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治療オプション:
Militian Inessa Mesropovna 、薬局による医学的評価、 最終更新日:30.03.2022
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同じ成分を持つトップ20の薬:
経口避妊薬は、避妊の方法としてこの製品を使用することを選択した女性の妊娠防止に適応されます。.
経口避妊薬は非常に効果的です。. 表1は、経口避妊薬と他の避妊方法の組み合わせのユーザーの典型的な偶発的な妊娠率を示しています。. これらの避妊法の有効性は、滅菌を除いて、それらが使用される信頼性に依存します。. メソッドを正しく一貫して使用すると、故障率が低下する可能性があります。. メソッドを正しく一貫して使用すると、故障率が低下する可能性があります。.
表1:継続使用の最初の年に偶発的な妊娠を経験した女性の方法%の継続的な使用の最初の年の間に予想される最低および典型的な失敗率。
方法。 | 最低期待*。 | 典型的な ⁇ 。 |
(避妊なし)。 | (85)。 | (85)。 |
経口避妊薬。 | ||
組み合わせた。 | 0.1。 | 3‡ |
プロゲスチンのみ。 | 0.5。 | 3‡ |
殺精子クリームまたはゼリーのダイヤフラム。 | 6 | 18 |
殺精子剤のみ(泡、クリーム、ゼリー、 ⁇ の ⁇ 剤)。 | 3 | 21 |
⁇ スポンジ。 | ||
nulliparous。 | 6 | 18 |
多動。 | 9 | 28 |
IUD。 | 0.8から2。 | 3§ |
殺精子剤のないコンドーム。 | 2 | 12 |
定期的な禁欲(すべての方法)。 | 1から9。 | 20 |
注射可能なプロゲストーゲン。 | 0.3から0.4。 | 0.3から0.4。 |
インプラント。 | ||
6カプセル。 | 0.04。 | 0.04。 |
2ロッド。 | 0.03。 | 0.03。 |
女性滅菌。 | 0.2。 | 0.4。 |
男性滅菌。 | 0.1。 | 0.15。 |
J.トラッセルなどの人口評議会の許可を得て複製。. al:米国における避妊の失敗:更新。. 家族計画の研究、21(1)、1990年1月〜2月。. *メソッドを開始する(必ずしも初めてではない)カップルの間で偶発的な妊娠を経験すると予想される女性の割合の著者の最良の推測、および何らかの理由で停止しない場合、最初の年に一貫して正しくそれを使用するカップル妊娠以外。. ⁇ この用語は、方法の使用を開始する(必ずしも初めてではない)「典型的な」カップルを表し、妊娠以外の理由で使用を中止しない場合、最初の年に偶発的な妊娠を経験します。. bo複合とプロゲスチンの両方の典型的なレートの組み合わせ。. §薬用IUDと非薬用IUDの両方の一般的なレートを組み合わせたもの。 |
以下は、詳細の「ピルを取る方法」セクションで患者に与えられた指示の概要です。 患者ラベリング。.
患者には5つのカテゴリーの指示が与えられます。
- 覚えておくべき重要なポイント:患者に言われます。 (a。) 彼女は毎日1錠を同時に服用する必要があります。, 。(b。) 多くの女性は、最初の1〜3サイクルの間に、斑点や軽い出血、または胃の苦痛を持っています。, 。(c。) 錠剤の欠落は、斑点や軽い出血を引き起こす可能性もあります。, 。(d。) ⁇ 吐や下 ⁇ がある場合、または併用薬を服用している場合は、避妊のバックアップ方法を使用する必要があります。, および/または彼女が錠剤を思い出すのに苦労している場合。, 。(e。) 他に質問がある場合。, 彼女は医師に相談すべきです。.
- 彼女が薬を飲む前に:彼女は薬を飲むのに何日かかるかを決めるべきです。, 彼女のピルパックに28錠あるかどうかを確認します。, そして、彼女が薬を飲むべき順序に注意してください。 (ピルパックの図式図は、患者の挿入物に含まれています。).
- 最初のパックを開始する必要がある場合:Day-Oneスタートは最初の選択肢としてリストされ、日曜日のスタート(期間の開始後の日曜日)は2番目の選択肢として与えられます。. 彼女が日曜日のスタートを使用する場合、彼女が7つの薬を飲む前に性交をしている場合、彼女は最初のサイクルでバックアップ方法を使用する必要があります。.
- サイクル中に何をすべきか:患者は、パックが空になるまで毎日1つの錠剤を同時に服用することをお勧めします。. 彼女が28日間のレジメンにいる場合、最後の非アクティブなタブレットの翌日に次のパックを開始し、パック間の日数待機しないでください。.
- 丸薬または丸薬を逃した場合の対処法:患者は、1日目と日曜日の両方の開始で、サイクルのさまざまな時間に1つ、2つ、または2つ以上の丸薬を見逃した場合に何をすべきかについての指示を受けます。. 患者は、錠剤を失ってから7日間に無防備な性交をした場合、妊娠する可能性があると警告されています。. これを回避するには、この7日間でコンドーム、フォーム、スポンジなどの別の避妊方法を使用する必要があります。.
現在以下の条件を持つ女性には、経口避妊薬を使用しないでください。
- 血栓性静脈炎または血栓塞栓性障害。
- 深部静脈血栓性静脈炎または血栓塞栓性障害の過去の病歴。
- 脳血管または冠動脈疾患。
- 乳房の癌腫が知られている、または疑われる。
- 子宮内膜の癌、または他の既知または疑われるエストロゲン依存性腫瘍。
- 診断されていない異常な性器出血。
- 妊娠の胆 ⁇ うっ滞性黄 ⁇ または以前の錠剤使用を伴う黄 ⁇ 。
- 肝腺腫または癌腫。
- 妊娠が知られている、または疑われている。
- ALTの上昇の可能性があるため、ダサブビルの有無にかかわらず、オンビタスビル/パリタプレビル/リトナビルを含むC型肝炎の薬物併用を受けている(参照)。 警告。, C型肝炎治療に伴う肝酵素上昇のリスク。).
WARNINGS
The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, 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 hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population*. For further information, the reader is referred to a text on epidemiological methods.
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Thromboembolic Disorders And Other Vascular Problems
The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.
Myocardial Infarction
An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30.
Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older, with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Figure 1) among women who use oral contraceptives.
FIGURE 1: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN-YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE
Layde PM, Beral V: Further analyses of mortality in oral contraceptive users: Royal College of General Practitioners' oral contraception study. (Table 5) Lancet 1981;1:541-546.
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, while estrogens may create a state of hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users (see section 10 in WARNINGS). Such increases in risk factors have been associated with an increased risk of heart disease and the risk increases with the number of risk factors present. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Thromboembolism
An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.
A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.
Cerebrovascular Diseases
Oral contraceptives have been shown to increase both the relative and attributable risk of cerebrovascular events (thrombotic and hemorrhagic strokes); although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and non-users, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes.
In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women.
Dose-Related Risk Of Vascular Disease From Oral Contraceptives
A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. A decline in serum high density lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptive. The amount of both hormones should be considered in the choice of an oral contraceptive.
Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing 0.05 mg or less of estrogen.
Persistence Of Risk
There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. 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 to 49 years old who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least six years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.
Estimates Of Mortality From Contraceptive Use
One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 2).
TABLE 2: ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE
Method of control and outcome | AGE | |||||
15 to 19 | 20 to 24 | 25 to 29 | 30 to 34 | 35 to 39 | 40 to 44 | |
No fertility control methods* | 7 | 7.4 | 9.1 | 14.8 | 25.7 | 28.2 |
Oral contraceptives nonsmoker† | 0.3 | 0.5 | 0.9 | 1.9 | 13.8 | 31.6 |
Oral contraceptives smoker† | 2.2 | 3.4 | 6.6 | 13.5 | 51.1 | 117.2 |
IUD† | 0.8 | 0.8 | 1 | 1 | 1.4 | 1.4 |
Condom* | 1.1 | 1.6 | 0.7 | 0.2 | 0.3 | 0.4 |
Diaphragm/spermicide* | 1.9 | 1.2 | 1.2 | 1.3 | 2.2 | 2.8 |
Periodic abstinence* | 2.5 | 1.6 | 1.6 | 1.7 | 2.9 | 3.6 |
Ory HW: Mortality associated with fertility and fertility control: 1983. Fam Plann Perspect 1983; 15:50-56. *Deaths are birth related. † Deaths are method related. |
These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risk. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.
The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's–but not reported until 1983. However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.
Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985;66:1-4 and Porter JB, Jick H, Walker AM. Mortality among oral contraceptive users. Obstet Gynecol 1987;70:29-32), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risk may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.
Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.
Carcinoma Of The Reproductive Organs
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. The overwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of the age and parity of first use or with most of the marketed brands and doses. The Cancer and Steroid Hormone (CASH) study also showed no latent effect on the risk of breast cancer for at least a decade following long-term use. A few studies have shown a slightly increased relative risk of developing breast cancer, although the methodology of these studies, which included differences in examination of users and nonusers and differences in age at start of use, has been questioned.
Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
In spite of many studies of the relationship between oral contraceptive use and breast cancer and cervical cancers, a cause-and-effect relationship has not been established.
Hepatic Neoplasia
Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.
Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment
During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs. Discontinue Zenchent prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir,with or without dasabuvir (see CONTRAINDICATIONS). Zenchent can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen.
Ocular Lesions
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; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.
Oral Contraceptive Use Before Or During Early 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 taken inadvertently during early pregnancy.
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.
It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. 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. Oral contraceptive use should be discontinued if pregnancy is confirmed.
Gallbladder Disease
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.
The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.
Carbohydrate And Lipid Metabolic Effects
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.
However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.
A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS, 1a and 1d), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.
Elevated Blood Pressure
An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.
Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users.
Headache
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.
Bleeding Irregularities
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.
Women with a history of oligomenorrhea or secondary amenorrhea or young women without regular cycles prior to taking oral contraceptives may again have irregular bleeding or amenorrhea after discontinuation of oral contraceptives.
REFERENCES
*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. N Engl J Med, 1981; 305: 612-618, 672-677; with author's permission.
PRECAUTIONS
Sexually-Trans mitted Diseases
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually trans mitted diseases.
Physical Examination And Follow-Up
It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
Lipid Disorders
Liver Function
If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.
Fluid Retention
Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.
Emotional Disorders
Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related.
Contact Lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
Interactions With Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrineinduced platelet aggregability.
- Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
- Other binding proteins may be elevated in serum.
- Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
- Triglycerides may be increased.
- Glucose tolerance may be decreased.
- Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
Carcinogenesis
See WARNINGS section.
Pregnancy
Teratogenic Effects
Pregnancy Category X
See CONTRAINDICATIONS and WARNINGS sections.
Nursing Mothers
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, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.
Vomiting And/Or Diarrhea
Although a cause-and-effect relationship has not been clearly established, several cases of oral contraceptive failure have been reported in association with vomiting and/or diarrhea. If significant gastrointestinal disturbance occurs in any woman receiving contraceptive steroids, the use of a back-up method of contraception for the remainder of that cycle is recommended.
Pediatric Use
Safety and efficacy of Zenchent® have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated.
Information For The Patient
See patient labeling.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
- Thrombophlebitis
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
- Nausea
- Vomiting
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Temporary infertility after discontinuation of treatment
- Edema
- Melasma which may persist
- Breast changes: tenderness, enlargement, and secretion
- Change in weight (increase or decrease)
- Change in cervical ectropion and secretion
- Possible diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine
- Rash (allergic)
- Mental depression
- Reduced tolerance to carbohydrates
- Vaginal candidiasis
- Change in corneal curvature (steepening)
- Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:
- Premenstrual syndrome
- Cataracts
- Changes in appetite
- Cystitis-like syndrome
- Headache
- Nervousness
- Dizziness
- Hirsutism
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Vaginitis
- Porphyria
- Impaired renal function
- Hemolytic uremic syndrome
- Budd-Chiari syndrome
- Acne
- Changes in libido
- Colitis
幼児による大量の経口避妊薬の急性摂取後の深刻な悪影響は報告されていません。. 過剰摂取は吐き気を引き起こす可能性があり、離脱出血は女性で発生する可能性があります。.
避妊以外の健康上の利点。
経口避妊薬の使用に関連する以下の非避妊健康上の利点は、0.035 mgのエチニルエストラジオールまたは0.05 mgのメストラノールを超えるエストロゲン用量を含む経口避妊製剤を主に利用した疫学研究によって裏付けられています。.
月経への影響。
- 月経周期の規則性の増加。
- 失血の減少と鉄欠乏性貧血の発生率の低下。
- 月経困難症の発生率の低下。
排卵の抑制に関連する影響。
- 機能性卵巣 ⁇ 胞の発生率の低下。
- 子宮外妊娠の発生率の低下。
長期使用による影響。
- 乳房の線維腺腫および線維 ⁇ 胞性疾患の発生率の低下。
- 急性骨盤内炎症性疾患の発生率の低下。
- 子宮内膜がんの発生率の低下。
- 卵巣がんの発生率の低下。