Chloe

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

Chloe: 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: Chloe

ATX code: G03HB01

Active ingredient: cyproterone acetate + ethinylestradiol (cyproterone acetate + ethinylestradiol)

Manufacturer: Zentiva, ks (Czech Republic)

Description and photo update: 2018-27-07

Prices in pharmacies: from 505 rubles.

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Chloe is an oral combined contraceptive with antiandrogenic activity.

Release form and composition

Chloe is produced in the form of film-coated tablets: biconvex, round; active tablets - yellow-orange, placebo tablets - white (in 1 blister, a set of tablets - 21 pieces of yellow-orange and 7 pieces of white, in a cardboard box 1 or 3 blisters).

Composition of 1 yellow-orange tablet (active):

active ingredients: cyproterone acetate - 2 mg, ethinylestradiol - 0.035 mg;
additional components: povidone, lactose monohydrate, anhydrous colloidal silicon dioxide, colloidal aluminum oxide, sodium carboxymethyl starch (type A), magnesium stearate;
film shell: Opadry II Yellow OY-L-32901 dye (titanium dioxide, hypromellose 2910, lactose monohydrate, macrogol 4000, purified water, iron oxide black, red and yellow).

Composition of 1 white tablet (placebo): colloidal anhydrous silicon dioxide, lactose monohydrate, sodium carboxymethyl starch (type A), povidone, magnesium stearate, colloidal aluminum oxide.

Pharmacological properties

Pharmacodynamics

Chloe is a combined low-dose, monophasic oral contraceptive with antiandrogenic activity. The mechanism of action of the drug is due to the properties of its active substances: cyproterone acetate, an antiandrogenic steroid, and ethinylestradiol, oral estrogen.

Cyproterone acetate is inherent in the ability to competitively bind to receptors of natural androgens (including dehydroepiandrosterone, testosterone, androstenedione), produced in the body of women in small quantities, mainly in the ovaries, adrenal glands, skin. By blocking androgen receptors in target organs, the substance prevents the processes associated at the level of intracellular mechanisms with hormone-receptor complexes, thereby helping to reduce the manifestation of androgenization in women. This effect of Chloe makes it possible to treat diseases caused by increased production of androgens or hypersensitivity to these hormones.

Chloe's therapy helps to reduce the excessive activity of the sebaceous glands, which plays an important role in the appearance of seborrhea and acne. Due to this property of the drug, 3-4 months after the start of its administration, the existing rash, as a rule, disappears, and before that, the increased oily skin and hair is usually eliminated. Hair loss that often accompanies seborrhea is also significantly reduced. When Chloe is used by women of reproductive age, a few months after the start of the course, they have a decrease in the clinical manifestations of mild forms of hirsutism.

Along with the antiandrogenic effect of cyproterone acetate, it also demonstrates gestagenic activity that mimics the properties of the corpus luteum hormone, suppresses the production of gonadotropic hormones by the pituitary gland and slows down the ovulation process, which leads to its contraceptive effect.

Ethinylestradiol enhances the central and peripheral effects of cyproterone acetate on ovulation, ensuring the maintenance of high viscosity of cervical mucus, blocking the entry of sperm into the uterine cavity, thereby maintaining a reliable contraceptive effect. During the period of therapy, a more regular cycle is noted, the appearance of painful menstruation decreases, the intensity of bleeding decreases, which leads to a decrease in the threat of developing iron deficiency anemia.

Pharmacokinetics

Cyproterone acetate after oral administration by Chloe is completely and rapidly absorbed from the gastrointestinal tract (GIT). The bioavailability of this substance is 88%, the maximum concentration (C _max) in the blood plasma is observed 1.6 hours after taking 1 Chloe tablet and is equal to 15 ng / ml.

The antiandrogenic drug is characterized by a high bond with blood plasma albumin, no more than 3.5–4% is found in free form. Due to the fact that binding to plasma proteins is nonspecific, changes in the concentration of sex steroid binding globulin (SHBG) do not affect the pharmacokinetic parameters of cyproterone acetate.

The pharmacokinetics of this active substance is two-phase, the half-life (T _½) for the first phase is 0.8 hours, for the second - 2.3 days. The total plasma clearance of cyproterone acetate is 3.6 ml / min / kg, the biotransformation process proceeds through hydroxylation and conjugation, the main metabolite is 15b-hydroxyl derivative. It is excreted through the intestines and by the kidneys in the form of metabolites in a ratio of 2: 1, a small part through the intestines unchanged. For metabolites of cyproterone acetate, T _½ is 1.8 days.

Ethinylestradiol after taking Chloe is completely and quickly absorbed from the gastrointestinal tract, C _{max is} reached after 1.7 hours and is approximately 80 pg / ml. During absorption and the first passage through the liver, the substance undergoes an intensive metabolic transformation, as a result of which the bioavailability can be 45%, while having a significant individual variability.

Ethinylestradiol almost completely binds to proteins (mainly albumin) of blood plasma, only 2% is in free form. Against the background of continuous use, it enhances the hepatic synthesis of SHBG and corticosteroid-binding globulin (CGG). During the period of Chloe's treatment, the serum SHBG level increases from about 100 to 300 nmol / L, and the serum SHBG concentration increases from 50 to 95 μg / ml.

The pharmacokinetics of ethinyl estradiol consists of two phases, on average T _½ in the first phase is 1-2 hours, in the second - about 20 hours. Plasma estrogen clearance is approximately 5 ml / min / kg. The substance is excreted from the body in the form of metabolites: about 60% - through the intestines and about 40% - by the kidneys.

With breast milk, up to 0.2% of the dose of cyproterone acetate and up to 0.02% of ethinylestradiol are excreted.

Indications for use

contraception in women in the presence of androgenization phenomena;
androgen-dependent diseases in women: androgenic alopecia, acne (mainly in pronounced forms, accompanied by seborrhea, inflammatory manifestations with the formation of nodes, including nodular cystic acne and papular pustular acne), mild forms of hirsutism.

Contraindications

Absolute:

diabetes mellitus complicated by diabetic angiopathy;
liver tumors (benign and malignant);
severe liver damage, including a history, or severe functional liver disorders (the appointment is allowed no earlier than 6 months after the normalization of liver tests);
conditions preceding thrombosis (including angina pectoris, transient ischemic attacks);
thromboembolism or thrombosis (arterial and venous), including a history, including pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke and other cerebrovascular disorders;
an established hereditary / acquired tendency to develop venous or arterial thrombosis, for example, protein S deficiency, protein C deficiency, antithrombin III deficiency, resistance to activated protein C, hyperhomocysteinemia, and identified antiphospholipid antibodies (lupus anticoagulant, anticardiolipin antibodies);
multiple / severe risk factors for arterial or venous thrombosis, such as diseases of the vessels of the brain or coronary arteries, atrial fibrillation, complicated valvular heart disease, uncontrolled arterial hypertension, subacute bacterial endocarditis, severe dyslipoproteinemia, extensive trauma, prolonged immobilization of the legs, surgery, neurosurgical operations, burdened family history, obesity with a body mass index (BMI) more than 30 kg / m², smoking in women over 35 years old;
combined use with any other hormonal contraceptive;
diagnosed hormone-dependent malignant lesions or suspicion of them, including tumors of the genital organs or the mammary gland (including in the anamnesis);
congenital hyperbilirubinemia (Dubin-Johnson, Rotor and Gilbert syndromes);
pancreatitis accompanied by severe hypertriglyceridemia;
a history of indications of migraine occurring against the background of focal neurological symptoms;
vaginal bleeding of unknown origin;
established or suspected pregnancy;
lactation period;
glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
hyperprolactinemia;
age after 40 years;
hypersensitivity to any of the constituents of the product.

In the event that any of the above conditions occur for the first time against the background of using the tool, it must be immediately canceled.

Chloe is not prescribed for men.

Relative contraindications (it is recommended to use the product with caution):

liver and gallbladder diseases;
ulcerative colitis;
kidney disease;
idiopathic jaundice or itching during a previous pregnancy;
dyslipoproteinemia;
tetany, chorea, epilepsy;
porphyria;
phlebeurysm;
multiple sclerosis;
mastopathy;
uterine fibroids;
sickle cell anemia;
tuberculosis;
depression;
otosclerosis with hearing loss during a previous pregnancy;
adolescence (in the absence of regular ovulatory cycles).

Chloe's instructions for use: method and dosage

Chloe tablets are taken orally 1 pc. per day, at about the same time, preferably after breakfast or dinner. The tablet should be swallowed whole with a small amount of liquid without breaking or chewing.

If no hormonal contraceptives have been used in the previous month, Chloe is used on the first day of the natural cycle (menstrual bleeding), taking a pill from the calendar package of the corresponding day of the week. It is also permissible to start the course on days 2–5 of the menstrual cycle, but in this case, during the first 7 days of taking the pills from the first package, you will need to resort to a barrier method of contraception.

Before starting treatment, it is recommended to take the tablets from the calendar pack every day in sequence in accordance with the direction of the arrow on the foil. After completing the intake of all active yellow-orange tablets (21 pcs.) From the calendar package for the next 7 days, placebo tablets, white, should be used. In the same seven-day interval, 2-3 days after the last intake of the active pill, menstrual bleeding should appear due to drug withdrawal. A new pack is required to start the day after taking the last placebo pill from the previous one, regardless of whether the bleeding has ended or not.

In the case when another combined oral contraceptive (COC) was taken before using Chloe, it is recommended to start treatment with the drug the next day after taking the last active tablet of the previous drug (for drugs containing 21 tablets). But at the same time, Chloe's therapy cannot be started later than the next day after the usual 7-day break in admission. If the previous contraceptive contains 28 tablets, Chloe should be started after using the last inactive tablet.

When using a contraceptive patch or vaginal ring on Chloe, you should switch to the day of their removal, but no later than the day when you need to stick a new patch or insert a new ring.

The transition to Chloe after using "mini-pili" - preparations containing only gestagens, can be started any day without interruption, when using injectable forms - on the day of the next injection, and in case of using an implant - on the day of its removal. During the first 7 days of using the drug, it is necessary in all cases to additionally use a barrier method of contraception (condom).

If an abortion was carried out in the first trimester of pregnancy, after it you can immediately start using Chloe without resorting to additional methods of contraception.

After an abortion in the II trimester of pregnancy or childbirth, provided that there is no breastfeeding, Chloe's use should be started 21-28 days later. At a later start of treatment with the drug, it is required to use additional condoms during the first 7 days. If unprotected sex took place between the abortion or childbirth and the beginning of the intake, before using Chloe, it is necessary to exclude a possible pregnancy or wait for the first menstruation.

In the case when a woman did not have time to take the next active pill in time, the last one should be taken as soon as possible, and the next pill should be taken in the usual way. If you are less than 12 hours late, Chloe's contraceptive effect persists.

If Chloe's intake was delayed for more than 12 hours, a decrease in contraceptive protection may occur. The more pills were not taken, and the closer the pass was to the weekly break, the higher the likelihood of pregnancy. In this case, it should be taken into account that it is impossible to interrupt the intake of the drug for more than 7 days, and also that Chloe will need to be taken continuously for 7 days in order to adequately suppress the hypothalamic-pituitary-ovarian regulation.

Below are recommendations on the basis of which further measures should be taken if the interval from the moment of taking the last pill was more than 36 hours (delay - more than 12 hours):

first week: it is necessary to take the missed pill as soon as possible, even if it requires taking two pills at the same time, and after that continue using Chloe as usual; additionally, a barrier method of contraception should be used for the next 7 days; if sexual intercourse occurred in the weekly interval before skipping a dose, it is required to take into account the possibility of pregnancy;
second week: the last missed pill must be taken as soon as possible, even if you have to use two pills at the same time, after that the remedy should be taken at the usual time; if a woman regularly took Chloe for a week before the first missed pill, there is no need to use additional methods of contraception; otherwise, or when two or more pills have been missed within 7 days, it is necessary to resort to auxiliary contraception;
the third week: due to the upcoming interruption in the use of active pills, the risk of pregnancy increases, but if Chloe was taken correctly within 7 days preceding the first missed dose, there is no need to use additional contraceptive protection; in the first recommended option, it is required to take the last missed tablet as soon as possible, even if you need to take two doses at the same time, the rest of the tablets should be continued at the usual time; when the active tablets from the current package run out, you must immediately start taking the drug from the next package (using a placebo is skipped); bleeding caused by the withdrawal of Chloe is unlikely until all the tablets from the second pack are taken, but spotting and breakthrough bleeding may occur during use of the drug;in the second option, you can interrupt the use of tablets from the current package and, after taking a week break (including the day of the pass), start taking the tablets from the new package; if the expected menstruation does not occur after the missed pill intake during the usual break, pregnancy must be excluded.

If the patient vomits within 3-4 hours after taking Chloe, incomplete absorption of active substances may occur. In this case, the same recommendations should be followed as when skipping a pill.

When it is necessary to delay the onset of menstrual bleeding, it is recommended to start taking active tablets from a new package immediately after completing the intake from the current one, without interruption. Thus, it is possible to delay menstruation at the request of the woman, or until the second pack ends, however, while taking it, breakthrough uterine bleeding or spotting spotting may occur. Chloe should resume regular use after taking the usual 7-day break.

When it is necessary to postpone the onset of menstruation to another day of the week, the next interval in taking the tablets should be reduced by the desired number of days. The shorter the break, the higher the likelihood of no withdrawal bleeding and the appearance of spotting or heavy bleeding while taking the pills from the second pack.

In the treatment of hyperandrogenic conditions, the duration of Chloe's use is set taking into account the severity of the disease. After symptom relief, it is recommended to continue treatment for at least another 3-4 months. If a relapse occurs a few weeks or months after the end of the course, repeated drug therapy is allowed. When resuming treatment with a break of four weeks or more, the aggravation of the threat of venous thromboembolism (VTE) should be taken into account.

Side effects

digestive system: often - abdominal pain, nausea; infrequently - diarrhea, vomiting;
nervous system: often - headache; infrequently - migraine; with an unknown frequency - worsening of the course of epilepsy;
immune system: rarely - hypersensitivity reactions;
mental disorders: often - mood swings / decreased; infrequently - decreased libido; rarely - increased libido; with an unknown frequency - aggravation of the course of endogenous depression;
metabolism and nutrition: often - an increase in body weight; infrequently - fluid retention; rarely - weight loss;
cardiovascular system: rarely - thromboembolism;
skin and subcutaneous tissues: infrequently - urticaria, rash; with an unknown frequency - erythema multiforme, erythema nodosum;
genitals and mammary gland: often - engorgement of the mammary glands, tenderness / pain in the mammary glands; infrequently - an increase in the mammary glands; rarely - discharge from the mammary glands, discharge from the vagina; with an unknown frequency - metrorrhagia (acyclic spotting / bleeding); in post-marketing studies, cases of painful menstrual bleeding and absence of menstrual bleeding were recorded - the frequency could not be estimated;
organ of vision: rarely - intolerance to contact lenses.

Serious adverse reactions that have been reported in women using COCs (which also includes Chloe):

nervous system and sensory organs: dizziness, visual impairment

digestive system: cholecystitis, changes in liver function indicators, liver tumors (benign / malignant), pancreatitis

cardiovascular system: increased blood pressure, stroke, venous / arterial thromboembolic disorders;
skin and subcutaneous tissues: chloasma;
metabolism: effects on peripheral insulin resistance or impaired glucose tolerance, hypertriglyceridemia;
allergic reactions: in the presence of hereditary angioedema, exogenous estrogens can cause / intensify the symptoms of angioedema.

The appearance / worsening of conditions, the connection of which with the use of COCs has not been fully proven:

the formation of stones in the gallbladder;
jaundice and / or pruritus due to cholestasis;
porphyria;
hemolytic uremic syndrome;
systemic lupus erythematosus;
cervical cancer;
Sydenham's chorea;
hearing loss caused by otosclerosis;
herpes during a previous pregnancy;
ulcerative colitis, Crohn's disease.

Overdose

Overdose symptoms may include: vomiting, nausea, and slight vaginal bleeding. In this condition, symptomatic therapy is recommended. The specific antidote is unknown.

special instructions

Before starting to use Chloe, a complete medical examination is required, including cytological examination of cervical mucus and examination of the mammary glands. The patient also needs to exclude pregnancy and the presence of pathologies from the blood coagulation system. In the case of prolonged use of the drug, it is recommended to carry out control examinations every 6 months.

With the existing risk factors, before starting the course, it is necessary to conduct a thorough assessment of the possible threat of complications and the expected benefit from treatment, taking into account the individual characteristics of the patient.

Patients taking Chloe may have an increased risk of developing VTE when compared with women not receiving the drug. During the first year of taking the drug, as well as when it is resumed after a break of 4 weeks or more, the likelihood of VTE is the highest. VTE can be fatal in about 1–2% of cases. The approximate incidence of VTE with the use of oral contraceptives containing a low dose of estrogen (less than 0.05 mg) can be up to 4 cases per 10,000 women per year, compared with 0.5–1 cases per 10,000 women who do not use COCs. At the same time, the incidence of VTE associated with pregnancy is approximately 6 cases per 10,000 women per year.

According to epidemiological studies, when Chloe is taken, the frequency of VTE is 1.5–2 times higher than when using COCs containing levonorgestrel, and is equal to the incidence of this complication when taking COCs containing desogestrel / gestodene / drospirenone.

With polycystic ovary syndrome, there is an increased risk of cardiovascular disease.

Also, epidemiological studies have demonstrated a relationship between the use of hormonal contraceptives and an increased risk of arterial thromboembolism (including myocardial infarction, transient ischemic attacks). Thrombosis of other vessels, including arteries and veins of the liver, brain, kidneys, mesentery and retina, have been reported in patients using hormonal contraceptives.

You should immediately consult a doctor if you experience the following symptoms of venous / arterial thrombosis:

sudden severe chest pain with possible radiation to the left arm;
one-sided leg pain and / or swelling;
movement disorders;
sudden attack of cough;
worsening of the severity and frequency of migraines;
unusually intense, prolonged headache;
sudden shortness of breath;
sharp abdomen;
diplopia;
sudden partial / complete loss of vision;
collapse (with / or without partial seizure);
dizziness;
slurred speech or aphasia;
weakness or significant loss of sensitivity that suddenly occurs in one part of the body or on one side.

If a planned surgical operation on the lower extremities is necessary, Chloe's intake should be suspended at least four weeks before it is carried out and should not be resumed until two weeks after the end of immobilization. In the case when the use of the drug could not be discontinued in advance, it is required to decide on the appointment of antithrombotic therapy.

If during the period of Chloe's treatment there is an increase in migraine attacks or an increase in their severity (which may indicate the possible appearance of cerebral circulation disorders), the drug should be urgently canceled.

Taking COCs must be discontinued if recurrent cholestatic jaundice occurs, which first appeared during pregnancy or previous use of sex hormones.

Patients with diabetes mellitus during treatment should be closely monitored. Although COCs can affect glucose tolerance and insulin resistance, usually no dose adjustment of hypoglycemic drugs is required.

Women who have chloasma are advised to avoid exposure to ultraviolet radiation while using Chloe.

If in patients with hirsutism, symptoms have significantly increased or have developed recently, other possible causes should be taken into account in the differential diagnosis, including such as congenital dysfunction of the adrenal cortex or androgen-producing tumor.

During the first months of taking Chloe, irregular bleeding is sometimes possible (spotting spotting or profuse breakthrough bleeding), and therefore it is recommended to assess any irregular bleeding after an adaptation period of about 3 months (3 cycles). If irregular bleeding is repeated or resumed after the previous several regular cycles, the non-hormonal causes of their occurrence should be considered and appropriate examinations carried out in order to exclude the development of malignant tumors and pregnancy.

In some cases, there may be no withdrawal bleeding in the interval between taking the tablets. In case of irregular use of the contraceptive or the absence of menstrual bleeding for two consecutive cycles, pregnancy should be ruled out before continuing to take Chloe.

When planning pregnancy, treatment should be completed 3 months before pregnancy occurs.

While taking Chloe, it is possible to reduce the level of follicle-stimulating hormone, luteinizing hormone, as well as change the results of allergic skin tests. Since the contraceptive effect of the drug can be fully manifested only by the seventh day from the beginning of the course, it is advisable to use additional non-hormonal contraceptives in the first week of admission.

There are reports of a slight increase in the risk of cervical cancer with prolonged use of COCs. The connection between the appearance of this disease and the use of COCs has not been proven.

During the period of use of oral combined contraceptives, in rare cases, the development of liver tumors was noted, leading to life-threatening intra-abdominal bleeding. When carrying out differential diagnostics, this must be taken into account in the case of an enlarged liver, the development of severe pain in the abdomen, or the appearance of symptoms of bleeding into the abdominal cavity.

Application during pregnancy and lactation

According to the instructions, Chloe is contraindicated during pregnancy, if pregnancy is suspected and during lactation.

Pediatric use

Chloe is indicated only after the onset of menarche.

With impaired renal function

In the presence of kidney disease, the drug should be taken with caution.

For violations of liver function

Chloe is contraindicated in patients with severe diseases or impaired liver function (before normalization of liver function indicators), as well as in the presence of a liver tumor (including a history of data) or congenital hyperbilirubinemia.

It is recommended to use the remedy with caution in the development of idiopathic jaundice or itching during the last pregnancy, liver and gallbladder diseases.

Use in the elderly

Chloe is contraindicated in patients over 40 years of age. The drug is not used after menopause.

Drug interactions

inducers of liver microsomal enzymes: barbiturates, hydantoins, rifampicin, carbamazepine, primidone, and possibly griseofulvin, felbamate, topiramate, oxcarbazepine - the clearance of cyproterone and ethinyl estradiol increases, which can lead to a decrease in the reliability of contraception, or the development of bleeding;
ampicillin, tetracyclines, rifampicin - Chloe's contraceptive effect decreases.

Analogs

Chloe's counterparts are Model Pure, Erica-35.

Terms and conditions of storage

Keep out of the reach of children, at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Chloe

Reviews about Chloe are quite contradictory. Many patients note the effectiveness of the drug in the treatment of androgen-dependent diseases, as well as its positive contraceptive effect. The tool, according to a large number of reviews, normalizes the level of hormones, restores the cycle, relieves menstrual pain, improves the condition of the skin and hair, prevents pregnancy during admission, and almost does not cause pronounced side reactions.

However, there are also reviews in which patients indicate the appearance of many undesirable effects during the treatment period. Such disorders include complete loss of libido, irritability, lethargy, headaches, bitterness in the mouth, diarrhea, increased cravings for sweets, weight gain, depression before menstruation. The disadvantage of the drug Chloe, according to the patients, is also a large number of contraindications for use and its rather high cost.

Price for Chloe in pharmacies

The approximate price for Chloe may be: 28 tablets in a set - 660-780 rubles, 84 tablets - 1640-1790 rubles.

Chloe: prices in online pharmacies

Drug name

Price

Pharmacy

Chloe 2 mg + 35 μg film-coated tablets 28 pcs.

505 RUB

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Chloe tablets 35mkg + 2mg 28 pcs.

578 r

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Chloe 2 mg + 35 mcg film-coated tablets 84 pcs.

1297 RUB

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Chloe tablets 35mkg + 2mg 84 pcs.

1651 RUB

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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!