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Altoprev

Last reviewed on RxList: 5/21/2019
Altoprev Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/21/2019

Altoprev (lovastatin) Extended-Release is a cholesterol-lowering drug ("statin") used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors. Common side effects of Altoprev include:

The recommended dosing range for Altoprev is 20-60 mg/day, in single doses taken in the evening at bedtime. Altoprev may interact with cimetidine, blood thinners, spironolactone, or other "statin" medications. Tell your doctor all medications and supplements you use. Altoprev must not be used during pregnancy. It may harm a fetus. It is important to prevent pregnancy while taking this medication. Consult your doctor to discuss using at least 2 forms of birth control while taking Altoprev. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Altoprev (lovastatin) Extended-Release Tablets 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.

QUESTION

What is cholesterol? See Answer
Altoprev Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Lovastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Also call your doctor at once if you have:

  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • infections;
  • headache; or
  • accidental injury.

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.

Read the entire detailed patient monograph for Altoprev (Lovastatin Extended-Release Tablets)

SLIDESHOW

Lower Your Cholesterol, Save Your Heart See Slideshow
Altoprev Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trial Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical trials with Altoprev® , (467 patients with mean exposure to study drug of approximately 11.6 weeks), 3.2% of patients were discontinued due to adverse reactions. This was similar to the discontinuation rate in the placebo (2/34, 5.9%) and lovastatin immediate-release (3.3%) treatment groups.

Pooled results from clinical trials with Altoprev® show that the most frequently reported adverse reactions in the Altoprev® group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the lovastatin and placebo groups. In controlled clinical trials, clinical adverse reactions reported in ≥ 5% of patients in any treatment group are shown in Table 2 below.

Table 2 : Pooled Controlled Studies TESS by Body System and COSTART Term, Most Common ( ≥ 5% in Any Group)

Randomized Patients   Treatment
Placebo
n=34
Altoprev®
n=467
Mevacor®
n= 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)

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

In AFCAPS/TexCAPS [see CLINICAL PHARMACOLOGY] 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.

In AFCAPS/TexCAPS, the number of participants with consecutive elevations of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ( > 3 times the upper limit of normal), over a median of 5.1 years of follow-up, was not significantly different between the lovastatin immediaterelease and placebo groups [18 (0.6%) vs. 11 (0.3%)]. The starting dose of lovastatin immediaterelease was 20 mg/day; 50% of the lovastatin immediate-release treated participants were titrated to 40 mg/day at Week 18. Of the 18 participants on lovastatin immediate-release with consecutive elevations of either ALT or AST, 11 (0.7%) elevations occurred in participants taking 20 mg/day, while 7 (0.4%) elevations occurred in participants titrated to 40 mg/day. Elevated transaminases resulted in discontinuation of 6 (0.2%) participants from therapy in the lovastatin immediate-release group (n=3,304) and 4 (0.1%) in the placebo group (n=3,301).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Altoprev® and/or are class effects of HMG CoA reductase inhibitors (statins). Because these reactions are reported class effects of HMG CoA reductase inhibitors (statins). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use [see WARNINGS AND PRECAUTIONS].

Neurological: dysfunction of certain cranial nerves (including alteration of taste, impairment of extraocular 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.

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

Related Resources for Altoprev

Read the Altoprev User Reviews »

© Altoprev Patient Information is supplied by Cerner Multum, Inc. and Altoprev Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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