Please give some examples of errors and how would you improve them: Orphan designations pursuant to Section 526 of the Federal Food and Drug Cosmetic Act as amended by the Orphan Drug Act (P.L. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. Influence of age on toremifene pharmacokinetics. Anon.
Pagani O, Gelber S, Price K et al. Tamoxifen and toremifene concentrations in plasma are greatly decreased by rifampin. 26. Clomifen (auch Clomiphen) ist ein Arzneistoff aus der Gruppe der selektiven Estrogenrezeptormodulatoren (SERM). Subpart B—Labeling requirements for prescription drugs and/or insulin. 22. 9.
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Antineoplastic agent; a nonsteroidal estrogen agonist-antagonist that is structurally and pharmacologically related to tamoxifen.Palliative treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or estrogen-receptor unknown tumorsEfficacy in treatment of advanced breast cancer in menBecause of demonstrated cross-resistance with tamoxifen, usefulness of toremifene as second-lineUnder investigation as a preventive agent for prostate cancerAvailable as toremifene citrate; dosage expressed in terms of toremifene.Higher dosages (200 or 240 mg daily) associated with greater toxicity but provide no additional benefit in metastatic breast cancer.Use with caution and monitor liver function carefully.Known hypersensitivity to toremifene or any ingredient in the formulation.Hypercalcemia and tumor flare reported (usually during the first weeks of therapy) in patients with metastatic breast cancer who have bone metastases.Monitor patients with bone metastases closely for hypercalcemia during first weeks of therapy.Monitor serum calcium concentrations periodically during therapy.Endometrial hyperplasia and endometrial cancer reported.Pulmonary embolism, thrombophlebitis, thrombosis, cerebrovascular accident, and TIA reported.Cardiac failure, MI, arrhythmia, angina pectoris, and edema reported.Increased hepatic enzyme concentrations (e.g., AST, alkaline phosphatase, bilirubin) and jaundice reported.Obtain liver function tests periodically during therapy.Cataracts, dry eyes, abnormal visual fields, corneal keratopathy, glaucoma, abnormal vision/diplopia, and corneal opacity (corneal verticulata) reported.Distributed into milk in rats; not known whether distributed into human milk.No substantial differences in safety and efficacy relative to younger adults,Decreased clearance in patients with hepatic impairment (i.e., cirrhosis, fibrosis).Hot flushes (flashes), sweating, nausea, vaginal discharge, dizziness, edema, vomiting, vaginal bleeding.Inhibitors of CYP3A4-6: Potential pharmacokinetic interaction (increased toremifene concentrations).Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased toremifene concentrations).Drugs that decrease renal calcium excretion (e.g., thiazide diuretics): Potential pharmacologic interaction (increased risk of hypercalcemia).Monitor PT; adjust anticoagulant dosage if necessaryAnticonvulsants (e.g., carbamazepine, clonazepam, phenobarbital, phenytoin)Possible decreased toremifene concentrations (due to increased clearance and decreased elimination half-life of toremifene)Decreased peak plasma concentration and AUC of toremifeneWell absorbed following oral administration, with peak plasma concentration usually attained within 3 hours.Steady-state concentrations are reached in about 4–6 weeks.Crosses the placenta and accumulates in the fetus in rodents.Increased toremifene volume of distribution in geriatric female patients; however, no change in AUC.Extensively metabolized, principally via CYP3A4 to N-demethyltoremifene, which exhibits antiestrogenic effects but has weak antitumor potency in vivo.Excreted as metabolites principally in feces, with about 10% excreted in urine over 1 week.Elimination is slow due to enterohepatic circulation.Increased toremifene elimination half-life in patients with hepatic impairment (i.e., cirrhosis, fibrosis).Pharmacokinetics are not altered in patients with renal impairment.Increased toremifene elimination half-life in geriatric female patients; however, no change in clearance.25°C (may be exposed to 15–30°C); protect from heat and light.Acts as an estrogen antagonist on breast tissue and as a weak estrogen agonist on endometrium, bone, and lipids.In breast cancer, competitively binds to estrogen receptors and blocks tumor growth stimulated by estrogen.Decreases total and LDL-cholesterol concentrations.Acts as an estrogen agonist on the uterus and exhibits proliferative and tumor-promoting effects on the endometrium.Importance of receiving routine gynecologic care and of immediately informing clinician if any new breast lumps or abnormal gynecologic symptoms, including menstrual irregularities, abnormal vaginal bleeding, change in vaginal discharge, or pelvic pain/pressure occur.Importance of informing patients with bone metastases about the typical manifestations of hypercalcemia and instructing patients to report promptly any symptoms to their clinician.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.Importance of informing patients of other important precautionary information.2.
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Gershanovich M, Garin A, Baltina D et al.
Wenn du die Website weiter nutzt, gehen wir von deinem Einverständnis aus. (21 CFR Ch. 11. Toremifene for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia: results of a double-blind, placebo controlled, phase IIB clinical trial. Available for Android and iOS devices. Synopsis; Chemistry; APIs // Active Pharmaceutical Ingredients. Bishop J, Murray R, Webster L et al.
21 CFR Parts 201 and 202. The pharmacy price is 170 – 220 euros for 100 tablets with 60mg each active ingredient citrate.Toremifen citrat, Toremifene dihydrogen citrate, Toremifene dihydrogen citrate, Toremifene dihydrogen citrate, AcapodsMolecular formula: (toremifene citrate) C26H28CINO • C6H8O72- {p – [(Z) -4-chloro-1,2-diphenyl-1-butenyl] phenoxy} -N, N-dimethylethylamine citrate (1: 1). Clinical potential of new antiestrogens. 20.
Toremifene, sold under the brand name Fareston among others, is a medication which is used in the treatment of advanced breast cancer in postmenopausal women. Anon. High dose toremifene in advanced breast cancer resistant to or relapsed during tamoxifen treatment. Antiatherogenic effects of adjuvant antiestrogens: a randomized trial comparing the effects of tamoxifen and toremifene on plasma lipid levels in postmenopausal women with node-positive breast cancer.
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25.
Comparison of toremifene and tamoxifen in post-menopausal patients with advanced breast cancer: a randomized double-blind, the Nordic phase III study. 16.
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