Isibloom is an oral contraceptive containing desogestrel and ethinyl estradiol indicated for the prevention of pregnancy.
Indications for use
- Oral contraception.
Mechanism of action
Isibloom is a combination oral contraceptive which inhibits the synthesis of gonadotropins and suppresses ovulation. In addition, the movement of spermatozoa through the cervical canal slows down, and a change in the state of the endometrium prevents the implantation of a fertilized egg. Ethinyl estradiol is a synthetic analogue of endogenous estradiol, desogestrel has a pronounced gestagenic and antiestrogenic action, similar to endogenous progesterone, weak androgenic and anabolic activity. The drug has a beneficial effect on lipid metabolism: it increases the concentration of high-density lipoprotein in the blood plasma without affecting the content of low-density lipoprotein. The drug reduces the amount of blood loss during menstrual bleeding (with initial menorrhagia), normalizes the menstrual period, has a beneficial effect on the skin (especially in acne vulgaris).
Dosage and mode of application
Isibloom contains 21 active pills each containing desogestrel and ethinyl estradiol and 7 inert pills (hormone-free).
Tablets are taken orally, from the first day of the period. Take 1 tablet a day for 28 days, if possible at the same time of day. After taking the last active tablet, you will l have a menstrual-like bleeding as a result of the withdrawal of the drug. Begin a new package without making a break (on the same day of the week). This pill regimen is followed as long as there is a need for contraception. When complying with the rules of admission, the contraceptive effect is maintained for 7 hormone-free days.
In the case of an overdose, you may experience nausea, vomiting, spotting. The drug does not have a specific antidote, treatment is symptomatic. If overdose symptoms occur in the first 2-3 hours after taking a tablet, gastric lavage may be indicated.
If you have the following side effects after taking Isibloom, you should stop using the drug:
- arterial hypertension;
- hemolytic uremic syndrome;
- loss of hearing due to otosclerosis.
Rare side effects:
arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism);
exacerbation of reactive systemic lupus erythematosus.
Very rare side effects:
arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins;
Chorea Sydenham (passing after the abolition of the drug).
Other side effects are less severe but more common. The feasibility of continuing hormonal contraception is decided individually by a doctor, based on the benefit/risk ratio:
- Reproductive system: acyclic bleeding from the vagina, amenorrhea after withdrawal of the drug, a change in the state of vaginal mucus, inflammatory processes of the vagina (eg: candidiasis);
- Mammary glands: tension, pain, enlargement of the mammary glands, galactorrhea;
- Gastrointestinal and hepatobiliary system: nausea, vomiting, Crohn’s disease, ulcerative colitis, the occurrence or worsening of jaundice and / or itching associated with cholestasis, cholelithiasis;
- Skin: nodular/exudative erythema, rash, chloasma;
- Central nervous system: a headache, migraine, mood changes, depressive states;
- Metabolic disorders: fluid retention in the body, change (increase) in body weight, decrease in tolerance to carbohydrates;
- Eyes: increased sensitivity of the cornea when wearing contact lenses;
- Other: allergic reactions.
Isibloom is contraindicated for use in the presence of the following conditions/diseases:
- pregnancy or suspicion of it;
- severe and/or multiple risk factors for venous or arterial thrombosis (including moderate to severe arterial hypertension with a blood pressure of 160/100 mm Hg or more);
- precursors of thrombosis (including transient ischemic attack, angina), including a history;
- a migraine with focal neurologic symptoms, including a history;
- venous or arterial thrombosis/thromboembolism (deep vein thrombosis of the tibia, pulmonary embolism, myocardial infarction, stroke), including a history, venous thromboembolism in relatives;
- diabetes mellitus (with angiopathy);
- pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia;
- severe liver disease,
- cholestatic jaundice (including during pregnancy),
- hepatitis, including a history;
- jaundice due to the intake of LC containing steroids;
- cholelithiasis, including a history;
- Gilbert’s syndrome, Dubin-Johnson syndrome, Rotor syndrome;
- liver tumors (including in the anamnesis);
- severe itching, otosclerosis, or progression of otosclerosis during a previous pregnancy or while taking glucocorticosteroids;
- hormone-dependent malignant neoplasms of the genital organs and mammary glands (including a suspicion of them);
- vaginal bleeding of unknown etiology;
- smoking over the age of 35 (more than 15 cigarettes per day);
- individual hypersensitivity to desogestrel/ethinyl estradiol or other components of the drug.
Conditions that increase the risk of venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, a family history, obesity (body mass index more than 30 kg / m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, fibrillation auricles, prolonged immobilization, extensive surgery, surgery on the lower limbs, severe injury, varicose veins and superficial thrombophlebitis, the postpartum period, severe depression (including a history), changes in biochemical parameters (resistance of activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C or S, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant); diabetes mellitus not complicated by vascular disorders, systemic lupus erythematosus, Crohn’s disease, ulcerative colitis, sickle cell anemia; hypertriglyceridemia (including a family history), acute and chronic liver disease.
- Drugs that induce hepatic enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, and drugs containing St. John’s wort, reduce the effectiveness of oral contraceptives and increase the risk of bleeding. The maximum level of induction is usually achieved not earlier than 2-3 weeks but can last up to 4 weeks after the drug discontinuation;
- Ampicillin, tetracycline may reduce efficacy (interaction mechanism is not established). With joint use, it is recommended to use an additional barrier method of contraception during the entire course of treatment and for 7 days (for rifampicin – 28 days) after discontinuation of the drug;
- Oral contraceptives can reduce carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.
Pregnancy and breastfeeding
Use of Isibloom during pregnancy and breastfeeding is contraindicated.
What if I miss a pill?
If the delay in taking an active pill is no more than 12 hours, you should take the missed pill and then continue taking pills at the usual time. If the delay exceeds 12 hours, then contraceptive reliability in this period is not guaranteed and you need to use additional contraceptive methods.
When missing 1 tablet In the first or second week of the period, it is necessary to take 2 tablets the next day and then continue regular intake, using additional contraceptive methods until the end of the period. When skipping 1 tablet in the third week of the period, in addition to the measures listed, you should skip 7 inert tablets and start a new package.
Missing active pills increases the likelihood of ovulation and/or bleeding, so in such cases, it is recommended to use additional methods of contraception. If you missed any inert tablets, you may throw them away since they do not contain any medication.
When using Isibloom for birth control, medical supervision is required at least every 6 months. After suffering viral hepatitis, use of the drug is possible no earlier than after 6 months (with normalization of liver function).
In the case of vomiting or diarrhea, the use of a barrier method of contraception is required.
When using oral hormonal contraceptives, you should stop smoking (increased frequency of thromboembolism of different localization, especially in women over 35 years of age).
The drug (ethinyl estradiol/desogestrel) cannot be used by men.
Since the drug can be potentially dangerous for certain groups of patients, it is necessary to inform your doctor about pregnancy, breastfeeding, the presence of allergies and other diseases (see “Contraindications”), as well as the use of any other medicines, nutritional supplements and herbal medicines.
If you experience an allergic reaction or a hypersensitivity reaction, you should immediately seek medical attention.