Nortrel 7/7/7 is a hormonal combination contraceptive which contains 2 hormones, norethisterone and ethinyl estradiol, that are used to prevent pregnancy.
- Oral contraception.
The contraceptive effect of Nortrel 7/7/7 is based on the interaction of various factors: suppression of ovulation and changes in cervical secretion.
In addition to a contraceptive effect, the preparation has a number of positive properties that should be considered when choosing a birth control method. The cycle becomes more regular, menstruation less painful, bleeding decreases. The latter can reduce the incidence of iron deficiency anemia.
Besides, norethisterone has other properties, in particular, anti-mineralocorticoid activity, due to which weight gain and other symptoms associated with fluid retention are prevented. It also prevents estrogen sodium retention, ensuring good tolerability and improvement in premenstrual syndrome. In combination with ethinyl estradiol, norethisterone has a positive effect on the lipid profile, increasing the HDL content. Norethisterone has an anti-androgenic effect, a positive effect on the skin, reduces the appearance of acne and sebum production. Also, norethisterone does not counteract the increase in the level of globulin that binds to sex hormones caused by ethinyl estradiol, which is useful for binding and inactivating endogenous androgens.
Norethisterone has no androgenic, estrogenic, glucocorticoid, and anti-glucocorticoid activity. This, in combination with the anti-mineralocorticoid and anti-androgenic properties, indicates a similar pharmacological and biochemical profile of norethisterone with the natural hormone progesterone. In addition, the substance may reduce the risk of endometrial and ovarian cancer.
Each Nortrel 7 / 7 / 7 pack contanins 28 tablets; 7 light yellow tablets (0.5 mg norethindrone/0.035 mg ethinyl estradiol), 7 blue tablets (0.75 mg norethindrone/0.035 mg ethinyl estradiol), 7 peach tablets (1 mg norethindrone/0.035 mg ethinyl estradiol, and 7 white inert tablets).
Tablets are taken daily, at about the same time, according to the scheme indicated on the blister, with a small amount of liquid. Take the first tablet on the first day of your period. Take the drug for 28 days in a row. Each subsequent package begins immediately after the end of the previous one. Menstrual-like bleeding usually occurs 2-3 days after you take the last active tablet from the pack and may not stop before taking the pills from the next pack.
How to start taking Nortrel 7/7/7:
- If hormonal contraceptives were not used in the last month, start taking birth control pills on the first day of your period;
- If you used another combined hormonal contraceptive in the last month, start taking the tablets on the next day after taking the last “active” pill of the previous COC or the day after the last “active” day of the previous COC;
- If you used a progestogen-only method (mini-pills, injections, implants) in the last month, start taking the tablets on any day after taking the last mini-pill (when switching from an implant or intrauterine system – on the day of their removal, when switching from an injection – instead of the next injection);
- After an abortion in the first trimester of pregnancy, start taking birth control pills immediately on the same day after surgery. In this case, there is no need to use additional contraceptives;
- After childbirth or abortion during the second trimester of pregnancy, start taking the tablets 21–28 days after delivery or abortion. If you start taking the pills later, it is recommended to use an additional backup method of birth control in the first 7 days. However, if you have already had sexual intercourse, you should start using the hormonal contraception only after you make sure you are not pregnant (wait for your menstruation).
To date, there are no clinical studies regarding Nortrel 7/7/7 overdose. Based on the general experience of using COCs, an overdose may cause nausea, vomiting or vaginal bleeding. There is no special antidote, the treatment is symptomatic.
- Immune system: asthma, hypersensitivity;
- Nervous system: a headache;
- Mental disorders: depressed mood, increased libido, decreased libido;
- Vascular system: a migraine, hypertension, arterial hypotension;
- Digestive system: nausea, vomiting, diarrhea;
- Skin and subcutaneous tissue: acne, eczema, pruritus, alopecia, erythema nodosum, erythema polymorphism;
- Reproductive system and mammary glands: menstrual disorders, intermenstrual bleeding, breast tenderness, engorgement of the mammary glands, enlargement of the mammary glands, discharge from the mammary glands, vaginal discharge, vulvovaginal candidiasis, vaginal infections;
- General disorders: fluid retention, weight gain, weight loss.
Individual adverse reactions
Women taking COCs noted an increased risk of developing arterial thrombotic/thromboembolic events, including myocardial infarction, stroke, venous thrombosis and pulmonary thromboembolism.
The following serious adverse reactions have also been reported by some women using Nortrel 7/7/7 tablets:
- venous thromboembolic disorders;
- arterial hypertension;
- liver tumors;
- Crohn’s disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria, systemic lupus erythematosus, pregnant herpes, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice;
- acute or chronic liver dysfunction (until liver function indicators are normalized);
- angioedema (in women with a hereditary predisposition).
Adverse reactions that were observed in patients taking this drug included emotional lability, depression, loss of libido, venous and arterial thromboembolic events, including peripheral deep venous occlusions, thrombosis and pulmonary embolism, myocardial infarction, stroke.
Other side effects associated with Nortrel 7/7/7 include hearing loss associated with otosclerosis, hypertriglyceridemia, pancreatitis, gallstones, changes in glucose tolerance, or the effect on insulin resistance, jaundice and/or pruritus associated with cholestasis, hypersensitivity reactions, including rash, urticaria.
The frequency of diagnosing breast cancer is somewhat increased in women using COCs. Since breast cancer in women under 40 years of age is rarely observed, an increase in the number of breast cancer diagnoses in women who are currently using or have recently used COCs is insignificant relative to the overall risk of breast cancer. The relationship with the use of hormones is unknown.
You cannot use Nortrel 7/7/7 for birth control or you must immediately cancel this drug in the following conditions:
- hypersensitivity to the active substances (norethisterone and ethinyl estradiol) or any of the excipients of the drug;
- the presence or a high risk of venous thromboembolism (VTE):
- VTE at the moment or in history (deep vein thrombosis, pulmonary embolism);
random or acquired susceptibility to VTE, for example, resistance to activated protein C (APC), including Leiden V factor, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S;
- serious surgical intervention with prolonged immobilization;
- arterial thromboembolism (ATE) at the moment or in history (for example, myocardial infarction) or prodromal state (in particular, angina pectoris);
- disorders of cerebral circulation – at the moment, in history or prodromal state (for example, transient ischemic attack (TIA);
- random or acquired susceptibility to ATE, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
- a migraine with focal neurological symptoms in a history;
- high risk of ATE due to the presence of multiple risk factors, such as diabetes mellitus with vascular complications; severe hypertension; severe
- pancreatitis at the moment or in history, associated with severe hypertriglyceridemia;
- a history of serious liver diseases;
- severe renal failure;
- the presence or a history of liver tumors (benign or malignant);
- established or suspected malignant tumors caused by sex steroid hormones (reproductive organs or mammary glands);
- vaginal bleeding of unexplained etiology.
- concomitant use with medicines that contain ombitasvir, ritonavir and dasabuvir.
Stop taking Nortrel pills prior to using Ombitasvir/paritaprevir/ritonavir, dasabuvir and restart the hormonal contraception 2 weeks after completion of treatment. The drug may also interact with rifampin, phenobarbital, phenytoin, carbamazepine, St. John’s wort. The effect may be reduced by ampicillin, tetracycline, griseofulvin, phenylbutazone. Atorvastatin, acetaminophen, ascorbic acid may potentiate the contraceptive. Nortrel may enhance the effect of cyclosporine, prednisolone, theophylline, tizanidine, voriconazole and affect laboratory tests (coagulation factors, glucose tolerance, binding proteins and others).
Nortrel 7/7/7 is contraindicated for use during pregnancy.
It is necessary to immediately cancel the drug in case of pregnancy. There was no reported increase in the risk of congenital malformations in children born to women who took COCs before pregnancy, as well as the existence of a teratogenic effect if they inadvertently take COCs in the early stages of pregnancy. Available data on the use of the drug during pregnancy are too limited to draw conclusions about the negative impact of the contraceptive on pregnancy, the health of the fetus or newborn. There is no significant epidemiological data.
When you resume taking Nortrel tablets, you should consider the increased risk of VTE in the postpartum period.
The drug can affect breastfeeding, because, under their influence, the amount of breast milk may decrease. Given this, COCs are not recommended for use during breastfeeding. The active ingredients of the drug (norethisterone and ethinyl estradiol) or their metabolites can penetrate into breast milk.
- If you missed 1 tablet in Weeks 1, 2, or 3, take it as soon as you remember;
- If you missed 2 tablets in Week 1 or Week 2, take 2 tablets the day you remember and 2 tablets the next day; and then continue taking the pills according to the usual schedule (1 pill per day) until you finish the pack. You need to use a backup method of contraception (a condom or spermicide) if you have sexual activity in the seven days after missing Nortrel tablets;
- If you missed 2 tablets in the third week or missed 3 or more tablets in a row, continue taking 1 tablet a day until Sunday. On Sunday, throw out the rest of the tablets and start a new pack that same day. At the same, you need to use a backup method of contraception if you have sexual activity in the seven days after missing Nortrel tablets;
- If you missed any tablets in the Week 4, you may not worry since they do not contain any hormones and therefore do not provide a contraceptive effect. You may simply throw them away.
The drug is not indicated after menopause.
The drug is not indicated for use in children.
Studies on the effect of Nortrel 7/7/7 on the reaction rate when driving or working with other mechanisms were not performed. There was no effect on the ability to drive or work with mechanisms for women using COCs.
The data of preclinical studies do not indicate the presence of a special risk for the human body based on standard toxicity studies with repeated use, genotoxicity, carcinogenicity, and reproductive toxicity. However, sex steroids can promote the growth of certain hormone-dependent tissues and tumors.
In case of serious violations of the gastrointestinal tract (such as vomiting or diarrhea), incomplete absorption of the drug is possible, therefore the use of additional contraceptives is recommended. If vomiting occurs 3-4 hours after taking an active pill, you should immediately take an additional pill.
The decision on the use of hormonal contraception should be made after assessing the individual risk factors.
If you have any of the following conditions or risk factors, you should discuss with your doctor the appropriateness of the use of Nortrel 7/7/7.
In case of exacerbation or at the first manifestations of any of these conditions or risk factors, women are advised to consult a doctor and determine the need to stop taking birth control pills.
In the case of suspected or confirmed VTE or ATE, the use of the contraceptive should be discontinued. If anticoagulant therapy is initiated, it is necessary to use alternative adequate contraception because of the teratogenic effect of anticoagulants.
The risk of developing venous thromboembolism (VTE)
The use of any combination hormonal contraceptives increases the risk of developing VTE in women who use them compared to those who do not use them. Drugs containing norethisterone are associated with a lower risk of VTE. The decision on the use of birth control pills should be taken only by a doctor. It is necessary to make sure that a patient is aware of the risk of developing VTE associated with the use of the drug, the degree of influence of her risk factors and the fact that the risk of VTE is highest during the first year of use.
In 2 out of 10,000 women who do not take COCs and are not pregnant, VTE develops during the year. However, each woman’s risk can be significantly higher depending on the risk factors she has.
In very rare cases, women taking COCs reported the occurrence of thromboses of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, brain vessels or retina.
Risk factors for VTE
The risk of developing VTE-complications in women using COCs may be significantly higher if there are additional risk factors, especially multiple ones.
Use of Nortrel 7/7/7 is contraindicated in women with multiple risk factors, which may increase the risk of venous thrombosis.
If a woman has more than one risk factor, the risk increase may be greater than the sum of risks associated with each individual factor, therefore the overall risk of developing VTE should be taken into account. If the benefit/risk ratio is unfavorable, do not use COCs.
- Obesity (body mass index > 30 kg/m2), the risk increases significantly with an increase in body mass index;
- Prolonged immobilization, major surgery, surgery on the lower limbs or pelvic organs, neurosurgical interventions or extensive trauma. In such situations, it is recommended to discontinue using the drug (in the case of a planned surgical intervention – for at least 4 weeks) and resume hormonal contraception 2 weeks after the full recovery of motor activity. In order to avoid unwanted pregnancy, a patient should use other methods of birth control;
- Family history (VTE with someone from relatives or parents, especially at a relatively young age, for example, under the age of 50) – women are advised to consult a specialist before using any COC;
- Other conditions associated with VTE are cancer, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis), and sickle cell anemia;
- Age – especially women over the age of 35.
Symptoms of VTE (deep vein thrombosis and pulmonary embolism)
Women should be advised to consult a physician immediately in the event of the following symptoms:
- Symptoms of deep vein thrombosis: unilateral swelling of the legs and/or feet or areas along the vein in the leg; pain or hypersensitivity in the leg, feeling hot in the affected leg; redness or discoloration of the skin on the leg;
- Symptoms of pulmonary embolism: sudden dyspnea of unknown etiology or rapid breathing; a sudden cough, possibly with blood, sudden pain in the chest, fainting or dizziness, fast or irregular heartbeat.
Some of these symptoms (for example, shortness of breath, cough) are nonspecific or may be misinterpreted as more common or less serious events (for example, as respiratory tract infections).
Other manifestations of vascular occlusion may include sudden pain, swelling, acute abdomen and slight blueing of the limb.
The risk of ATE
According to epidemiological studies, the use of any COC is associated with an increased risk of ATE (myocardial infarction) or cerebrovascular events (stroke). ATE phenomena can be fatal.
Risk factors for ATE
With the use of Nortrel 7/7/7, the risk of developing ATE complications or cerebrovascular events increases in women with risk factors. Use of the drug is contraindicated if a woman has one serious or multiple risk factors for ATE, which can increase the risk of developing arterial thrombosis. If a woman has more than one risk factor, the increase in risk may be greater than the sum of risks associated with each individual factor, therefore the overall risk should be taken into account. If the benefit/risk ratio is unfavorable, do not use the contraceptive.
- Age – especially over the age of 35;
- Smoking – women using COCs are advised to refrain from smoking. Women over the age of 35 who continue to smoke are strongly advised to use another method of contraception;
- Arterial hypertension;
- Obesity (body mass index > 30 kg/m2) – the risk increases significantly with an increase in body mass index;
- Family history – if there is a genetic predisposition, women are advised to consult a specialist before using any COC;
- Migraine – increasing the frequency or severity of a migraine during the period of using birth control pills can require an immediate withdrawal of the drug;
- Other conditions associated with vascular side effects – diabetes mellitus, hyperhomocysteinemia, heart valve defects, atrial fibrillation, dyslipoproteinemia and systemic lupus erythematosus.
The results of some epidemiological studies indicate an increased risk of developing cervical cancer with prolonged use of COCs (over 5 years), but this statement remains controversial.This increased risk gradually disappears within 10 years after the end of taking birth control pills. An increase in the number of breast cancer diagnoses in women who are currently using or have recently used COCs is insignificant relative to the overall risk of breast cancer. The results of these studies provide no evidence of a causal relationship.
In very rare cases, women using hormonal contraceptives reported the development of benign and malignant liver tumors, in some cases leading to life-threatening intra-abdominal bleeding. In the event of complaints of severe pain in the epigastric region, an enlarged liver or signs of intra-abdominal bleeding during differential diagnosis, you should consider the possibility of a liver tumor.
Although a slight increase in blood pressure has been reported in many women taking COCs, a clinically significant increase in blood pressure is rarely observed.
Immediate withdrawal of Nortrel 7/7/7 is necessary only in these rare cases: in the case of prolonged hypertension or the inability to monitor blood pressure indicators with antihypertensive agents. If necessary, the use of birth control pills can be resumed after achieving normalization of blood pressure.
Some women reported the occurrence or exacerbation of the following diseases during pregnancy and the use of the contraceptive, but their relationship with the use of estrogens/progestins is not definitively established: jaundice and/or itching associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham’s chorea, herpes in pregnancy, hearing loss associated with otosclerosis.
In women with hereditary angioedema, the drug can induce or exacerbate the symptoms of angioedema.
Steroid hormone metabolism may be weak in patients with impaired liver function. Acute or chronic abnormal liver function may require the withdrawal of COCs.
Stop taking the tablets in the case of recurrent cholestatic jaundice and/or itching associated with cholestasis, which previously occurred during pregnancy or previous use of sex hormones,
Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence that the treatment regimen should be changed for women with diabetes who take Nortrel 7/7/7. However, women with diabetes mellitus should be carefully examined during the use of hormonal contraception, especially at the beginning of treatment.
Cases of exacerbation of endogenous depression, epilepsy, Crohn’s disease and ulcerative colitis were also noted with the use of the preparation.
Chloasma can sometimes occur, especially in women with a history of chloasma in pregnant women. Women prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation during the period of hormonal contraception.
The tablets contain lactose. In the presence of rare hereditary intolerance to galactose or glucose-galactose malabsorption, in the case of a lactose-free diet, the indicated amount of lactose should be taken into account.
Consultation / medical examination
Before starting or resuming Nortrel 7/7/7, it is recommended to collect a full medical history (including family history), undergo a full medical examination and exclude pregnancy. It is necessary to measure blood pressure and conduct a medical examination, taking into account contraindications and features of the application. Women should pay attention to information on venous and arterial thrombosis, including the risk associated with the use of the drug.
Patients are advised to carefully read the instructions for use and adhere to the doctor’s recommendations.
The frequency and nature of examinations should be based on the existing norms of medical practice, taking into account the individual characteristics of each woman.
Patients should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and any other sexually transmitted disease.
The effectiveness of Nortrel 7/7/7 may decrease if a tablet is missed (see “What if I miss a pill?”), a violation of the gastrointestinal tract or with the simultaneous use of other drugs (see “Interactions”).
When taking COCs, women may have irregular bleeding (spotting or breakthrough bleeding), especially during the first few months of use. If such bleeding continues after three menstrual cycles, they should be considered serious.
If irregular bleeding persists or appears after a period of regular menstruation, non-hormonal causes of bleeding and appropriate diagnostic measures should be considered, including testing to exclude the presence of tumors and pregnancy. Diagnostic measures may include curettage.
Some women may not experience withdrawal bleeding in the period of taking inert tablets. In the case of taking the contraceptive in accordance with the instructions for use, pregnancy is unlikely. However, if the use of birth control pills was irregular and the withdrawal bleeding is absent for two cycles, you need to exclude pregnancy prior to continuing hormonal contraception.