The Salina Journal from Salina, Kansas on October 20, 1996 · Page 52
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The Salina Journal from Salina, Kansas · Page 52

Salina, Kansas
Issue Date:
Sunday, October 20, 1996
Page 52
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ZOCOR (SIMVASTATIN) PLEASE READ THIS SUMMARY CAREFULLY, AND THEN ASK YOUR DOCTOR ABOUT ZOCOR. NO ADVERTISEMENT CAN PROVIDE ALL THE INFORMATION NEEDED TO PRESCRIBE A DRUG. THIS ADVERTISEMENT DOES NOT TAKE THE PLACE OF CAREFUL DISCUSSIONS WITH YOUR DOCTOR. ONLY YOUR DOCTOR HAS THE TRAINING TO WEIGH THE RISKS AND BENEFITS OF A PRESCRIPTION DRUG FOR YOU. USES OF ZOCOR ZOCOR is a prescription drug that is indicated as an addition to diet lor many patients with high cholesterol when diet and exercise are inadequate. For patients with coronary heart disease (CHD) and high cholesterol, ZOCOR is indicated as an addition to diet to reduce the risk ol death by reducing coronary death; to reduce the risk of heart attack; and to reduce the risk lor undergoing myocardial revascularizatlon procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). WHEN ZOCOR SHOULD NOT BE USED Some people should not lake ZOCOR. Discuss this with your doctor. ZOCOR should not be used by patients who are allergic to any of Its Ingredients. In addition to the active Ingredient simvastalin, each (ablet contains the following Inactive ingredients: cellulose, lactose, magnesium stearate, iron oxides, talc, titanium dioxide, and starch. Butylaled hydroxyanisole is added as a preservative. Patients with liver problems: ZOCOR should not be used by patients with active liver disease or repeated blood test results indicating possible liver problems. (See WARNINGS.) Women who are or may become pregnant: Pregnant women should not lake ZOCOR because it may harm the fetus. Women of eblldbearlng age should not take ZOCOR unless It Is highly unlikely that they will become pregnant. If a woman does become pregnant while on ZOCOR, she should stop taking the drug and talk to her doctor at once. Women who are breast-feeding should not take ZOCOR. WARNINGS Liver: About 1% ot patients who took ZOCOR In clinical trials developed elevated levels of some liver enzymes. Patients who had these increases usually had no symptoms. Elevated liver enzymes usually relumed to normal levels when therapy with ZOCOR was stopped. Your doctor should perform routine blood tests to check these enzymes before and during treatment with ZOCOR. The tests should occur at 6 weeks and 12 weeks after you begin taking ZOCOR, and about every 6 months thereafter. If your enzyme levels increase, your doctor should order more frequent tests. If your liver enzyme levels remain unusually high, your doctor should discontinue your medication. Tell your doctor about any liver disease you may have had In the past and about how much alcohol you consume. ZOCOR should be used with caution in patients who consume large amounts of alcohol. Muscle: Tell your doctor right away If you experience any muscle pain, tenderness, or weakness at any time during treatment with ZOCOR, particularly If you have a lever or II you are generally not feeling well, so your doctor can decide II ZOCOR should be stopped. Some patients may have muscle pain or weakness while taking ZOCOR. Rarely, this can Include muscle breakdown resulting In kidney damage. The risk of muscle breakdown Is greater In patient* taking certain other drugs along with ZOCOR, such as the llpld-lower- Ing drug Lopid* (Gemtibroill), a fltarate, llpld-lowering doses ol nlcotlnlc acid (nlacln), the antibiotic erythromycln, certain Intravenous/lniectable antlfungal drugs, or drugs that suppress the Immune system (called Immunosuppresslve drugs, such as Sendlmmune" [Cyclosporine]). Patients using ZOCOR along with any of these drugs should be carefully monitored by their physician. The risk ol muscle breakdown Is greater In patients with kidney problems or diabetes. II you have conditions that can Increase your risk of muscle breakdown, which In turn can cause kidney damage, your doctor should temporarily withhold or stop ZOCOR. Such conditions Include severe Infection, low blood pressure, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures. Discuss this with your doctor, who can explain these conditions to you. Because there an risks In combining therapy with ZOCOR with llpld-lowering doses ot nlcotlnlc add (nlacln) or with drugs thai suppress the Immune system, your doctor should carefully weigh the potential benefits and risks. He or she should also carefully monitor patients lor any muscle pain, tenderness, or weakness, particularly during the Initial months ol therapy and II the dose ol either drug is Increased. Your doctor may also monitor the level ol certain muscle enzymes in your body, but then Is no assurance that such monitoring will prevent the occurrence ol severe muscle disease. PRECAUTIONS Before starting treatment with ZOCOR, try to lower your cholesterol by other methods such as diet, exercise, and weight loss. Ask your doctor about how best to do this. Any other medical problems thai can cause high cholesterol should also be treated. ZOCOR Is less effective in patients with the rare disorder known as homozygous lamilial hypercholes- teroiemia. Drag Interactions: Because of possible serious drug interactions, it is important to tell your doctor what other drugs you are taking, including those obtained without a prescription. ZOCOR can interact with Lopid, nlacin, erylhromycin, certain inlravenous/injeclable antifungal drugs, and drugs that suppress the Immune system (called immunosuppressive drugs, such as Sandimmune). (See WARNINGS, Muscle.) Some patients taking lipld-lowering agents similar to ZOCOR*(Simvaslatin) and coumarin anticoagulants (a type of blood thinner) have experienced bleeding and/or increased blood clotting time. Patients taking these medicines should have their blood tested before starting therapy with ZOCOR and should continue to be monitored. Endocrine (Hormone) Function: ZOCOR and other drugs in this class may affect the production of certain hormones. Caution should be exercised II a drug used to lower cholesterol levels is administered to patients also receiving other drugs (e.g., ketoconazole, spironolactone, cimetidine) that may decrease the levels or activity of hormones. If you are taking any such drugs, tell your doctor. Central Nervous System Tojlclty; Cancer, Mutations, Impairment ol Fertility: Like most prescription drugs, ZOCOR was required to be tested on animals before it was marketed for human use. Often these tests were designed to achieve higher drug concentrations than humans achieve at recommended dosing. In some tests, the animals had damage to the nerves in the central nervous system. In studies of mice with high doses of ZOCOR, the likelihood of certain types of cancerous tumors Increased. No evidence ol mutations of or damage to genetic material has been seen. In one study with ZOCOR, there was decreased fertility in male rats. Pregnancy: Pregnant women should not take ZOCOR because It may harm the fetus. Safety in pregnancy has not been established. There have been no reports of birth defects in the children of patients taking ZOCOR. However, In studies with lipld-lowering agents similar to ZOCOR, there have been rare reports of birth defects of the skeleton and digestive system. Therefore, women of chlldbearlng age should not take ZOCOR unless it is highly unlikely they will become pregnant. If a woman does become pregnant while taking ZOCOR, she should stop taking the drug and talk to her doctor at once. The active Ingredient ot ZOCOR did not cause birth delects in rats at 6 times the human dose or in rabbits al 4 limes the human dose. Nursing Mothers: Drugs taken by nursing mothers may be present in their breast milk. Because of the potential for serious adverse reactions in nursing Infants, a woman taking ZOCOR should not breast- feed. (See WHEN ZOCOR SHOULD NOT BE USED.) Pedlatric Use: ZOCOR is not recommended for children or patients under 20 years of age. SIDE EFFECTS Most patients tolerate treatment with ZOCOR well; however, like all prescription drugs, ZOCOR can cause side elfects, and some of them can be serious. Side effects that do occur are usually mild and short- lived. Only your doctor can weigh the risks versus the benefits of any prescription drug. In clinical studies with ZOCOR, less than 1.5% ot patients dropped out of the studies because of side effects. In a large, long-term study, patients taking ZOCOR experienced similar side effects to those patients taking placebo (sugar pills). Some of the side effects that have been reported with ZOCOR or related drugs are listed below. This list Is not complete. Be sure to ask your doctor about side effects before taking ZOCOR and to discuss any side effects that occur. Digestive System: Constipation, diarrhea, upset stomach, gas, heartburn, stomach pain/cramps, anorexia, loss of appetite, nausea, inflammation of the pancreas, hepatitis, jaundice, fatty changes in the liver, and, rarely, severe liver damage and failure, cirrhosis, and liver cancer. Muscle, Skeletal: Muscle cramps, aches, pain, and weakness; joint pain; muscle breakdown. Nervous System: Dizziness, headache, insomnia, tingling, memory loss, damage to nerves causing weakness and/or loss ot sensation and/or abnormal sensations, anxiety, depression, tremor, loss of balance, psychic disturbances. Skin: Rash, itching, hair loss, dryness, nodules, discoloration. Eye/Senses: Blurted vision, altered taste sensation, progression of cataracts, eye muscle weakness. Hypersensltlvlly (Allergic) Reactions: On rare occasions, a wide variety ol symptoms have been reported to occur either alone or together in groups (referred to as a syndrome) that appeared to be based on allergic-type reactions, which may rarely be fatal. These have included one or more ol the following: a severe generalized reaction that may Include shortness ot breath, wheezing, digestive symptoms, and low blood pressure and even shock; an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing; symptoms mimicking lupus (a disorder In which a person's immune system may attack parts of his or her own body); severe muscle and blood vessel inflammation; bruises; various disorders ol blood cells (that could result in anemia, Infection, or blood clotting problems) or abnormal blood tests; inflamed or painful joints; hives; fatigue and weakness: sensitivity to sunlight; fever, chills; (lushing; difficulty breathing; and severe skin disorders thai vary from rash to a serious burn-like shedding of skin all over the body, including mucous membranes such as the lining of the mouth. Other Loss of sexual desire, breast enlargement, Impotence. Laboratory Tests: Liver function test abnormalities including elevated alkaline phosphalase and billru- bin; thyroid function abnormalities. NOTE: This summary provides Important Information about ZOCOR. II you would like more Information, ask your doctor or pharmacist to let you read the professional labeling and then discuss It with them. MERCK Vtal Point. PA 1MW ZOCOR is a registered trademark ol Merck & Co, Inc. •Lopid is a registered trademark ot Warner-Lambert Company. "Sandimmune is a registered trademark of Sandoz AG. Copyright © 1996 by Merck & Co., Inc. All rights reserved. J6Z018(419) THE movie Peter Gallagher plays a grieving husband in this week's tender To Gillian on Her 37th Birthday (PG-13). He's still in love with late wife Michelle Pfeiffer. Relatives try to snap him out of it and seek custody of his daughter (Claire Danes). New videos for lazy weekends. • Multiplicity (PG-13), above.' \ Overworked Michael Keaton has himself cloned three times over, " ' Wife AndieMacDowell doesn't ', catch on. The premise Is interesting. Otherwise, not compelling. "- , • Fear (R). Mark Wahlberg stajks/teen" ; Reese Wftherspoon and he? fipi# < < tety bad ai\d pretty fipiy« ' . , J » Don't Be a Menace to Squt/?- '"-/ Central While Drinking ftwjatoe, , \ In trie Hood (R), Damon and Snap " Wayans spoof the violent, reglity- based movies about life in the ghetto. Hit-and-miss. Funny (n parts. books It's 1996, and yet these well-written documents show that brutality is not merely a ghost of past regimes. • The Tenth Circle of Hell: A Memoir of Ltfe in the Death Camps of Bosnia (BASICBOOKS, $20). A Croatian journalist chronicles the torture and death visited upon citizens of a town at the mercy of Serbs on an "ethnic cleansing" mission. Rezak Hukanovic escaped a prison camp in 1992. • Troublemaker (hieMan's Crusade Against China's Cruelty (RANDOM HOUSE, $25). Chinese dissident Harry Wu gained international attention last year when he was arrested at China's border, tried and hustled out of the country. His book covers things he says he has seen and videotaped, including a network of abusive prisons holding millions. C3 By Myron e.Pttt», with LauritWenwr Send comments to The Week," 1000 Wilson Blvd., Arlington, Va. 22229-0013; e-mail: 19 USA WEEKEND • Oct. 18-20, IW6

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