Recommended Topic Related To:

Altocor

"Feb. 28, 2012 -- Memory loss, confusion, high blood sugar, and type 2 diabetes are possible side effects of the popular cholesterol-lowering drugs known as statins, the FDA warns.

Brand name and generic versions of statin drugs must c"...

Altocor

Altocor

Altocor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Altocor (lovastatin) Extended-Release is a cholesterol-lowering drug ("statin") used in addition to diet to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors. This medication is available in generic form. Common side effects include infection, headache, nausea, abdominal pain, insomnia, indigestion, weakness, and muscle pain.

The usual recommended starting dose of Altocor is 20, 40, or 60 mg once a day given in the evening at bedtime. The recommended dosing range is 10-60 mg/day, in single doses. Patients should be placed on a standard cholesterol-lowering diet before receiving Altocor and should continue on this diet during treatment. Altocor may interact with azole antifungals, antibiotics, HIV protease inhibitors, nefazodone, cyclosporine, grapefruit juice, gemfibrozil, other fibrates, niacin (nicotinic acid), amiodarone, verapamil, anticoagulants, and other cholesterol-lowering drugs. Tell your doctor all medications and supplements you use. Altocor must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Because a small amount of another drug in this class passes into breast milk and because of the potential for serious adverse reactions in nursing infants, women taking Altocor should not breastfeed.

Our Altocor (lovastatin) Extended-Release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Altocor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ALTOCOR™ (lovastatin extended-release tablets)

ALTOCOR™ (lovastatin extended-release tablets) Clinical Studies

In clinical studies with ALTOCOR™ (lovastatin extended-release tablets) , adverse reactions have generally been mild and transient. In controlled studies with 467 patients who received ALTOCOR™ (lovastatin extended-release tablets) , < 3% of patients were discontinued due to adverse experiences attributable to ALTOCOR (lovastatin extended-release tablets) ™ . This was similar to the discontinuation rate in the placebo and lovastatin immediate-release treatment groups. Pooled results from clinical studies with ALTOCOR™ (lovastatin extended-release tablets) show that the most frequently reported adverse reactions in the ALTOCOR™ (lovastatin extended-release tablets) group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the lovastatin and placebo groups. The most frequent adverse events thought to be related to ALTOCOR™ (lovastatin extended-release tablets) were nausea, abdominal pain, insomnia, dyspepsia, headache, asthenia, and myalgia. In controlled trials (e.g., vs. placebo and vs. lovastatin immediate-release), clinical adverse experiences reported as ≥ 5% in any treatment group are shown in Table VII below.

Table VII: Pooled Controlled Studies TESS by Body System and COSTART Term, Most Common ( ≥ 5% in Any Group)

Randomized Patients   Treatment
n = Placebo 34 ALTOCOR™ 467 MEVACOR™ 329
Body System COSTART Term  
Body as a Whole Infection 3 (9) 52 (11) 52 (16)
Accidental Injury 3 (9) 26 (6) 12 (4)
Asthenia 2 (6) 12 (3) 6 (2)
Headache 2 (6) 34 (7) 26 (8)
Back Pain 1 (3) 23 (5) 18 (5)
Flu Syndrome 1 (3) 24 (5) 18 (5)
Pain 0 14 (3) 17 (5)
Digestive Diarrhea 2 (6) 15 (3) 8 (2)
Musculoskeletal Arthralgia 2 (6) 24 (5) 20 (6)
Myalgia 5 (15) 14 (3) 11 (3)
Nervous Dizziness 2 (6) 10 (2) 5 (2)
Respiratory Sinusitis 1 (3) 17 (4) 20 (6)
Urogenital Urinary Tract Infection 2 (6) 8 (2) 9 (3)

Lovastatin Immediate-Release

Lovastatin Immediate-Release Phase III Clinical Studies

In Phase III controlled clinical studies involving 613 patients treated with lovastatin immediate-release, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study [see Expanded Clinical Evaluation of Lovastatin (EXCEL) Study]. Persistent increases of serum transaminases have been noted (see WARNINGS, Liver Dysfunction). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 %. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS, Myopathy/Rhabdomyolysis).

Expanded Clinical Evaluation of Lovastatin (EXCEL) Study

Lovastatin immediate-release was compared to placebo in 8,245 patients with hypercholesterolemia [Total-C 240-300 mg/dL (6.2-7.8 mmol/L)] in the randomized, double-blind, parallel, 48-week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in ≥ 1% in any treatment group are shown in the table below. For no event was the incidence on drug and placebo statistically different.

Table VIII: Clinical Adverse Events Reported as Possibly, Probably or Definitely Drug-Related in ≥ 1% in Any Treatment Group in the EXCEL Study

  Placebo
(N=1663)
%
Lovastatin IR
20 mg q.p.m.
(N=1642)
%
Lovastatin IR
40 mg q.p.m.
(N=1645)
%
Lovastatin IR
20 mg b.i.d.
(N=1646)
%
Lovastatin IR
40 mg b.i.d.
(N=1649)
%
Body As a Whole
  Asthenia 1.4 1.7 1.4 1.5 1.2
Gastrointestinal
  Abdominal pain 1.6 2.0 2.0 2.2 2.5
  Constipation 1.9 2.0 3.2 3.2 3.5
  Diarrhea 2.3 2.6 2.4 2.2 2.6
  Dyspepsia 1.9 1.3 1.3 1.0 1.6
  Flatulence 4.2 3.7 4.3 3.9 4.5
  Nausea 2.5 1.9 2.5 2.2 2.2
Musculoskeletal
  Muscle cramps 0.5 0.6 0.8 1.1 1.0
  Myalgia 1.7 2.6 1.8 2.2 3.0
Nervous System/Psychiatric
  Dizziness 0.7 0.7 1.2 0.5 0.5
  Headache 2.7 2.6 2.8 2.1 3.2
  Skin Rash 0.7 0.8 1.0 1.2 1.3
Special Senses
  Blurred vision 0.8 1.1 0.9 0.9 1.2

Other clinical adverse experiences reported as possibly, probably or definitely drug-related in 0.5% to 1.0% of patients in any drug-treated group are listed below. In all these cases the incidence on drug and placebo was not statistically different. Body as a Whole: chest pain; Gastrointestinal: acid regurgitation, dry mouth, vomiting; Musculoskeletal: leg pain, shoulder pain, arthralgia; Nervous System/Psychiatric: insomnia, paresthesia; Skin: alopecia, pruritus; Special Senses: eye irritation.

In the EXCEL study (see CLINICAL PHARMACOLOGY, Clinical Studies), 4.6% of the patients treated up to 48 weeks were discontinued due to clinical or laboratory adverse experiences which were rated by the investigator as possibly, probably or definitely related to therapy with lovastatin immediate-release. The value for the placebo group was 2.5%.

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

In AFCAPS/TexCAPS (see CLINICAL PHARMACOLOGY, Clinical Studies) involving 6,605 participants treated with 20-40 mg/day of lovastatin immediate-release (n=3,304) or placebo (n=3,301), the safety and tolerability profile of the group treated with lovastatin immediate-release 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 immediate-release 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) (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.

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

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.

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, y-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.

Read the entire FDA prescribing information for Altocor (Lovastatin Extended-Release Tablets) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cholesterol Management

Tips to keep it under control.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations