3 ). Pediatric Patients Aged 10 Years of Age and Older with HoFH : Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily ( 2.4 ). See full prescribing information for atorvastatin calcium tablets dosage modifications due to drug interactions ( 2.5 ). 2.1 Important Dosage Information Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose. 2.2 Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium tablets are 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily. 2.3 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium tablets are 10 mg once daily. The dosage range is 10 mg to 20 mg once daily. 2.4 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of atorvastatin calcium tablets are 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. 2.5 Dosage Modifications Due to Drug Interactions Concomitant use of atorvastatin calcium tablets with the following drugs requires dosage modification of atorvastatin calcium tablets [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )] . Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium tablets 20 mg once daily. In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg once daily . Select Azole Antifungals or Macrolide Antibiotics In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg once daily. For additional recommendations regarding concomitant use of atorvastatin calcium tablets with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions ( 7.1 ).