Tri-Sprintec is a triphasic hormonal contraceptive drug containing norgestimate and ethinyl estradiol. It is produced by Teva Pharmaceuticals USA to protect women from unplanned pregnancies.
Indications for use
Mechanism of action
This birth control preparation is a combined hormonal contraceptive which the main effect is achieved by means of several mechanisms. The ovulation is inhibited by the gonadotropic substance release. Tri-Sprintec arrests the process of the egg maturation. As a result, the ovulation is suppressed and fertilization is excluded.
Hence, this preparation increases cervical mucus viscosity. This process contributes to the processing of the spermatozoa through the fallopian tubes. It becomes difficult for a fertilized egg to stick to the uterine cavity.
Mode of application and dosage
The package contains 28 pills. Tri-Sprintec should be taken daily within this 28-days regimen. A 7-day break is not mandatory. 7 last pills contain placebo or Ferrum. If the menstruation doesn’t come the possibility of the pregnancy should be excluded.
Tri-Sprintec is contraindicated in the following health conditions (even if they were observed for the first time during the hormonal contraceptives application):
- venous or arterial thrombosis diagnosed or suspected including в том числе DVT, thromboembolism of pulmonary artery, myocardial infarction;
- any of cerebrovascular dysfunctions;
- the conditions as a sign of thrombosis or thromboembolism: diagnosed or suspected;
- inherited or acquired predisposition to the any of the mentioned above conditions: diagnosed or suggested;
- complicated heart valve dysfunctions, arterial fibrillation disorders; blood vessels of the brain disorders; uncontrollable arterial hypertension; dislipoproteinemia of a severe form, diabetes mellitus; smoking if your age is over 35; excessive weight; major trauma;
- liver decompensation;
- hepatic tumors: diagnosed ;
- severe hepatic insufficiency;
- paranephric insufficiency;
- pancreatitis: diagnosed or suggested;
- vaginal hemorrhages of unknown etiology;
- diagnosed or suggested pregnancy;
- lactation period;
- any kind of allergy or hypersensitivity to drug components.
- Be cautious when applying this birth control pills in the following conditions:
- predisposition to thrombosis or thromboembolism: smoking, myocardial infarction or cerebral circulation dysfunction at a young age at any of your family members or close relatives;
- inherited Quincke’s edema;
- the disorders appeared on the background of the pregnancy;
- after-labor period.
- Cardiovascular system: arterial hypertension, myocardial infarction, brain circulation disorders, deep vein thrombosis, arterial thromboembolism, edema of various etiology.
- Tumors: hepatic benign malignant neoplasms, cervix carcinoma and mammary gland neoplasms.
- Hepatobiliary system: Cholestatic icterus, Chiari syndrome, вintrahepatic cholestasis.
- Digestive Tract: nausea, vomiting, abdominal pain, gaseous distention, colitis.
- Genital system: spotting, breakthrough bleeding, amenorrhea, menstrual cycle changes, uterine fibroid increase in size, vaginal candidiasis, increase in cervical secretion, cervical ectropion, the decrease in libido, premenstrual syndrome, temporary infertility when taking the medication;
- Mammary glands: pain and tendernessя, galactorrhea, increase in volume, decrease in lactation during premenstrual syndrome.
- Skin: nodal fever, rash, chloasma, erythema multiforme, acne, seborrhea, alopecia, hirsuties, pigmentation on the face skin, trichauxis, pemphigoid, melanoderma.
- Vision organs: cataract, oculomotor nerve damage, curvature chamfer change, discomfort when putting the contact lenses.
- Central nervous system: headache, mood changes, irritation, depressed state, chorea minor.
- Metabolic system: fluid retention, change of the body mass, glucose intolerance, change of appetite.
- Renal system: decrease in renal function, hemolytic-uremic syndrome.
- Others: dizziness, migraine.
Drugs that induce the induction of enzymes that metabolize estrogens (eg, estrogen-2-hydroxylase-coenzyme 3A4 of the cytochrome P-450 system), reduce the contraceptive effectiveness of hormonal drugs. The induction of these same isozymes can lead to a decrease in the blood concentration of the progestogen component. Potentially clinically relevant in this respect are drugs and plant substances that affect the enzymes involved in the biological transformation of contraceptive steroid hormones (eg, St. John’s Wort, barbiturates, carbamazepine, phenytoin, sulfonamides, pyrazolone derivatives, rifampicin).
It has been proved that some protease inhibitors and some antiretroviral drugs increase (for example, indinavir) or reduce (for example, ritonavir) the concentration of combined hormonal contraceptives in the plasma.
Another type of interaction is the violation of intrahepatic circulation of estrogens, as a result of which the excretion is accelerated and the concentration of ethinyl estradiol is reduced. When co-administered with certain antibiotics (eg, ampicillin or tetracycline) takes place, insufficient cleavage of conjugates of estrogens and fatty acids by intestinal bacteria is observed.
What if I miss a dose?
If a woman skips the habitual time of admission, the tablet should be taken immediately. The delay of the habitual admission time up to 12 hours provides a reliable contraceptive effect. The effectiveness of the drug decreases with a delay in admission time for more than 12 hours. If more than 12 hours have passed since the habitual time of the drug administration or if more than one pill is skipped, Tri-Sprintec should be immediately renewed leaving a skipped tablet in the package. However, before the end of this cycle, additional means of contraceptive, such as a condom or vaginal contraceptive suppositories, should be used. In such situations, one cannot rely on the method of “safe days” or “temperature” method of contraception.
Tri-Sprintec and pregnancy
Tri-Sprintec is contraindicated during pregnancy and breastfeeding. The possibility of pregnancy should be excluded in any woman in a reproductive age in the presence of a characteristic of pregnancy symptoms, especially in those who did not follow all the instruction for the drug use.
If your menstruation doesn’t come within a flexible period of 4 weeks, if there is a morning weakness, drowsiness the pregnancy should be excluded or proved.
If the patient plans a pregnancy, she may withdraw Tri-Sprintec at any time. If the patient simultaneously takes potentially harmful to the fetus (teratogenic) drugs and therefore needs a pregnancy prevention, the decision on the possibility of withdrawing the drug may be taken only after consultation with the doctor.
If pregnancy is diagnosed during birth control drug application, the drug should be immediately discontinued. However, extensive epidemiological studies have not discovered any magnified risk of developmental dysfunctions in children born to women who received sex hormones (including COCs) before pregnancy, or teratogenic effects, when sexual hormones were mistakenly taken for early pregnancy.