RALOXIFENE (Systemic)
Some commonly used brand names are:
In the U.S.?
Category
- Estrogen receptor modulator, selective
- osteoporosis prophylactic
Description
Raloxifene (ral-OX-i-feen) is used to help prevent and treat thinningof the bones (osteoporosis) only in postmenopausal women.
It works like an estrogen to stop the bone loss that can develop in womenafter menopause, but it does not increase the bone density as much as daily0.625 mg doses of conjugated estrogens. Raloxifene will not treat hot flashesof menopause and may cause hot flashes to occur. Also, raloxifene does notstimulate the breast or uterus as estrogen does.
Raloxifene lowers the blood concentrations of total and low-density lipoprotein(LDL) cholesterol, the bad cholesterols, but it does not increase concentrationsof high-density lipoprotein (HDL) cholesterol, the good cholesterol, in yourblood.
This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For raloxifene, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to raloxifene. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Raloxifene is not recommended during pregnancy. Presently,raloxifene is to be used in postmenopausal women only. It has been shown tocause serious birth defects or other problems in animals. Be sure you havediscussed this with your doctor.
Breast-feeding?It is not known whether raloxifene passes intobreast milk. However, raloxifene is not recommended during breast-feedingbecause it may cause unwanted effects in nursing babies. Presently, raloxifeneis to be used in postmenopausal women only.
Older adults?This medicine has been tested only in women pastmenopause and has not been shown to cause different side effects or problemsin elderly people than it does in adults who have just gone through menopause.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingraloxifene, it is especially important that your health care professionalknow if you are taking any of the following:
- Cholestyramine (e.g., Questran)?Cholestyramine can significantlyreduce the absorption of raloxifene
- Estrogens, injection (e.g., Premarin) or
- Estrogens, oral (e.g., Premarin, Estrace, Estratab) or
- Estrogens, transdermal (e.g., Climara, Estrace, Vivelle)?Raloxifeneshould not be used with estrogens
- Warfarin (e.g., Coumadin)?Raloxifene may decrease the effectof warfarin, and the dose of warfarin may need to be adjusted when addingor stopping raloxifene
Other medical problems?The presence of other medicalproblems may affect the use of raloxifene. Make sure you tell your doctorif you have any other medical problems, especially:
- Blood clot formation, active or history of, including deep vein thrombosis,pulmonary embolism, and retinal embolism?Raloxifene may slightly increasethe chances of these conditions and, if they are already present, cause themto worsen
- Cancer or tumors or
- Congestive heart failure or
- Any other condition that increases the risk of blood clots?Takingraloxifene while having one of these conditions may worsen the chance thatblood clots can form
- Liver disease?This condition may cause higher concentrationsof raloxifene in the blood
Proper Use of This Medicine
A paper withinformation for the patient will be given to you with your filled prescription,and will provide many details concerning the use of raloxifene. Read this paper carefully and ask your health care professional ifyou need additional information or explanation.
Many patients trying to prevent or treat bone loss will not notice anysigns of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed.
Dosing?The dose of raloxifene will be different fordifferent patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average dose of raloxifene. If your dose isdifferent, do not change it unless your doctor tells you to do so.
- For oral dosage form (tablets):
- For preventing bone loss:
- Adults?60 mg once a day, with or without meals.
- For treating bone loss:
- Adults?60 mg once a day, with or without meals.
Missed dose?If you miss a dose of this medicine, skip the misseddose and go back to your regular dosing schedule. Do not double doses. Ifyou have any questions about this, check with your doctor.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that you keep your appointments with yourdoctor even if you feel well.
Before you have any kind of surgery, tell the medicaldoctor in charge that you are using this medicine. Discuss discontinuinguse of raloxifene 3 days before you think you will have a long period of inactivity,sitting, or bed rest, such as after having surgery or going on a long trip.The doctor may have you start the medicine again after you are back on yourfeet and fully mobile. If you are going on a trip and stay on raloxifene,you should walk regularly or move about when possible. Remaining still forlong periods may cause blood clots for some people, and raloxifene may rarelyworsen their condition.
If you are able to become pregnant, stop using themedicine immediately if you think you have become pregnant and check withyour doctor. Raloxifene is recommended for women who are past menopause.
Raloxifene does not act like an estrogen to stimulate the uterus or breast. If you experience vaginal bleeding, breast pain or enlargement,or swelling of hands or feet while on raloxifene, you should report it toyour doctor.
Other ways that may be used with raloxifene to helpprevent or treat bone loss are taking calcium plus vitamin D supplements andgetting weight-bearing exercise. You may want to discuss these optionswith your doctor.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
Stop taking this medicineand get emergency help immediately if any of the following side effectsoccur:
Rare
Coughing blood; headache or migraineheadache; loss of or change in speech, coordination,or vision; pain or numbness in chest, arm, or leg; shortness of breath (unexplained)
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:
More common
Hot flashes, including sudden sweating and feelings of warmth(especially common during the first 6 months of treatment); increased white vaginal discharge; joint or musclepain; mental depression; problems of stomach or intestines, including passing of gas, upset stomach,or vomiting; swollen joints; trouble in sleeping; weight gain (unexplained)
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Developed: 03/26/1998
Revised: 02/08/2002
