Bonade

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Bonade: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Bonadea

ATX code: G03AA

Active ingredient: ethinylestradiol (Ethinylestradiol), dienogest (Dienogest)

Manufacturer: Zentiva, c.s. (Zentiva, ks) (Czech Republic); Haupt Pharma Munster, GmbH (Germany)

Description and photo update: 2019-26-08

Prices in pharmacies: from 300 rubles.

Buy

Bonade is a monophasic oral combined estrogen-gestagenic contraceptive drug.

Release form and composition

Dosage form Bonade - film-coated tablets: shape - round, biconvex; color - white (21 pcs. in blisters, 1 or 3 packs in a cardboard box).

Active ingredients in 1 tablet:

ethinylestradiol - 0.03 mg;
dienogest - 2 mg.

Additional substances:

core: magnesium stearate - 0.8 mg; lactose monohydrate - 57.17 mg; povidone 30LP - 3 mg; corn starch - 12 mg; sodium starch glycolate - 5 mg;
shell: aquapolish white 014.17 МС (hydrogenated cotton seed oil - 5%; hypromellose - 48%; hydroxypropyl cellulose - 12%; titanium dioxide - 15%; talc - 20%) - 9 mg.

Pharmacological properties

Pharmacodynamics

Bonade is a combined monophasic low-dose estrogen-progestogen oral contraceptive, the effectiveness of which is mainly based on a combination of suppressing ovulation and increasing the viscosity of cervical secretions.

The gestagenic component of the contraceptive - dienogest, a derivative of nortestosterone, has an antiandrogenic effect and improves the lipid profile, increasing the content of high density lipoproteins (HDL).

With regular use of combined oral contraceptives (COCs), the menstrual cycle is regulated, painful periods are less common, and the duration and intensity of bleeding decreases.

Pharmacokinetics

The main pharmacokinetic characteristics of dienogest:

absorption: after oral administration, dienogest is rapidly and almost completely absorbed. The indicator of its maximum concentration (Cmax = 51 ng / ml) in blood plasma after administration is achieved after 2.4 ± 1.4 hours. Bioavailability (in combination with ethinylestradiol) is about 96%;
distribution: dienogest binds up to 90% to serum albumin and does not bind to specific transport proteins - SHBG (sex hormone-binding globulin) and CGG (corticosteroid-binding globulin). As a result, any effect of the drug on the physiological processes of the transport of endogenous steroids is unlikely. The increase in SHBG levels induced by ethinylestradiol does not affect the binding of dienogest to serum proteins. Equilibrium concentration (Css) is reached approximately on the 5th day of therapy, taking the drug increases the level of dienogest in the blood plasma 1–5 times daily, the concentration of SHBG does not affect the pharmacokinetics of the substance;
metabolism: the main metabolic pathway of dienogest is hydroxylation, but partly the substance is also metabolized through conjugation, hydrogenation and aromatization, as a result of which inactive metabolites are formed;
excretion: the total clearance rate after a single oral dose is 3.6 l / h. The half-life (T _1/2) of dienogest is from 8.5 to 10.8 hours. An insignificant amount is excreted by the kidneys unchanged, the main dose is excreted in the form of metabolites by the kidneys and with bile in a ratio of 3 ÷ 1. For metabolites, T _1/2 = 14.4 hours.

The main pharmacokinetic characteristics of ethinyl estradiol are:

absorption: after oral administration, ethinyl estradiol is absorbed quickly and completely. Cmax = 67 ng / ml is achieved in blood plasma 1.5–4 hours after administration. When absorbed, ethinyl estradiol undergoes presystemic elimination in the liver and is metabolized, so its average bioavailability after oral administration is only 44%;
distribution: up to 98% of ethinyl estradiol non-specifically binds to albumin; ethinylestradiol is an inducer of SHBG synthesis. The fixed volume of its distribution (Vd) is 2.8-8.6 l / kg. Css is achieved in the second half of the treatment cycle, when serum drug levels are 2 times higher than those for a single dose;
metabolism: ethinylestradiol is subject to first-pass conjugation both in the liver and in the mucous membrane of the small intestine. The main metabolic pathway is aromatic hydroxylation, followed by conjugation with glucuronic (sulfuric) acids;
excretion: the metabolic clearance of ethinylestradiol from blood plasma varies within the range of 2.3-7 ml / min / kg. Its plasma concentration decreases in two phases: for the first, T _1/2 is about 1 hour, for the second - from 10 to 20 hours. Metabolites are excreted by the kidneys and liver in a ratio of 4 ÷ 6, T _1/2 = 24 hours. Ethinylestradiol is not excreted unchanged.

Indications for use

contraception;
acne of mild to moderate severity in women who need contraception, in cases of ineffectiveness of other therapeutic methods (use of systemic antibiotics or local treatment) - with a therapeutic purpose.

Contraindications

Absolute:

predisposition to arterial or venous thrombosis (congenital / acquired), namely, resistance to activated protein C, including Leiden factor V, hyperhomocysteinemia, deficiency of antithrombin III, proteins S and C, the presence of antibodies to phospholipids;
arterial / venous thrombosis and thromboembolism, including a burdened history (including deep vein thrombosis, myocardial infarction, pulmonary embolism);
conditions that precede thrombosis (including angina pectoris), including a burdened history;
cerebrovascular disease: stroke, transient ischemic attacks, including a burdened history;
diabetes mellitus, accompanied by vascular complications;
extensive injuries;
obesity (with a body mass index of 30 kg / m ²);
migraine with focal neurological symptoms, including a burdened history;
pancreatitis with severe hypertriglyceridemia, including a burdened history;
the presence of multiple / pronounced risk factors for arterial / venous thrombosis, namely atrial fibrillation, complicated lesions of the valvular apparatus of the heart, diseases of the cerebral vessels or coronary arteries of the heart, severe dyslipoproteinemia, uncontrolled arterial hypertension, serious surgical interventions, surgical interventions performed on the organs of small pelvis and lower extremities, smoking over the age of 35, prolonged immobilization, neurosurgical interventions;
liver failure and severe liver disease (Bonade can be used after normalization of liver enzymes), including Dubin-Johnson and Rotor syndromes;
malignant / benign liver tumors, including a burdened history;
hormone-dependent malignant neoplasms, including neoplasms of the mammary glands or genitals (identified / suspected);
intolerance to galactose, glucose-galactose malabsorption or lactase deficiency (the drug contains lactose);
bleeding from the vagina of unknown etiology;
pregnancy (confirmed / suspected) and breastfeeding period;
individual intolerance to the components of the drug.

Relative (the use of Bonade tablets requires caution in the presence of the following risk factors, diseases and conditions):

hypertriglyceridemia;
diseases that arose for the first time or worsened during pregnancy or against the background of previous use of sex hormones, namely, cholestasis, porphyria, herpes during pregnancy, otosclerosis with hearing impairment, gallbladder disease, jaundice, Sydenham's chorea;
the presence of risk factors for the development of thromboembolism and thrombosis, namely, migraine without focal neurological symptoms, smoking, obesity (with a body mass index of up to 30 kg / m ²), uncomplicated valvular heart disease, arterial hypertension, dyslipoproteinemia, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident in one of the closest relatives at a young age);
angioedema (hereditary);
other diseases that can occur with peripheral circulatory disorders, namely, phlebitis of superficial veins, diabetes mellitus, cancer, sickle cell anemia, Crohn's disease and ulcerative colitis, systemic lupus erythematosus, hemolytic uremic syndrome;
postpartum period.

Bonade is not intended for use in men.

Instructions for use Bonade: method and dosage

Bonade tablets should be taken orally with a little water and swallowed whole. You need to take 1 tablet daily at the same time for a course of 21 days, observing the scheme indicated on the package. After the end of the package, take a break for 7 days, during this period (2-3 days after taking the last tablet from the package), menstrual bleeding usually occurs. At the end of the break, begin the next 21-day course from a new package. Whether the withdrawal bleeding has ended before this time or not does not matter.

Features of the beginning of taking Bonade:

the lack of taking any hormonal contraceptives in the previous month: the first pill is taken on the first day of the natural menstrual cycle (the pill should be marked with the corresponding day of the week). If the reception of Bonade starts from 2-5 days of the cycle, during the first 7 days of the course, it is additionally necessary to use a barrier method of contraception;
switching from other combined oral contraceptives: you should not take a break, Bonade is taken the next day after taking the last pill from the previous package. If the previous package contains inactive tablets (without active ingredient), you can start taking it the next day after taking the last active tablet. It is also possible to start the course after the usual break in use (7 days for medicines that contain 21 tablets) or after taking the last tablet without active ingredients (for medicines that contain 28 tablets in the package);
switching from mini-pills (oral contraceptives containing only gestagen): you can interrupt taking a mini-pill any day, the Bonade course starts the next day, without changing the time of taking the pills. During the first 7 days of the course, additional barrier methods of contraception must be used;
switching from a contraceptive vaginal ring or patch: the course begins on the day they are removed, but no later than the day when a new patch was to be glued or a new ring was introduced;
switching from injectable contraceptives: the course begins on the day when the next injection is to be made;
transition from implants or intrauterine contraceptives (intrauterine device), which release progestogen: the course starts on the day when the implant or intrauterine contraceptive is removed. During the first 7 days of the course, additional barrier methods of contraception must be used;
the period after an abortion in the first trimester of pregnancy or a spontaneous miscarriage: in most cases, Bonade is prescribed immediately (a doctor's consultation is required);
postpartum period: the course begins after the first normal menstrual cycle. Your doctor may recommend that you start taking Bonade earlier.

The contraceptive effect of Bonade is preserved in cases when the delay in taking the next pill is no more than 12 hours. If this period lasts longer, contraceptive protection is reduced. The risk of pregnancy increases with the number of tablets missed in a row, and also the closer this skip is to the beginning or end of the intake.

If you miss more than 1 tablet in a row, you should consult your doctor.

In cases of missing 1 tablet, the following recommendations should be considered:

first week of the course: the pill should be taken as soon as possible, even if you need to take 2 tablets at once. Then Bonade's reception is continued according to the standard scheme. It is recommended to use a barrier method of contraception for 7 days. If there was sexual intercourse within a week before missing the pill, there is a possibility of pregnancy, you should consult your doctor;
second week of the course: the pill should be taken as soon as possible, even if you need to take 2 tablets at once. Then Bonade's reception is continued according to the standard scheme. If during the previous week the dosing regimen was not violated, the contraceptive effect remains, no additional contraceptive measures are needed. Otherwise, as well as in cases of missing 2 or more pills, additional contraceptive measures are required for 7 days;
third week of the course: in cases where the dosage regimen was not violated during the previous week, the Bonade effect does not decrease. In the future, you can adhere to one of two schemes: the missed pill is taken as soon as possible, even if for this you need to take 2 tablets at once, then according to the standard scheme (you should not take a break before taking the drug from the next package; before the end of the second package, withdrawal bleeding is unlikely, however, on the days of taking Bonade, there may be spotting or breakthrough uterine bleeding); they stop taking pills from the current package, take a seven-day break (taking into account the day of admission), after which they start using the drug from a new package.

If during a break in taking Bonade, menstrual bleeding does not occur, pregnancy can be assumed. It is recommended that you consult your doctor before taking the tablets from the next package.

You can stop taking Bonade at any time. If a woman interrupts the course due to a desire to become pregnant, it is recommended to first wait for the first normal menstruation. Using this method, the doctor can more easily determine the expected due date.

Vomiting or diarrhea may affect the absorption of Bonade's active ingredients. If these violations are observed 3-4 hours after taking the pill, the result is equivalent to a pass in taking the drug (in these cases, you must adhere to the relevant recommendations).

In order to delay the onset of menstrual bleeding, tablets from a new package must be taken without a seven-day break. With strict adherence to the drug regimen, withdrawal bleeding usually occurs regularly every 4 weeks. If there is a need to change these days, you need to shorten (but not prolong) the next break in taking pills.

For patients under 18 years of age, Bonade can be prescribed only after the onset of menarche.

The drug should not be taken after menopause.

Side effects

During the period of Bonade's therapy, especially during the first months of use, there may be the development of irregular bleeding (in the form of spotting bleeding or breakthrough uterine bleeding).

Other probable violations (very often -> 1/10; often -> 1/100, 1/1000, 1/10 000, <1/1000; very rarely - <1/10 000, taking into account individual cases; with an unspecified frequency - if it is impossible to assess the incidence of adverse reactions):

hematopoietic system: rarely - anemia;
nervous system: often - headache; infrequently - migraine, dizziness; rarely - cerebrovascular disorders, ischemic stroke, dystonia;
cardiovascular system: infrequently - change (increase / decrease) in blood pressure; rarely - thrombophlebitis, cardiovascular disorders, venous / arterial thrombosis and thromboembolism, increased diastolic pressure, orthostatic circulatory dystonia, hot flashes, venous disease, varicose veins, pain along the veins, tachycardia;
endocrine system: rarely - virilism;
respiratory system: rarely - hyperventilation, bronchial asthma;
digestive system: infrequently - vomiting, abdominal pain, bloating, discomfort, nausea, diarrhea; rarely - enteritis, gastritis, dyspeptic symptoms;
musculoskeletal system: rarely - myalgia, pain in the back and extremities, discomfort in the skeleton and muscles;
immune system: rarely - allergic reactions;
metabolism and nutrition: infrequently - increased appetite; rarely - anorexia;
psyche: rarely - depression; very rarely - mood changes; with unspecified frequency - aggressive behavior, insomnia, low mood, sleep disturbances;
organ of vision, hearing and labyrinth disorders: rarely - oscillopsia, dryness of the mucous membrane of the eyes, irritation of the mucous membrane of the eyes, dizziness, tinnitus, sudden hearing loss, hearing impairment; with an unspecified frequency - discomfort when wearing contact lenses;
infections and parasitic diseases: infrequently - vulvovaginitis, vaginitis, vaginal candidiasis or other vulvovaginal fungal infections; rarely - salpingo-oophoritis, cystitis, cervicitis, mastitis, urinary tract infections, fungal infections, sinusitis, viral infections, herpetic lesions of the oral cavity, bronchitis, influenza, upper respiratory tract infections;
neoplasms (benign, malignant and unspecified), including cysts and polyps: infrequently - ovarian cysts; rarely - uterine fibroids, cysts of the appendages of the uterus and mammary glands, fibrocystic mastopathy, breast lipoma;
skin and subcutaneous tissues: infrequently - itching (including generalized itching), alopecia, acne, rash (including macular rash); rarely - allergic / atopic dermatitis, hyperhidrosis, neurodermatitis, psoriasis, eczema, hirsutism, hyperpigmentation, chloasma, dandruff, seborrhea, skin reaction - cellulite, vascular "stars"; with an unspecified frequency - erythema nodosum, urticaria, erythema multiforme;
genitals and mammary gland: often - pain in the mammary glands, a feeling of discomfort; infrequently - a change in the duration and volume of menstrual bleeding (including profuse, scanty or absence of menstrual bleeding), vaginal discharge, breast enlargement and swelling, a feeling of fullness / engorgement in the mammary gland, acyclic bleeding (incl. bleeding from the vagina and metrorrhagia), painful menstrual spotting, pain in the pelvic area; rarely - dyspareunia, dysplasia of the cervical epithelium, galactorrhea; with an unspecified frequency - decrease / increase in libido, discharge from the mammary glands;
laboratory parameters: rarely - hypercholesterolemia, hypertriglyceridemia;
general disorders and disorders: infrequently - fatigue, poor health, asthenia, changes in body weight (decrease, increase or fluctuations); rarely - flu-like phenomena, irritability, chest pain, fever, peripheral edema; with unspecified frequency - fluid retention.

There is also evidence of the development of adverse reactions during the use of other combined oral contraceptives:

benign / malignant liver tumors;
chloasma;
venous and arterial thromboembolic disorders;
stroke;
hypertriglyceridemia;
pancreatitis;
dizziness;
cholecystitis;
violations of the functional parameters of the liver, vision;
increased blood pressure;
impaired glucose tolerance or influence on peripheral insulin resistance;
symptoms of angioedema (development / appearance) in the presence of a burdened family history.

Disorders that have not been linked to Bonadet's use: ulcerative colitis associated with cholestasis itching and / or jaundice, porphyria, gallstones, hemolytic uremic syndrome, systemic lupus erythematosus, Sydenham's chorea, Crohn's disease, herpes during a previous pregnancy otosclerosis-related hearing loss, cervical and breast cancer.

Overdose

There have been no data on serious side effects due to overdose.

Overdose symptoms may include nausea / vomiting, minor vaginal bleeding, or spotting spotting.

If necessary, symptomatic therapy is recommended. Bonade has no specific antidote.

special instructions

As a rule, the disappearance of acne symptoms is noted after 3-4 months of taking Bonade.

It should be borne in mind that Bonade does not protect against HIV infections and other sexually transmitted diseases.

A decrease in the effectiveness of Bonade can be observed as a result of missing a pill, due to vomiting / diarrhea, and also when used in combination with certain drugs.

Taking Bonade can affect the results of laboratory tests, including biochemical indicators of the efficiency of the thyroid gland, kidneys and adrenal glands, liver, blood coagulation system, carbohydrate metabolism, as well as the plasma concentration of blood proteins and lipid / lipoprotein composition of the blood. Typically, these deviations are within the normal laboratory range.

Before the appointment of Bonade, a detailed history should be collected, the woman should undergo a medical examination, taking into account contraindications, special instructions and precautions. Further examinations must be carried out regularly. They should include, first of all, the exclusion of pregnancy and disorders of the blood coagulation system, the determination of blood pressure indicators, the condition of the mammary glands, pelvic organs and the abdominal cavity (including cytological examination of the cervical epithelium). In cases of prolonged therapy, such examinations should be carried out at least once every six months.

Conditions / diseases in which you should immediately consult a doctor:

prescribing other medicines;
the appearance of unusually heavy uterine bleeding;
the absence of 2 times in a row withdrawal bleeding or the appearance of suspicion of pregnancy;
local seal in the mammary gland;
any changes in the state of health, in particular any conditions listed in the instructions for use;
the appearance of the likelihood of prolonged immobilization (for example, when a plaster cast is applied to the lower limb), planning of hospitalization or surgery;
skipping the pill during the first week of taking Bonade from the package in cases where the patient had intercourse a week before.

When driving vehicles, patients need to be careful, because in rare cases, dizziness may develop during therapy.

Application during pregnancy and lactation

As a result of extensive epidemiological studies, an increased risk of developing defects in children whose mothers received sex hormones before pregnancy or through negligence in the early stages of pregnancy has not been identified. Despite this, Bonade is contraindicated for pregnant women. In case of pregnancy that occurs during therapy, the use of the drug should be discontinued immediately and consult a doctor.

When taking combined oral contraceptives, it is possible to suppress lactation with a decrease in the amount of breast milk and a qualitative change in its composition. Therefore, it is not recommended to use Bonade for contraception until breastfeeding is complete.

Pediatric use

For girls, the drug Bonade is prescribed only after the onset of menarche.

With impaired renal function

Bonade's effect in women with impaired renal function has not been specifically studied. According to the available data, changes in the dosage regimen are not required for such patients.

For violations of liver function

It is contraindicated to take Bonade for women with severe hepatic dysfunction, before normalization of liver enzymes, as well as with liver tumors (benign / malignant) at the present time or in history.

Use in the elderly

Elderly patients after menopause are not prescribed Bonade.

Drug interactions

According to the instructions, Bonade can affect the metabolism of other drugs, which leads to a change in their concentration in tissues and blood plasma.

Medicines that reduce the effectiveness of Bonade:

antiepileptic drugs, drugs used for tuberculosis and HIV infection, drugs for the treatment of depressive conditions based on St.
medicines with antibacterial action: during the entire time of combined use and for another 7 days after its termination, the use of barrier methods of contraception is required.

Drugs that can affect the metabolism of the active components of Bonade:

medicines with antifungal action;
blockers of histamine H ₂ -receptors for the treatment of gastric ulcer and duodenal ulcer;
some medicines with antihypertensive and antidepressant effects;
antibiotics to treat bacterial infections (macrolides such as erythromycin);
grapefruit juice.

Analogs

Bonade's analogues are Rigevidon, Minisiston 20 Fem, Vidora, Regulon, Lindinet, Non-ovlon, Mersilon, Yarina, Yarina Plus, Zhanin, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Bonade

Most patients who took the drug for therapeutic purposes or as a contraceptive were satisfied with their choice. Bonade, according to reviews, not only reliably protects against unwanted pregnancy, but also improves the condition of the skin and hair, regulates the menstrual cycle and makes it possible to control it. In almost all patients, side effects were not observed or were mild and quickly passed. For a long course, which is important in the case of contraceptives, the cost of the drug is very important. Bonade also stands out among its analogues for the better in this respect, it is called inexpensive.

As a disadvantage, everyone points to the difficulty of acquiring Bonade due to its absence in many pharmacies.

The price of Bonade in pharmacies

Estimated price of Bonade film-coated tablets, 2 mg + 0.03 mg:

packing 21 pcs. - 550-610 rubles;
packing 63 pcs. - 1158-1276 rubles.

Bonade: prices in online pharmacies

Drug name

Price

Pharmacy

Bonade 2 mg + 0.03 mg film-coated tablets 21 pcs.

RUB 300

Buy

Bonade tablets p.p. 2mg + 0.03mg 21 pcs.

RUB 513

Buy

Bonade 2 mg + 0.03 mg film-coated tablets 63 pcs.

RUB 900

Buy

Bonade tablets p.p. 2mg + 0.03mg 63 pcs.

1225 RUB

Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!