Regulation

Regulon is included in the category of complex monophasic contraceptive preparations for oral administration. Has a contraceptive and estrogen-progestogenic effect.

Indications Regulon

It is used as a means of preventing the onset of unwanted conception.

But in this case, various tests confirm the presence of the drug therapeutic properties (in addition to contraceptive). For example, his treatment will be advisable in the presence of a woman with bleeding from the uterus, having dysfunctional character, and in addition, with PMS, dysmenorrhea and so on.

The medication can effectively eliminate the pain that appears periodically in the lower abdominal region, reduces the profuse and painfulness of menstruation and dyspravia, and also eliminates weak secretions that have a dark shade from the vagina during the perimenstrual period and from pains in the area of the breast glands.

Regulon is often prescribed to increase the effectiveness of endometriosis treatment. During uterine fibroids it is used to stop the growth of neoplasm (this makes sense if its diameter is no more than 2 cm). At the same time, the drug helps the resorption of ovarian retention cysts.

[1], [2], [3], [4]

Release form

The drug is released in tablet form, in the amount of 21 pieces inside the blister plates. The box contains 1 or 3 such plates.

[5], [6], [7], [8], [9]

Pharmacodynamics

The medicinal effect is provided by the ability of its acting elements to inhibit the pituitary binding of gonadotropins (among such lutropines and FSH). Because of this, the process of ovulation is complicated and the density of cervical mucus increases, which prevents the passage of spermatozoons into the uterine cavity.

Ethinyl estradiol is an artificial analogue of the substance estradiol (it begins to be produced by the female body from the moment of the first menstruation).

Desogestrel has a strong anti-estrogenic and gestagenic effect, similar to the effect of internal progesterone. The component has a low androgenic and anabolic activity.

During the use of drugs in women (if the initial menorrhagia is noted), blood loss during periods of menstruation significantly decreases, and the condition of the epidermis improves (especially if the patient has acne).

[10], [11], [12], [13],

Pharmacokinetics

Desogestrel together with ethinyl estradiol almost completely and at high speed are absorbed from the digestive tract. Desogestrel is immediately exposed to metabolism, during which a bioactive decay product - 3-keto-desogestrel is formed.

Cmax values are noted after 1.5 hours from the time of admission and are 2 ng / ml (for desogestrel), and after 1-2 hours and amount to 80 pg / ml (for ethinyl estradiol).

The level of bioavailability of desogestrel is between 62-81%, and ethinyl estradiol - about 60% (due to the processes of presystem conjugation and the first hepatic passage of the element).

The half-life of 3-keto-desogestrel is 30 hours (metabolites are excreted from the body with urine and feces in a ratio of 4 to 6), and ethinyl estradiol is 24 hours (about 40% of the element, together with its decay products, is excreted in the urine, and the remainder (about 60% ) is excreted with feces).

[14], [15], [16]

Dosing and administration

Scheme of drug use.

Begin taking the drug should be from the 1st day of the beginning of the menstrual cycle - in the amount of 1 piece daily (at the same time of the day), in a period of 21 days. Next, after taking the last pill, you need to take a 7-day break, during which period there should be a similar to menstrual bleeding.

Later, on the 8th day after taking the last medication tablet (after 4 weeks from the start of the drug application on the same day of the week), even with continued bleeding, the drug is being used again - from a new blister plate.

Admissible duration of use of medication.

In accordance with the above instructions, you can take the medicine at any time when the woman needs contraception. With the use of tablets, taking into account all the rules and recommendations, the contraceptive effect of drugs remains for a period of 7 days.

The initial procedure is the 1st pill.

Begin the use of Regulon is necessary from the first day of the cycle. Use with additional contraception is not required. At the beginning of drug use in the interval of the 2nd-5th days of the cycle, during the first week of its use it is necessary to additionally use barrier contraception.

If more than 5 days have passed since the beginning of menstruation, it is recommended to postpone the beginning of taking the medication for the next menstrual cycle.

Scheme of the use of the medicine after childbirth.

Women who refused breastfeeding after 3 weeks from the date of delivery are allowed to start using drugs (before that you need to consult a gynecologist). In this case, there is no need for additional use of contraceptives.

If the sexual intercourse has taken place not long after sorts, the beginning of application of a medicine should be postponed before the onset of a new cycle.

At the beginning of Regulon use, after 21 days after delivery, during the first week of the initial cycle of use, contraceptives should be used additionally.

Drug use after an abortion procedure.

In the absence of any contraindications, the drug can be used from the 1st day after the abortion procedure. In this case, additional contraceptives should not be used.

It is often enough to prescribe medication and after scraping procedures.

The advisability of taking drugs after the procedure of curettage or abortion (for example, with a stiff pregnancy) is associated with the need to restore healthy ovaries and with the need to prevent the development of complications of an inflammatory nature - according to statistics, they are observed in about every third woman who underwent a second abortion .

Thanks to the use of drugs, it is possible to compensate for the shortage of progesterone associated with abortion, as well as the development of proliferative processes caused by it inside the reproductive system (among them fibromyoma, hypertrophy in the field of Teka-tissue, Stein-Leventhal syndrome, internal endometriosis, mastopathy, endometriosis, endometrial hyperplasia, Frenkel syndrome and so on).

The process of transition from other hormonal means.

During the transition from another contraceptive, it is necessary to take the 1st pill for the next day after the end of the pack, calculated for 28 days (21 days of use + 7 days of the interval). Use additional contraception is not required.

In the case of switching from a mini-drink substance, the 1st Regulon tablet is used on the first day of a new cycle. There is no need for additional contraceptives.

In the absence of menstruation during the use of mini-pills, it is allowed to start taking drugs at any of the days of the cycle, but only after a diagnosed absence of pregnancy.

For the first 7 days of the initial cycle of use, additional methods of protection (such as a cap containing spermicides, a condom or abstinence from sexual contacts) are required. The calendar method of protection in this case will be ineffective.

Application to delay the onset of menstruation.

To delay menstrual bleeding drug continue to use, not making a 7-day break. In the case of a delay in menstruation, bleeding may occur in a breakthrough type or in a spotting effect, but they do not weaken the contraceptive properties of drugs.

Restoring the regular mode of drug use occurs after 7 days of interruption.

The scheme of taking the drug in case of missing one tablet.

In cases where from the moment the admission was missed it took up to 12 hours, the tablet should be used as soon as it is remembered. Then the application continues in the standard mode.

In cases when more than 12 hours have elapsed from the moment of missing the drug, the medicine loses 100% contraceptive reliability for the period of this cycle. In this regard, before the start of a new cycle, additional contraception is required.

If the drug intake was missed during the first 2 weeks of the cycle, the next day you need to take 2 tablets at a time, and then continue using the standard scheme (with additional contraceptives before this cycle ends).

If you miss the use in the interval of 14-21 days, you need to continue the regular use of drugs, using a previously forgotten tablet, and also without making a 1-week break.

Skipping a tablet increases the likelihood of ovulation or the appearance of bloody vaginal discharge. This is due to the fact that the medicine contains a small portion of estrogen. Therefore, in such cases it is necessary to additionally use barrier contraception.

[21], [22], [23], [24]

Use Regulon during pregnancy

Take Regulon during pregnancy is strictly prohibited. For the time of breastfeeding, you should either stop using drugs or do not breast-feed. This is necessary due to the fact that tablets taken at the postpartum stage reduce the amount of milk produced, worsen lactation and adversely affect the development of the child.

The onset of pregnancy after the period of drug use.

The contraceptive effect of drugs develops due to the ability of its constituent components (artificial analogs of estradiol with progestogens) to prevent the emergence of a mature egg from the follicle.

As a contraceptive it can be used for several years, and in this regard, many women are concerned about whether the drug will have a negative effect on the reproductive system, as well as on the course of pregnancy in the future.

With the proper administration of the drug (the use of the scheme indicated in the drug instruction and the observance of all indications prescribed by the gynecologist), conception planning can be carried out at the end of its application without any obstacles. Often after the abolition of Regulon, pregnancy occurs approximately six months later of regular sexual activity.

At the planning stage, it is recommended to stop using the medication for at least 3 months before the possible conception period.

Contraindications

The main contraindications:

• the presence of hypersensitivity to the elements of the therapeutic agent;
• severe forms of hepatic disease;
• functional hyperbilirubinemia, which has a benign form (this includes rare hepatoses of pigment type, which are hereditary in nature);
• the presence of a history of jaundice that occurred during pregnancy;
• hyperlipidemia of a family nature;
• presence in the anamnesis of hepatic tumors;
• elevated values of blood pressure in moderate or severe degree;
• migraine;
• presence in the anamnesis of thromboembolism or thrombosis and existing strongly pronounced or numerous factors that increase the likelihood of their occurrence, and in addition the presence in the anamnesis of information that the patient had thrombosis precursors;
• herpes of the second type;
• the presence of bleeding from the vagina, with unknown etiology;
• diagnosed estrogen-dependent neoplasms or the presence of suspicions of their presence;
• diabetes mellitus in a severe stage (accompanied by angiopathy);
• gestational diabetes mellitus;
• disorders of hemocoagulation;
• severe pruritus and otosclerosis (or progression of these disorders), caused by a previous pregnancy or by the use of SCS.

[17], [18],

Side effects Regulon

Among the most serious negative reactions to the use of the drug (in case of their appearance, it is necessary to cancel the drug use):

• increase in blood pressure;
• thromboembolism in the arteries or veins (this includes the formation of thrombi in the deep veins, myocardial infarction with stroke, etc.);
• thromboembolism in the area of the hepatic / renal veins or arteries, and in addition thromboembolism in the mesenteric or retinal veins or arteries (single);
• caused by otosclerosis, hearing loss;
• HUS;
• porphyria;
• exacerbation of the process of the reactive form of SLE (occasionally);
• Sydenham's chorea, which occurs after discontinuation of the drug (singly).

Among the side effects that are less dangerous to health:

• acyclic form of bleeding, not related to menstruation, and in addition the occurrence of bloody discharge from the vagina;
• amenorrhea, which develops after discontinuation of drug use;
• galactorrhea;
• change in the condition of the cervical mucus;
• tenderness and tension of the mammary glands, as well as their increase;
• the appearance of inflammation inside the vagina;
• vaginal candidiasis;
• vomiting along with nausea;
• the appearance or exacerbation of jaundice or itching caused by cholestasis;
• hloazma;
• transmural ileitis;
• cholelithiasis;
• erythema, which has exudative or nodular form;
• occurrence of a rash on the epidermis;
• migraine, as well as headaches;
• mood lability and depression;
• increased sensitivity of the ocular cornea;
• a decrease in tolerance for carbohydrates;
• weight gain;
• cumulation of fluid inside the body;
• allergy symptoms.

[19], [20]

Overdose

Poisoning with Regulon can lead to nausea, symptoms of dyspepsia, severe headaches, vomiting, and also cramps in the calf muscles and vaginal discharge of bloody type that are not associated with menstruation.

The drug does not have an antidote, so symptomatic measures should be taken to eliminate signs of intoxication. As a first aid in the use of a large portion of the medication, the gastric lavage procedure is used (it is required to hold it during the first 2-3 hours from the time the substance is consumed).

[25],

Interactions with other drugs

The medicinal efficacy of oral contraceptive drugs is weakened when combined with inducers of hepatic enzymes (among them carbamazepine, oxcarbazepine, primidone with rifampicin and topiramate, and in addition hydantoin, felbamate and barbiturates, grizeo-wolfin and St. John's wort medicines). However, with the combination of these substances, the risk of bleeding breakthroughs increases.

Maximum indices are noted at least after 2-3 weeks, but may persist until 1 month after discontinuation of drug use.

Cycle breakdown and weakening of the contraceptive properties of the medication can be observed when combined with drugs such as barbiturates, laxatives, antibiotics (especially ampicillin or tetracycline), certain antispasmodics and antidepressants.

In situations where it is necessary to use the above medicines, barrier barrier contraception should be used (throughout the duration of the therapy, and in addition, during the additional 7-28 days - considering which drug was used).

If the use of Regulon requires the use of anticoagulants, it is necessary to further monitor the values of PTV. Sometimes the dosage regimen of the anticoagulant used may also be required.

In connection with the increased risk of complications, it is forbidden to combine the drug with hepatotoxic medicines.

The use of oral contraceptive drugs can weaken the body's tolerance for carbohydrates, and in addition increase the need for insulin and ingested hypoglycemic agents.

[26], [27], [28], [29], [30], [31]

Storage conditions

Regulon is required to be kept in a place that is closed from penetration of small children. Temperature values are within the limits of 15-30 ° C.

[32], [33], [34]

Shelf life

Regulon is allowed to be applied within 36 months from the date of manufacture of the therapeutic agent.

[35]

Analogues

Analogues of the drug are Novinet, Mersilon and Marvelon with Tri-Mersey.

[36], [37], [38]

Reviews

Regulon is considered one of the most popular contraceptives - this fact is confirmed by numerous reviews.

Most of the women who use this drug, note a small number of adverse manifestations of drugs, high reliability and affordable cost, and in addition the fact that after the end of the application of Regulon conception occurs without significant difficulties.

But negative opinions about the drug also occur - they usually talk about the negative effects of the drug (such as having acyclic bleeding of varying severity, nausea, itching in the genital area and a noticeable weight gain).

In the responses of specialists this is due to the fact that often such symptoms are associated with the patient's hypersensitivity to any elements of the drug, or because the medication simply does not fit this particular woman. To minimize the risk of negative reactions to a minimum, it is necessary to follow the drug instruction exactly.

In the absence of improvements, in such a case, it is necessary to consider the option of canceling the drug and selecting another contraceptive (all the required examinations must be done beforehand).