Altoprev

DRUG DESCRIPTION

ALTOPREV® lovastatin extended-release tablets contain a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding ?-hydroxyacid form. This is a principal metabolite and inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol.

Lovastatin is [1 S -[1?(R*),3?,7?,8?(2 S*,4 S*),8a?]]-1,2,3,7,8,8a-hexa-hydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovas-tatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is:

Altoprev (lovastatin extended-release tablets) Structural Formula Illustration

Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile.

ALTOPREV® (lovastatin extended-release tablets) extended-release tablets are designed for once-a-day oral administration and deliver 20 mg, 40 mg, or 60 mg of lovastatin. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: acetyltributyl citrate; butylated hydroxyanisole; candellila wax; cellulose acetate; confectioner's sugar (contains corn starch); F D & C yellow # 6; glyceryl monostearate; hypromellose; hypromellose phthalate; lactose; methacrylic acid copolymer, type B; polyethylene glycols (PEG 400, PEG 8000); polyethylene oxides; polysorbate 80; propylene glycol; silicon dioxide; sodium chloride; sodium lau-ryl sulfate; synthetic black iron oxide; red iron oxide; talc; titanium dioxide and triacetin.

What are the possible side effects of lovastatin (Altoprev, Mevacor)?

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

Stop using lovastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • mild stomach pain, gas, bloating, stomach upset, heartburn;
  • nausea;
  • ...

Read All Potential Side Effects and See Pictures of Altoprev »

What are the precautions when taking lovastatin extended-release tablets (Altoprev)?

Before taking lovastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with lovastatin. Ask your doctor or pharmacist for more information.

Older adults may be...

Read All Potential Precautions of Altoprev »


Altoprev Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lovastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with lovastatin. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

This medication must not be used during pregnancy. Lovastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Altoprev Patient Information Including Side Effects

Brand Names: Altoprev, Mevacor

Generic Name: lovastatin (Pronunciation: LOE va sta tin)

  • What is lovastatin (Altoprev)?
  • What are the possible side effects of lovastatin (Altoprev)?
  • What is the most important information I should know about lovastatin (Altoprev)?
  • What should I discuss with my healthcare provider before taking lovastatin (Altoprev)?
  • How should I take lovastatin (Altoprev)?
  • What happens if I miss a dose (Altoprev)?
  • What happens if I overdose (Altoprev)?
  • What should I avoid while taking lovastatin (Altoprev)?
  • What other drugs will affect lovastatin (Altoprev)?
  • Where can I get more information?

What is lovastatin (Altoprev)?

Lovastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Lovastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

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

What are the possible side effects of lovastatin (Altoprev)?

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

Stop using lovastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • mild stomach pain, gas, bloating, stomach upset, heartburn;
  • nausea;
  • constipation; or
  • diarrhea.

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 the most important information I should know about lovastatin (Altoprev)?

In rare cases, lovastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take lovastatin if you have liver disease, or if you are breast-feeding.

Before taking lovastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or a blood disorder:

Avoid eating foods that are high in fat or cholesterol. Lovastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol while taking lovastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking lovastatin.

There are many other drugs that can interact with lovastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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  • Altoprev


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