Simvastatin

Generic Name: Simvastatin

ZOCOR (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an 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.

Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:


ZOCOR (simvastatin) Structural Formula  - Illustration

Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.

Tablets ZOCOR for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxypropyl cellulose, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.

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The primary uses of simvastatin are to treat dyslipidaemia and to prevent atherosclerosis-related complications such as stroke and heart attacks in those who are at high risk. It is recommended to be used as an addition to a low-cholesterol diet.

In the Scandinavian Simvastatin Survival Study (a placebo-controlled, randomized clinical trial of five years' duration), simvastatin reduced overall mortality in people with existing cardiovascular disease and high LDL cholesterol by 30% and reduced cardiovascular mortality by 42%. The risks of heart attack, stroke, or needing a coronary revascularization procedure were reduced by 37%, 28%, and 37%, respectively.

The Heart Protection Study evaluated the effects of simvastatin in people with risk factors including existing cardiovascular disease, diabetes, or stroke, but having relatively low LDL cholesterol. In this trial, which lasted 5.4 years, overall mortality was reduced by 13% and cardiovascular mortality was reduced by 18%. People receiving simvastatin experienced 38% fewer nonfatal heart attacks and 25% fewer strokes.

Simvastatin has been used to explore whether statins have an effect on delaying on the onset and progression of age-related macular degeneration (AMD). Results from one trial showed participants assigned to simvastatin had lower odds (0.51 OR) of having AMD progression at three years compared to those assigned to placebo, though the results were not significant. Overall, evidence is insufficient to conclude that simvastatin has an effect in delaying the onset and progression of AMD.

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, or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • nasal congestion
  • nausea
  • runny nose
  • sneezing
  • sore throat
  • stomachache
  • sweating
  • swelling
  • swollen joints
  • troubled 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
  • constipation
  • diarrhea
  • difficulty with swallowing
  • 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
  • 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
  • tightness in the chest
  • troubled breathing with exertion
  • 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.

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—At first, 10 to 20 milligrams (mg) once a day in the evening. For high risk patients who may develop heart disease, your doctor may start your dose at 40 mg per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children 10 to 17 years of age—At first, 10 mg once a day in the evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
      • 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.

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
  • Clarithromycin
  • Cobicistat
  • Cyclosporine
  • Danazol
  • Darunavir
  • Erythromycin
  • Fosamprenavir
  • Gemfibrozil
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Mibefradil
  • Mifepristone
  • Nefazodone
  • Nelfinavir
  • Paritaprevir
  • Posaconazole
  • 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
  • Amiodarone
  • Amlodipine
  • Azithromycin
  • Bezafibrate
  • Carbamazepine
  • Ceritinib
  • Ciprofibrate
  • Ciprofloxacin
  • Clofibrate
  • Colchicine
  • Conivaptan
  • Dalfopristin
  • Daptomycin
  • Delavirdine
  • Diltiazem
  • Eltrombopag
  • Eslicarbazepine Acetate
  • Fenofibrate
  • Fenofibric Acid
  • Fluconazole
  • Fusidic Acid
  • Lomitapide
  • Lumacaftor
  • Niacin
  • Pazopanib
  • Quinupristin
  • Ranolazine
  • Risperidone
  • Simeprevir
  • Tadalafil
  • Verapamil
  • 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
  • Bosentan
  • Clopidogrel
  • Dasatinib
  • Digoxin
  • Dronedarone
  • Efavirenz
  • Fosphenytoin
  • Interferon Beta
  • Levothyroxine
  • Oat Bran
  • Oxcarbazepine
  • Pectin
  • Phenytoin
  • Rifampin
  • St John's Wort
  • Ticagrelor

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

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.

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of simvastatin in children 10 to 17 years of age. However, safety and efficacy of simvastatin in children younger than 10 years of age have not been established.

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

Geriatric

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 muscle problems, which may require caution in patients receiving simvastatin.

Pregnancy

Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

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.

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