Prescription Drug Information: Lovastatin (Page 8 of 8)

Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS)

In AFCAPS/TexCAPS (see CLINICAL PHARMACOLOGY , Clinical Studies in Adults) involving 6,605 participants treated with 20 to 40 mg/day of lovastatin (n = 3,304) or placebo (n = 3,301), the safety and tolerability profile of the group treated with lovastatin was comparable to that of the group treated with placebo during a median of 5.1 years of follow-up. The adverse experiences reported in AFCAPS/TexCAPS were similar to those reported in EXCEL (see ADVERSE REACTIONS , Expanded Clinical Evaluation of Lovastatin (EXCEL) Study).

Concomitant Therapy

In controlled clinical studies in which lovastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with lovastatin or cholestyramine. Other lipid-lowering agents were not administered concomitantly with lovastatin during controlled clinical studies. Preliminary data suggests that the addition of gemfibrozil to therapy with lovastatin is not associated with greater reduction in LDL-C than that achieved with lovastatin alone. In uncontrolled clinical studies, most of the patients who have developed myopathy were receiving concomitant therapy with cyclosporine, gemfibrozil or niacin (nicotinic acid). The combined use of lovastatin with cyclosporine or gemfibrozil should be avoided. Caution should be used when prescribing other fibrates or lipid-lowering doses (≥ 1 g/day) of niacin with lovastatin (see WARNINGS , Myopathy/Rhabdomyolysis).

The following effects have been reported with drugs in this class. Not all the effects listed below have necessarily been associated with lovastatin therapy.

Skeletal: muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use (see WARNINGS, Myopathy/Rhabdomyolysis).

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, peripheral neuropathy, peripheral nerve palsy, psychic disturbances, anxiety, insomnia, depression.

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Hypersensitivity Reactions: An apparent hypersensitivity syndrome has been reported rarely which has included one or more of the following features: anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome.

Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma; anorexia, vomiting, fatal and non-fatal hepatic failure.

Skin: alopecia, pruritus. A variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails) have been reported.

Reproductive: gynecomastia, loss of libido, erectile dysfunction.

Eye: progression of cataracts (lens opacities), ophthalmoplegia.

Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Adolescent Patients (Ages 10 to 17 Years)

In a 48 week controlled study in adolescent boys with heFH (n = 132) and a 24 week controlled study in girls who were at least 1 year post-menarche with heFH (n = 54), the safety and tolerability profile of the groups treated with lovastatin (10 to 40 mg daily) was generally similar to that of the groups treated with placebo (see CLINICAL PHARMACOLOGY , Clinical Studies in Adolescent Patients and PRECAUTIONS , Pediatric Use).

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

After oral administration of lovastatin to mice, the median lethal dose observed was > 15 g/m2.

Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 to 6 g.

Until further experience is obtained, no specific treatment of overdosage with lovastatin can be recommended.

The dialyzability of lovastatin and its metabolites in man is not known at present.

DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets and should continue on this diet during treatment with lovastatin tablets (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets should be given with meals.

Adult Patients

The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Treatment Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin tablets if cholesterol levels fall significantly below the targeted range.

Dosage in Patients Taking Danazol, Diltiazem, Dronedarone or Verapamil

In patients taking danazol, diltiazem, dronedarone or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day (see CLINICAL PHARMACOLOGY , Pharmacokinetics , WARNINGS , Myopathy/Rhabdomyolysis , PRECAUTIONS , Drug Interactions , Other Drug Interactions).

Dosage in Patients Taking Amiodarone

In patients taking amiodarone concomitantly with lovastatin tablets, the dose should not exceed 40 mg/day (see WARNINGS , Myopathy/Rhabdomyolysis and PRECAUTIONS , Drug Interactions , Other Drug Interactions).

Adolescent Patients (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia

The recommended dosing range of lovastatin 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 Guidelines4 , 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 tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

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.

Concomitant Lipid-Lowering Therapy

Lovastatin tablets are 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, 10 mg are available as light peach, unscored, round, flat beveled tablets debossed “926” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0926-06) and 1000 (NDC 0093-0926-10).

Lovastatin Tablets USP, 20 mg are available as light blue, unscored, round, flat beveled tablets, debossed “576” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0576-06) and 1000 (NDC 0093-0576-10).

Lovastatin Tablets USP, 40 mg are available as light green, unscored, round, flat beveled tablets, debossed “928” on one side and “TEVA” on the other side. Packaged in bottles of 60 (NDC 0093-0928-06) and 1000 (NDC 0093-0928-10).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Lovastatin Tablets, USP must be protected from light.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

Rev. U 7/2020

Package/Label Display Panel

NDC 0093-0926- 06

Lovastatin
Tablets, USP
10 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0576- 06

Lovastatin
Tablets, USP
20 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0928- 06

Lovastatin
Tablets, USP
40 mg

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0926
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
BUTYLATED HYDROXYANISOLE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Light Peach) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 926;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0926-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0926-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0576
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOVASTATIN (LOVASTATIN) LOVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
BUTYLATED HYDROXYANISOLE
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 576;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0576-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0576-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
LOVASTATIN
lovastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0928
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
STARCH, CORN
BUTYLATED HYDROXYANISOLE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
Product Characteristics
Color GREEN (Light Green) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 928;TEVA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0928-06 60 TABLET in 1 BOTTLE None
2 NDC:0093-0928-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075551 12/17/2001
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 07/2020 Teva Pharmaceuticals USA, Inc.

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