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Details with Side Effects
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Rhabdomyolysis and myopathy [see WARNINGS AND PRECAUTIONS]
- Liver enzyme abnormalities [see WARNINGS AND PRECAUTIONS]
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 who received Altoprev®, < 3% of patients were discontinued due to adverse experiences attributable to Altoprev®. This was similar to the discontinuation rate in the placebo and lovastatin immediate-release 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, n=||Treatment|
|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)|
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 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 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.
Eye: progression of cataracts (lens opacities), ophthalmoplegia.
Laboratory Abnormalities: elevated transaminases, alkaline phosphatase, γ-glutamyl transpeptidase, and bilirubin; thyroid function abnormalities.
Read the Altoprev (lovastatin extended-release tablets) Side Effects Center for a complete guide to possible side effects
Drug interaction studies have not been performed with Altoprev®. The types, frequencies and magnitude of drug interactions that may be encountered when Altoprev® is administered with other drugs may differ from the drug interactions encountered with the lovastatin immediate-release formulation. In addition, as the drug exposure with Altoprev® 60 mg is greater than that with lovastatin immediate-release 80 mg (maximum recommended dose), the severity and magnitude of drug interactions that may be encountered with Altoprev® 60 mg are not known. It is therefore recommended that the following precautions and recommendations for the concomitant administration of lovastatin immediate-release with other drugs be interpreted with caution, and that the monitoring of the pharmacologic effects of Altoprev® and/or other concomitantly administered drugs be undertaken where appropriate.
Strong CYP 3A Inhibitors
Lovastatin is metabolized by CYP3A4 but has no CYP3A inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A. Strong inhibitors of CYP3A (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, and nefazodone), increase the risk of myopathy by reducing the elimination of lovastatin. The use of lovastatin with strong CYP3A inhibitors is contraindicated. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].
Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone
The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A inhibitors, but which can cause myopathy when given alone. [see WARNINGS AND PRECAUTIONS].
Gemfibrozil – Avoid the concomitant use of Altoprev with gemfibrozil [see WARNINGS AND PRECAUTIONS].
Other fibrates - Use caution when prescribing Altoprev with other fibrates. [see WARNINGS AND PRECAUTIONS].
Avoid the concomitant use of Altoprev with cyclosporine [see WARNINGS AND PRECAUTIONS].
Danazol, Diltiazem, Dronedarone or Verapamil
Do not exceed 20 mg of Altoprev daily in patients receiving concomitant therapy with danazol, diltiazem, dronedarone, or verapamil.. [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].
In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time has been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. In patients taking anticoagulants, prothrombin time should be determined before starting Altoprev and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of Altoprev is changed, the same procedure should be repeated. Lovastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
Cases of myopathy, including rhabdomyolysis have been reported with lovastatin coadministered with colchicine. Exercise caution when prescribing Altoprev with colchicine.
The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. Exercise caution when prescribing Altoprev with ranolazine. Dose adjustment of Altoprev may be necessary during coadministration with ranolazine.
In normal volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol.
In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations.
Oral Hypoglycemic Agents
In pharmacokinetic studies of lovastatin immediate-release in hypercholesterolemic non-insulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide.
Read the Altoprev Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/25/2013
This monograph has been modified to include the generic and brand name in many instances.
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