Tamoxifen 20mg tab 100 pcs

$15.34

Tamoxifen 20mg tab 100 pcs

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Description

Composition
Active substance:
Tamoxifen citrate 15.2 mg and 30.4 mg, equivalent to 10 mg and 20 mg of tamoxifen.
Excipients:
Corn starch 40.0 mg (100.0 mg), 40.0 mg lactose (103.1 mg), 7.0 mg of povidone (14.0 mg), magnesium stearate 1.0 mg (2.5 mg) sodium starch glycolate 10.0 mg (20.0 mg), purified water (qs).
Description:
Round, biconvex tablets with a yellowish white to white with a creamy yellowish tint.
At 10 mg tablets on one side – the number “10”; 20 mg tablets on one side -. the number “20”
Product form:
Tablets of 10 mg and 20 mg.
30 or 100 tablets per plastic vials with control of the first opening.
1 bottle together with instructions for use in a cardboard box.
Contraindications
– Hypersensitivity to tamoxifen and / or any other ingredients of the formulation. – Pregnancy and lactation.
Precautions: renal failure, diabetes, eye diseases (including cataracts), deep vein thrombosis and thromboembolic disease (including history), hyperlipidemia, leukopenia, thrombocytopenia, hypercalcemia, concomitant therapy indirect anticoagulants.
Dosage
20 mg
Indications
Estrogen-dependent breast cancer in women (especially after menopause) and male breasts.
The drug can be used to treat ovarian cancer, endometrial cancer, kidney cancer, melanoma, sarcomas of soft tissues in the presence of estrogen receptor in the tumor, as well as for the treatment of prostate cancer with resistance to other drugs.
Interaction with other drugs
With simultaneous use of tamoxifen and cytotoxic drugs increases the risk of blood clots.
There are reports on enhancing anticoagulation effect of tamoxifen coumarin drugs, such as warfarin (requires careful monitoring for correcting dose anticoagulation).
Drugs that reduce the excretion of calcium (eg, thiazide diuretics series), may increase the risk of hypercalcemia.
The combined use of tamoxifen and tegafur may contribute to chronic active hepatitis and cirrhosis.
Simultaneous use of tamoxifen with other hormones (especially estrogen-containing contraceptives) leads to a weakening of the specific action of both drugs. With simultaneous use of tamoxifen with drugs metabolized by CYP3A4 isoenzyme (eg, rifampicin) may decrease plasma concentrations of tamoxifen. The clinical effect is not known.
Due to a possible reduction in the plasma concentration and clinical effect of Tamoxifen while the use of potent inhibitors isoenzyme CYP2D6 (e.g., paroxetine, fluoxetine, quinidine, cinacalcet, bupropion, antidepressants of serotonin reuptake group of selective inhibitors), such combination therapy, if possible, should be to avoid.
With simultaneous use of tamoxifen and bromocriptine an increase in plasma concentrations of tamoxifen and N-dezmetiltamoksifena.
Should not be used concurrently with tamoxifen with anastrozole, as it may weaken the pharmacokinetic effects of the latter.
Overdose
When drug overdose probably increased side reactions associated with the pharmacological action of the drug, including an anti-estrogen.
Some sources reported that multiple receiving standard doses of tamoxifen may cause prolongation of the QT interval on the electrocardiogram.
There is no specific antidote. In case of overdose symptomatic treatment is carried out.
pharmachologic effect
Pharmacological group:
Antineoplastic drug – an anti-estrogen.
Pharmacodynamics:
Tamoxifen is a nonsteroidal antiestrogen agent having as weak estrogenic properties. Its action is based on the ability to block estrogen receptors. Tamoxifen, as well as some of its metabolites compete with estradiol for binding sites with cytoplasmic estrogen receptors in tissues of the breast, uterus, vagina, the anterior pituitary gland and tumors with a high content of estrogen receptors. In contrast, the estrogen receptor complex receptor complex tamoxifen does not stimulate the synthesis of DNA in the nucleus and inhibits cell division that leads to the regression of tumor cells and their death.
Pharmacokinetics:
After ingestion Tamoxifen well absorbed. The maximum serum concentration is achieved in the range of 4 to 7 hours after receiving a single dose. The equilibrium concentration of tamoxifen in serum is usually achieved after 3-4 weeks of administration. Relationship to plasma proteins – 99%.
It is metabolized in the liver to form several metabolites. Tamoxifen excretion from the body has a biphasic pattern with an initial half-life of 7 to 14 hours and followed by a slow terminal elimination half-life for 7 days. It provided mainly in the form of conjugates, mainly with faeces and only a small amount excreted in the urine.
Pregnancy and breast-feeding
Tamoxifen is contraindicated in pregnancy.
Prior to initiating therapy with tamoxifen pregnancy must be excluded. In the course of tamoxifen have been cases of spontaneous abortions, birth defects and fetal death. Patients taking tamoxifen should avoid becoming pregnant by using reliable non-hormonal contraceptive methods both during treatment and for two months after his termination.
Tamoxifen inhibits lactation. After the cessation of drug therapy lactation is not renewed. Data about whether tamoxifen is excreted through breast milk are not available. Contraindicated in lactating women taking tamoxifen. Choice as to what should be discontinued (breast-feeding or treatment) should be based on the need for maternal care.
Conditions of supply of pharmacies
On prescription.
side effects
Below is a list of adverse reactions, likely while taking tamoxifen.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Endometrial pathology (including hyperplasia and polyps), uterine fibroids, endometrial cancer, uterine sarcoma (usually mixed tumors Mueller), transient worsening clinical manifestations of tumors, ovarian cysts, polyps vagina.
Blood disorders and lymphatic system
Anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, pancytopenia.
Violations by the immune system
Hypersensitivity reactions, urticaria.
Violations by the metabolism and nutrition
Fluid retention, hypercalcemia (in patients with bone metastases).
psychiatric disorders
Depression, confusion.
Disorders of the nervous system
Ischemic cerebrovascular disease, stroke, headache, dizziness, sensory disturbances (including paraesthesia and dysgeusia), vertigo.
For part of the view
Cataract, retinopathy, vision disturbance (including blurring and loss of visual acuity), cornea disease (including corneal opacities), neuritis and optic neuropathy.
Violations by the vessels “Tides”, thromboembolic events (including deep vein thrombosis, pulmonary capillary thrombosis and thromboembolism).
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Interstitial pneumonia, cough.
Disorders of the gastrointestinal tract
Abdominal pain, nausea, vomiting, diarrhea, constipation, pancreatitis.
Disorders of the liver and biliary tract
Changing the “liver” enzymes, fatty liver, cirrhosis, hepatitis, cholestasis, hepatic failure, including fatal, hepatocellular insufficiency, hepatic necrosis.
For the skin and mucous membranes
Rash, hair loss, angioedema, Stevens-Johnson Syndrome, cutaneous vasculitis, bullous pemphigoid, erythema multiforme, cutaneous lupus.
Violations by the musculoskeletal system and connective tissue
Leg cramps, myalgia.
Violations by the reproductive system and breast
Endometriosis, vaginal bleeding, vaginal discharge, genital itching, amenorrhea / menstrual irregularities in women in pre-menopausal women.
Congenital, familial and hereditary diseases
Variegated porphyria.
General disorders and disturbances at the injection site
Fatigue, increased pain in the bones and the site of the tumor.
Laboratory and instrumental data
Improving the performance of triglycerides.
other
Decreased libido in men, impotence in men.
There is an increased likelihood of thrombosis. Possible hemorrhage.
special instructions
There is evidence that tamoxifen may increase the risk of thromboembolic events (including stroke, deep vein thrombosis and pulmonary embolism). When tamoxifen doctor should carefully study the history of the patient’s disease, and family history of venous thromboembolism about. The patient should be instructed to report immediately to your doctor any symptoms of venous thromboembolism. In the event of symptoms at any thromboembolic complications, the patient should immediately seek medical help. In such cases, treatment with tamoxifen is prescribed cancel and antithrombotic drugs.
Simultaneous treatment with tamoxifen and cytotoxic agents increases the risk of thromboembolic complications.
Tamoxifen is prescribed to patients with caution in the presence of leukopenia and thrombocytopenia. When treating such patients CBC should periodically (including determination of platelet count).
Patients in premenopausal receiving tamoxifen for breast cancer, menstruation may cease or become irregular.
Due to the risk of hypercalcemia in the first weeks of treatment with tamoxifen should be especially careful to watch for female patients who have bone metastases. In case of hypercalcaemia should start appropriate treatment. In severe cases, tamoxifen overturned. Requires constant monitoring of calcium in blood serum.
At the beginning of treatment, the patient should undergo ophthalmologic examination. In some cases, while taking tamoxifen were observed visual disturbances such as: corneal, cataract and retinopathy. Periodic eye examination is necessary for patients receiving tamoxifen for a long time. If during treatment with tamoxifen have any blurred vision (cataract, retinopathy), the patient should undergo urgent ophthalmologic examination. Most adverse events occurred during treatment with tamoxifen, disappear after discontinuation.
In patients receiving tamoxifen may develop endometrial pathology, including hyperplasia, polyps, tumors, and uterine sarcoma (usually mixed tumors Muller). The causative mechanism of these disorders is unknown but may be associated with estrogen-like effect of tamoxifen. If during or after treatment with tamoxifen patient notes at the symptoms of gynecological disorders vaginal bleeding, irregular menstruation, vaginal discharge, pain or a feeling of pressure in the abdomen), it should immediately undergo a medical examination.
In several clinical studies in patients with tamoxifen therapy the past, it has been reported that in patients with breast cancer after tamoxifen have additional foci of the primary tumor is not localized in the endometrium and the opposite of the affected breast. A causal relationship has not been established, the clinical significance of the observations is not known.
In the course of treatment with tamoxifen is recommended for all patients to undergo periodic medical examinations, including gynecologic, with mandatory supervision of the endometrium. The frequency and volume of such surveys are selected individually depending on the patient’s condition. The results of long-term carcinogenicity studies of tamoxifen conducted on rodents, carcinogenic drug to the liver. Is known to occur hepato-cellular carcinoma in clinical trials of tamoxifen. Preliminary results suggest an increased risk of cancers of the gastrointestinal tract in patients with breast cancer receiving tamoxifen; that is why in the course of treatment requires constant monitoring of liver function tests. It is also recommended to carry out the analysis of serum triglycerides.
According to the literature, CYP2D6 poor metabolizers may reduce the level of endoksifena plasma. Endoksifen – one of the most important active metabolites of tamoxifen. Simultaneous administration of drugs tamoxifen and CYP2D6 inhibitor drugs can reduce the concentration of the active metabolite endoksifena, i.e. avoid simultaneous administration of strong CYP2D6 enzyme inhibitors (such as paroxetine, fluoxetine, quinidine, tsinakaltset, bupropion).
The composition of the drug Tamoxifen include lactose monohydrate. Patients with such rare heritable diseases as intolerance galactose, lactose or insufficient glucose-galactose malabsorption, should not take the drug.
The effect on the ability to operate vehicles, machinery
Tamoxifen does not affect the ability to drive and use machines. However, when taking tamoxifen may develop side effects such as dizziness, drowsiness, blurred vision, so the appearance of the described adverse events should refrain from carrying out these activities.
Storage conditions
At a temperature of 15 to 25C.
Keep out of the reach of children!.
Dosing and Administration
The dosage regimen is generally determined individually depending on the evidence. The daily dose is 20-40 mg. As a standard dose is recommended intake of 20 mg of tamoxifen daily inwardly long. If signs of progression reception cancel preparation disease.
Tablets should be taken with liquid, squeezed small amounts of liquid in one go in the morning, or by separating the required dose into two doses, morning and evening.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Farmakor PRODUCTION

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