Norminest Fe Tablets

Os contraceptivos orais são indicados para a prevenção da gravidez em mulheres que optam por usar esses produtos como método contraceptivo.

Os contraceptivos orais são altamente eficazes. A Tabela I lista as taxas típicas de gravidez acidental para usuários de contraceptivos orais combinados e outros métodos contraceptivos.¹ A eficácia desses métodos contraceptivos, exceto a esterilização, depende da confiabilidade com que são utilizados. O uso correto e consistente de métodos pode resultar em taxas de falha mais baixas.

TABELA I: TAXAS DE FALHA MAIS ESPERADAS E TÍPICAS DURANTE O PRIMEIRO ANO DE USO CONTÍNUO DE UM MÉTODO

Para atingir a máxima eficácia contraceptiva, os contraceptivos orais devem ser tomados exatamente como descrito e em intervalos não superiores a 24 horas.

Horário de 28 dias: Para um SUNDAY START quando o fluxo menstrual começa no domingo ou antes dele, o primeiro comprimido (branco ou azul ou verde-amarelo) é tomado nesse dia.

Para começar o dia 5, conte o primeiro dia de fluxo menstrual como o dia 1 e o primeiro comprimido (branco ou azul ou verde-amarelo) será realizado no dia 5. Com um SUNDAY START ou DAY 5 START, 1 comprimido (branco ou azul ou verde-amarelo) é tomado todos os dias ao mesmo tempo por 21 dias. Em seguida, os comprimidos marrons são tomados por 7 dias, independentemente de o sangramento ter parado ou não. Após a ingestão de todos os 28 comprimidos, se o sangramento parou ou não, o mesmo esquema posológico é repetido a partir do dia seguinte.

Instruções aos pacientes

• Para alcançar a máxima eficácia contraceptiva, a pílula contraceptiva oral deve ser tomada exatamente conforme indicado e em intervalos não superiores a 24 horas.
• Importante: As mulheres devem ser instruídas a usar um método adicional de proteção até os primeiros 7 dias de administração no ciclo inicial.
• Devido ao risco normalmente aumentado de tromboembolismo após o parto, as mulheres devem ser instruídas a não iniciar o tratamento com contraceptivos orais antes de 4 semanas após o parto a termo. Se a gravidez terminar nas primeiras 12 semanas, o paciente deve ser instruído a iniciar contraceptivos orais imediatamente ou dentro de 7 dias. Se a gravidez terminar após 12 semanas, o paciente deve ser instruído a iniciar contraceptivos orais após 2 semanas.^{33, 77}
• Se ocorrer sangramento ou avanço, o paciente deve continuar o medicamento de acordo com o cronograma. Se persistir um sangramento ou avanço, o paciente deve notificar seu médico.
• Se a paciente perder 1 comprimido, ela deve ser instruída a tomá-lo assim que se lembrar e depois tomar a próxima pílula no horário regular. A paciente deve ser avisada de que a falta de uma pílula pode causar manchas ou sangramentos leves e que ela pode estar um pouco enjoada nos dias em que toma a pílula perdida com a pílula programada regularmente. Se o paciente perdeu mais de um comprimido, ele não deve tomar os comprimidos perdidos e eles devem ser descartados. Ela deve ser aconselhada a tomar a próxima pílula no próximo horário regular e continuar a tomá-las conforme programado. Além disso, ela deve usar um método contraceptivo adicional, além de tomar suas pílulas pelo restante do ciclo.
• Uso de contraceptivos orais em caso de menstruação perdida :

1. Se o paciente não aderiu ao regime posológico prescrito, a possibilidade de gravidez deve ser considerada após o primeiro período perdido e os contraceptivos orais devem ser retidos até que a gravidez seja descartada.
2. Se o paciente aderiu ao regime prescrito e perde 2 períodos consecutivos, a gravidez deve ser descartada antes de continuar o regime contraceptivo.

Os contraceptivos orais não devem ser utilizados em mulheres com as seguintes condições :

• Tromboflebite ou distúrbios tromboembólicos
• Uma história passada de tromboflebite venosa profunda ou distúrbios tromboembólicos
• Doença arterial vascular ou coronariana cerebral
• Carcinoma conhecido ou suspeito da mama
• Carcinoma do endométrio e neoplasia dependente de estrogênio conhecida ou suspeita
• Sangramento genital anormal não diagnosticado
• icterícia colestática da gravidez ou icterícia com o uso prévio da pílula
• Adenomas hepáticos, carcinomas ou tumores benignos do fígado
• Gravidez conhecida ou suspeita

Os contraceptivos orais combinados não devem ser utilizados em mulheres que recebem combinações de medicamentos para hepatite C contendo ombitasvir / paritaprevir / ritonavir, com ou sem dasabuvir, devido ao potencial de elevações da alanina aminotransferase (ALT) .

WARNINGS

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease, although the risk of serious morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, hypercholesterolemia, obesity and diabetes.^2-5

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 formulations containing 0.05 mg or higher of estrogen.^6-11 The effects of long-term use with lower dose formulations of both estrogens and progestogens remain 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. Relative risk, the ratio of the incidence of a disease among oral contraceptive users to that among non-users, cannot be assessed directly from case control studies, but the odds ratio obtained is a measure of relative risk. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide not only a measure of the relative risk but a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population.^12-13

Thromboembolic Disorders And Other Vascular Problems

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.^{2-5, 13} The relative risk of heart attack for current oral contraceptive users has been estimated to be 2 to 6.^{2, 14-19} The risk is very low under the age of 30. However, there is the possibility of a risk of cardiovascular disease even in very young women who take oral contraceptives.

Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women 35 or older, with smoking accounting for the majority of excess cases.²⁰

Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 among women who use oral contraceptives .¹⁶

TABLE II: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE

Adapted from P.M. Layde and V. Beral, Table V16

Oral contraceptives may compound the effects of well-known risk factors for coronary artery disease, such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age and obesity.^{3, 13, 21} In particular, some progestogens are known to decrease HDL cholesterol and impair oral glucose tolerance, while estrogens may create a state of hyperinsulinism.^21-25 Oral contraceptives have been shown to increase blood pressure among users . Similar effects on risk factors have been associated with an increased risk of heart disease. 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.^{12, 13, 26-31} One cohort study has shown the relative risk to be somewhat lower, about 3 for new cases (subjects with no past history of venous thrombosis or varicose veins) and about 4.5 for new cases requiring hospitalization.³² The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.¹²

A 2-to 6-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives.¹⁸ If feasible, oral contraceptives should be discontinued at least 4 weeks prior to and for 2 weeks after elective surgery and during and following prolonged immobilization. Since the immediate postpartum period also is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than 4 to 6 weeks after delivery in women who elect not to breast feed.³³

Cerebrovascular Diseases

An increase in both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes) has been shown in users of oral contraceptives. 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.³⁴

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.³⁵ The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers 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.³⁵ The attributable risk also is greater in women 35 or older and among smokers.¹³

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.^36-38 A decline in serum high density lipoproteins (HDL) has been reported with some progestational agents.^22-24 A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease.³⁹ 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 contraceptives. The amount of both hormones should be considered in the choice of an oral contraceptive.³⁷

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 the lowest estrogen content that produces satisfactory results for the individual.

Persistence Of Risk Of Vascular Disease

There are three studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives.^{17, 34, 40} 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 who had used oral contraceptives for 5 or more years, but this increased risk was not demonstrated in other age groups.¹⁷ In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small.⁴⁰ Subarachnoid hemorrhage also has a significantly increased relative risk after termination of use of oral contraceptives.³⁴ However, these studies were performed with oral contraceptive formulations containing 0.05 mg or higher of estrogen.

Estimates Of Mortality From Contraceptive Use

One study gathered data from a variety of sources which have estimated the mortality rates associated with different methods of contraception at different ages .⁴¹ 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 risks. 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 in the U.S. until 1983.^{16, 41} 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^{78, 79,} the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking 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.⁸⁰

TABLE III: ESTIMATED 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

Carcinoma Of The Breast And Reproductive Organs

Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives. The 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.^{42, 43} The Cancer and Steroid Hormone study also showed no latent effect on the risk of breast cancer for at least a decade following long-term use.⁴³ A few studies have shown a slightly increased relative risk of developing breast cancer,^44-47 although the methodology of these studies, which included differences in examination of users and non-users and differences in age at start of use, has been questioned.^47-49 Some studies have reported an increased relative risk of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use.^{81, 82}

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.^50-53 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 or cervical cancers, a cause and effect relationship has not been established.

Hepatic Neoplasia

Benign hepatic adenomas are associated with oral contraceptive use although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases per 100,000 for users, a risk that increases after 4 or more years of use.⁵⁴ Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.^55-56

Studies in the United States and Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users.^57-59

However, these cancers are extremely rare in the United States and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users is less than 1 per 1,000,000 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 Norminest/Norquest prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir . Norminest/Norquest 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.^60-62 More recent studies do not suggest a teratogenic effect, particularly insofar as cardiac anomalies 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.^65-66 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.⁶⁷ The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.⁶⁸

Carbohydrate And Lipid Metabolic Effects

Oral contraceptives have been shown to impair oral glucose tolerance.⁶⁹ Oral contraceptives containing greater than 0.075 mg of estrogen cause glucose intolerance with impaired insulin secretion, while lower doses of estrogen may produce less glucose intolerance.⁷⁰ Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.^{25, 71} However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose.⁶⁹ Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

Some women may develop persistent hypertriglyceridemia while on the pill.⁷² As discussed earlier , changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.²³

Elevated Blood Pressure

An increase in blood pressure has been reported in women taking oral contraceptives. The incidence of risk also was reported to increase with continued use and among older women.⁶⁶ 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^73-75 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 3 months of use. Non-hormonal 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.

Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.

PRECAUTIONS

General

PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV (AIDS) AND OTHER SEXUALLY TRANSMITTED 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

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

Liver Function

If jaundice develops in any woman receiving oral contraceptives 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.

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:

1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
3. Other binding proteins may be elevated in serum.
4. Sex steroid binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
5. Triglycerides may be increased.
6. Glucose tolerance may be decreased.
7. 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

Pregnancy

Pregnancy Category X.

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.

Information For The Patient

REFERENCES

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Uso concomitante com terapia combinada com HCV - elevação da enzima hepática Não co-administre Norminest / Norquest com combinações de medicamentos para HCV contendo ombitasvir / paritaprevir / ritonavir, com ou sem dasabuvir, devido ao potencial de elevações da ALT .

Eficácia reduzida e incidência aumentada de sangramento inovador e irregularidades menstruais foi associado ao uso concomitante de rifampicina. Uma associação semelhante, embora menos marcada, tem sido sugerido com barbitúricos, fenilbutazona, fenitoína sódica e possivelmente com griseofulvina ampicilina e tetraciclinas.76

REFERÊNCIAS

76. Stockley, eu .: Pharm J 216: 140-143, 1976.

Um risco aumentado das seguintes reações adversas graves foi associado ao uso de contraceptivos orais :

• Tromboflebite
• Tromboembolismo arterial
• Embolia pulmonar
• Infarto do miocárdio
• Hemorragia cerebral
• Trombose cerebral
• Hipertensão
• Doença da vesícula biliar
• Adenomas hepáticos, carcinomas ou tumores benignos do fígado

Há evidências de uma associação entre as seguintes condições e o uso de contraceptivos orais embora sejam necessários estudos confirmatórios adicionais :

• Trombose mesêntrica
• Trombose da retina

As seguintes reações adversas foram relatadas em pacientes recebendo contraceptivos orais e são acreditado para ser relacionado a drogas :

• Náusea
• Vômitos
• Sintomas gastrointestinais (como cãibras abdominais e inchaço)
• Sangramento inovador
• Spotting
• Mudança no fluxo menstrual
• Amenorréia
• Infertilidade temporária após a descontinuação do tratamento
• Edema
• Melasma que pode persistir
• Alterações mamárias: ternura, aumento, secreção
• Mudança de peso (aumento ou diminuição)
• Mudança na erosão cervical e secreção
• Diminuição da lactação quando administrada imediatamente após o parto
• icterícia colestática
• Enxaqueca
• Erupção cutânea (alérgica)
• Depressão mental
• Tolerância reduzida a carboidratos
• Candidíase vaginal
• Mudança na curvatura da córnea (aumento)
• Intolerância às lentes de contato

As seguintes reações adversas foram relatadas em usuários de contraceptivos orais e a associação não foi confirmada nem refutada :

• Síndrome pré-menstrual
• Cataratas
• Mudanças no apetite
• Síndrome do tipo cistite
• Dor de cabeça
• Nervosismo
• Tontura
• Hirsutismo
• Perda de pêlos no couro cabeludo
• Eritema multiforme
• Eritema nodoso
• Erupção hemorrágica
• Vaginite
• Porfiria
• Função renal comprometida
• Síndrome hemolítica urêmica
• Síndrome de Budd-Chiari
• Acne
• Mudanças na libido
• Colite

Efeitos graves de doenças não foram relatados após ingestão aguda de grandes doses de contraceptivos orais por crianças pequenas. Sobredosagem pode causar náusea e sangramento por abstinência pode ocorrer em mulheres.

Saúde não contraceptiva Beneftis

Os seguintes benefícios não contraceptivos à saúde relacionados ao uso de contraceptivos orais são apoiados por estudos epidemiológicos que utilizaram amplamente formulações contraceptivas orais contendo doses de estrogênio superiores a 0,035 mg de etinilestradiol ou 0,05 mg de mestranol.^6-11

Efeitos na menstruação :

• Aumento da regularidade do ciclo menstrual
• Diminuição da perda de sangue e diminuição da incidência de anemia por deficiência de ferro
• Diminuição da incidência de dismenorreia

Efeitos relacionados à inibição da ovulação :

• Diminuição da incidência de cistos ovarianos funcionais
• Diminuição da incidência de gestações ectópicas

Efeitos do uso a longo prazo :

• Diminuição da incidência de fibroadenomas e doença fibrocística da mama
• Diminuição da incidência de doença inflamatória pélvica aguda
• Diminuição da incidência de câncer endometrial
• Diminuição da incidência de câncer de ovário

Os contraceptivos orais combinados atuam pela supressão de gonadotrofinas. Embora o mecanismo primário dessa ação seja a inibição da ovulação, outras alterações incluem alterações no muco cervical (que aumentam a dificuldade de entrada de espermatozóides no útero) e no endométrio (que pode reduzir a probabilidade de implantação).

Norminest^® Fe Tablets (21 noretindrona azul 0,5 mg e etinilestradiol 0,035 mg comprimidos seguidos por 7 comprimidos de fumarato ferroso marrom de 75 mg) e Norquest^® Os comprimidos de Fe (21 comprimidos de noretindrona verde-amarela 1 mg e etinilestradiol 0,035 mg, seguidos por 7 comprimidos de fumarato ferroso marrom 75 mg) estão disponíveis em blisters de 100 × 28 comprimidos.

CUIDADO: A lei federal proíbe a distribuição sem receita médica.

REFERÊNCIAS

1. Trussell, J., et al.: Stud Fam Plann 21 (1): 51-54, 1990.

63. Ferencz, C., et al.: Teratologia 21: 225-239, 1980.

64. Rothman, K.J., et al.: Sou J Epidemiol 109 (4): 433-439, 1979.

77. Dickey, R.P.: Gerenciamento de pacientes com pílulas contraceptivas, Oklahoma, Creative Informatics Inc.1984.

Fabricado por: Syntex Laboratories, Inc. Palo Alto, GA 94304. Revisado: agosto de 2017