Products

Simtanin 20

Uses For simvastatin

Simvastatin is used together with a proper diet to treat high cholesterol levels in the blood. Using simvastatin may help prevent medical problems caused by such substances clogging the 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 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood .

Simvastatin is available only with your doctor's prescription .

Importance of Diet

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed .

Simvastatin should not be taken with large amounts of grapefruit juice or other grapefruit products because these may increase the concentrations of simvastatin in the body .

Before Using simvastatin

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 simvastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to simvastatin 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

Simvastatin is safe to use, for treating certain types of high cholesterol, in boys 10 to 17 years of age and in girls 10 to 17 years of age, who have been experiencing monthly menstruation for at least 1 year. Safety and efficacy in children younger than 10 years of age have not been established .

Adolescent girls taking simvastatin should be counseled on appropriate contraceptive methods .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of simvastatin in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	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.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using simvastatin 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.

Atazanavir
Darunavir
Fosamprenavir
Itraconazole
Lopinavir
Mibefradil
Ritonavir
Tipranavir

Using simvastatin 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
Amprenavir
Bezafibrate
Ciprofibrate
Ciprofloxacin
Clarithromycin
Clofibrate
Cyclosporine
Dalfopristin
Danazol
Delavirdine
Erythromycin
Fenofibrate
Fluconazole
Fusidic Acid
Gemfibrozil
Indinavir
Ketoconazole
Nefazodone
Nelfinavir
Niacin
Quinupristin
Risperidone
Saquinavir
Telithromycin
Verapamil
Warfarin

Using simvastatin 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.

Azithromycin
Bosentan
Carbamazepine
Colchicine
Conivaptan
Dasatinib
Digoxin
Diltiazem
Efavirenz
Fosphenytoin
Imatinib
Levothyroxine
Oat Bran
Oxcarbazepine
Pectin
Phenytoin
Rifampin
St John's Wort
Voriconazole

Interactions with Food/Tobacco/Alcohol

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 simvastatin 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 simvastatin, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Proper Use of simvastatin

Take simvastatin only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered .

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly .

Remember that simvastatin will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down .

If you are taking amiodarone (Cordarone(R)) or verapamil (Calan(R), Verelan(R)) together with simvastatin, your simvastatin dose should NOT exceed 20 mg per day, unless directed by your doctor or pharmacist. If you are taking cyclosporine (Restasis(R), Sandimmune(R)), danazol (Danocrine(R)), or gemfibrozil (Lopid(R)) together with simvastatin, your simvastatin dose should NOT exceed 10 mg per day. When used together, these medicines may increase your risk of muscle injury which can lead to kidney failure, particularly at higher doses of simvastatin. If you are taking amiodarone, cyclosporine, danazol, gemfibrozil, or verapamil and simvastatin, call your doctor right away if you have dark-colored urine, have a fever, have muscle cramps or spasms, have muscle pain or stiffness, feel very tired or weak, or have diarrhea .

Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking simvastatin. Grapefruit juice may increase the amount of simvastatin in the body which may increase your risk of muscle injury and could result in kidney failure .

Dosing

The dose of simvastatin 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 simvastatin. 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 high cholesterol:
- For oral dosage form (tablets):
  - Adults—At first, 20 to 40 milligrams (mg) once a day in the evening, as instructed by your doctor. Your doctor may increase your dose if needed.
  - Children (10 to 17 years of age)—At first, 10 mg once a day in the evening. Your doctor may increase your dose up to a maximum of 40 mg per day if needed.
  - Children (less than 10 years of age)—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of simvastatin, 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.

Precautions While Using simvastatin

It is very important that your doctor check your progress at regular visits to make sure that simvastatin is working properly. Blood tests may be needed to check for unwanted effects .

Your doctor will need to check your liver before you start using simvastatin .

Check with your doctor immediately if you think that you may be pregnant. Do not take simvastatin if you are pregnant. simvastatin may cause birth defects or other problems in the baby if taken during pregnancy. Do not breastfeed while you are using simvastatin .

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking simvastatin .

Do not use excessive amounts of alcohol while taking simvastatin because it can worsen the adverse effects of simvastatin on the liver .

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney 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 .

Simvastatin Side Effects

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:

Less common

Body aches or pain
chills
cough
dark-colored urine
difficulty in breathing
difficulty in moving
ear congestion
fever
headache
joint pain
loss of voice
muscle cramps, spasms or stiffness
muscular pain, tenderness, wasting or weakness
nasal congestion
runny nose
sneezing
sore throat
swollen joints
unusual tiredness or weakness

Rare

Blindness
blurred vision
decreased vision

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: