"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
PREFEST (estradiol, norgestimate) is indicated in women who have a uterus for the:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
- Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
DOSAGE AND ADMINISTRATION
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 woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (See BOXED WARNINGS and WARNINGS). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
PREFEST (estradiol, norgestimate) regimen consists of the daily administration of a single tablet containing 1 mg estradiol (pink color) for three days followed by a single tablet of 1 mg estradiol combined with 0.09 mg norgestimate (white color) for three days. This regimen is repeated continuously without interruption.
- For treatment of moderate to severe vasomotor symptoms and vulvar and vaginal
atrophy associated with menopause, the patient should start with the first
tablet in the first row, and place the weekday schedule sticker which starts
with the weekday of first tablet intake in the appropriate space. After all
tablets from the blister card have been used, the first tablet from a new
blister card should be taken on the following day. This dose may not be the
lowest effective dose for treatment of vasomotor symptoms and vulvar and vaginal
Patients should be re-evaluated at three-month to six-month intervals to determine if treatment for symptoms is still necessary.
- For prevention of postmenopausal osteoporosis, the patient should start with the first tablet in the first row, and place the weekday schedule sticker which starts with the weekday of first tablet intake in the appropriate space. After all tablets from the blister card have been used, the first tablet from a new blister card should be taken on the following day. This dose may not be the lowest effective dose for the prevention of postmenopausal osteoporosis.
If a tablet is missed for one or more days, therapy should be resumed with the next available tablet. The patient should continue to take only one tablet each day in sequence.
The lowest effective dose of PREFEST (estradiol, norgestimate) has not been determined.
PREFEST (estradiol, norgestimate) is available as two separate, round-shaped tablets for oral administration supplied in a blister card with the following configuration: 3 pink tablets, followed by 3 white tablets for a total of 30 tablets per blister card.
Each blister card contains 15 tablets of each of the following components:
1 mg estradiol: pink tablets embossed with “1” and “J-C” on one side and “E2” and “O-M” on the other side.
1 mg estradiol/0.09 mg norgestimate: white tablets embossed with “1/90” and “J-C” on one side and “E2/N” and “O-M” on the other side.
NDC: 61570-125-30 PREFEST (estradiol, norgestimate) , 30 Tablets/Blister
This product is stable for 24 months. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Keep out of reach of children.
Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ 08869.
Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.
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