Altoprev

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 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)

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.

>10%

CPK elevation (11%)

1-10%

Flatulence (4-5%)

Abdominal pain (2-3%)

Constipation (2-3%)

Diarrhea (2-3%)

Myalgia (2-3%)

Nausea (2-3%)

Dyspepsia (1-2%)

Weakness (1-2%)

Blurred vision (0.8-1%)

Rash (0.8-1%)

Muscle cramps (0.6-1%)

Dizziness (0.5-1%)

<1%

Dermatomyositis

Increased LFTs

Hepatotoxicity

Myopathy

Rhabdomyolysis

Postmarketing Reports

Interstitial lung disease

Serious side effects have been reported with Altoprev. See "Drug Precautions" section.

Common side effects of Altoprev include:

• constipation
• memory loss or forgetfulness
• confusion
• muscle pain, tenderness, or weakness
• fever
• nausea
• blurred vision
• itching
• rash

This is not a complete list of Altoprev side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take Altoprev exactly as prescribed.

Altoprev comes as an extended-release (long-acting) tablet to take by mouth and is taken once a day at bedtime.

Swallow Altoprev tablets whole, do not crush, chew, or split tablets.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Altoprev at the same time.

Lovastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Lovastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Lovastatin is used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors

Lovastatin is used in adults and children who are at least 10 years old.

Lovastatin may also be used for other purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).1 2 3 4 5 118 119

General

• Patients should be placed on a standard lipid-lowering diet before initiation of lovastatin therapy and should remain on this diet during treatment with the drug.1 118 119

Monitoring during Antilipemic Therapy

• ACC/AHA cholesterol management guideline recommends obtaining lipoprotein concentrations within 4–12 weeks following initiation of statin therapy (to assess response and adherence) and monitoring every 3–12 months thereafter as clinically indicated.350

• Periodically reinforce adherence to lifestyle modifications.350

Administration

Oral Administration

Manufacturer and some clinicians recommend that patients avoid grapefruit juice.64 118 119 379 (See Specific Drugs and Foods under Interactions.) Because extent of the interaction may be influenced by quantity and timing of grapefruit juice consumption,118 other clinicians suggest that small amounts (e.g., 240 mL) may be acceptable.376 378

Administer orally with the evening meal.118

Administer orally in the evening at bedtime.119

Dosage

Pediatric Patients

Children 10–17 years of age who require reductions in LDL-cholesterol of ≥20%: Initially, 20 mg once daily.1 118

Children 10–17 years of age who require small reductions in LDL-cholesterol: Consider initial dosage of 10 mg once daily.1 118

Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed.1 Recommended dosage range is 10–40 mg daily.1 118

Adults

Select appropriate statin intensity to achieve optimal ASCVD risk reduction.350 Giving maximally tolerated statin intensity is preferred over giving lower statin dosages in combination with nonstatin drugs, a strategy not yet shown to reduce ASCVD risk.350

ACC/AHA cholesterol management guideline recommends initiating high-intensity statin therapy (i.e., with atorvastatin or rosuvastatin) unless contraindicated.350

ACC/AHA cholesterol management guideline recommends moderate-intensity statin therapy (e.g., lovastatin 40 mg once daily†).350

If estimated 10-year ASCVD risk ≥7.5%, consider high-intensity statin therapy (i.e., with atorvastatin or rosuvastatin) unless contraindicated.350

In patients <40 or >75 years of age, consider potential benefits, adverse effects, drug interactions, and patient preferences when deciding to initiate, continue, or intensify statin therapy.350

Estimated 10-year ASCVD risk ≥7.5%: ACC/AHA cholesterol management guideline recommends moderate- (e.g., lovastatin 40 mg once daily) to high-intensity statin therapy (i.e., with atorvastatin or rosuvastatin).350

Estimated 10-year ASCVD risk of 5 to <7.5%: ACC/AHA cholesterol management guideline states may consider moderate-intensity statin therapy.350

Consider potential benefits, adverse effects, drug interactions, and patient preferences before initiating statin therapy.350

ACC/AHA cholesterol management guideline recommends high-intensity statin therapy (i.e., with atorvastatin or rosuvastatin) unless contraindicated.350

In patients at increased risk for developing statin-associated adverse effects or in whom high-intensity statin therapy is inappropriate or contraindicated, consider moderate-intensity statin therapy (e.g., lovastatin 40 mg once daily) if tolerated.350

Patients >75 years of age: Individualize therapy based on potential benefits, adverse effects, drug interactions, and patient preferences; may consider moderate-intensity statin therapy if tolerated.350

Usual initial dosage is 20 mg once daily.118

Patients who require reductions in LDL-cholesterol concentrations of ≥20%: Initially, 20 mg once daily.1 118

Patients who require smaller reductions in LDL-cholesterol: Consider initial dosage of 10 mg once daily.1 118

Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed.1 Recommended dosage range is 10–80 mg daily given in 1 or 2 divided doses.1 118

Recommended dosage range is 20–60 mg once daily.119 Adjust dosage at intervals of ≥4 weeks until desired effect on lipoprotein concentrations is observed.1

ACC/AHA cholesterol management guideline states may consider decreasing statin dosage when LDL-cholesterol concentrations are <40 mg/dL on 2 consecutive measurements; however, no data to suggest that LDL-cholesterol concentrations <40 mg/dL increase risk of adverse effects.350

Prescribing Limits

Pediatric Patients

Children 10–17 years of age: Maximum 40 mg daily.1 118

Adults

Maximum 80 mg daily.1

Special Populations

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.1 118

Contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.1 118

Renal Impairment

Use with caution in patients with severe renal impairment (Clcr <30 mL/min).1 Carefully consider dosage increases >20 mg daily in such patients; if deemed necessary, implement with extreme caution.1

Use dosages >20 mg daily in patients with severe renal impairment only after careful consideration of the expected benefits versus potential risks of myopathy and rhabdomyolysis.119 (See Musculoskeletal Effects under Cautions.)

Geriatric Patients

Dosage adjustment based on age-related pharmacokinetic differences not necessary.118

Usual initial dosage in patients ≥65 years of age is 20 mg once daily; use higher dosages only after careful consideration of potential risks and benefits.119 (See Musculoskeletal Effects under Cautions.)

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 (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)]. 

Erythromycin

Do not use Altoprev concomitantly with erythromycin [see Contraindications (4) and Warnings and Precautions (5.1)].

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 (5.1)].

Gemfibrozil – Avoid the concomitant use of Altoprev with gemfibrozil [see Warnings and Precautions (5.1)].

Other fibrates - Use caution when prescribing Altoprev with other fibrates. [see Warnings and Precautions (5.1)].

Niacin (nicotinic acid) (≥1 g/day)

Use caution when prescribing Altoprev with lipid-modifying (≥1 g/day) doses of niacin. [see Warnings and Precautions (5.1)].

Cyclosporine

Avoid the concomitant use of Altoprev with cyclosporine [see Warnings and Precautions (5.1)].

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 (2.3),Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)]. 

Amiodarone

Do not exceed 40 mg of Altoprev daily in patients receiving concomitant therapy with amiodarone. [see Dosage and Administration (2.3),Warnings and Precautions (5.1)].

Coumarin Anticoagulants

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.

Colchicine

Cases of myopathy, including rhabdomyolysis have been reported with lovastatin coadministered with colchicine. Exercise caution when prescribing Altoprev with colchicine.

Ranolazine

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.

1. Azie, N, et. al. Clin Pharmacol Ther 1998; 64(4): 369-377.

2. Gullestad, L., et. al. Transplantation Proceedings 1999; 31: 2163-2165.

3. Kantola, T, et al. Clin Pharmacol Ther 1998; 63(4):397-402.

4. Kivisto, K., et.al. Br. J Clin Pharmacol 1998; 46: 49-53.

5. Kyrklund, C. et. al. Clin Pharmacol Ther 2001; 69(5): 340-345.

6. Manson, J.M., Freyssinges, C., Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology. 19(6):439-446. 1996.

7. Neuvonen, P. J. et.al. Clin Pharmacol Ther 1998; 60(1): 54-61.

8. Pan, H. Y. et.al. Br. J Clin Pharmacol 1991; 31: 665-670.

9. Rogers, J. D. et.al. Clin Pharmacol Ther 1999; 66(4): 358-366.

40 mg Bottle

NDC 70515-629-30               30 Tablets

Altoprev®
(lovastatin)
extended-release tablets

40 mg

Rx only

COVIS

Each tablet contains lovastatin 40 mg.

Read package insert for prescribing
information.

KEEP OUT OF THE REACH OF CHILDREN.

Dispense in tight, light-resistant container
as defined in the USP.

Store at 20°-25°C (68°-77°F). Excursions
permitted to 15°-30°C (59°-86°F) [See
USP Controlled Room Temperature].

Avoid excessive heat and humidity.

Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

Made in Hungary     Rev. 3/16     100243

Applies to lovastatin: oral tablet, oral tablet extended release

Along with its needed effects, lovastatin (the active ingredient contained in Altoprev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lovastatin:

• Bladder pain
• bloody or cloudy urine
• chest tightness
• cough
• dark-colored urine
• difficult, burning, or painful urination
• difficulty with moving
• fever
• frequent urge to urinate
• headache
• joint pain
• lower back or side pain
• muscle aching, cramps, spasms, or stiffness
• muscle pain, tenderness, or weakness
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• swollen joints
• trouble with breathing
• unusual tiredness or weakness

Some side effects of lovastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated or full feeling
• blurred vision
• diarrhea
• difficulty having a bowel movement (stool)
• dizziness
• excess air or gas in the stomach or intestines
• heartburn
• indigestion
• lack or loss of strength
• nausea
• passing gas
• rash
• stomach discomfort, upset, or pain

Applies to lovastatin: oral tablet, oral tablet extended release

Hepatic

Persistent elevations in liver function tests to three times normal values have been reported in up to 2% of patients on lovastatin (the active ingredient contained in Altoprev) in clinical trials. Overall, 1.5% of patients were withdrawn from study due to elevations in serum transaminases. While most patients remained asymptomatic with these elevations, cases of cholestatic jaundice and hepatitis have been reported.

Liver function tests should be closely monitored. Lovastatin should be discontinued in patients with persistent, significant elevations (three times the upper limit of normal) in liver function parameters.[Ref]

Common (1% to 10%): Elevations in liver function tests
Frequency not reported: Hepatitis (including chronic active hepatitis), cholestatic jaundice, fatty change in the liver, cirrhosis, fulminant hepatic necrosis[Ref]

Gastrointestinal

Common (1% to 10%): Flatulence, abdominal pain, diarrhea, constipation, nausea
Frequency not reported: Dyspepsia, heartburn, anorexia, vomiting
Postmarketing reports: Abdominal discomfort[Ref]

Gastrointestinal side effects are among the most common complaints in patients on lovastatin. These effects tend to be mild and transient in nature and will often dissipate with continued therapy.[Ref]

Musculoskeletal

HMG-CoA reductase inhibitors (statins) have been associated with rare cases of severe myopathy and rhabdomyolysis, accompanied by increases in creatine kinase, myoglobinuria, proteinuria, and renal failure. These conditions appear to be dose related, usually occurring with doses greater than 30 mg per day. The incidence and severity of myopathy may be increased by concomitant administration of lovastatin (the active ingredient contained in Altoprev) with drugs that can cause myopathy when given alone, such as gemfibrozil and other fibrates, niacin, and potent inhibitors of CYP450 3A4 (i.e., cyclosporine, antifungal azoles, macrolide antibiotics, large amounts of grapefruit juice). Other variables associated with an increased risk of statin-induced myopathy include, advanced age, small body stature, female gender, renal and/or hepatic dysfunction, perioperative periods, hypothyroidism, diabetes mellitus, and alcoholism.

Milder forms of myotoxicity (i.e., myalgia) are commonly reported and occur in approximately 5% to 7% of patients taking a statin drug.

Patients should be instructed to report promptly symptoms of muscle pain, weakness, or tenderness. If such symptoms develop, creatine kinase should be measured, and if markedly elevated, lovastatin should be discontinued. The value of routine monitoring of creatine kinase is not known. In some studies up to 11% of patients experienced elevations in creatine kinase while on lovastatin. In most cases these elevations were mild, transient, and not associated with clinical symptoms.

Itraconazole used concomitantly with lovastatin has led to one reported case of severe rhabdomyolysis in a 63-year-old woman. Caution should be exercised when HMG-CoA reductase inhibitors and azole antifungals are prescribed concurrently.

Exposure to HMG-CoA reductase inhibitors is associated with a decreased risk of bone fractures in persons older than 50.[Ref]

Frequency not reported: Elevations in creatine kinase, muscle cramps, myopathy, rhabdomyolysis, arthralgia, myalgia, tendon rupture, dermatomyositis[Ref]

Hematologic

Frequency not reported: Hemolytic anemia, thrombocytopenia, thrombotic thrombocytopenic purpura (TTP), leukopenia (These effects may be manifestations of a hypersensitivity reaction)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Frequency not reported: Cranial nerve dysfunction, tremor, vertigo, memory loss, drowsiness, weight loss, decline in cognitive function, paresthesias, peripheral neuropathy, peripheral nerve palsy
Postmarketing reports: Asthenia, fatigue, malaise, hypoesthesia, insomnia[Ref]

Renal

Frequency not reported: Acute renal failure secondary to rhabdomyolysis[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, purpura, alopecia (These effects may be manifestations of a hypersensitivity reaction)[Ref]

Endocrine

Frequency not reported: Hypospermia, gynecomastia, thyroid dysfunction, acid maltase deficiency (the genetic disorder also referred to as Pompe's Disease), pancreatitis[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema, lupus erythematous-like syndrome, polymyalgia rheumatic, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever (including severe hyperthermia), chills, flushing, malaise, dyspnea, toxic epidermal necrolysis[Ref]

Immunologic

Frequency not reported: Lupus-like syndrome with positive ANA and elevated ESR, polymyalgia rheumatica, vasculitis[Ref]

Ocular

Frequency not reported: Progression of cataracts, ophthalmoplegia[Ref]

Metabolic

Very rare (less than 0.01%): Hyperkalemia[Ref]

Psychiatric

Frequency not reported: Decreased libido, anxiety, insomnia, depression, suicidal thoughts, delusions, paranoia, agitation, nightmares[Ref]

Genitourinary

Halkin, et al report a case in which use of both lovastatin (the active ingredient contained in Altoprev) and pravastatin on different occasions in the same patient led to reversible impotence. The impotence resolved within 2 weeks after discontinuation of the HMG-CoA reductase inhibitor.[Ref]

Frequency not reported: Erectile dysfunction, impotence, testicular pain[Ref]

Oncologic

Frequency not reported: Tumor growth, hepatocellular carcinomas and adenomas. pulmonary adenomas (all in rodents)[Ref]

Respiratory

Postmarketing reports: Interstitial lung disease

Some side effects of Altoprev may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Summary of Use during Lactation

No relevant published information exists on the use of lovastatin during breastfeeding. Because of a concern with disruption of infant lipid metabolism, the consensus is that lovastatin should not be used during breastfeeding.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Cholestyramine, Colesevelam, Colestipol

References

Substance Name

Lovastatin

CAS Registry Number

75330-75-5

Drug Class

Anticholesteremic Agents

Antilipemic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors