Women who use norgestimate and ethinyl estradiol may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent.
If scheduled withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule missed one or more active tablets or started taking them on a day later than she should have , consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy.
Discontinue norgestimate and ethinyl estradiol use if pregnancy is confirmed. Carefully observe women with a history of depression and discontinue norgestimate and ethinyl estradiol if depression recurs to a serious degree.
The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased. A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking norgestimate and ethinyl estradiol. The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:.
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 clinical practice.
The safety of norgestimate and ethinyl estradiol was evaluated in 4, healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of norgestimate and ethinyl estradiol for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles.
Serious Adverse Reactions: breast cancer 1 subject , carcinoma of the cervix in situ 1 subject , hypertension 1 subject , and migraine 2 subjects. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections and Infestations : Urinary tract infection;. Neoplasms Benign, Malignant and Unspecified Incl. Cysts and Polyps : Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst;. Immune System Disorders : Hypersensitivity;. Metabolism and Nutrition Disorders : Dyslipidemia;. Psychiatric Disorders : Anxiety, insomnia;. Nervous System Disorders : Syncope, convulsion, paresthesia, dizziness;. Eye Disorders : Visual impairment, dry eye, contact lens intolerance;.
Cardiac Disorders : Tachycardia, palpitations;. Vascular Events : Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush;. Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident;.
Respiratory, Thoracic and Mediastinal Disorders : Dyspnea;. Gastrointestinal Disorders : Pancreatitis, abdominal distension, diarrhea, constipation;. Hepatobiliary Disorders : Hepatitis;. Skin and Subcutaneous Tissue Disorders : Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne;.
Musculoskeletal, Connective Tissue, and Bone Disorders : Muscle spasms, pain in extremity, myalgia, back pain;. Reproductive System and Breast Disorders : Ovarian cyst, suppressed lactation, vulvovaginal dryness;.
Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Substances decreasing the plasma concentrations of COCs:. Drugs or herbal products that induce certain enzymes, including cytochrome P 3A4 CYP3A4 , may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St.
John's wort. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation.
CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs. The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects including cardiac anomalies and limb reduction defects following exposure to low dose COCs prior to conception or during early pregnancy.
Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child.
COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.
Safety and efficacy of norgestimate and ethinyl estradiol have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older.
Use of this product before menarche is not indicated. Norgestimate and ethinyl estradiol has not been studied in postmenopausal women and are not indicated in this population. The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment.
The pharmacokinetics of norgestimate and ethinyl estradiol has not been studied in women with renal impairment. There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.
COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
Acne is a skin condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sex hormone-binding globulin SHBG and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established.
No specific pharmacodynamic studies were conducted with norgestimate and ethinyl estradiol. Steady-state concentration of EE is achieved by Day 7 of each dosing cycle. Non-linear accumulation approximately 8 fold of NG is observed as a result of high-affinity binding to SHBG, which limits its biological activity Table 3. The effect of food on the pharmacokinetics of norgestimate and ethinyl estradiol has not been studied. Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites.
Although NGMN and its metabolites inhibit a variety of P enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant K i. EE is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.
Unchanged NGM was not detected in the urine. In addition to deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM. In three US clinical trials with norgestimate and ethinyl estradiol, 1, women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24, cycles of exposure. There were no exclusions on the basis of weight; the weight range for women treated was 82 to lbs, with a mean weight of about lbs.
The pregnancy rate was approximately 1 pregnancy per women-years. In four clinical trials with norgestimate and ethinyl estradiol, 4, women aged 15 to 41 years were studied for 24 cycles, providing a total of 45, cycles of exposure. There were no exclusions on the basis of weight; the weight range for women treated was 80 to lbs, with a mean weight of about lbs.
Norgestimate and ethinyl estradiol was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, six- 28 day cycle studies. Two hundred twenty- one patients received Tri-norgestimate and ethinyl estradiol and patients received placebo. Mean age at enrollment for both groups was 28 years. Table 4 summarizes the changes in lesion count for each type of lesion. Counsel patients about the following information:.
Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. In fact, recent studies have discovered that this is a myth.
When it was first invented, hormonal birth control had much larger doses of hormones that could lead to weight gain. However, today hormonal birth control comes in lower doses.
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Why Nurx? Product details Tri-Previfem is a hormone-based contraceptive pill combining progestin and estrogen that helps to prevent pregnancy by tricking your body into thinking that it is already pregnant. Download WordPress Themes Free. Download Nulled WordPress Themes.
Premium WordPress Themes Download. Free Download WordPress Themes. Tags Increased menstrual regularity Treats acne Decreased risk of ovarian cysts Decreased painful periods Decreased menstrual blood loss. Active Ingredients White pills: Ethinyl estradiol estrogen [0. Risks Do not take if you use tobacco and are over 35 years old. Do not take if pregnant. Increased risk for blood clots. Increased risk for stroke and heart attack. We are doctors, nurses, nurse practitioners, pharmacists, and physician assistants who are passionate about providing patient care.
Drugs » Dermatological Disorders. High risk of arterial or venous thrombotic disease eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms.
Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Increased risk of cardiovascular events eg, stroke, MI esp.
Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Uncontrolled dyslipidemias. Gallbladder disease. Pregnancy-related cholestasis.
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