Lovastatin (Page 11 of 11)

Adolescent Patients (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines ††, CLINICAL PHARMACOLOGY , and INDICATIONS AND USAGE ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

Concomitant Lipid-Lowering Therapy

Lovastatin is effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).

Dosage in Patients with Renal Insufficiency

In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).

HOW SUPPLIED

Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with “CTI 143”

Bottle of 14………………………………………………………………………………………………………………….(NDC 43063-548-14)

Bottle of 30………………………………………………………………………………………………………………….(NDC 43063-548-30)

Bottle of 90………………………………………………………………………………………………………………….(NDC 43063-548-90)

Bottle of 180………………………………………………………………………………………………………………..(NDC 43063-548-93)

____________________________________

4 National 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.

Storage

Store at 20º to 25º C (68º to 77º F). [See USP Controlled Room Temperature.] Lovastatin Tablets must be protected from light and stored in a well-closed, light-resistant container.

Revised: March 2017 CTI-13 Rev. J

Principal Display Panel – Bottle Label

Lovastatin Tablets USP 40 mg

Rx Only

43063548 Label
(click image for full-size original)
LOVASTATIN lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-548(NDC:61442-143)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLOXAMER 188
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
BUTYLATED HYDROXYANISOLE
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code CTI;143
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-548-14 14 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43063-548-30 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:43063-548-90 90 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:43063-548-93 180 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075991 11/25/2002
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-548)

Revised: 09/2020 PD-Rx Pharmaceuticals, Inc.

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