Formula: C26H29NO, chemical name: (Z)-2--N,N-dimethylethanamine (as citrate).
Pharmacological group: antineoplastic agents/antineoplastic hormonal agents and hormone antagonists; hormones and their antagonists/estrogens, gestagens; their homologues and antagonists.
Pharmachologic effect: antitumor, antiestrogenic.
Pharmacological properties
Tamoxifen binds (competitively) in target organs with estrogen receptors, just like estrogens, it is transferred to the nucleus of the tumor cell along with the receptor and, thus, blocks the action of estrogens. Tamoxifen is well absorbed from the gastrointestinal tract, the maximum plasma concentration is reached after 4–7 hours, the time to reach Css is 3–4 weeks. Tamoxifen is 99% bound to plasma proteins. Metabolized in the liver by demethylation and hydroxylation. Tamoxifen elimination has 2 phases: an initial half-life of 7–14 hours, followed by a terminal half-life of 7 days. Tamoxifen is excreted mainly in the form of metabolites through the intestines, and is excreted in small quantities by the kidneys.
Indications
Breast cancer: especially in men after castration, in menopausal women, carcinoma in situ of the mammary gland; adjuvant treatment of breast cancer; endometrial cancer; estrogen-sensitive tumors.
Method of administration of tamoxifen and dose
Tamoxifen is taken orally (regardless of meals). The dosage regimen, depending on the indications, is set individually. Breast cancer - 1-2 times a day, 20-40 mg, endometrial cancer - 1-2 times a day, 20-30 mg. The maximum daily dose is 40 mg. Therapy is carried out until signs of regression of the process appear (long-term).
Before starting tamoxifen therapy, women should undergo a thorough gynecological examination. Tamoxifen causes ovulation, which increases the likelihood of pregnancy, so women of reproductive age should use reliable non-hormonal methods of contraception during treatment and for 3 months after its end. Tamoxifen use should be discontinued if vaginal bleeding or vaginal discharge occurs. bloody discharge, the appearance of signs of thromboembolism of the branches pulmonary artery(shortness of breath), thrombosis of the veins of the lower extremities (swelling or pain in the legs). During therapy, it is necessary to monitor the blood picture (platelets, leukocytes), blood coagulation indicators and the functional state of the liver. An ophthalmological examination is necessary before and periodically during treatment. In patients with bone metastases, at the beginning of therapy it is necessary to determine the calcium level in the blood serum (in case of severe hypercalcemia, the use of tamoxifen should be temporarily discontinued). In patients with hyperlipidemia, treatment requires monitoring of triglycerides and cholesterol in the blood serum. Tamoxifen is ineffective in treating patients who have metastases (especially to the liver).
Contraindications for use
Hypersensitivity, breastfeeding, pregnancy.
Restrictions on use
History of pulmonary embolism and deep vein thrombosis during treatment with indirect coumarin anticoagulants, leukopenia, thrombocytopenia, hyperlipidemia, hypercalcemia, visual impairment or cataracts.
Use during pregnancy and breastfeeding
Taking tamoxifen is contraindicated during pregnancy. Tamoxifen treatment must be stopped during treatment breast-feeding.
Side effects of tamoxifen
Blood and circulatory system: thromboembolism, thrombophlebitis, thrombocytopenia, transient leukopenia;
sense organs and nervous system: headache, fatigue, dizziness, confusion, depression, blurred vision, retinopathy, cataracts, corneal changes;
digestive system: abdominal pain, nausea, loss of appetite, vomiting, constipation, increased levels of liver enzymes, severe impairment of the functional state of the liver (hepatitis, cholestasis);
genitourinary system: vaginal discharge or bleeding, irregular menstruation or amenorrhea in premenopausal patients, itching in the genital area, development of reversible cystic ovarian tumor, fluid retention;
allergic reactions: rash on the code;
others: pain in the bones and/or in the area of the lesion, alopecia, hypercalcemia, increase in the size of the lesion and adjacent areas), paroxysmal sensation of heat, hyperthermia; with prolonged use - changes in the endometrium, which include intrauterine fibroids, polyps, hyperplasia and, in isolated cases, endometrial cancer.
Interaction of tamoxifen with other substances
When tamoxifen is used together with cytostatics, the possibility of thrombosis increases. Estrogens may decrease the therapeutic effects of tamoxifen when used together. Tamoxifen potentiates the effects of indirect anticoagulants. Tamoxifen can be used in combination with progestins.
Men take tamoxifen to preserve muscle mass and preventing the development of gynecomastia (growth of the mammary glands).
What is tamoxifen?
Tamoxifen citrate, best known by its trade name Nolvadex, is a specific estrogen receptor modulator (SERM). Powerful and effective, Nolvadex was developed to combat estrogen in breast cancer patients. Estrogens ( female hormones) bind to receptors in the chest area and promote the development of tumors. Tamoxifen interferes with this binding. The effect on the brain is that tamoxifen prevents the conversion of testosterone to estrogen, so the level of the female hormone remains low.
Tamoxifen in men is also used after a course of anabolic steroids to stimulate natural production and increase testosterone, which has been suppressed due to the use of steroids.
In this case, tamoxifen stimulates the production of luteinizing () and follicle-stimulating hormones () by the pituitary gland, which, in turn, affect the production of testosterone in a man. Without LH and FSH, there is no natural testosterone production; LH plays a major role in this process. Because of this effect, tamoxifen is sometimes prescribed to men to treat infertility.
TAMOXIFEN FOR GYNECOMASTIA IN MEN
Tamoxifen drugs were originally used to fight breast cancer, but are now increasingly being used by men taking anabolic steroids.
Tamoxifen in this case helps to avoid aromatization and prevent the development of gynecomastia (growth of the mammary glands in men). When aromatization occurs, testosterone (male hormone) is converted into estrogens (female hormones), and as the level of estradiol increases and the action of the receptors increases, gynecomastia develops. Tamoxifen binds to the receptors, thereby preventing estrogen from binding and causing this condition.
Another use of tamoxifen in men is antiandrogen therapy.
This type of hormonal treatment is often used in the treatment of prostate cancer. It slows the growth of cancer cells and relieves symptoms in many men by lowering testosterone levels, but can cause a number of side effects due to. For example, they can increase the level of estrogen, which stimulates the growth of breast tissue, which leads to gynecomastia and pain in the mammary glands.
Recent studies have shown that tamoxifen can be used as an alternative to surgical treatment for gynecomastia in men. Tamoxifen is effective for treating breast problems caused by androgen deprivation therapy in men (for example, in the treatment of prostate cancer), compared with radiation therapy or anastrozole (Arimidex - an anticancer drug, an aromatase inhibitor).
TAMOXIFEN: SIDE EFFECTS IN MEN
Although tamoxifen is really effective drug for men, it can cause side effects. The most common problems are associated with extremely long-term use, for example in patients with breast cancer.
With long-term use, tamoxifen citrate may suppress the production of insulin-like growth factor-1 (IGF-1) to some extent.
The peptide hormone IGF-1 is considered more powerful than growth hormone itself for bulking purposes. muscle tissue. However, with most anabolic steroids, IGF-1 increases dramatically, and tamoxifen will not suppress it much.
Although tamoxifen is classified as an estrogen antagonist, in some parts of the body tamoxifen actually works as an estrogen agonist. This means that it works like estrogen.
For example, by acting in this way in the liver, tamoxifen can increase the level of sex hormone binding globulin (SHGB) in men, which deactivates testosterone, thereby reducing it in the body. Free testosterone is unbound testosterone in the body, and it is its level that strongly correlates with the positive effects of high testosterone, such as increased muscle mass, strength, and libido. By lowering free testosterone, tamoxifen can impair the process of building muscle mass, so it is not taken in isolation from other drugs for muscle growth. Despite the significant increase in testosterone due to tamoxifen, the effect of the main male hormone is neutralized due to an increase in SHBG.
Other side effects of tamoxifen in men:
- Decreased cognitive abilities (thinking, memory, etc.) (9% of men).
- Weight gain (22% of men).
- Sexual disorders (22%).
- Hot flashes (13%).
- Blood thickening, risk of thrombosis (9%).
- Vision problems (3% of men).
Thus, in one experiment, of 64 men who received tamoxifen, 13 (20%) stopped taking it - either on their own or as directed by doctors - due to unacceptable side effects of the treatment.
How exactly does this medication work?
Experts were able to establish that the cells of malignant neoplasms quite often contain protein substances that tend to interact with female sex hormones, thereby provoking increased growth of the tumor cell. Using tamoxifen, it is possible to block these protein components, and, consequently, stop the further spread of the malignant neoplasm.
How can sensitivity to this drug be determined?
To determine sensitivity to the components of this pharmaceutical product, it is recommended to undergo a special analysis of a malignant neoplasm, which will determine receptors for both progesterone and estrogen.
What is a reaction called a "flare"?
During the first course of therapy with this medication, it is quite possible that “signs of exacerbation of the pathology” may occur. Such signs include hot flashes and general weakness, as well as painful sensations in the bones or in the chest area. It is this phenomenon that is called “flare”. In most cases, the severity of these signs gradually disappears. A very large number of patients perceive this phenomenon as a very strong side reaction of the body to the drug, which in turn pushes them to abandon its use. You shouldn't make hasty conclusions. First, get advice from a specialist who can confirm or refute your suspicions.
How should I take this drug?
Tamoxifen can be taken before, during, or after meals, while washing down the tablets of this medication with a small amount of liquid.
Is it possible to replace this medication with any drug with fewer complications?
In fact, such a drug exists - it is toremifene. It is a second generation medication and has fewer adverse reactions. If a woman completely misses menstruation, then she can use the help of medications from the group of aromatase inhibitors. This type of medicine can be classified as femaru, so extraza, Arimidex and some other medicines. If available menstrual cycle specialists opt for such medications as buserelin, zoladex, goserelin and some others.
What are the benefits of this medication?
Its most important advantage is considered to be that this drug is truly highly effective against breast cancer. Moreover, it is also accessible to large masses of the population.
What are its disadvantages?
Its most important disadvantage is considered to be a large number of side effects.
There are many reasons for the development of gynecomastia. The most common of them include both a violation of the ratio of testosterone and estrogen, and various diseases metabolic processes, cirrhosis of the liver , inflammatory processes in the ovarian area, HIV infection, tumors of the stomach, lungs and the like. To identify this pathology, the patient should first consult a specialist. He will examine the patient and also prescribe a number of necessary examinations.
As for the direct treatment of this disease, in this case everything depends on the form of this pathology. If gynecomastia is the result of excessive levels of estrogen in the patient’s body, then doctors prescribe special hormonal medications. One such medication is tamoxifen. Tamoxifen tends to suppress the overall level of estrogen, thereby restoring the natural appearance of the male mammary glands. We note right away that treatment with tamoxifen in all cases is very long-term. Since this drug tends to provoke the development of various side effects, during the course of treatment it is very important that men monitor any changes in their body as closely as possible.
In most cases, experts prescribe Tamoxifen Ebeve in the amount of twenty milligrams per day. If there is any common form of malignant neoplasm on the face, then it is quite possible to increase the daily dosage to thirty to forty milligrams. The maximum daily dose of this medicine It is generally accepted that it is forty milligrams. The therapeutic effect of such treatment is most often observed after four to ten weeks of therapy. If there are already metastases in the patient’s bones, then the necessary healing effect will have to wait for months.
If your doctor has prescribed you more than one tablet of this medication per day, then you can easily divide the total amount into two doses, that is, drink half in the morning and the other half in the evening. The duration of therapy with tamoxifen ebeve directly depends on both the severity of the existing pathology and its course. In most cases, the course of therapy is very long, and all because the tablets of this drug are recommended to be taken until remission occurs.
Even if a person has any impairment of the normal functioning of the liver or kidneys, this is not a reason to adjust the dose of this medication. The dosage, as well as treatment regimens for children with this drug, have not yet been established by specialists. The most effective therapeutic effect can be achieved in the fight directly against estrogen receptor positive malignant neoplasms, which made themselves felt during the postmenopausal period.
It should also be noted that Tamoxifen Ebeve can be safely used along with both radiation therapy and chemotherapy. It is also important to say that if you have diabetes, eye diseases or thromboembolic disease, this pharmaceutical should be prescribed with extreme caution.
Since this drug has an estrogenic effect, it can be used to treat both cancer and polyps, as well as hyperplasia. If before this the patient had to use the help of this medication, then before starting a course of treatment for a cancer tumor, various therapeutic and gynecological examinations should be regularly carried out for six months, or even more. If a woman develops vaginal discharge, vaginal bleeding or pain in the pelvic area during the course of therapy, then it is very important that the doctor determines as soon as possible the real reason development of this type of phenomena.
If a woman uses tamoxifen ebeve to prevent breast cancer, then she needs to be checked for endometrial hyperplasia at least once a month. If atypical hyperplasia occurs, treatment with this medication will need to be stopped immediately. Since some people experience this tool the development of certain visual impairments is noted, experts advise periodically visiting patients with breast cancer, which can occur during menopause. In addition, this drug has found its wide use in the fight against breast cancer in men, malignant neoplasms in the ovaries, kidneys or endometrium. It is also used in the case of melanoma or soft tissue sarcoma, which contain estrogen receptors. You cannot do without the help of this medication in the case of prostate cancer. If this occurs pathological condition this drug is prescribed to patients only if other drugs fail to provide the required therapeutic effect.
Let us immediately draw the attention of readers to the fact that this medication also has some contraindications for use, so it is not prescribed to all patients. So, for example, if a person was noted increased sensitivity to any of its components, then it is best to refuse the help of this remedy. Under no circumstances should tamoxifen be used by pregnant women or breastfeeding mothers. This drug is prescribed with extreme caution to those citizens who have severe thrombophlebitis, thrombocytopenia, one or another eye pathology, thromboembolic disease, leukopenia or hyperlipidemia.
It is also important to note the fact that while taking this drug, a wide variety of side effects can become apparent. In fact, there are quite a lot of them. The most common side effects include vomiting, thrombophlebitis, pain in the affected areas, nausea, leukopenia, dizziness, diarrhea, and loss of appetite. In case of an overdose, the patient also experiences far from pleasant symptoms. There is no antidote for this drug, so treatment is symptomatic.
As for dosages, in this case everything depends on the existing pathology. So, for example, in the fight against breast cancer, women are most often prescribed tamoxifen in the amount of twenty to forty milligrams in the morning and evening. For endometrial cancer, this medication is prescribed twenty to thirty milligrams one to two times a day. It should be noted that tablets of this drug must be taken without prior chewing. They should be taken with a small amount of water.
Since this medication is quite strong, before using it it is very important to first consult a specialist, and also undergo full examination all organs and systems.
It has long been known that exactly Clomid is the most popular drug for athletes. Tamoxifen is used by them only in the most extreme cases.
What explains this? Does Clomid really deserve the most recognition?
Right now we will try to find answers to these questions.
Let's start with the fact that in fact these drugs are almost identical. Considering the structure of the molecules of these two medications, one can immediately note the fact that they are very similar to one another. Moreover, both of these drugs belong to the category triphenylethylenes. With all this, Clomid is considered to be much weaker, and its effect is immediately several times weaker. If the daily dosage of Clomid is fifty to one hundred milligrams, then tamoxifen is prescribed in doses of twenty to forty milligrams. Considering these facts, it becomes clear that using Clomid makes no sense in the fight against breast cancer.
The advantage of tamoxifen is, of course, good, but only if we are talking about cancer. If we talk about athletes, then in this case the leading position is occupied by Clomid. In fact, it is common for both medications to interact with estradiol receptors, since both of them have a weakly expressed estrogenic effect. The thing is that Clomid does not tend to have a very strong effect on the liver. negative impact, while tamoxifen causes extremely serious side effects in this organ. They make themselves felt especially often during a long course of therapy with this drug.
With all this, tamoxifen also has some advantages, and there are many of them. Its first advantage is considered to be that this medication tends to increase the amount of very high-density cholesterol in the patient’s blood. This is very important, since this is the type of cholesterol that is classified as “good”. If the level of “good” cholesterol in the human body dominates over the level of “bad” cholesterol, this makes it possible to prevent the development of a number of disorders of the cardiovascular system. Surely, you know that this type of violation is observed among competitive level athletes very often.
Another advantage of this drug is that it is a mild estrogen. And finally, this medication is considered to be much safer than Clomid. In the course of numerous studies, experts were able to establish that long-term therapy with Clomid leads to irreversible impairments in the quality and acuity of vision. In general, there have been and will continue to be debates regarding which of these drugs is the best. This is not surprising, since both of these medications have both positive and negative qualities.
Gross formula
C 26 H 29 NOPharmacological group of the substance Tamoxifen
Nosological classification (ICD-10)
CAS Code
10540-29-1Characteristics of the substance Tamoxifen
Antitumor agent (anti-estrogen). Tamoxifen citrate is a white, odorless, crystalline powder. Very slightly soluble in water (1:5000), easily soluble in hot water (1:2), soluble in ethanol, methanol, acetone. Hygroscopic at high humidity, sensitive to ultraviolet radiation. Molecular weight 563.65.
Pharmacology
pharmachologic effect- antitumor, antiestrogenic.Competitively binds to estrogen receptors in target organs, like estrogens, translocates along with the receptor into the tumor cell nucleus and thus blocks the effect of estrogens.
Well absorbed from the gastrointestinal tract, T max - 4-7 hours, time to reach C ss - 3-4 weeks. Plasma protein binding - 99%. Metabolized in the liver by hydroxylation and demethylation. The main metabolite, N-desmethyl tamoxifen, has activity similar to that of tamoxifen. Elimination is biphasic with an initial T1/2 of 7-14 hours followed by a slow terminal T1/2 of 7 days. It is excreted primarily through the intestines, mainly in the form of metabolites, and a small amount by the kidneys.
Use of the substance Tamoxifen
Breast cancer: especially in menopausal women, in men after castration, carcinoma in situ mammary duct; adjuvant therapy for breast cancer. Estrogen-sensitive tumors; endometrial cancer.
Contraindications
Hypersensitivity, pregnancy, breastfeeding.
Restrictions on use
History of deep vein thrombosis and pulmonary embolism during treatment with indirect coumarin anticoagulants, thrombocytopenia, leukopenia, hypercalcemia, hyperlipidemia, cataracts or visual impairment.
Use during pregnancy and breastfeeding
Contraindicated during pregnancy (pregnancy should be excluded before starting treatment).
Breastfeeding should be discontinued during treatment (it is not known whether tamoxifen penetrates into breast milk).
Side effects of Tamoxifen
From the nervous system and sensory organs: headache, dizziness, fatigue, depression, confusion, blurred vision, corneal changes, cataracts and retinopathy.
From the cardiovascular system and blood (hematopoiesis, hemostasis): thrombophlebitis, thromboembolism, transient leukopenia, thrombocytopenia.
From the gastrointestinal tract: abdominal pain, nausea, vomiting, loss of appetite, constipation, increased levels of liver enzymes, severe liver dysfunction (cholestasis, hepatitis).
From the outside genitourinary system: bleeding or vaginal discharge, amenorrhea or irregular menstruation in premenopausal patients, the occurrence of reversible cystic ovarian tumor, fluid retention, itching in the genital area.
Allergic reactions: skin rash.
Others: alopecia, pain in the area of the lesion and/or in the bones, an increase in the size of soft tissue formations (accompanied by severe erythema of the affected areas and adjacent areas), hypercalcemia, paroxysmal sensation of heat, increased body temperature; with long-term use - cases of endometrial changes, including hyperplasia, polyps, intrauterine fibroids and in isolated cases - endometrial cancer.
Interaction
When combined with cytostatics, the risk of thrombosis increases. Estrogens may reduce the therapeutic effect of tamoxifen. Can be used in combination with progestins. Potentiates the effect of indirect anticoagulants.
Routes of administration
Inside.
Precautions for the substance Tamoxifen
Before starting treatment, women should undergo a thorough gynecological examination. Tamoxifen causes ovulation, which increases the risk of pregnancy, so women of reproductive age should use reliable methods of contraception (non-hormonal) during treatment and for 3 months after the end of treatment.
The drug should be stopped if bloody discharge from the vagina or vaginal bleeding appears, signs of thrombosis of the veins of the lower extremities (pain in the legs or swelling), or thromboembolism of the branches of the pulmonary artery (shortness of breath).
During treatment, it is necessary to monitor blood clotting indicators, blood patterns (leukocytes, platelets), and liver function indicators. An ophthalmological examination is recommended before and periodically during treatment.
In patients with bone metastases, serum calcium concentrations should be determined periodically during the initial treatment period (in case of severe hypercalcemia, tamoxifen should be temporarily discontinued). In patients with hyperlipidemia, during treatment it is necessary to monitor the concentration of cholesterol and TG in the blood serum.
Ineffective in treating patients with metastases (especially to the liver).
Interactions with other active ingredients
Trade names
| Name | The value of the Vyshkowski Index ® |
| 0.0087 | |
Release form
Pills
Compound
Tamoxifen citrate 30.4 mg, which corresponds to the content of tamoxifen 20 mg. Excipients: lactose monohydrate - 142.6 mg, sodium starch glycolate - 20 mg, povidone - 5 mg, microcrystalline cellulose - 49.6 mg, magnesium stearate - 2.4 mg. Shell composition: white dye opadry - 5 mg (lactose - 1.8 mg, titanium dioxide - 1.3 mg, hypromellose - 1.4 mg, polyethylene glycol 4000 - 0.5 mg).
Pharmacological effect
Tamoxifen is a nonsteroidal antiestrogenic agent that also has weak estrogenic properties. Its action is based on its ability to block estrogen receptors. Tamoxifen, as well as some of its metabolites, compete with estradiol for binding sites with cytoplasmic estrogen receptors in the tissues of the breast, uterus, vagina, anterior pituitary gland and tumors with a high content of estrogen receptors. In contrast to the estrogen receptor complex, the tamoxifen receptor complex does not stimulate DNA synthesis in the nucleus, but inhibits cell division, which leads to regression of tumor cells and their death.
Pharmacokinetics
Absorption and distribution After oral administration, tamoxifen is well absorbed. Cmax in serum is achieved within 4 to 7 hours after taking a single dose. Equilibrium concentration of tamoxifen in serum is usually achieved after 3-4 weeks of dosing. Communication with plasma proteins is 99%. Metabolism and excretion Metabolized in the liver with the formation of several metabolites. The elimination of tamoxifen from the body has a biphasic character with an initial T1/2 from 7 to 14 hours and followed by a slow terminal T1/2 for 7 days. It is excreted mainly in the form of conjugates, mainly with feces and only small amounts are excreted in the urine.
Indications
Estrogen-dependent cancer of the mammary glands in women (especially in menopause) and mammary glands in men. The drug can be used to treat ovarian cancer, endometrial cancer, kidney cancer, melanoma, soft tissue sarcomas in the presence of estrogen receptors in the tumor, as well as for the treatment of prostate cancer glands with resistance to other drugs.
Contraindications
Pregnancy; - lactation period (breastfeeding); - hypersensitivity to tamoxifen and/or any other ingredient of the drug. With caution: renal failure, diabetes mellitus, eye diseases (including cataracts), deep vein thrombosis and thromboembolic disease ( including a history), hyperlipidemia, leukopenia, thrombocytoenia, hypercalcemia, concomitant therapy with indirect anticoagulants.
Precautionary measures
Use during pregnancy and breastfeeding
The use of the drug during pregnancy is contraindicated. There is no sufficient data on whether tamoxifen passes into breast milk, therefore the drug should not be used during lactation or the issue of stopping breastfeeding must be decided.
Directions for use and doses
The dosage regimen is usually set individually depending on the indications. The daily dose is 20-40 mg. As a standard dose, it is recommended to take 20 mg of tamoxifen orally daily for a long time. If signs of disease progression appear, the drug should be discontinued. The tablets should be taken without chewing, with a small amount of liquid, in 1 dose in the morning, or by dividing the required dose into 2 doses in the morning and evening.
Overdose
Acute overdose with tamoxifen has not been observed in humans. It should be expected that an overdose may cause an increase in the adverse reactions described above. There are no specific antidotes; treatment should be symptomatic.
Interaction with other drugs
When tamoxifen and cytostatics are prescribed simultaneously, the risk of thrombosis increases. Antacids, histamine H2 receptor blockers and other drugs of similar action, increasing the pH value in the stomach, can cause premature dissolution and loss of the protective effect of the enteric tablet. The interval between taking tamoxifen and these drugs should be 1-2 hours. There are reports of tamoxifen enhancing the anticoagulant effect of coumarin drugs (for example, warfarin). Drugs that reduce calcium excretion (for example, thiazide diuretics) may increase the risk of developing hypercalcemia. Combined use tamoxifen and tegafur can contribute to the development of active chronic hepatitis and cirrhosis of the liver. Simultaneous use of tamoxifen with other hormonal drugs (especially estrogen-containing contraceptives) leads to a weakening of the specific effect of both drugs.
special instructions
Women receiving tamoxifen should undergo regular gynecological examination. If bloody vaginal discharge or vaginal bleeding occurs, the drug should be discontinued. In patients with bone metastases, serum calcium concentrations should be determined periodically during the initial treatment period. In case of severe disturbances, taking tamoxifen should be temporarily stopped. If signs of venous thrombosis of the lower extremities appear (pain in the legs or swelling), pulmonary embolism (shortness of breath), the drug should be stopped. Tamoxifen can cause ovulation, which increases the risk of pregnancy, due to than women who are active sex life, during (and for approximately 3 months after) treatment with tamoxifen, the use of mechanical or non-hormonal contraception is recommended. During the period of therapy, it is necessary to periodically monitor blood coagulation parameters, calcium levels in the blood, blood picture (leukocytes, platelets), liver function indicators, blood pressure, and an examination by an ophthalmologist. In patients with hyperlipidemia, during treatment it is necessary to monitor the concentration of cholesterol and triglycerides in the blood serum .Influence on the ability to drive vehicles and operate machinery. During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
