Anastroz tablets for oral administration contain 1 mg of Anastrozole, a non \u2013 steroidal aromatase inhibitor. It is chemically described as 1. 3 \u2013 Benzenediacetonitrile, a, a, a’. a’ \u2013tetramethyl-5- (1H- 1 ,2,4 \u2013triazol \u2013 I \u2013yImethyl). Its molecular formula is C I 7 H I 9 N 5 and its structural formula is:<\/p>\n
![\"Anastroz](\"https:\/\/i0.wp.com\/www.zuviuslifesciences.in\/media\/79641\/anastroz-daigram.jpg?ssl=1\")
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[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Composition” tab_id=”1593249990156-dfa30689-9933″][vc_column_text]Each film coated tablet contains Anastrozole 1mg IP.<\/strong>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Mechanism of Action \/ Pharmcodynamics” tab_id=”1584624217050-ebb8ae5e-43a6″][vc_column_text]<\/p>\n Many breast cancers have estrogen \u00a0receptors and growth of these tumors can be stimulated by estrogen. In \u00a0postmenopausal women, the principal sources of circulating estrogen (primarily \u00a0estradiol) is conversion of adrenally \u00a0– \u00a0generated androstenedione to estrone by aromatase in peripheral tissues, \u201csuch \u00a0as adipose tissue\u201d with further conversion of estrone to estradiol. Many breast \u00a0cancers also contain aromatase; the importance of tumor – generated estrogens \u00a0is uncertain.<\/p>\n Treatment of breast cancer has \u00a0included efforts to decrease estrogen levels, by ovariectomypremenopausally and \u00a0by use of anti – estrogens and progestational agents both pre- and post \u00a0\u2013menopausally; and these interventions lead to decreased tumor mass or delayed \u00a0progression of tumor growth in some women.<\/p>\n Anastrozole is a potent and \u00a0selective non-steroidal aromatase inhibitor. It significantly lowers serum \u00a0estradiol concentrations and has no detectable effect on formation of adrenal \u00a0corticosteroids or aldosterone.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Pharmacokinetics” tab_id=”1584624459062-96fb7e5b-0e23″][vc_column_text]<\/p>\n The orally administered \u00a0Anastrozole is well absorbed into the systemic circulation with 83% to 85% of \u00a0the radiolabel recovered in urine and feces. Food does not affect the extent of \u00a0absorption.<\/p>\n Elimination of \u00a0Anastrozole is primarily via hepatic \u00a0metabolism (approximately 85% ) and to a lesser extent, renal excretion \u00a0(approximately 11% ), Anastrozole has a mean terminal elimination half \u2013life of \u00a0approximately 50 hours in postmenopausal women. The major circulating \u00a0metabolite of Anastrozole is triazole, lacks pharmacologic activity. The \u00a0pharmacokinetic parameters are similar in patients and in healthy \u00a0postmenopausal volunteers. The pharmacokinetis of Anastrozole \u00a0are linear over the dose range of 1 to 20 mg \u00a0and do not change with repeated dosing. Consistent with the approximately 2 \u00a0\u2013day terminal elimination half \u2013life, plasma concentrations approach steady \u2013 \u00a0state levels at about 7 days of once daily dosing and steady- state levels are \u00a0approximately three- to four- fold higher than levels observed after a single \u00a0dose of Anastrozole is 40% bound to plasma proteins in the therapeutic range.<\/p>\n METABOLISM AND EXCRETION<\/strong><\/p>\n Anastrozole is extensively \u00a0metabolized with about 10% \u00a0of the dose \u00a0excreted in the urine as unchanged drug within 72 hours of dosing, and the \u00a0remainder (about 60% of the dose) is excreted in urine as metabolites . \u00a0Metabolism of Anastrozole occurs by N \u2013dealkylation, hydroxylation and \u00a0glucuronidation. Three metabolites of Anastrozole have been identified in human \u00a0plasma and urine. The known metabolites are triazole, a glucuronide conjugate \u00a0of hydroxy \u2013 Anastrozole, and a glucuronide of Anastrozole itself. Sereval \u00a0minor (less than 5% of the radioactive dose) \u00a0metabolites have not been identified.<\/p>\n Because renal elimination is not \u00a0a significant pathway of elimination, total body clearance of Anastrozole is \u00a0unchanged even in severe (creatinine clearance less than 30ml\/min\/1.73m2) renal \u00a0impairment, dosing adjustment in patients with renal dysfunction is not \u00a0necessary. Dosage adjustment is also unnecessary in patients with stable \u00a0hepatic cirrhosis.<\/p>\n SPECIAL POPULATIONS GERIATRIC<\/strong><\/p>\n Anastrozole pharmacokinetics have \u00a0been investigated in postmenopausal female volunteers \u00a0and patients with breast cancer. No age \u00a0related effects were seen \u00a0over the range \u00a0< 50 to \u00a0> 80 years.<\/p>\n RACE<\/strong><\/p>\n Estradiol and estrone sulfate \u00a0levels were similar between Japanese and Caucasian postmenopausal women who \u00a0received 1 mg of Anastrozole daily for 16 days. Anastrozole mean steady- state \u00a0minimum plasma concentrations in Caucasian and Japanese postmenopausal women \u00a0were 25.7 and 30.4ng\/ml, respectively.<\/p>\n RENAL INSUFFICIENCY<\/strong><\/p>\n Anastrozole pharmacokinetics have \u00a0been investigated in subjects with renal insufficiency. Anastrozole renal \u00a0clearance decreased proportionally with creatinine clearance and was \u00a0approximately 50% lower in volunteers with severe renal impairment (creatinine \u00a0clearance < 30 ml\/min\/1.73m2) compared to controls. Since only about 10% of \u00a0Anastrozole is excreted uncharged in the urine, the reduction in renal \u00a0clearance did not influence the total body clearance.<\/p>\n HEPATIC INSUFFICIENCY<\/strong><\/p>\n Hepatic metabolism accounts for \u00a0approximately 85% of Anastrozole elimination. Anastrozole pharmacokinetics have \u00a0been investigated in subjects with hepatic cirrhosis related to alcohol abuse. \u00a0The apparent oral clearance (CL\/F) of Anastrozole was approximately 30% lower \u00a0in subjects with stable hepatic cirrhosis than in control subjects with normal \u00a0liver function. However, plasma Anastrozole concentrations in the subjects \u00a0with \u00a0hepatic cirrhosis were within the \u00a0range of concentrations seen in normal subjects across all clinical trials, so \u00a0that no \u201cdosage\u201d adjustment is needed.<\/p>\n PHARMACODYNAMICS<\/strong><\/p>\n EFFECT ON ESTRADIOL<\/strong><\/p>\n Mean serum concentrations of \u00a0estradiol was \u00a0evaluated in multiple \u00a0daily dosing trials with 0.5, 1, 3, 5, and 10mg of Anastrozole in \u00a0postmenopausal women with advanced breast cancer. Clinically significant \u00a0suppression of serum estradiol was seen with all doses. Doses of 1 mg and \u00a0higher resulted in suppression of mean serum concentrations of estradiol to the \u00a0lower limit of detection \u00a0(3.7pmol\/L). \u00a0The recommended daily dose, Anastrozole 1 mg, reduced estradiol by approximately70% \u00a0within 24 hours by approximately 80% after 14 days of daily dosing. Suppression \u00a0of serum estradiol was maintained for up to 6 days after cessation of daily \u00a0dosing Anastrozole 1 mg.<\/p>\n The effect of Anastrozole on \u00a0estradiol levels in premenopausal women has not been studied. Because aromatization \u00a0of adrenal androgens is not a significant sources of estradiol in premenopausal \u00a0women (women with functioning ovaries as evidenced by menstruation and\/ or \u00a0premenopausal LH, FSH and estradiol levels), Anastrozole would not be expected \u00a0to lower estradiol levels in premenopausal women.<\/p>\n EFFECTS ON CORTICOSTEROIDS<\/strong><\/p>\n In multiple daily dosing trials \u00a0with 3, 5 and 10 mg, the selectivity of Anastrozole was assessed by examining \u00a0effects on corticosteroid synthesis. For all doses, Anastrozole did not affect \u00a0cortisol or aldosterone secretion at baseline or in response to ACTH. No \u00a0glucocorticoid or mineral ocorticoid replacement therapy is necessary with \u00a0Anastrozole.<\/p>\n OTHER ENDOCRINE EFFECTS<\/strong><\/p>\n In multiple daily dosing trials \u00a0with 5 and 10 mg, thyroid-stimulating hormone (TSH) is measured; there was no \u00a0increase in TSH during the administration of Anastrozole. Anastrozole does not \u00a0possess direct progestogenic, androgenic, or estrogenic activity in animals, \u00a0but does perturb the circulating levels of progesterone, androgens, and \u00a0estrogens.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Indications” tab_id=”1584624839401-59481bbb-bdc7″][vc_column_text]Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.<\/p>\n Anastrozole is indicated for the first – line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.<\/p>\n Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with dieases progression following tamoxifen therapy. Patients with ER-negative disease and paitents who did not respond to previous tamoxifen therapy rarely responded to Anastrozole.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Dosage & Administration” tab_id=”1584625017135-3ffdd9c5-1bd6″][vc_column_text]<\/p>\n The dose of Anastrozole is one 1 mg tablet taken once a day. For patients with advanced breast cancer. Anastrozole should be continued until tumor progression.<\/p>\n For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial Anastrozole was administered for five years.<\/p>\n PATIENTS WITH HEPATIC IMPAIRMENT<\/strong><\/p>\n Hepatic metabolism accounts for approximately 85% of Anastrozole elimination.\u00a0 Although clearance of Anastrozole was decreased in patient with cirrhosis due to alcohol abuse, plasma Anastrozole concentrations stayed in the usual range seen in patients without liver disease. Therefore, no changes in dose are recommrnded for patients with mild – to – moderate hepatic impairment, although patients should be monitored for side effects. Anastrozole has not been studied in patients with severe hepatic impairment.<\/p>\n PATIENTS WITH RENAL IMPAIRMENT<\/strong><\/p>\n No changes in dose are necessary for patients with renal impairment.<\/p>\n USE IN THE ELDERLY<\/strong><\/p>\n No dosage adjustment is necessary.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Warnings” tab_id=”1587972754163-7c720f17-70c2″][vc_column_text]Evidence of fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights), was observed in rats administered doses of 1 mg\/kg\/day (which produced plasma Anastrozole Cssmax and AUCO- 24 hr that were 19 times and 9 times higher than the respective values found in the postmenopausal volunteers at recommended dose). There was no evidence of teratogenicity in rats administered dose up to 1.0 mg\/kg\/day. In rabbits, Anastrozole caused pregnancy failure at dose equal to or greater than 1.0 mg\/kg\/day (about 16 times the recommended human dose on a mg\/m basis); there was no evidence of teratogenicity in rabbits administered 0.2 mg\/kg\/day (about 3 times the recommended human dose on a mg\/m2 basis).<\/p>\n There are no adequate and well – controlled studies in pregnant women using Anastrozole.If Anastrozole is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be appraised of the potential hazard to the fetus or potential risk for loss of the pregnancy.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Precautions” tab_id=”1587972847591-d61e5c30-d759″][vc_column_text]<\/p>\n General<\/strong> PREGNANCY –\u00a0<\/strong>\u00a0\u00a0PREGNANCY CATEGORY D –\u00a0<\/strong>\u00a0NURSING MOTHERS<\/strong><\/p>\n It is not known if Anastrozole is \u00a0excreted in human milk. Because many drugs are excreted in human milk, caution \u00a0should be exercised when Anastrozole is administered to a nursing woman.<\/p>\n PEDIATRIC USE<\/strong><\/p>\n The safety and efficacy of \u00a0Anastrozole in pediatric patients have not been established.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Adverse Reactions (Side Effects)” tab_id=”1587972887448-935588b6-ace4″][vc_column_text]The most commonly reported events with Anastrozole are Hot flushes, Asthenia, Pain, Back pain, headache, Abdominal pain, Infection, accidental injury, Flu syndrome, Chest pain, Vasodilation, Hypertension, Nausea, Constipation, Diarrhea, Dyspepsia, Gastrointestinal disorder, Lymphoedma, Peripheral edema, Weight gain, Hypercholesteremia, Arthritis, Arthalgia, Osteoporosis, Fracture, Bone pain, Arthrosis, Depression,\u00a0 Insomnia, dizziness, Anxiety, Paraesthesia. Pharyngitis, increased Cough, Dyspnea, Rash , Sweating, Leukorrhea, Urinary Tract Injection, Breast pain, Vulvovaginitis, Vaginal Discharge, Hair Thinning, Vaginal bleeding, Anorexia, Vomiting, Somnolence, Erythema Multiforme, Steven Johnson syndrome, Angioedema, Utricaria, Anaphylaxis, Mood disturbances, Cataracts, Venous thromboembolic events, Ischemic cerebrovascular\u00a0 events, and Endometrial cancer.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Drug Interactions” tab_id=”1587972928831-f0cd43aa-9dab”][vc_column_text]<\/p>\n Anastrozole inhibitied in vitro \u00a0metabolic reactions catalyzed by cytochromes P450 1A2, 2C8\/9,and 3A4 but \u00a0only \u00a0at relatively high concentrations. \u00a0Anastrozole did not inhibit P450 2A6 or the polymorphic P450 2D6 in human liver \u00a0microsomes. \u00a0Anastrozole did not alter \u00a0the pharmacokinetics of antipyrine. Although there have been no formal \u00a0interaction studies other than with antipyrine, based on these in vivo and in \u00a0vitro studies, it is unlikely that co – administration of a 1 mg dose of \u00a0Anastrozole with other drugs will result in clinically significant drug \u00a0inhibition of cytochrome P450 \u2013 medicated metabolism of the other drugs. An \u00a0interaction study with warfarin showed no clinically significant effect of \u00a0Anastrozole on warfarin pharmacokinetics or anticoagulant activity. At a median \u00a0follow-up of 33 months, the combination of Anastrozole and tamoxifen did not \u00a0demonstrate any efficacy benefit when compared with tamoxifen in all patients \u00a0as well as in the hormone receptor-positive subpopulation. This treatment arm \u00a0was discontinued from the trial. Based on clinical and pharmacokinetic results \u00a0from the ATAC trail, tamoxifen should not be administered with Anastrozole. \u00a0Co-adminintration of Anastrozole and tamoxifen resulted in reduction of \u00a0Anastrozole plasma levels by 27% compared \u00a0with those achieved with Anastrozole alone.<\/p>\n Estrogen-containing therapies \u00a0should not be used with Anastrozole as they may diminish its pharmacologic \u00a0action.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Overdose & Contradiction” tab_id=”1587972973810-566be5c2-4d42″][vc_column_text]<\/p>\n Clinical trials been conducted with Anastrozole up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of Anastrozole that result in life \u2013 threatening symptoms has not been established. In rats, lethality was observed after single oral doses that were greater than 100 mg\/kg (about 800 times the recommended human dose on a mg\/m2 basis) and was associated with severe \u00a0irritation to the stomach (necrosis, gastritis, ulceration, and hemorrhage). \u00a0In an oral acute toxicity study in the dog the median lethal dose was greater than 45 mg\/kg\/day. There is no specific antidote to over dosage and treatment must be symptomatic. In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because Anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.<\/p>\n CONTRAINDICATIONS<\/strong><\/p>\n Anastrozole is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients.<\/p>\n<\/div>\n<\/div>\n<\/div>\n [\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Storage” tab_id=”1587973020107-b728d303-d403″][vc_column_text][\/vc_column_text][\/vc_tta_section][vc_tta_section title=”Presentation” tab_id=”1587973068971-e3eeb3cc-f5e0″][vc_column_text][\/vc_column_text][\/vc_tta_section][\/vc_tta_tour][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":" Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.<\/p>\n Anastrozole is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.<\/p>\n Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole.<\/p>\n <\/p>\n","protected":false},"featured_media":7311,"template":"","meta":{"spay_email":""},"product_cat":[66,69],"product_tag":[175,174],"jetpack-related-posts":[{"id":7659,"url":"https:\/\/zuviuslifesciences.in\/old\/product\/zuvitroz-tab\/","url_meta":{"origin":6705,"position":0},"title":"Zuvitroz Tab","date":"July 15, 2020","format":false,"excerpt":"[vc_row][vc_column][vc_tta_tour color=\"peacoc\" active_section=\"1\"][vc_tta_section title=\"Description\" tab_id=\"1584624217032-a15849ed-97bb\"][vc_column_text] Coming Soon [\/vc_column_text][\/vc_tta_section][vc_tta_section title=\"Composition\" tab_id=\"1593256673750-3638ffc1-7c86\"][\/vc_tta_section][vc_tta_section title=\"Mechanism of Action \/ Pharmcodynamics\" tab_id=\"1584624217050-ebb8ae5e-43a6\"][\/vc_tta_section][vc_tta_section title=\"Pharmacokinetics\" 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\nAnastrozole is not recommended \u00a0for use in premenopausal women as safety and efficacy has not been established \u00a0Before starting treatment with Anastrozole, pregnancy must be excluded. \u00a0Anastrozole should be administered under the supervision of a qualified \u00a0physician experienced in the use of anticancer agents.<\/p>\nAnastrozole Tab – 1MG<\/h3>\n