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Tamooex 15.2mg by Korea United Pharma x 1 Strip

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Product Description

TAMOOEX
ÊUTICA AND PRESENTATION:  Tamooex presents itself in the form of coated tablets, round and white coloration, for oral administration, containing 15.2 mg of tamoxifen citrate equivalent to 10mg Tamoxifen and 30.4 mg of tamoxifen citrate, equivalent to 20mg Tamoxifen. Boxes of 30 tablets.

"DO NOT USE THIS PRODUCT IF THE EXPIRY DATE IS OVERDUE"
Tell your doctor the occurrence of pregnancy during treatment or after its completion. Inform your doctor if you are breastfeeding. follow the guidance of your doctor respecting schedules, doses and duration of treatment. not stop treatment without the knowledge of your doctor. Inform the doctor the appearance of unpleasant reactions. Women taking Tamooex should report to the doctor the occurrence of abnormal vaginal bleeding. If this occurs, its causes must be promptly investigated.
"ALL PRODUCT MUST BE STORED OUT OF THE REACH OF CHILDREN"
Inform your doctor of any medication you are using before starting or during treatment. This medicine should not be used during pregnancy and lactation.
"DO NOT TAKE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR MAY BE HAZARDOUS TO YOUR HEALTH" 
Tamooex is exclusively orally.
TECHNICAL INFORMATION - TAMOOEX
Mode of Action: Tamoxifen is an antiestrogen with weak estrogenic activity in some animals, especially in large doses. The precise mechanisms of drug action are not yet well known. many of tamoxifen and estradiol metabolites compete for binding to cytoplasmic estrogen receptors in tissues such as breast, uterus, vagina and pituitary tumors containing high concentrations of receptors estrogen. Although the receptor complexes Tamoxifen and its metabolites are translocated to the nucleus, binding to the nuclear chromatin appears to occur abnormally persists for a longer period of time as the estrogen receptor complex. The synthesis of DNA response to estrogen and are, thus markedly reduced. Unlike the case provided a rat study demonstrated that tamoxifen does not interfere with the refueling of cytoplasmic estrogen receptors. The antiestrogenic effects in vivo and antitumor Tamoxifen appear to result from the combined actions of many of the unchanged drug and its metabolites identified, but their relative contributions have not been fully clarified. Following the short-term administration in women who do not ovulate, Tamoxifen can induce ovulation by stimulating the release of gonadotropin in the hypothalamus, which in turn stimulates the release of gonadotropins from the pituitary.
Pharmacokinetics - TAMOOEX
Tamoxifen is slowly absorbed by oral administration, with peak serum concentrations occurring usually 3 to 6 hours after a single dose. The extent of absorption in humans has not yet been properly determined, but limited information animal studies suggest that the drug is well absorbed. These studies also suggest that Tamoxifen and its metabolites undergo extensive circulation enterepática.Na oral administration, peak serum concentrations reach about 17ng/mL tamoxifen after a single dose of 10mg; 42ng/mL after 20mg, and 65 to 70ng/mL after a single dose of 40mg, however, there is considerable variation between individuals in relation to serum concentrations achieved after single doses and at steady state with continuous doses. By oral administration of a single dose of Tamoxifen, peak serum concentrations of N-desmethyltamoxifen, the main metabolite of the drug, usually ranges from 20 ‰ to 50 ‰ unchanged compared to tamoxifen, however, with continuous dosing, the concentrations of N-desmethyltamoxifen balance generally range from 1 to 2 times compared to tamoxifen unchanged. In continuous administration orally, Tamoxifen 10mg twice a day for 3 months, equilibrium concentrations of Tamoxifen and N-desmethyltamoxifen are, on average, 120ng/mL (range, 67 to 183ng/mL), and 336ng/mL (range 148 to 654ng/mL), respectively. equilibrium concentrations of Tamoxifen are usually reached after 3 to 4 weeks of continuous doses, whereas the N-desmethyltamoxifen are usually reached after 3 to 8 weeks of dose continuous.Serum concentrations of equilibrium can be reached faster with cumulative dose regimen, there is no therapeutic advantage to this procedure. distribution of Tamoxifen and its metabolites in body fluids and tissues of the human body has not been fully elucidated. In a study with a limited number of women receiving tamoxifen radioactively labeled prior to hysterectomy, the concentrations of radioactivity detected in uterine tissues were higher than those in sera from 4 to 96 hours of drug administration. Uterine concentrations of radioactivity were present in higher endometrium. Tamoxifen metabolites are distributed into bile of animals. Generally, the distribution of Tamoxifen and its metabolites in the cytosol of human breast tumor tissue appears to be similar to the relative concentrations present in the serum, although concentrations in the cytosol may exhibit greater than the individual variations in serum. Whether Tamoxifen is excreted in milk. limited information to suggest that Tamoxifen has a half-life of distribution from 7 to 14 hours and half-life of approximately 7 days (range 3 to 21 days). The half-life of elimination of N-desmethyltamoxifen, its main metabolite is estimated to be 9 to 14 days. Tamoxifen is rapidly and extensively metabolized by demethylation, especially for a small part and subsequent deamination and also hydroxylation. Initial studies suggested that 4-hydroxytamoxifen (metabolite B) was the major metabolite of the drug. However, subsequent studies using test methodologies best, have shown that 4-hydroxytamoxifen is a minor metabolite, N-desmethyltamoxifen and (metabolite X) page. The biological activity of N-desmethyltamoxifen seems to be similar to the activity of tamoxifen. Undergoes N-demethylation to form desmethyltamoxifen NN-desdimetiltamoxifeno (metabolite Z), which undergoes subsequent deamination to form the primary alcohol metabolite (metabolite Y). Both, 4-hydroxytamoxifen and the side chain of the primary alcohol derivative of Tamoxifen, have been identified as minor metabolites in plasma. 3,4-diidroxitamoxifeno and unidentified metabolite (metabolite E) have also been detected in plasma in small amounts. With the continuous administration of Tamoxifen, serum N-desmethyltamoxifen are typically about 1 to 2 times those of tamoxifen unchanged, while NN-desdimetiltamoxifeno is about 20 ‰ to 40 ‰ unchanged from those of tamoxifen and concentration the primary metabolite of alcohol is about 5 ‰ to 25 ‰ those Tamoxifen unchanged. Hydroxylated metabolites concentrations and metabolite E appear to be less than 5 ‰ than Tamoxifen unchanged. The relative contribution of tamoxifen and its metabolites in vivo antiestrogenic effects and antitumor drug has not been fully clarified, but results from several studies in vivo and in vitro suggest that the in vivo effects of Tamoxifen result of combined actions of unchanged drug and many its metabolites identified. Fate excretion of tamoxifen and its metabolites has not yet been elucidated. But after oral administration of a dose of 20mg tamoxifen in women radiolabeled approximately 6.5 ‰ of the administered dose was excreted in the feces in a period of 2 weeks mainly as polar conjugates, Tamoxifen unchanged and unconjugated metabolites were responsible for less than 30 ‰ fecal radioactivity. Tamoxifen and N-desmethyltamoxifen have been detected in the urine in small amounts. In animals, Tamoxifen and / or their metabolites appear to undergo extensive enterepática circulation and are excreted in feces and urine as glucuronides, other conjugates and non-polar metabolites identified.
INDICATIONS - TAMOOEX
Adjunctive therapy Tamooex is indicated for the treatment of breast cancer with axillary lymph node negative women following total mastectomy or segmental, axillary dissection and radiotherapy.The data are insufficient to predict which women are most likely to benefit and to determine whether Tamooex provides some benefit to women with tumors smaller than 1 cm. Tamooex is indicated for the treatment of breast cancer with axillary lymph node positive postmenopausal women after Total or segmental mastectomy, axillary dissection and radiotherapy. In some studies Tamooexadjuvant, most of the benefits so far has been in the subgroup with four or more positive axillary nodes. quantification of estrogen and progesterone may help to predict whether adjuvant therapy withTamooex be beneficial. Therapy for advanced disease: Tamooex is effective in treating metastatic breast cancer in men and women. In premenopausal women with metastatic breast cancer,Tamooex is an alternative to oophorectomy or ovarian irradiation. Evidence indicating that patients whose tumors are estrogen receptor-positive are likely to benefit most from treatment withTamooex .


CONTRAINDICATIONS - TAMOOEX
Tamooex is contraindicated in patients with known hypersensitivity to the active drug or any component of the formulation. Tamooex should not be administered during pregnancy. In premenopausal patients should undergo a careful examination to rule out any possibility of pregnancy prior to treatment of breast cancer or infertility Tamooex .

GENERAL PRECAUTIONS - TAMOOEX
Tamooex must be used carefully in patients with thrombocytopenia or leukopenia. Observations of leukopenia and thrombocytopenia occasionally have been reported. Decreases in platelet counts, usually 50,000 to 100.000/mm3, infrequently lower, have occasionally been reported in patients taking Tamooex for treatment of breast cancer. In patients with significant thrombocytopenia, rare bleeding episodes have occurred, but there is no sure that these episodes occur because therapy with Tamooex . Complete blood counts, including platelet counts, should be performed at regular intervals. During pharmacovigilance, T4 elevations were reported for a few postmenopausal patients which can be explained by increases in the thyroid binding globulin. These elevations were not accompanied by clinical hyperthyroidism. Variations in the index cariopcínico vaginal swab and estrogenic effects of varying degrees on Pap smears have not often appeared in postmenopausal patients when Tamooex was administered. pharmacovigilance experience In Tamooex , rare cases of hyperlipidemia have been reported. Periodic monitoring of plasma levels in relation to triglyceride and cholesterol may be indicated in patients with preexisting hyperlipidemia.
Carcinogenesis: A conventional carcinogenesis study in rats (doses of 5, 20 and 35mg/Kg/dia for up to 2 years) revealed hepatocellular carcinoma at all doses, and the incidence of these tumors was significantly higher in rats receiving doses of 20 or 35mg/Kg/dia (69 ‰) than in those who received doses of 5mg/kg/day (14 ‰). The incidence in those receiving doses of 5mg/kg/day (29.5 mg/m2) was significantly higher than in controls. In addition, preliminary data from two independent reports, studies of 6 months duration in rats showed liver tumors, which were classified as malignant by these studies. endocrine changes in immature and mature mice were investigated in a study 13 months of life. Ovarian tumors and interstitial cell testicular tumors were detected in those receiving Tamooex but not in controls.
Mutagenesis: Although no genotoxic potential has been discovered in bacteria conventional tests in vitro and in vivo test systems with prokaryotic and eukaryotic systems of drug metabolism present. Increased levels of DNA found in liver of rats exposed to Tamooex . Tamooex format also increases levels of micronuclei in vitro human lymphoblast cell line (MCL-5). Based on these findings, Tamooex is genotoxic in MCL-5 cells of rodents and humans.  
Impairment of Fertility: The fertility rate decreased in rats after administration of 0.04 mg / kg for two weeks. There was a decrease in the number of implantation and all fetuses died. Following administration of 0.16 mg / kg in rats from day 7 to day 17 of pregnancy, there was an increase in the number of fetal deaths. administration in rabbits of 0.125 mg / kg, the 6th to 18th day of pregnancy resulted in abortion or premature calving. Fetal deaths occurred at high doses. There were no teratogenic changes in segment II study in rats or rabbits. Several pregnant marmosets received doses of 10mg/kg/day during organogenesis or in the last half of pregnancy. No deformation was seen and, although the dose was high enough to interrupt the pregnancy some animals, who in fact maintained pregnancy showed no abnormalities. Rats that received 0.16 mg / kg from day 17 of pregnancy until a day before weaning showed an increase in the number of pups born dead. It was reported that some pups born of these rats showed slower learning without statistical significance in a study. In another study, where significance was reported, this was obtained by comparing animals receiving the drug with other controls of the study. recommended human daily dose of 20 to 40mg corresponds to 0.4 to 0.8 mg / kg for a woman average weight of 50Kg.
Use in pregnancy and lactation: Tamooex can cause fetal harm when administered to pregnant women. Patients should be advised not to become pregnant while taking Tamooex , and should use barrier contraceptive measures or non-hormonal, if they are sexually active. Effects on reproductive functions are expected due to the antiestrogenic properties of the drug. In reproduction studies in rats at doses below those used in humans, non-teratogenic changes in skeletal development were observed, but they were reversible. In addition, in fertility studies in rats and teratogenesis studies in rabbits at doses below those used in humans, we observed a low incidence of embryo implantation, high incidence of fetal death or intrauterine growth retardation, with lower learning some of the pups compared to controls. Several pregnant marmosets were dosed during organogenesis or in the last half of pregnancy. No deformation was observed and although the dose was high enough to interrupt pregnancy in some animals, those who, in fact, kept the pregnancy showed no evidence of malformations. No adequate and well controlled studies of the drug in pregnant women. have been reported miscarriages, fetal malformations, fetal deaths, and vaginal bleeding. Whether Tamooex is administered during pregnancy or if the patient becomes pregnant during treatment, or even two months after the end of therapy Tamooex , the patient should be advised of the potential risk to the fetus, including long-term risk. It is not known if Tamooex is excreted in breast milk.Because many drugs are excreted in human milk and considering the potential for serious adverse reactions in infants due to Tamooex , should making the decision to discontinue breastfeeding or drug administration, noting its importance to the mother.
Warnings - TAMOOEX
Visual disturbances, including corneal damage, cataracts and retinopathy have been reported in patients receiving Tamooex . Like other hormonal adjuvant therapies (estrogens and androgens), hypercalcemia has been described in some patients with breast cancer and bone metastases, after a few weeks initiation of treatment with Tamooex . If hypercalcemia occurs, appropriate measures should be taken and, if severe, the use of Tamooex should be discontinued. A small number of cases of endometrial hyperplasia and polyps have been reported in association with treatment Tamooex tablets. A definitive relationship between therapy with Tamooex and these cases has not been fully established. Women taking Tamooex should report to the doctor the occurrence of abnormal vaginal bleeding. If this occurs, its causes must be promptly investigated. Num randomized in Sweden with Tamooex as adjunctive therapy at a dose of 40 mg daily, over a period of 2 to 5 years, there was an increase in the incidence of uterine cancer. Thirteen of 931 patients treated with Tamooex versus two of 915 in the control group developed uterine cancer. However, an examination of more than 12,000 patients showed, in 12 other large adjuvant studies in progress (including NSABP B-14), patients who received Tamooex in doses of 20 to 40 mg daily for periods 1-5 years or more versus control showed no increased incidence of uterine cancer. within a single screening in Sweden, the incidence of second primary breast cancer was reduced with the use of Tamoxifen. Screening In NSABP B-14, in which patients were randomized to receive Tamooex 20mg/day for 5 years vs. placebo, the incidence of second primary breast cancer was also reduced.
DRUG INTERACTIONS - TAMOOEX
Tamooex demonstrates hypoprothrombinemic potentiate the effect of warfarin (anticoagulant). In patients on warfarin therapy, substantial prolongation in prothrombin time have occurred after several days of initiating therapy Tamooex . Clear signs of bleeding (eg, hematemesis, hematuria, subdural hematoma and intraocular hemorrhage) have also occurred during concurrent therapy with these drugs. As the mechanism of this interaction has not been clarified, the simultaneous use of Tamooex and coumarin-derivative anticoagulants should be done carefully. If drugs are used simultaneously, the patient must be constantly monitored, including its prothrombin time and anticoagulant dosage adjusted according to the case. Tamooex and its derivatives (tamoxifen, N-desmethyltamoxifen and 4-hydroxytamoxifen) has been shown to be potent inhibitors of hepatic cytochrome P450 mixed function oxidative. The effect of Tamooex metabolism and excretion of other antineoplastic drugs such as cyclophosphamide and other drugs that require mixed function oxidative activation is not known. at least one patient receiving Tamooex concurrently and phenobarbital serum concentrations were decreased Tamoxifen about 80 ‰, however, the clinical significance of this interaction is not known. Serum concentrations of tamoxifen and N-desmethyltamoxifen were increased in patients receiving Tamooex and bromocriptine concurrently.

ADVERSE REACTIONS - TAMOOEX
Adverse reactions to Tamooex are relatively mild and rarely severe enough to require discontinuation of treatment. If adverse reactions are severe, sometimes it is possible to manage them for the simple dose reduction without loss of control of patients treated with doença.Em Tamooex for metastatic breast cancer, the most frequent adverse reactions are hot flashes, nausea and / or vomiting. These symptoms may occur in up to 25 ‰ of patients. Less frequently occurring adverse reactions such as vaginal bleeding, vaginal discharge, menstrual irregularities, and skin rash. Generally, these symptoms are not severe enough to require shown dosage reduction or discontinuation of therapy. Increased bone pain and / or tumor, and local heating have been associated sometimes with a good tumor response. Patients with increased bone pain may require additional analgesia. Patients with soft tissue disease may have sudden increase in the size of preexisting lesions, sometimes associated with marked erythema lesion or around, and / or development of new lesions. When present, bone pain or local heat occur soon after the start of administration Tamooex and usually regress rapidly. Additional adverse reactions observed infrequently are hypercalcemia, peripheral edema, lack of taste, pruritus vulvae, depression, dizziness, loss of light direction, headache and decrease in the volume and / or partial loss of hair. There have been rare reports of thromboembolic events occurring during therapy with Tamooex . In patients with cancer, in general, it is known that there is an increased incidence of thromboembolic events, but is not yet fully established if it has something to do with Tamooex . When cytotoxic agents are combined with Tamooex , there is an increase in this incidence. Ovarian cysts were observed in a small number of premenopausal patients with advanced breast cancer treated with Tamooex . Tamooex is well tolerated in men with breast cancer. The literature and case reports suggest that the safety of Tamooex in men is similar to that observed in women. In men treated with oligospérmicos Tamooex levels of LH, FSH, testosterone and estrogen levels are elevated. No clinically significant change was reported. 
DOSAGE - TAMOOEX
The dose of Tamoxifen Citrate is expressed within the limits of Tamoxifen.
Breast cancer: When Tamooex is used alone as an adjunct to surgery and radiation therapy in the treatment of breast cancer, the usual dosage of the drug is 10 mg 2 to 3 times a day. There is no evidence that high doses are required. The optimal duration of therapy adjuvant Tamooex not been fully established, but therapy for more than 2 years (for example, usually 5 years) is more effective than shorter treatments. When Tamooex is used in combination with chemotherapy, as an adjunct to surgery in the treatment of breast cancer in postmenopausal women or age 50 or older, which have negative axillary lymph nodes, the usual dosage of the drug is 10mg, 2 times a day. The optimal duration of adjuvant therapy with Tamooex has not yet been fully established. For the treatment of advanced breast carcinoma in postmenopausal women, the usual dose of Tamooex is 20 or 40mg daily, given in two divided doses: one in the morning and another in the evening. By not get significantly different responses in rats with both doses, most clinicians believe 20mg per day normally be used at the start of therapy. If there is a response objective, it is evident within 4 to 10 weeks, however, many months of therapy may be required before an objective response occurs in patients with bone metastases. for the treatment of advanced breast cancer (metastasis) in men the usual dose of Tamooex is 20 or 40mg per day, administered in two divided doses: morning and evening. When Tamooex alone or in combination with radiation therapy was used as an adjuvant to surgery in the treatment of breast cancer in males, a dose of 20mg Tamooex was used, usually for 1 to 2 years. The optimal duration of therapy has not been fully established. However, as adjunctive therapy exceeding two years (eg 5 years) appears to be more effective than short-term therapy for women with breast carcinoma, some clinicians use the same long term treatment of Tamooex for male patients.
Other Uses: To stimulate ovulation doses of 5 to 40mg Tamooex have been administered 2 times per day for 4 days.
Overdosage - TAMOOEX
In studies to determine the lethal dose of acute Tamooex were observed accesses and breathing difficulties when the drug was administered in high doses. There is currently enough information about overdose Tamooex in humans. A study to determine the maximum tolerated dose of Tamooex , acute neurotoxicity manifested by tremor, hyperreflexia, unsteady walking and dizziness occurred in patients with locally advanced (metastatic) who have received high doses of Tamooex , that is, doses exceeding 400mg/m2 of body surface area, followed by maintenance doses (150mg/m2, given twice daily) to reverse multi-drug resistance. These effects occurred 3 to 5 days after the beginning of therapy with the drug and disappeared 2 to 5 days after cessation of treatment. We did not notice any permanent neurological toxicity.Although a causal relationship to Tamooex has not been established, attacks were reported in at least one of the patients, many days after discontinuation of the drug, but neurotoxic effects were fixed. for patients receiving doses exceeding 250mg/m2, followed by maintenance doses of 80mg/m2 administered twice a day, prolongation of the interval on the ECG been reported. On patient whose body surface area was 1.5 m2, the dose of administration and minimal maintenance, which occurred in neurological symptoms and changes relative the electrocardiogram, were at least 6 times higher compared to the maximum recommended dose.
Treatment: There is no known specific treatment for overdose Tamooex . Therefore, treatment should be symptomatic.