Loestrin 24 Fe is a birth control medication containing norethindrone and ethinyl estradiol. The placebo pills are comprised of ferrous fumarate. The main aim of this medication is the ovulation suppression resulting in absence of unwanted pregnancy.
Indications for use
- Uterine hypoplasia.
Mechanism of action
Loestrin 24 Fe is a contraceptive agent. It is a combined highly-dosed estrogen-progestin drug. It suppresses pituitary secretion of gonadotropic hormones. The contraceptive effect is achieved due to the blocking effect of the progestin and estrogenic components on the hypothalamic-pituitary-ovarian system. The estrogen component is the highly effective synthetic analog of the follicular hormone -estradiol, which participates in the menstrual cycle with the yellow body hormone (progestin, gestagen). The gestagenic component is norethisterone acetate, which inhibits the synthesis of LH and FSH by the pituitary and thus, blocks ovulation. Due to the combination of estrogen with gestagen, the drug under the appropriate use pattern can both stimulate and delay menstruation helping stop acyclic uterine hemorrhages.
Mode of application and dosage
The drug should be taken both in the usual mode (“24 + 4” pattern mode: during 24 days the intake of active tablets, then for 4 days – the reception of inactive tablets containing ferrous fumarate), and in a flexible mode.
Adaptable elongated mode (flexible mode) is based on the previously approved regimen of the drug looking like “24 + 4” and is that the active Loestrin 24 Fe tablets can be taken daily continuously for up to 120 days. Thus, the continuous period of active tablets intake can be 24-120 days, and the duration of a break in taking the tablets should not exceed 4 days. The results of a comparative, open, randomized study in parallel groups showed that the flexible regimen aimed at achieving a maximum duration of intervals without menstruation to 120 days, reduced the total number of menstruation days in a year from 66 (24 + 4 regimen) to 41 day (“flexible” reception mode).
- Hepatic insufficiency;
- Congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome);
- Hepatic tumors (hemangioma, liver cancer);
- Thromboembolism (including history and increased risk of its development);
- Cerebral circulation disorders (ischemic stroke, hemorrhagic stroke);
- Ischemic heart disease;
- Cardiac disorders;
- Diabetes mellitus;
- Sickle cell anemia;
- Breast and endometrial cancer;
- Endometrial hyperplasia;
- Fibroadenoma milk black fever;
- Fat metabolism disorders;
- Jaundice or pruritus during a former pregnancy;
- Otosclerosis with worsening during pregnancy;
- Age group over 40.
Precautions include the following conditions:
- Gallbladder and hepatic diseases;
- Ulcerative colitis;
- Uterine fibroids;
- Multiple sclerosis;
- Varicose veins;
- Renal disorders;
- Adolescence (without regular ovulatory cycles).
Infectious and parasitic disorders
Infrequently: candidiasis of the oral mucosa, vaginal candidiasis, herpes simplex.
Immune system disorders
- Infrequent: allergic reactions;
- Rarely: bronchial asthma;
- Frequency is unknown: hypersensitivity reactions.
Blood and lymphatic system
Rarely: anemia, thrombocytopenia.
- Often: emotional lability;
- Infrequently: depression, nervousness, sleep disorder;
- Rarely: anorgasmia.
Nervous system dysfunctions
- Often: headache;
- Infrequently: paresthesia, dizziness, migraine;
- Rarely: tremor.
Infrequent: conjunctivitis, dry eye syndrome, visual impairment.
Rarely: hearing loss.
Infrequently: extrasystoles, tachycardia.
- Infrequent: pulmonary embolism, increased blood pressure, lower blood pressure, varicose veins;
- Rarely: arterial and venous thromboembolism, fainting.
Respiratory system, chest and mediastinal organs disturbances
Gastrointestinal tract disorders
- Often: nausea;
- Infrequent: vomiting, gastroenteritis, diarrhea;
- Rarely: constipation, abdominal pain, bloating.
Hepatic system disorders
Skin and subcutaneous tissues
- Infrequent: itchy skin, rash, seborrhea, acne;
- Rarely: alopecia, dry skin, eczema, photodermatitis, acneiform dermatosis, hypertrichosis, striae, nodal erythema, erythema multiforme.
Musculoskeletal and connective tissue
Infrequent: pain in the neck, in the extremities, in the lumbar region; muscle cramps.
Disorders from the renal and urinary tract
Violations of the genitals and mammary gland
- Often: pain in the mammary glands, tenderness of the mammary glands, metrorrhagia, an absence of menstrual bleeding;
- Infrequently: neoplasms of the mammary glands, galactorrhea, ovarian cyst, “hot flashes”, leucorrhoea, dry vaginal mucosa, pelvic pain, pap smear changes, decreased libido, mammary glands, painful menstrual bleeding, scanty menstrual-like bleeding;
- Rarely: fibrocystic mastopathy, vaginitis, cervical polyp, cervical neoplasia, endometrial atrophy, copious menstrual bleeding, dyspareunia, postcoital bleeding, bleeding “cancellation”, enlargement of the uterus.
Endocrine system dysfunctions
Very rarely: changes in glucose tolerance or influence on insulin resistance.
General health disorders
- Often: weight gain;
- Infrequent: increased appetite, weight loss, anorexia, edema, asthenia, excessive thirst, sweating.
Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin) are able to enhance the metabolism of the steroid hormones that are a part of the drug.
Reduction of the concentration effect in the main aim achievement is observed with simultaneous use with certain antibiotics (ampicillin, rifampicin), which is associated with a change in the microflora in the intestine.
The contraceptive effect reduces in case of regular excessive use of ethanol.
What if I miss a dose?
If you miss a dose follow the recommendations given on the blister. If you miss a dose within the first 12 days of the menstrual cycle, you should apply the tablet at the moment of this idea realization. The additional methods of contraception may not be used.
If you understand you miss a pill within more than 12 days apply the drug immediately if 2 pills at once are taken. The additional means for birth control should be applied.
Loestrin 24 Fe and pregnancy
Loestrin 24 Fe is contraindicated for use during pregnancy. When a pregnancy is diagnosed at the moment of this preparation application, you must immediately discontinue the drug. The carried out epidemiological trials discovered neither an increase in the risk of birth defects in children born to mothers who had taken hormonal contraceptive drugs before the diagnosed pregnancy, or a teratogenic effect when they were negligently taken early in pregnancy.
The available data on the use of the drug during pregnancy are too limited and do not allow to draw a conclusion about its negative effect on pregnancy or on the health of the fetus or newborn.
Loestrin 24 Fe is contraindicated during the lactation period. It can decrease the amount of breastmilk and change its quality. A small number of sex hormones and/or their metabolites can penetrate into breast milk and, possibly, can affect the baby’s health.