See also:
What is the most important information I should know about Bedol?
You should not use this medicine if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, history of an allergic reaction to Bedol topical, or a hormone-related cancer such as breast or uterine cancer.
Bedol topical can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
Do not use Bedol topical if you are breast-feeding a baby.
Topical Bedol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.
Children should avoid coming into contact with skin areas where you have applied Bedol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.
Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.
Talk with your doctor about your individual risks before using Bedol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
See also:
What are the possible side effects of Bedol?
Applies to Bedol: vaginal cream, vaginal insert extended release, vaginal tablet
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by Bedol (the active ingredient contained in Bedol G GAM). In the event that any of these side effects do occur, they may require medical attention.
Major Side EffectsYou should check with your doctor immediately if any of these side effects occur when taking Bedol:
Less common:
If any of the following symptoms of overdose occur while taking Bedol, get emergency help immediately:
Symptoms of overdose:
Some of the side effects that can occur with Bedol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:
Bedol is a Hormone Replacement Therapy (HRT). It contains the female hormone Bedol.
Bedol is used in postmenopausal women, particularly in women who have had their womb removed (have had a hysterectomy) and therefore do not require combined oestrogen/progestagen therapy.
Bedol is
Used for: Relief of symptoms occurring after menopause: During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Bedol alleviates these symptoms after menopause. Bedol should only be prescribed if the symptoms seriously hinder the patient’s daily life.
Prevention of osteoporosis (thinning of the bones), if the patient is at high risk of future fracture and if unable to take other medications for this purpose.
There is only limited experience of treating women older than 65 years.
Bedol is topical emulsion containing Bedol. Bedol is a form of estrogen, a female sex hormone that regulates many processes in the body.
Bedol is used to after menopause to reduce moderate to severe hot flashes. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe.
Bedol may also be used for purposes not listed in this medication guide.
Generally refers to the 17-beta-isomer of Bedol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Bedol-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the placenta. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of Bedol binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.
Use Bedol spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Bedol spray.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.
How to use Bedol intramuscularRead the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
This medication is injected into a muscle as directed by your doctor, usually every 4 weeks. For the treatment of prostate cancer, this medication is usually given every 1 to 2 weeks. The dosage is based on your medical condition and response to treatment.
If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If stored at low temperatures, crystal may form in the liquid. To dissolve these crystals, simply warm the product to room temperature prior to use. Learn how to store and discard medical supplies safely.
Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder of when to receive your doses.
Tell your doctor if your condition does not improve or if it worsens.
For topical use only. Bedol is not for ophthalmic, oral, or intravaginal use. Bedol should not be applied to the face or breasts.
Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin.
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual women. Postmenopausal women should be re-evaluated periodically as clinically appropriate.
Treatment Of Moderate To Severe Vasomotor Symptoms Due To MenopauseThe single approved dose of Bedol is 3.48 grams daily. Apply one pouch (1.74 grams) to the left thigh and calf and one pouch (1.74 grams) to the right thigh and calf each morning. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
The lowest effective dose of Bedol for this indication has not been determined.
How suppliedDosage Forms And StrengthsTopical emulsionEach gram of Bedol contains 2.5 mg of Bedol hemihydrate. Each pouch contains 1.74 grams of Bedol.
Bedol (Bedol topical emulsion), nominal 0.05 mg/day: Bedol is packaged in foil-laminated pouches. A daily dose of Bedol is two foil-laminated pouches.
Each pouch contains 1.74-grams. Each 1.74-gram, foil-laminated pouch contains 4.35 mg of Bedol hemihydrate USP, EP. Each box of Bedol contains fourteen 1.74-gram, foil-laminated pouches.
1-month supply carton of 56 pouches, NDC 99207-190-56
Storage And HandlingStore at 20-25°C (68-77°F); excursions permitted to 15-40°C (59-104°F).
Manufactured for: Medicis Pharmaceuticals, A Division of Valeant Pharmaceuticals North America Bridgewater, NJ 08807. Manufactured by: Ei Inc. Kannapolis, NC 28083 Bedol is a registered trademark of Medicis Pharmaceutical Corporation. Revised: March 2015
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What other drugs will affect Bedol?
CYP3A4 Interaction
Bedol is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of lovastatin
Pharmacokinetics Itraconazol Ketoconazol Erythromyci Clarithromyci Telithromyci HIV protease inhibitor Nefazodon Cyclosporin Large quantities of grapefruit juice (>1 quart daily
Interactions with lipid-lowering drugs that can cause myopathy when given alone
The risk of myopathy is also increased by the following lipid-lowering drugs that are not potent CYP3A4 inhibitors, but which can cause myopathy when given alone
See WARNINGS, Myopathy/Rhabdomyolysis Gemfibrozi Other fibrate Niacin (nicotinic acid) (=1 g/day
Other drug interaction
Danazol: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol particularly with higher doses of lovastatin
Amiodarone or Verapamil: The risk of myopathy/rhabdomyolysis is increased when either amiodarone or verapamil is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class
Coumarin Anticoagulants: In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two-second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, prothrombin time be determined before starting lovastatin and frequently enough during early therapy to insure that no significant alteration of prothrombin time occurs Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of lovastatin is changed, the same procedure should be repeated. Bedol therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants
Propranolol: In normal volunteers, there was no clinically significant pharmacokinetic o pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol
Digoxin: In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations
Oral Hypoglycemic Agents: In pharmacokinetic studies of MEVACOR in hypercholesterolemic noninsulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide
