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Flolipid (Generic Simvastatin)

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Why is this medication prescribed?

Simvastatin is used in conjunction with diet, weight loss, and exercise to lower the risk of heart attack and stroke as well as the likelihood that a patient will require heart surgery if they already have heart disease or are at risk for acquiring it. Simvastatin is also used to improve blood levels of high-density lipoprotein (HDL) cholesterol, generally known as “good cholesterol,” and to lower levels of fatty substances including low-density lipoprotein (LDL) cholesterol, also known as “bad cholesterol,” and triglycerides. Children and teens with familial heterozygous hypercholesterolemia (an inherited disorder in which cholesterol cannot be eliminated from the body naturally) who are 10 to 17 years old can also use simvastatin to lower the levels of cholesterol and other fatty substances in their blood. Statins, often known as HMG-CoA reductase inhibitors, include simvastatin. It functions by reducing the amount of cholesterol that may accumulate on the artery walls and obstruct blood flow to the heart, brain, and other organs of the body. This is done by delaying the body’s creation of cholesterol.

Your heart, brain, and other organs of your body receive less oxygen as a result of the buildup of cholesterol and fats along the artery walls (a condition known as atherosclerosis). It has been demonstrated that simvastatin can prevent heart disease, angina (chest discomfort), strokes, and heart attacks by lowering your blood levels of cholesterol and fats.

How should this medicine be used?

Simvastatin is available as a tablet and an oral suspension for consumption. The tablets are typically taken in the evening, once daily. On an empty stomach, the suspension is typically taken once daily in the evening. Simvastatin should be taken every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Simvastatin should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Before each usage, thoroughly shake the suspension for at least 20 seconds.

You should not measure your dose of simvastatin suspension with a regular teaspoon. You risk receiving too much or too little medication if you estimate your dose with a household teaspoon because they are not precise measuring tools. Use a properly designated measurement tool instead, such as an oral syringe or medicine spoon. If you need assistance procuring or using a measurement device, consult your doctor or pharmacist.

Your doctor might prescribe you a modest dose of simvastatin to start, and then progressively increase it up to once every four weeks.

Simvastatin should still be taken even if you feel fine. Without consulting your doctor, do not discontinue taking simvastatin.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking simvastatin,

  • If you have any allergies, including to simvastatin, other drugs, or any of the substances in simvastatin tablets or oral suspension, notify your doctor right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Inform your physician if you take antifungal drugs including itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); danazol; erythromycin (E.E.S., E-Mycin, Erythrocin); gemfibrozil (Lopid); cobicistat-containing drugs (Stribild); clarithromycin (Biaxin, in Prevpac); cyclosporine (Gengraf, Neoral, Sandimmune); HIV protease inhibitors such atazanavir (Reyataz), darunavir (Prezista), and fosamprenavir (Lexiva), nefazodone; telaprevir; and telithromycin; also known as indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus). If you take these medications, your doctor generally won’t recommend simvastatin for you.
  • Inform your doctor and pharmacist about any vitamins, nutritional supplements, herbal items, and prescription and over-the-counter medicines you are now taking or intend to take. Any of the following should be mentioned: Amiodarone (Cordarone, Pacerone); Amlodipine (Norvasc; Caduet; Lotrel); anticoagulants, also known as “blood thinners,” include diltiazem (Cardizem, Dilacor, Tiazac), digoxin (Digitek, Lanoxicaps, Lanoxin), colchicine (Colcrys), and warfarin (Coumadin, Jantoven); dronedarone (Multaq), niacin (nicotinic acid, Niacor, Niaspan), fenofibrate (Tricor), lomitapide (Juxtapid), ranolazine (Ranexa), and verapamil (Calan, Covera, Isoptin, Verelan) are examples of other drugs that decrease cholesterol. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects. Simvastatin may interact with additional drugs, so be sure to let your doctor know about all of the ones you are taking, even those that aren’t on this list.
  • If you have liver disease, let your physician know. Even if you do not think you have liver disease, your doctor will still order blood tests to determine how well your liver is functioning. If you already have liver disease or if testing indicate that you might be developing it, your doctor will likely advise you not to use simvastatin.
  • Inform your doctor if you consume more than two alcoholic beverages daily, are over 65 years old, or are Asian, particularly Chinese. Additionally, let your doctor know if you have ever had diabetes, seizures, muscle pain or weakness, low blood pressure, or renal illness.
  • If you are pregnant or plan to become pregnant, let your doctor know. Pregnancy should not occur while you are taking simvastatin. Discuss effective birth control options with your doctor. Simvastatin should be stopped immediately if you become pregnant while taking it, and your doctor should be contacted right away. Simvastatin may cause birth defects.
  • If you are breastfeeding, let your doctor know. Simvastatin should not be taken while nursing a baby.
  • Inform your doctor or dentist that you are taking simvastatin if you need surgery, including dental surgery. Inform your doctor that you are taking simvastatin if you need to be hospitalized because of a major accident or infection.
  • While taking simvastatin, find out from your doctor whether drinking alcohol is okay for you to do so. The risk of significant adverse effects can rise with alcohol use.

What special dietary instructions should I follow?

Consume a diet low in fat and cholesterol. Make sure to abide by all dietary and exercise advice given to you by your physician or nutritionist. For more dietary advice, you can also refer to the National Cholesterol Education Program (NCEP) website.

Grapefruit juice shouldn’t be consumed when taking simvastatin.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Simvastatin could have unwanted effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Abdominal pain
  • Nausea
  • Headache
  • Forgetfulness or memory loss
  • Confusion
  • Red or itching skin

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you encounter any of the symptoms listed below.

  • Muscular ache, tenderness, or weakness whether or not it is accompanied by a temperature or fatigue
  • Blood-red urine
  • Less urinations
  • Fatigue, weakness, or lack of energy
  • Reduced appetite
  • Stomach ache in the top right corner
  • Eyes or skin that have a yellow tint
  • Urine with a dark color
  • Cold or fever
  • Flushing
  • Blisters
  • Rash
  • Hives
  • Itching
  • Edema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Breathing or swallowing challenges
  • Hoarseness
  • Joints hurt
  • Responsiveness to light

Other negative effects of this medicine could occur. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. The tablets should be kept at room temperature, away from sources of extreme heat, and dry (not in the bathroom). Suspension should be kept at room temperature. Never freeze or chill the suspension. Use the suspension within 30 days of opening the bottle, and after 30 days, throw away any unused medication.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. Throughout your therapy, particularly if you start to experience symptoms of liver impairment, your doctor may request certain lab testing.

Inform your doctor and the lab staff that you are taking simvastatin prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Flolipid®
  • Zocor®
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