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Before Using
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
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. |
Breastfeeding
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.
Drug Interactions
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.
- Atazanavir
- Darunavir
- Fosamprenavir
- Itraconazole
- Lopinavir
- Mibefradil
- Tipranavir
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
- Amprenavir
- Bezafibrate
- Ciprofibrate
- Ciprofloxacin
- Clarithromycin
- Clofibrate
- Cyclosporine
- Dalfopristin
- Danazol
- Delavirdine
- Erythromycin
- Fenofibrate
- Fluconazole
- Fusidic Acid
- Gemfibrozil
- Indinavir
- Ketoconazole
- Nefazodone
- Nelfinavir
- Niacin
- Quinupristin
- Risperidone
- Ritonavir
- Saquinavir
- Telithromycin
- 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.
- Bosentan
- Carbamazepine
- Colchicine
- Conivaptan
- Dasatinib
- Digoxin
- Diltiazem
- Efavirenz
- Fosphenytoin
- Imatinib
- Levothyroxine
- Oat Bran
- Oxcarbazepine
- Pectin
- Phenytoin
- Rifampin
- St John's Wort
- Voriconazole
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.
- 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
- Liver disease, history—Use with caution. These conditions may increase the amount of simvastatin in your blood .
- Diabetes mellitus, uncontrolled - Use with caution.
- Kidney disease, severe—Use with caution. This medicine may make the condition worse .
- Liver disease, active or
- Liver enzymes, persistently high levels—This medicine should NOT be used in these conditions. Use of this medicine may make liver problems worse .
