LIPITOR Film-coated tablet Ref.[51699] Active ingredients: Atorvastatin

Source: FDA, National Drug Code (US) Revision Year: 2022

1. Indications and Usage

LIPITOR is 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

2. Dosage and Administration

2.1 Important Dosage Information

Take Lipitor 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 LIPITOR, and adjust the dosage if necessary.

2.2 Recommended Dosage in Adult Patients

The recommended starting dosage of LIPITOR is 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 LIPITOR is 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 LIPITOR is 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 LIPITOR with the following drugs requires dosage modification of LIPITOR [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 LIPITOR 20 mg once daily.
In patients taking nelfinavir, do not exceed LIPITOR 40 mg once daily.

Select Azole Antifungals or Macrolide Antibiotics:

In patients taking clarithromycin or itraconazole, do not exceed LIPITOR 20 mg once daily.

For additional recommendations regarding concomitant use of LIPITOR with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions (7.1).

10. Overdosage

No specific antidotes for LIPITOR are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance LIPITOR clearance.

16.2. Storage and Handling

Store at controlled room temperature 20-25°C (68-77°F).

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