Pharmaceutical and OTC Drugs for PMS and Menopause

CENESTIN
MENOPAUSE

CENESTIN - Duramed Pharmaceuticals, Inc.
A synthetic conjugated estrogen and progestin drug available by prescription

A tablet containing synthetic conjugated estrogen extracted from soy plants combined with medroxyprogesterone a synthetic progestin extracted from wild yam for use by women during menopause.

Benefits: Reduction in hot flashes, night sweats by providing hormone replacement. Osteoporosis studies in progress.

Side effects: Nausea, headache, vomiting, breakthrough bleeding, spotting, or change in menstrual periods. Breast tenderness, weight change, or swelling of your fingers or ankles.

Warnings: Reported to increase the chance of womb (endometrial) cancer in women who have been through menopause. This risk appears to depend on the length of time this drug is used and the amount of estrogen per dose. When used for an extended period, you should be evaluated at least every 6 months. If you experience abnormal vaginal bleeding, notify your doctor promptly. Do not use during pregnancy. May result in birth defects or cancer later in the child's life. If you become pregnant or think you may be pregnant, consult your doctor immediately. NOT RECOMMENDED if you have a history of cancer or pulmonary embolism.


ACTIVELLA
MENOPAUSE

ACTIVELLA - American Home Products
A synthetic conjugated estrogen and progestin drug available by prescription.

Manufactured by Novo Nordisk located in Denmark Activella is sold in the United States by American Home Products under a licensing agreement with Pharmacia.

Estrogen and progestin hormone replacement tablet taken once a day. Contains estradiol and progestin norethindrone acetate in tablet form derived largely from Soy. Estradiol, derived largely from soy is chemically the same estrogen found in pre menopausal women. Now available in the United States after two years of use in Europe.

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: In a 12-month trial, approximately 30 percent of women experienced some bleeding or spotting during the first three months of treatment. However, by the third month, 85 percent of women taking ACTIVELLA reported no bleeding. After one year, nearly all -- 97 percent of women -- were bleed-free.

Warnings:  Should not be used when pregnant, or if you have breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke.


VAGINAL RING
MENOPAUSE

VAGINAL RING - Warner Chilcott, Rockaway, New Jersey.
Estrogen replacement intravaginal estrogen ring.

Manufactured by Galen Holdings PLC, it is currently available in the United Kingdom under the name Menoring®. Warner Chilcott, Rockaway, New Jersey, distributes the vaginal ring in the United States.

The vaginal ring delivers estradiol, at a rate of 50 micrograms per day for three months. The product maintains very stable levels of estrogen.

Benefits: The vaginal ring delivers estrogen for three months.

Side effects: Not available

Warnings: Not available


Vivelle-Dot
MENOPAUSE

Vivelle-Dot - Noven Pharmaceuticals, Inc., Miami, Florida
Miniature transdermal estrogen replacement patch.

Noven Pharmaceuticals, Inc. manufactures the estrogen only (17-beta estradiol) Vivelle-Dot, patch for the treatment of menopausal symptoms and for the prevention of post menopausal osteoporosis.

Vivelle Ventures LLC (also known as Novogyne Pharmaceuticals) distributes Vivelle-Dot in the United States. Noven also manufactures CombiPatchTM the combination estrogen/progestin transdermal patch licensed to Aventis.

Benefits: It is the smallest estrogen patch in the world and offers patients a convenient, comfortable and cosmetically attractive means of administering hormone replacement therapy.

Side effects: Redness, rash, or skin irritation at the application site; or nausea. Other side effect can include dizziness, vomiting, bleeding between menstrual periods, breast tenderness, breast lumps, weight change, swelling of your fingers or ankles, or changes in vision. Contact your doctor if you notice yellowing skin or eyes; dark urine; abdominal pain, swelling, or tenderness; severe headaches; or coughing up blood.

Warnings: Can increase the chance of womb (endometrial) cancer in women who have been through menopause. This risk appears to depend on the length of time this drug is used and the amount of estrogen per dose. Do not use during pregnancy. May result in birth defects or cancer later in the child's life. Do not use if you have cancer or a history of cancer, abnormal vaginal bleeding, blood clots (e.g., pulmonary embolism, thrombophlebitis, stroke), migraines, any vision loss from eye disorders (e.g., ophthalmic vascular disease), porphyria, liver disease. You doctor should monitor you health if you have any of the following conditions: asthma, seizures (epilepsy), heart disease, kidney disease, diabetes, depression, endometriosis, high blood pressure, high blood pressure during pregnancy (toxemia), yellowing skin or eyes (jaundice) during pregnancy, upcoming surgery, uterine fibroid tumors, fluid retention (bloating) or weight gain during menstrual cycle, or high blood lipid levels (hypertriglyceridemia).


CombiPatch
MENOPAUSE

COMBIPATCH - Noven Pharmaceuticals, Inc.,
A synthetic conjugated estrogen and progestin drug patch available by prescription.

A hormone replacement adhesive skin patch that delivers two drugs (17 beta-estradiol and progestin norethindrone acetate) through the skin.

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Skin irritation, redness or rash at the application site. Nausea, bleeding between menstrual periods, breast tenderness, or weight change. Severe headache or vomiting, dizziness, swelling of fingers or ankles, yellowing of skin or eyes, changes in vision or speech, weakness or numbness of an arm or leg, breast lumps, or pain, swelling, or tenderness in the abdomen. Leg pain, chest pain, or sudden shortness of breath.

Warnings: Should not be used when pregnant, or if you have breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke.


Generic Estropipate
MENOPAUSE

GENERIC ESTROPIPATE - Mylan Laboratories
A prescription estrogen replacement drug

Estropipate tablets - the generic equivalent of Ogen made by Pharmacia Upjohn

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Nausea, headache; vomiting; breakthrough bleeding, spotting, or change in menstrual periods; breast tenderness; weight change; or swelling of your fingers or ankles. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Warnings: Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Estradiol Lingual Spray
MENOPAUSE

ESTRADIOL LINGUAL SPRAY - Flemington Pharmaceutical Corp
A prescription estrogen replacement drug

A mouth spray formulated with 17-beta estradiol, that is absorbed rapidly and results in fast relief of hot flashes.

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects:  Clinical trials in progress

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Estraderm
MENOPAUSE

ESTRADERM - Novartis Pharmaceuticals
A prescription transdermal estrogen replacement drug.

The synthetic estrogen 17-beta estradiol, administered by a rate limiting membrane (patch) attached to the skin.

Benefits:  Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Skin irritation, redness or rash at the application site. Nausea, bleeding between menstrual periods, breast tenderness, or weight change. Severe headache or vomiting, dizziness, swelling of fingers or ankles, yellowing of skin or eyes, changes in vision or speech, weakness or numbness of an arm or leg, breast lumps, or pain, swelling, or tenderness in the abdomen. Leg pain, chest pain, or sudden shortness of breath.

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women, women who have been through menopause. This can depend on how long you use this drug and the amount of estrogen per dose. Women using this drug for an extended period should be evaluated at least every 6 months. Not for use during pregnancy because it may result in birth defects or cancer later in the child's life. Do not use if you have cancer or a history of cancer, abnormal vaginal bleeding, blood clots (e.g., pulmonary embolism, thrombophlebitis, stroke), migraines, any vision loss from eye disorders (e.g., ophthalmic vascular disease), porphyria, liver disease. You may need additional monitoring if you have any of the following conditions: asthma, seizures (epilepsy), heart disease, kidney disease, diabetes, depression, endometriosis, high blood pressure, high blood pressure during pregnancy (toxemia), yellowing skin or eyes (jaundice) during pregnancy, upcoming surgery, uterine fibroid tumors, fluid retention (bloating) or weight gain during menstrual cycle, or high blood lipid levels (hypertriglyceridemia).


ORTHO-EST
MENOPAUSE

ORTHO-EST - Women First Healthcare
Estropipate tablets, a synthetic estrogen replacement drug available by prescription.

Obtained from processing Soy, it replaces an estrogen called estrone sulfate.

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects:  Women may experience side effects when taking estrogens. The most frequently reported side effects are breast tenderness, headache, nausea, and abdominal pain. You should not use hormone replacement therapy if you are pregnant.

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Ogen
MENOPAUSE

OGEN - Pharmacia Upjohn
Estropipate tablets, a synthetic estrogen replacement drug available by prescription.

Benefits: Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Nausea, headache; vomiting; breakthrough bleeding, spotting, or change in menstrual periods; breast tenderness; weight change; or swelling of your fingers or ankles. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Esclim
MENOPAUSE

ESCLIM - Women First Healthcare
Transdermal patch available by prescription.

Estrogen replacement transdermal patch formulated with estradiol obtained by processing the Yam Plant.

Benefits:  Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects:  Some women may experience side effects when taking estrogens. The most frequently reported side effects are breast tenderness, headache, nausea, and abdominal pain. Avoid using HRT if you are pregnant.

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Estrace
MENOPAUSE

ESTRACE -
Estrace tablets, a synthetic estrogen replacement drug available by prescription

Estrogen replacement tablets formulated with 17-beta estradiol

Benefits:  Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Nausea, headache, vomiting, breakthrough bleeding, spotting, change in menstrual periods, breast tenderness, weight change or swelling of your fingers or ankles.

Warnings:  Estrogens have been reported to increase the risk of endometrial carcinoma in Post-Menopausal women.


Climara
MENOPAUSE

CLIMARA - Berlex Laboratories, Inc.
Synthetic estrogen replacement drug available by prescription

Estrogen patch formulated with 17-beta estradiol

Benefits:  Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects: Redness, rash, or skin irritation at the application site; or nausea. Other side effect can include dizziness, vomiting, bleeding between menstrual periods, breast tenderness, breast lumps, weight change, swelling of your fingers or ankles, or changes in vision. Contact your doctor if you notice yellowing skin or eyes; dark urine; abdominal pain, swelling, or tenderness; severe headaches; or coughing up blood.

Warnings:  Estrogens have ben reported to increase the risk of endometrial carcinoma in Post-Menopausal women. This risk appears to depend on the length of time this drug is used and the amount of estrogen per dose. Do not use during pregnancy. May result in birth defects or cancer later in the child's life. Do not use if you have cancer or a history of cancer, abnormal vaginal bleeding, blood clots (e.g., pulmonary embolism, thrombophlebitis, stroke), migraines, any vision loss from eye disorders (e.g., ophthalmic vascular disease), porphyria, liver disease. You doctor should monitor you health if you have any of the following conditions: asthma, seizures (epilepsy), heart disease, kidney disease, diabetes, depression, endometriosis, high blood pressure, high blood pressure during pregnancy (toxemia), yellowing skin or eyes (jaundice) during pregnancy, upcoming surgery, uterine fibroid tumors, fluid retention (bloating) or weight gain during menstrual cycle, or high blood lipid levels (hypertriglyceridemia).


Ortho Prefest
MENOPAUSE

ORTHO PREFEST - Ortho-McNeil Pharmaceutical
A synthetic conjugated estrogen and progestin drug available by prescription

A hormone replacement tablet that contains 17 beta-estradiol and progestin norestimate.

Benefits:  Effective at relieving hot flashes, night sweats and vaginal dryness.

Side effects:  Headache, breast pain, back pain, fatigue, flu-like symptoms, abdominal pain, nausea, joint pain, painful menstruation, vaginal bleeding, vaginitis, inflammation of the throat, sinusitis and upper respiratory infections.

Warnings:  Estrogens should not be used by women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thru


Premarin
MENOPAUSE

PREMARIN - Wyeth-Ayerst
A conjugated equine estrogen drug available by prescription

A hormone replacement tablet made from estrogen extracted from the urine of pregnant mares. PRE- Pregnant / MA-Mare / RIN-Urine

Benefits:  Reduction in hot flashes and night sweats by providing hormone replacement. Reduction in bone mass loss, reducing the incidence of osteoporosis.

Side effects:  Weight gain, bloating, migraine headaches, depression, leg cramps, nausea, itching feet, swollen ankles, blood clots, increase in blood pressure.

Warnings:  Estrogen replacement has been reported to increase the risk of endometrial carcinoma in postmenopausal women. Much controversy surrounds the use of Premarin. Sold under many different brand names in other countries.


Prempro
MENOPAUSE

PREMPRO - Wyeth-Ayerst
A conjugated equine estrogen drug with progestin available by prescription

Prempro is a brand name of a equine conjugated estrogen and medroxyprogesterone product, used primarily to provide estrogen and progesterone replacement for menopausal women. Provides a fixed amount of each hormone daily.

Benefits:  Reduction of hot flashes

Side effects:  Estrogen can elevate the blood pressure, cause phlebitis and weight gain, increase the risk of blood clots, cause breast tenderness, bloating and fluid retention (edema).

Warnings: Estrogen replacement has been reported to increase the risk of endometrial carcinoma in postmenopausal women. In April of 2001, the American Heart Association (AHA) issued a Science Advisory recommending that physicians not prescribe HRT for secondary prevention of cardiovascular disease.


Raloxifene
OSTEOPOROSIS

RALOXIFENE -
RALOXIFENE is a nonsteroidal benzothiophene, which is currently the most extensively studied SERM in the bone field

SERMS (selective estrogen receptor modulators ) are a class of drugs that act on the estrogen receptors of some organ systems as estrogen agonists and on others as estrogen antagonists.

Benefits:  Has been shown to help reduce the incidence of spine fractures in women with osteoporosis and reduce the frequency of breast cancer.

Side effects: Increases the incidence of hot flashes, especially when given soon after the menopause. The frequency of other side effects is low, the most serious being the increased risk of thromboembolic events, as is known to occur with hormone replacement therapy.

Warnings: Do not take (raloxifene HCl)if you are or still can become pregnant, are nursing, have severe liver problems, or have had blood clots that required a doctor's treatment.


Evista
OSTEOPOROSIS

EVISTA - Eli Lilly
A (SERM) Selective Estrogen Receptor Modulator Prescription Drug

Evista is the trade name used by Eli Lilly for Raloxifene, a non steroidal benzothiophene, known as a type III anti-estrogen. A SERM selectively affects different estrogen receptors. Raloxifene causes the estrogen receptors in the breast to be less sensitive and the estrogen receptors in bones to be more sensitive.

Benefits:  Used for the prevention and treatment of osteoporosis. Does not stimulate endometrial proliferation. Has been shown to reduce vertebral fractures and reduce the incidence of breast cancer.

Side effects:  May increase incidence of hot flashes and cause leg cramps. Raloxifene may increase the incidence of postmenopausal symptoms (eg, hot flushes), especially when given soon after the menopause. The frequency of other side effects is low, the most serious being the increased risk of thromboembolic (blood clot) events, as is also known to occur with hormone replacement therapy

Warnings: Do not take EVISTA if you are or still can become pregnant, are nursing, have severe liver problems, or have had blood clots that required a doctor's treatment.


Etidronate
OSTEOPOROSIS

ETIDRONATE
A prescription drug used to prevent osteoporosis

A bisphosponate approved for the prevention and treatment of osteoporosis. Prevents the body from using bone calcium, known as bone resorption.

Benefits:  Slows or prevents the body from making bones weak and brittle by absorbing calcium from the bones.

Side effects:  Abdominal pain, esophagitis, dyspepsia, peptic ulceration.

Warnings:  Must be taken with full glass of water 1/2 hour before eating.


Alendronate
OSTEOPOROSIS

ALENDRONATE
A prescription drug used to prevent osteoporosis

A bisphosponate approved for the prevention and treatment of osteoporosis. Prevents the body from consuming its bone calcium.

Benefits: Slows or prevents bones from becoming weak and brittle which is caused when the body consumes bone calcium. This process increases after menopause and is called resorption.

Side effects: Side effects include stomach pain. Other less common side effects are nausea, vomiting, heartburn, stomach fullness, gas, constipation, diarrhea, headache or altered taste.

Warnings: Mineral water, juice or other beverages or food may decrease the medication's effectiveness. Fosamax should be taken with a full glass of water at least half an hour before eating.


Fosamax
OSTEOPOROSIS

FOSAMAX - Merck & Co., Inc.
FOSAMAX is a prescription drug known as a bisphosphonate.

FOSAMAX is the drug Alendronate. Patients taking alendronate should take adequate amounts of calcium and vitamin D supplements.

Benefits:  Helps increase bone mass and prevents fractures in women with osteoporosis.

Side effects: Side effects include stomach pain. Other less common side effects are nausea, vomiting, heartburn, stomach fullness, gas, constipation, diarrhea, headache or altered taste.

Warnings: Mineral water, juice or other beverages or food may decrease the medication's effectiveness. Fosamax should be taken with a full glass of water at least half an hour before eating.


Risedronate
OSTEOPOROSIS

RISEDRONATE -
A prescription drug used to prevent osteoporosis

A bisphosponate approved for the prevention and treatment of osteoporosis. Helps maintain bone density by slowing or preventing the loss of bone calcium.

Benefits:  Slows or prevents bones from becoming weak and brittle due to loss of bone calcium levels.

Side effects: Risedronate may cause upper gastrointestinal disorders, such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus) and esophageal or gastric ulcers. Patients should take Risedronate with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug.

Warnings: Risedronate should not be used in patients with low blood calcium, known allergy to Risedronate or an inability to stand or sit upright for at least 30 minutes. Low blood calcium and other disturbances of bone and mineral metabolism should be effectively treated before starting Risedronate therapy. Risedronate is not recommended for use in patients with severe kidney disease.


Actonel
OSTEOPOROSIS

ACTONEL - Aventis Pharmaceuticals (Procter & Gamble)
ACTONEL is a prescription drug known as a bisphosphonate.

ACTONEL is the drug Risedronate. Patients taking risedronate should take adequate amounts of calcium and vitamin D supplements.

Benefits:  Helps increase bone mass and prevents fractures in women with osteoporosis.

Side effects: Bisphosphonates may cause upper gastrointestinal disorders, such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus) and esophageal or gastric ulcers. Patients should take Actonel with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug.

Warnings: Mineral water, juice or other beverages or food may decrease the medication's effectiveness. Risedronate should be taken with a full glass of water at least half an hour before eating. Actonel should not be used in patients with low blood calcium, known allergy to Actonel or an inability to stand or sit upright for at least 30 minutes. Low blood calcium and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe kidney disease.


Sarafem
PMS

SARAFEM - Eli Lilly
A prescription drug used to treat premenstrual disphoric disorder (PMDD)

Sarafem contains fluoxetine hydrochloride, the same active ingredient used in Eli Lilly's antidepressant drug Prozac.

Benefits: Fluoxetine hydrochloride selectively affects neurotransmitters (the chemicals that send messages to and from the brain) and mechanisms in the central nervous system. It can improve mood and physical symptoms experienced during the menstrual cycle.

Side effects:  Fast talking, excited feelings, flu-like symptoms, irregular heartbeat.

Warnings:  May cause a rash. Can impair driving skills etc. Can cause fever, headache, convulsions, nausea, tremor, vomiting or diarrhea. May lead to vaginal bleeding when treatment is withdrawn.


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March 2001
LydiaPinkham.org
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