pitavastatin 1 mg
1 INDICATIONS AND USAGE Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
mylan pharmaceuticals inc.
ROUND WHITE M PU1
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16 HOW SUPPLIED/STORAGE AND HANDLING
PITAVASTATIN Tablets are available containing 1.045 mg, 2.090 mg or 4.180 mg of
PITAVASTATIN calcium equivalent to 1 mg, 2 mg or 4 mg of
PITAVASTATIN, respectively. The 1 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and PU1 on the other side. They are available as follows: NDC-0378-5055-93 bottles of 30 tablets NDC-0378-5055-77 bottles of 90 tablets NDC-0378-5055-05 bottles of 500 tablets The 2 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and PU2 on the other side. They are available as follows: NDC-0378-5056-93 bottles of 30 tablets NDC-0378-5056-77 bottles of 90 tablets NDC-0378-5056-05 bottles of 500 tablets The 4 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and PU4 on the other side. They are available as follows: NDC-0378-5057-93 bottles of 30 tablets NDC-0378-5057-77 bottles of 90 tablets NDC-0378-5057-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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