Pronunciation:

sim-va-STAT-in

Brand Names:

• Zocor

Dosage Forms:

• Tablet
• Suspension

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Simvastatin is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This medicine may help prevent medical problems (eg, heart or blood vessel problems, heart attacks, or strokes) caused by clogged blood vessels. Simvastatin may also be used to prevent certain types of heart problems in patients with risk factors for heart problems.

Simvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol. 1

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of simvastatin in children younger than 10 years of age. Safety and efficacy have not been established.

Teenage girls taking simvastatin should be counseled on appropriate birth control methods to prevent pregnancy.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of simvastatin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or muscle problems (eg, myopathy and rhabdomyolysis), which may require caution in patients receiving simvastatin.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Ceritinib
• Clarithromycin
• Cobicistat
• Cyclosporine
• Danazol
• Darunavir
• Erythromycin
• Fosamprenavir
• Gemfibrozil
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lonafarnib
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Paritaprevir
• Posaconazole
• Ribociclib
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Adagrasib
• Amiodarone
• Amlodipine
• Asciminib
• Avacopan
• Azithromycin
• Bempedoic Acid
• Bezafibrate
• Carbamazepine
• Ceftobiprole Medocaril
• Ciprofibrate
• Ciprofloxacin
• Clofibrate
• Colchicine
• Conivaptan
• Dabrafenib
• Dalfopristin
• Danicopan
• Daptomycin
• Darolutamide
• Delavirdine
• Digoxin
• Diltiazem
• Dronedarone
• Duvelisib
• Elafibranor
• Elexacaftor
• Eltrombopag
• Encorafenib
• Eslicarbazepine Acetate
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosnetupitant
• Fusidic Acid
• Glecaprevir
• Ivosidenib
• Larotrectinib
• Lefamulin
• Leflunomide
• Lenacapavir
• Leniolisib
• Letermovir
• Levamlodipine
• Levofloxacin
• Lomitapide
• Lorlatinib
• Lumacaftor
• Midostaurin
• Momelotinib
• Netupitant
• Niacin
• Olutasidenib
• Omaveloxolone
• Pacritinib
• Pazopanib
• Phenobarbital
• Phenprocoumon
• Pibrentasvir
• Pirtobrutinib
• Primidone
• Quinupristin
• Ranolazine
• Resmetirom
• Rifampin
• Risperidone
• Ritlecitinib
• Simeprevir
• Suzetrigine
• Tadalafil
• Tazemetostat
• Teriflunomide
• Ticagrelor
• Trofinetide
• Vadadustat
• Verapamil
• Voclosporin
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albiglutide
• Alitretinoin
• Apalutamide
• Bosentan
• Cilostazol
• Clopidogrel
• Efavirenz
• Fosphenytoin
• Fostemsavir
• Interferon Beta
• Levothyroxine
• Mavacamten
• Oat Bran
• Oxcarbazepine
• Pectin
• Phenytoin
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry Juice
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Chinese ancestry or
• Diabetes or
• Hypothyroidism (an underactive thyroid), not well-controlled or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Epilepsy (seizures), not well-controlled or
• Hypotension (low blood pressure) or
• Hypovolemia, severe or
• Kidney disease, severe or
• Metabolic disorders, severe or
• Sepsis (severe infection) or
• Surgery, major or
• Trauma—Patients with these conditions may be at risk for muscle or kidney problems.

• Hypercholesterolemia (high cholesterol in the blood), familial homozygous—Dosage may be adjusted in this condition.

• Liver disease, active or
• Liver enzymes elevated—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

If you are using the oral suspension:

• Take this medicine on the evening, on an empty stomach.
• Shake the oral suspension well for at least 20 seconds before using it. Use a marked measuring spoon, oral syringe, or medicine cup to measure the right dose.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet. Carefully follow your doctor's orders about any special diet.

If you are taking diltiazem (Cardizem®), dronedarone (Multaq®), or verapamil (Calan®, Isoptin®, Verelan®) together with simvastatin, your simvastatin dose should not be higher than 10 milligrams (mg) per day, unless otherwise directed by your doctor. Do not use more than 20 mg per day of simvastatin together with amiodarone (Cordarone®), amlodipine (Norvasc®), lomitapide (Juxtapid™), or ranolazine (Ranexa®). When used together with higher doses of simvastatin, these medicines may increase your risk of muscle injury and could result in kidney problems.

Tell your doctor if you regularly drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1 quart each day) while taking this medicine may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with simvastatin. This could cause unwanted effects on the liver.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (suspension or tablets):
  • For high cholesterol:
    • Adults—20 to 40 milligrams (mg) once a day in the evening. Your doctor may adjust your dose as needed.
    • Children 10 years of age and older—10 to 40 mg once a day in the evening. Your doctor may increase your dose as needed.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use simvastatin if you are also taking boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (eg, clarithromycin, daptomycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (eg, atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together with simvastatin may increase your risk of muscle injury and could result in kidney problems.

Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (eg, 80 milligrams) are used, but some people get myopathy with lower doses.

Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Dizziness

fainting

fast or irregular heartbeat

Less common

Bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chills

cough

dark-colored urine

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

dry mouth

ear congestion

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

joint pain

loss of consciousness

lower back or side pain

muscle cramps, spasms, stiffness, pain, tenderness, wasting, or weakness

nausea

runny or stuffy nose

sneezing

sore throat

stomachache

sweating

swelling

swollen joints

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

bloating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest tightness

constipation

diarrhea

difficulty with chewing, swallowing, or talking

double vision

drooping eyelids

general tiredness and weakness

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

muscle pain or weakness

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

skin rash, hives, or itching

sores, ulcers, or white spots in the mouth or on the lips

unusual bleeding or bruising

upper right abdominal or stomach pain

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Some side effects 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:

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

dizziness or lightheadedness

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

full feeling

heartburn

lack or loss of strength

pain or tenderness around the eyes and cheekbones

passing gas

sensation of spinning

skin rash, encrusted, scaly, and oozing

stomach discomfort, upset, or pain

tenderness in the stomach area

trouble sleeping

Incidence not known

Being forgetful

depression

discoloration of the skin

hair loss or thinning of the hair

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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