Norlyda is a hormonal contraception containing progestin only. The package contains 28 pills aiming at protecting from unwanted pregnancy.
Indications for use
Mechanism of action
Pharmacological action – contraceptive.
Norethisterone is the new progestin preparation of the third generation. It quickly and completely turns into levonorgestrel and its derivatives in the intestine and liver. In comparison with levonorgestrel, norethisterone has a less expressed gestagenic effect, and therefore the less significant effect on the lipid spectrum. It is doubtful that the creation of norgestimate is a significant advance in the improvement of progestin hormone because the biological effect is encouraged by its metabolites, the same levonorgestrel and, mainly, 13-beta-oxime.
Mode of application and dosage
Norlyda is taken once a day at one and the same time. The dosage is 0.35 mg. This birth control pills should be washed down with a full glass of water. The course is 28 days. The break is not required. When you start taking placebo pills the menstruation will come. When the first package is completed start a new one the second day.
- Thromboembolism (clotting of blood vessels);
- Thrombophlebitis (vein walls inflammation with forthcoming obstruction);
- Disordered cerebral circulation;
- Hepatic disorders;
- Disordered liver function;
- Vaginal hemorrhages of an unclear etiology;
- Hormone-dependent tumors, including the mammary gland tumors.
- Cardiovascular system: high blood pressure, myocardial infarction, disorders of cerebral circulation, deep vein thrombosis, arterial thromboembolism, thromboembolism of pulmonary or other vessels, edema.
- Tumors: benign and malignant hepatic tumors, cervical and breast cancer.
- Hepatobiliary system: cholestatic jaundice, Budd-Chiari syndrome, intrahepatic cholestasis, cholelithiasis.
- Gastrointestinal tract: nausea, vomiting, abdominal pain, flatulence, colitis.
- Genital organs: intermenstrual bleeding, spotting, amenorrhea, menstrual cycle swings, increased uterine fibroids, vaginal candidiasis, increased cervical secretion, cervical erosion, decreased libido, premenstrual syndrome, temporary infertility after the withdrawal of the preparation.
- Thoracic glands: soreness and sensation of tension, galactorrhea, tenderness, increase in size, reduction of lactation when taken immediately after birth.
- Skin condition: erythema nodosum, rash, chloasma, exudative erythema, acne, seborrhea, alopecia, hirsutism, pigmentation on the face, hypertrichosis, bullous disease (gestational herpes), chronic melasma.
- The organs of vision: cataracts, lesions of the eye nerve, curvature chamfer of the cornea, a feeling of discomfort when wearing contact lenses.
- Central nervous system: headache, mood changes, irritability, depression, chorea.
- Metabolism: fluid body retention, changes in body weight (decrease or increase), decreased glucose tolerance, changes in appetite.
- Renal System: decreased kidney function, hemolytic-uremic syndrome.
- Others: dizziness, migraine.
Drugs that inhibit the enzymes that metabolize estrogens (eg, estrogen-2-hydroxylase-coenzyme 3A4 of the cytochrome P-450 system), contribute to the reduction of hormonal drugs’ contraceptive effect. It is also possible that induction of these same isozymes can lead to a decrease in the blood concentration of the progestogen component. Potentially clinically relevant in this respect drugs and herbal supplements 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 discovered that some protease inhibitors and some antiretroviral drugs increase (for example, indinavir) or decrease (for example, ritonavir) the concentration of combined hormonal contraceptives in the blood.
Another type of interaction is the violation of intrahepatic circulation of estrogens, as a result of which the excretion is accelerated. When co-administered with certain antibiotics (eg, ampicillin or tetracycline), insufficient cleavage of conjugates of estrogens and fatty acids by intestinal bacteria is observed.
What if I miss a dose?
If you miss a dose of an inactive pill you may throw it away. It has no influence on the ovulation suppression. But if you miss an active pill you should estimate the time period when it happens:
- if less than 12 hours have passed you should take the pill immediately. The additional contraception is not mandatory because the contraceptive effect is not reduced;
- if more than 12 hours have passed the pill should be taken immediately even if 2 pills are taken in a raw. The contraceptive effect is reduced that’s why it is better to apply additional contraceptive methods.
Norlyda and pregnancy
Norlyda is contraindicated in pregnant women.
There were conducted epidemiological studies which have not discovered an increase in the risk of birth defects. The developmental defects were not defined in children whose mothers were taking contraceptives in the early stage of the pregnancy.
Combined oral contraceptives can influence lactation, i.e. decrease its volume and change the breast milk composition. Additionally, a small portion of contraceptive steroids and/or their metabolites can enter breast milk. In connection with this, Norlyda is contraindicated in the period of breastfeeding.