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Estradiol/Norgestimate
Overview
What is Prefest?
The PREFEST regimen provides for a single oral tablet to be taken once daily. The peach tablet containing 1 mg estradiol, USP is taken on days one through three of therapy; the white tablet containing 1 mg estradiol, USP and 0.09 mg norgestimate, USP is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST.
The estrogenic component of PREFEST is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. The structural formula is as follows:
CHO M.W. 272.38
The progestational component of PREFEST is micronized norgestimate, USP a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-. The structural formula is as follows:
CHNO M.W. 369.50
Each tablet for oral administration contains 1 mg estradiol, USP alone or 1 mg estradiol, USP and 0.09 mg of norgestimate, USP. The inactive ingredients are as follows:
The estradiol, USP tablet contains anhydrous lactose, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, magnesium stearate and microcrystalline cellulose.
The estradiol and norgestimate tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
What does Prefest look like?
What are the available doses of Prefest?
Sorry No records found.
What should I talk to my health care provider before I take Prefest?
Sorry No records found
How should I use Prefest?
PREFEST is indicated in women who have a uterus for the:
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 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
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 and ). 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 regimen consists of the daily administration of a single tablet containing 1 mg estradiol (peach 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.
What interacts with Prefest?
Sorry No Records found
What are the warnings of Prefest?
Sorry No Records found
What are the precautions of Prefest?
Sorry No Records found
What are the side effects of Prefest?
See , , and .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
| FOUR 12-MONTH CLINICAL TRIALS | |
| Body as a Whole | |
| Back pain | 69 (12%) |
| Fatigue | 32 (6%) |
| Influenza-like symptoms | 64 (11%) |
| Pain | 37 (6%) |
| Digestive System | |
| Abdominal pain | 70 (12%) |
| Flatulence | 29 (5%) |
| Nausea | 34 (6%) |
| Tooth disorder | 27 (5%) |
| Musculoskeletal System | |
| Arthralgia | 51 (9%) |
| Myalgia | 30 (5%) |
| Nervous System | |
| Dizziness | 27 (5%) |
| Headache | 132 (23%) |
| Psychiatric Disorders | |
| Depression | 27 (5%) |
| Reproductive System | |
| Breast pain | 92 (16%) |
| Dysmenorrhea | 48 (8%) |
| Vaginal bleeding (all) | 52 (9%) |
| Vaginitis | 42 (7%) |
| Resistance Mechanism Disorders | |
| Viral infection | 35 (6%) |
| Respiratory System | |
| Coughing | 28 (5%) |
| Pharyngitis | 38 (7%) |
| Sinusitis | 44 (8%) |
| Upper respiratory-tract infection | 121 (21%) |
Genitourinary system.
Breasts.
Cardiovascular.
Gastrointestinal.
Skin.
Eyes.
Central Nervous System.
Miscellaneous.
What should I look out for while using Prefest?
PREFEST should not be used in women with any of the following conditions:
See .
What might happen if I take too much Prefest?
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
How should I store and handle Prefest?
PREFEST (estradiol 1 mg and estradiol 1 mg/norgestimate 0.09 mg) tablets are packaged in cartons of six pouches each containing 30 tablets (NDC 51285-063-90). 1 mg estradiol, USP: Peach, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side.1 mg estradiol, USP and 0.09 mg norgestimate, USP: White, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side. Each pouch consists of a blister card containing 3 peach tablets followed by 3 white tablets. This pattern of 3 peach tablets and 3 white tablets repeats for a total of 30 tablets per blister card. Each blister card contains 15 tablets of each of the two tablets. The 3-day phases are alternated continuously during treatment.PREFEST (estradiol 1 mg and estradiol 1 mg/norgestimate 0.09 mg) tablets are packaged in cartons of six pouches each containing 30 tablets (NDC 51285-063-90). 1 mg estradiol, USP: Peach, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side.1 mg estradiol, USP and 0.09 mg norgestimate, USP: White, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side. Each pouch consists of a blister card containing 3 peach tablets followed by 3 white tablets. This pattern of 3 peach tablets and 3 white tablets repeats for a total of 30 tablets per blister card. Each blister card contains 15 tablets of each of the two tablets. The 3-day phases are alternated continuously during treatment.PREFEST (estradiol 1 mg and estradiol 1 mg/norgestimate 0.09 mg) tablets are packaged in cartons of six pouches each containing 30 tablets (NDC 51285-063-90). 1 mg estradiol, USP: Peach, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side.1 mg estradiol, USP and 0.09 mg norgestimate, USP: White, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side. Each pouch consists of a blister card containing 3 peach tablets followed by 3 white tablets. This pattern of 3 peach tablets and 3 white tablets repeats for a total of 30 tablets per blister card. Each blister card contains 15 tablets of each of the two tablets. The 3-day phases are alternated continuously during treatment.PREFEST (estradiol 1 mg and estradiol 1 mg/norgestimate 0.09 mg) tablets are packaged in cartons of six pouches each containing 30 tablets (NDC 51285-063-90). 1 mg estradiol, USP: Peach, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side.1 mg estradiol, USP and 0.09 mg norgestimate, USP: White, round, flat-faced, beveled-edge, unscored tablets, debossed with on one side and on the other side. Each pouch consists of a blister card containing 3 peach tablets followed by 3 white tablets. This pattern of 3 peach tablets and 3 white tablets repeats for a total of 30 tablets per blister card. Each blister card contains 15 tablets of each of the two tablets. The 3-day phases are alternated continuously during treatment.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Norgestimate is a derivative of 19-nortestosterone and binds to androgen and progestogen receptors, similar to that of the natural hormone progesterone; it does not bind to estrogen receptors. Progestins counter the estrogenic effects by decreasing the number of nuclear estradiol receptors and suppressing epithelial DNA synthesis in endometrial tissue.
Non-Clinical Toxicology
PREFEST should not be used in women with any of the following conditions:See .
There was no evidence of drug interactions in clinical studies in which dobutamine was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. Preliminary studies indicate that the concomitant use of dobutamine and nitroprusside results in a higher cardiac output and, usually, a lower pulmonary wedge pressure than when either drug is used alone.
See , , and .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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