Tri-Linyah is a triphasic oral contraceptive containing progestagen (norgestimate) and estrogen (ethinyl estradiol), that are used to prevent pregnancy.
Indications for use
- Oral contraception.
Mechanism of action
Tri-Linyah suppresses the release of gonadotropins, prevents the maturation of eggs in the ovaries and ovulation. In addition, the drug increases the viscosity of cervical mucus, which makes it difficult for sperm to enter the uterus, and acts on the epithelium of the endometrium, reducing the likelihood of implantation.
Dosage and mode of application
Tablets are taken orally, with water. To achieve the maximum contraceptive effect, you should take them exactly in accordance with the instructions for use, at the same time every day, for 28 days in a row, without interruption. For the convenience of checking the regularity of taking tablets, the days of the week are marked on the blister pack of the drug. Start taking tablets on the first day of the period in the order specified on the blister. Menstrual bleeding usually occurs during the fourth week of the period. Start a new Tri-Linyah pack without interruption even if you have no bleeding or it has not yet ended.
If the regimen of the preparation is observed correctly, the drug helps to prevent pregnancy from the first day of administration.
When switching from another combined oral contraceptive, Tri-Linyah pills should be started between 1 and 7 days after taking the last pill of the previous contraceptive. A break of more than 7 days without taking birth control pills is unacceptable.
If more than 7 days have passed between taking the last tablet of the previous preparation and taking the first tablet of Tri-Linyah, it’s necessary to use a non-hormonal method of contraception for the first 7 days (condoms, diaphragms, spermicides).
If you had unprotected sexual intercourse during the period free from taking birth control pills, you may be already pregnant.
When switching from progesterone-only contraceptives, Tri-Linyah should be started the day after the last tablet of the previous drug was taken. It’s necesary to use additional methods of contraception in the first 7 days.
The drug can be taken no earlier than 3 weeks after delivery, provided that the woman does not breastfeed the baby.
After an abortion or a miscarriage for a period of up to 20 weeks of pregnancy, birth control pills can be taken immediately. In this case, you do not need to use additional methods of contraception. After an abortion or miscarriage, ovulation may occur within 10 days. After an abortion or miscarriage at the gestation period of 20 weeks or more, the drug can be started on the day 21 day after an abortion or on the first day of the menstrual period (whichever comes first). In this case, you need to use additional non-hormonal methods of contraception for the first 7 days.
In exceptional cases (if there is a medical indication for immediate, reliable contraception), the use of Tri-Linyah can be started within 1 week after an abortion. However, in such case, a woman has an increased risk of thromboembolic complications.
If vomiting occurs within 3 hours after taking the tablet or you have diarrhea that lasts more than 24 hours, the effectiveness of the drug may be reduced. In this case, you need to use an additional method of non-hormonal contraception for 7 days. If vomiting / diarrhea continues, consult a doctor.
Taking large doses of norgestimate and ethinyl estradiol can cause an overdose. No serious complications were reported. In case of an overdose, you may experience nausea, vomiting and bleeding from the vagina.
There is no specific antidote. Symptomatic therapy is required.
In some cases, Tri-Linyah can cause the following side effects:
- urethra: urinary tract infections;
- cardiovascular system: palpitation, arterial hypertension, “hot flushes”, thromboses, tachycardia, myocardial infarction, deep vein thrombosis;
immune system: hypersensitivity;
- reproductive system: dysmenorrhea, metrorrhagia, lengthening of the interval between bleeding or absence of withdrawal bleeding, mastodynia, mastalgia, genital secretions, vaginal infections, enlargement of mammary glands, mammary glands, vulvovaginal dryness, ovarian cyst, cervical dysplasia , cervical cancer, breast cancer, breast cyst, mammary gland fibroadenoma, breast neoplasm;
- gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain, constipation, bloating, flatulence, pancreatitis, hepatitis, liver adenoma, focal nodular liver hyperplasia;
- skin and subcutaneous skin: acne, rash, alopecia, hirsutism, urticaria, pruritus, erythema, discoloration, papular rash, increased sweating, photosensitivity, Quincke’s edema, erythema nodule, night sweats;
- central nervous system: headache, migraine, dizziness, depression, insomnia, increased excitability, mood instability, fainting, paresthesia, anxiety, changes in libido, seizures, cerebrovascular disorders;
- metabolism: fluid retention, change in body weight (decrease or increase), changes in appetite (decrease or increase), dyslipidemia;
- musculoskeletal system: muscle spasm, pain in the lower limbs, back pain, myalgia;
- organs of vision: visual impairment, dry eyes, intolerance to contact lenses, thrombosis of retinal veins;
- organs of hearing: vertigo;
- respiratory system: dyspnoea, embolism of the lungs;
- common disorders: pain in the chest, swelling, asthenic condition.
Tri-Linyah is contraindicated for use in the following conditions / diseases:
- age under 18 years;
- postpartum period (3 weeks);
- breastfeeding period;
- arterial hypertension (160/100 mm Hg and above);
- hypersensitivity to norgestimate, ethinyl estradiol or other components of the drug;
- venous thrombosis, including in the history (including deep vein thrombosis, lung thromboembolism;
- hereditary predisposition to venous or arterial thrombosis (antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, the presence of antiphospholipid antibodies);
- the presence of serious or multiple risk factors for venous or arterial thrombosis;
- a migraine with aura;
- adenomas or carcinomas of the liver, including in the history;
- confirmed or suspected breast cancer;
- endometrial cancer or other confirmed or suspected estrogen-dependent neoplasms;
- genital bleeding of unclear etiology;
- confirmed or suspected pregnancy;
- heart valve disease with complications;
- diabetes mellitus with vascular lesions;
- serious violations of the liver, including in the history (until the liver function is restored);
- arterial thrombosis, including in the history (including acute disorders of cerebral circulation, myocardial infarction, retinal artery thrombosis) or precursors of thrombosis (including angina pectoris or transient ischemic attack);
- cholestatic jaundice when using other oral hormonal contraceptives or cholestatic jaundice during the previous pregnancy.
Take the drug with caution:
- acyclic bleeding;
- impaired renal function;
- persistent arterial hypertension;
- thrombophlebitis of superficial veins and varicose veins;
- damage to the valvular heart apparatus with complications;
- severe depression, including in the history;
- systemic lupus erythematosus;
- Crohn’s disease;
- ulcerative colitis;
- predisposition to venous or arterial embolism;
- prolonged immobilization or extensive surgical operation;
- risk factors for coronary heart disease (hyperlipidemia, hypertension or obesity);
- liver dysfunction;
- hypertriglyceridemia, including in a family history;
- acute impairment of liver function during the previous pregnancy or the previous use of oral hormonal contraceptives;
- smoking over the age of 35 years;
Drugs that reduce the effectiveness of Tri-Linyah with simultaneous admission:
In the case of simultaneous intake of drugs and plant remedies inducing enzymes involved in the metabolism of sex hormones, you need to use additional methods of contraception. The use of these drugs and herbal products leads to a decrease in the concentration of norgestimate and ethinyl estradiol and a decrease in the effectiveness of the contraceptive, which can cause breakthrough bleeding:
- preparations based on St. John’s wort;
HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors:
In the case of simultaneous intake of Tri-Linyah with HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors, a woman can observe significant changes in the concentration of estrogens and progesterone in blood plasma.
Several cases of pregnancy have been reported with concomitant use of Tri-Linyah and antibiotics.
A possible mechanism for the onset of pregnancy with simultaneous intake of combination oral contraceptives and antibiotics can be a violation of intrahepatic circulation of sex hormones. This is manifested, for example, by the acceleration of excretion and a decrease in the concentration of ethinylestradiol. Studies on the interaction of norgestimate and ethinyl estradiol with ampicillin and co-trimoxazole have shown that the pharmacokinetic parameters of the contraceptive vary insignificantly. With the joint use of Tri-Linyah and antibiotics such as rifampicin and griseofulvin, pregnancy may occur, so a woman shoud use additional non-hormonal contraceptive methods while taking the mentioned antibiotics.
Preparations increasing the concentration of sex hormones contained in Tri-Linyah:
The concentration of sex hormones may be decreased by the following drugs and products:
- inhibitors of CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, fluconazole);
- ascorbic acid;
- inhibitors of HMG-CoA reductase (atorvastatin, rosuvastatin);
- grapefruit juice.
The effect of Tri-Linyah on other medicinal products:
Birth control pills can cause an increase in the concentration of following preparations in a blood plasma:
Birth control pills can cause a decrease in the concentration of following preparations in a blood plasma:
- clofibric acid;
- salicylic acid;
Combination oral contraceptives can cause changes in hormonal parameters and liver function parameters:
- increase prothrombin levels and factors II, VII, VIII, IX, X, XII, XIII;
- decreases the level of antithrombin 3;
- increase the platelet aggregation caused by norepinephrine;
- increase the concentration of thyroxine-binding globulin;
- increase the serum content of other binding proteins may be increased.
- increase the levels of globulins that bind sex hormones;
- increase high-density lipoprotein and total cholesterol levels;
- increase or decrease low-density lipoprotein cholesterol levels;
- decrease glucose tolerance;
- decrease serum folate concentrations. This change can be important from a clinical point of view if a woman becomes pregnant soon after the drug cancelation.
Pregnancy and breastfeeding
Tri-Linyah is contraindicated for use in pregnant women.
Epidemiological studies have not revealed an increase in the risk of birth defects in children whose mothers have taken combination oral contraceptives before the pregnancy. Most studies have not revealed teratogenic effects, in particular, heart abnormalities and limb shortening, in offspring of women who mistakenly took the drug during pregnancy.
Birth control pills can affect lactation, i.e. reduce the amount and change the composition of breast milk. In addition, a small portion of contraceptive steroids and / or their metabolites can enter breast milk. In this regard, the drug is contraindicated in the period of breastfeeding.
What if I miss a pill?
Try not to miss doses because this increases the risk of becoming pregnant. If you miss a pill, follow the given instructions.
- If you miss 1 tablet in the 1st, 2nd or 3rd rows, take 2 tablets a day as soon as you remember about your mistake. Then take 1 tablet a day at your usual time.
- If you miss 2 pills in a row in the 1st or 2nd weeks, take 2 tablets a day for 2 next days. Then continue taking 1 tablet daily at your usual time until the package is finished. You need to use additional contraceptive methods for the next 7 days.
- If you miss 2 pills in a row in the 3rd week, discard the rest of the tablets and start a new Tri-Linyah package on the same day.
- If you miss 3 pills in a row in the 1st, 2nd or 3rd rows, discard the rest of the tablets and start a new Tri-Linyah package on the same day.
- If you miss an inactive pill, just throw it away it and continue taking 1 tablet at your usual time until the package is finished. If you miss an inactive tablet, you do not need to use additional contraceptives.
If you miss 2 or more active tablets (with hormones), you may not have menstruation in this period. If you do not have menstruation for 2 months in a row, you need to see your doctor, because you may be pregnant.
The drug DOES NOT PROTECT women from HIV infection (AIDS) and other sexually transmitted diseases.
Before using birth control pills, it is recommended to undergo a thorough physical examination. Examinations should be periodically repeated in accordance with the standards of quality gynecological care.
Before using the drug, you need to get acquainted with the information contained in the leaflets-inserts to the preparation.
If you have an undiagnosed, stable or repeated vaginal bleeding, you need to exclude a malignant tumor.
Combination oral contraceptives can be used 3 months after hepatitis (in severe cases after 6 months) after the functional hepatic tests become normal.
Thromboembolic and other vascular complications:
There is data that combination oral contraceptives can increase the risk of thromboembolic complications and thromboses. The risk of thromboembolic complications associated with the use of the drug does not depend on the duration of treatment and disappears after the drug cancelation.
Women taking birth control pills have an increased risk of postoperative thromboembolic complications.
If possible, the use of tablets should be discontinued at least 4 weeks before a scheduled operation that is associated with an increased risk of thromboembolism, and also during prolonged immobilization and during the recovery period.
Smoking over the age of 35, hypertension, hyperlipidemia, obesity, diabetes, preeclampsia in the history increase the risk of arterial thrombosis (stroke, myocardial infarction). The risk of vascular complications may be less when using combination oral contraceptives containing lower doses of estrogen and progestogen.
The risk of serious cardiovascular complications increases with age and in smoking women. Therefore, women who use Tri-Linyah should stop smoking.
In some cases, the preparation can increase blood pressure. The risk increases with age. Many women were able to normalize their blood pressure after the drug cancelation.
Women with stable arterial hypertension should normalize blood pressure before using the contraceptive. If a woman has a strong increase in blood pressure, birth control pills should be withdrawn.
There are reports of the onset of retinal thrombosis associated with the use of the medication.
The use of tablets should be discontinued in case of unexplained vision disorders (loss of vision), edema of the nipple, changes in the vessels of the retina, the appearance of a veil before your eyes or diplopia. In such situations, you need to see a doctor immediately.
Benign and malignant liver tumors occur very rarely. The risk of these tumors can increase with the use of combination oral contraceptives and depends on the duration of treatment. A rupture of benign adenomas of the liver can cause internal bleeding that may be fatal.
Women who use birth control pills may have intermenstrual bleeding, spotting or amenorrhea, especially during the first 3 months of taking the contraceptive. It’s necessary to consider non-hormonal causes of these menstrual disorders and, if necessary, undergo diagnostic procedures to exclude a tumor or pregnancy.
Some women may have amenorrhea or oligomenorrhea during the first 3 months of taking the contraceptive, especially if these conditions were observed in the past.
If you have a migraine or an unusual, severe headache, you should discontinue taking the tablets and see a doctor.
Cancer of the genitals and mammary glands:
The incidence of breast, endometrial, ovarian and cervical cancer in women using oral contraceptives has been the subject of numerous epidemiological studies. There are conflicting results, but most studies have shown that the use of combination oral contraceptives is not associated with a general increase in the risk of breast cancer. Some authors reported an increase in the relative risk of breast cancer, especially in young women. This increased relative risk depends on the duration of taking oral contraceptives. It is not possible to determine whether the increased risk is due to earlier diagnosis of breast cancer in women who have ever used sex hormones, the biological effects of hormonal contraceptives, or a combination of these two factors. The age at which women stops taking the tablets may be an important risk factor for breast cancer: the older the age, the more often breast cancer is diagnosed.
Before using the drug, it is necessary to consider a possible increased risk of breast cancer and weight this risk and the benefits of using Tri-Linyah.
Some studies revealed that prolonged hormonal contraception is accompanied by an increased risk of neoplasm of the cervix. The link of these data with the use of birth control pills has not been confirmed.
The medication can cause chloasma, in particular in women who had chloasma during the previous pregnancy. Women who are predisposed to chloasma should avoid exposure to sun and ultraviolet radiation while using the medication. Chloasma may not disappear completely.
Preparations based on ethinyl estradiol and norgestimate can reduce glucose tolerance. This effect depends on the dose of estrogen. In addition, progestogen can increase insulin secretion and cause insulin resistance. Women without diabetes are unlikely to experience changes in blood glucose levels. Women with impaired glucose tolerance or diabetes mellitus should be monitored while taking combination oral contraceptives.
A small percentage of women taking Tri-Linyah experience persistent hypertriglyceridemia. Some women taking the drug reported changes in serum triglyceride and lipoprotein levels.