Desogestrel and Ethinyl Estradiol

 

Ingredients

Active Ingredients: Desogestrel and Ethinyl Estradiol

Non-Active Ingredients: Vitamin E, pregelatinized starch, stearic acid, lactose monohydrate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, talc, yellow ferric oxide or red ferric oxide

 

Indications

Mircette (desogestrel/ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

 

How It Works

The primary action of the combination of an estrogen with a progestin is to suppress the hypothalamic-pituitary system, decreasing the secretion of gonadotropin-releasing hormone (GnRH). Progestins blunt luteinizing hormone (LH) release, and estrogens suppress follicle-stimulating hormone (FSH) from the anterior pituitary. Both estrogen and progestin ultimately inhibit maturation and release of the dominant ovule. 

 

Dosage

Tablets (desogestrel/ ethinyl estradiol - 0.15mg/0.02mg, 0.15mg/0.03mg)

To achieve maximum contraceptive effectiveness, Mircette (desogestrel/ethinyl estradiol) tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. Mircette may be initiated using either a Sunday start or a Day 1 start.  Counting the first day of menstruation as “Day 1”, the first light yellow tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green tablet.

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Precautions

Mircette is contraindicated in woman with thrombophlebitis or thromboembolic disorders, cerebral vascular or coronary artery disease (current or history), valvular heart disease with thrombogenic complications, severe hypertension, diabetes with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilization, known or suspected carcinoma of the breast (or personal history of breast cancer), carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal, genital bleeding,cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use, hepatic tumors (benign or malignant) or active liver disease, known or suspected pregnancy, heavy smoking (≥15 cigarettes per day) and over age 35, hypersensitivity to any of the components ofMircette.

 

When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking Mircette. 

 

If a patient misses 1 active tablet in the first three weeks, she should take the missed tablet as soon as she remembers. If the patient misses two consecutive active tablets in  either the 1st or  2nd week, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack.

 

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and Mircette use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Mircette should be discontinued if pregnancy is confirmed.

 

The use of Mircettefor contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast feed. Combination hormonal contraceptives containing some synthetic estrogens (ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives.

 

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic andthromboembolic events (such as myocardial infarction, thromboembolism, and stroke) hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited thrombophilias, hypertension,hyperlipidemias, obesity and diabetes.

An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established.

 

An increased risk of myocardial infarction has been attributed to oral contraceptive use.

Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarction in women in their mid-thirties or older with smoking accounting for the majority of excess cases. Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance.

 

Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest to those over 35 years, and hypertensive women who also smoke.

 

In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40-49 years old who had used oral contraceptives for five or more years. There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision.

 

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens

Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. If bleeding persists or recurs, non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy as in the case of any abnormal vaginal bleeding.

The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

 

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Oral contraceptives may cause some degree of fluid retention. If jaundice develops in any woman receiving oral contraceptives, the medication should be discontinued. 

 

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.

 

Drug Interactions

Mircette can potentially interact with numerous other medicines. Many of these interactions can be severe enough to cause accidental pregnancy. Some of the medicines that may lead to Mircette interactions include: Selegiline, St. John's wort, and Theophylline,Aminoglutethimide, Antibiotics, Aprepitant, Atorvastatin, Barbiturate medications, including (but not limited to): Amobarbital, Butalbital, Pentobarbital, Phenobarbital, Secobarbital, Cyclosporine.

 

Many seizure medications, such as: Carbamazepine, Felbamate, Lamotrigine, Oxcarbazepine, Phenytoin, Topiramate, Modafinil. 

 

Protease inhibitors, such as: Amprenavir, Atazanavir, Fosamprenavir, Indinavir, Nelfinavir, Ritonavir .

 

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use ofrifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines. 

 

Adverse/Side Effects

The following adverse reactions that are sometimes serious have been reported: Thrombophlebitis and venous thrombosis with or without embolism, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis, hypertension, gallbladder disease, hepatic adenomas or benign liver tumors, mesenteric thrombosis, retinal thrombosis

 

Adverse reactions that may become bothersome:  nausea, vomiting, gastrointestinal symptoms (such as abdominal pain, cramps and bloating), breakthrough bleeding,  spotting, change in menstrual flow, amenorrhea,  temporary infertility after discontinuation of treatment, edema/fluid retention, melasma/chloasma which may persist,  breast changes: tenderness, pain, enlargement, and secretion, decrease in serum foliate levels, exacerbation of porphyria, aggravation of varicose veins, change in weight or appetite (increase or decrease), change in cervicalectropion and secretion, possible diminution in lactation when given immediately postpartum,  cholestatic jaundice, migraine headache,  rash (allergic), mood changes, including depression, vaginitis, including candidiasis, change in corneal curvature (steepening), intolerance to contact lenses, exacerbation of systemic lupus erythematosus, exacerbation of chorea, anaphylactic/anaphylactoid reactions, including urticaria,angioedema, and severe reactions with respiratory and circulatory symptoms.

 

Other possible uncommon side effects: Pre-menstrual syndrome,cataract cystitis-like syndrome, headache, nervousness, dizziness, hirsutism, loss of scalp hair, erythema multiforme, dysmenorrhea, pancreatitis, erythema nodosum, hemorrhagic eruption, impaired renal function, hemolytic uremic syndrome, acne, changes in libido, colitis, Budd-Chiari syndrome, optic neuritis, which may lead to partial or complete loss of vision.

 

If you experience any of the above bothersome side effects, which persist speak with doctor immediately.

 

Overdose

In case of overdose immediately call your local emergency room or poison control center. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdose symptoms include nausea, and withdrawal bleeding may occur in females. 

 

Storage Instructions

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep out of the reach of children and pets.

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