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Fareston

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Overview

What is Fareston?

FARESTON (toremifene citrate) Tablets for oral administration each contain 88.5 mg of toremifene citrate, which is equivalent to 60 mg toremifene.

FARESTON is an estrogen agonist/antagonist. The chemical name of toremifene is: 2-{p-[(Z)-4-chloro-1,2-diphenyl-1-butenyl]phenoxy}-N,N-dimethylethylamine citrate (1:1). The structural formula is:

and the molecular formula is CHClNO • CHO. The molecular weight of toremifene citrate is 598.10. The pK is 8.0. Water solubility at 37°C is 0.63 mg/mL and in 0.02N HCl at 37°C is 0.38 mg/mL.

FARESTON is available only as tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch.



What does Fareston look like?



What are the available doses of Fareston?

Tablet is 60 mg, round, convex, unscored, uncoated, and white, or almost white, identified with TO 60 embossed on one side.

What should I talk to my health care provider before I take Fareston?

How should I use Fareston?

FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.

The dosage of FARESTON is 60 mg, once daily, orally. Treatment is generally continued until disease progression is observed.


What interacts with Fareston?

Sorry No Records found


What are the warnings of Fareston?

Sorry No Records found


What are the precautions of Fareston?

Sorry No Records found


What are the side effects of Fareston?

Sorry No records found


What should I look out for while using Fareston?

Hypersensitivity to the drug ()

QT Prolongation, Hypokalemia, Hypomagnesemia ()

FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided .


What might happen if I take too much Fareston?

Lethality was observed in rats following single oral doses that were ≥1000 mg/kg (about 150 times the recommended human dose on a mg/m basis) and was associated with gastric atony/dilatation leading to interference with digestion and adrenal enlargement.

Vertigo, headache, and dizziness were observed in healthy volunteer studies at a daily dose of 680 mg for 5 days. The symptoms occurred in two of the five subjects during the third day of the treatment and disappeared within 2 days of discontinuation of the drug. No immediate concomitant changes in any measured clinical chemistry parameters were found. In a study in postmenopausal breast cancer patients, toremifene 400 mg/m/day caused dose-limiting nausea, vomiting, and dizziness, as well as reversible hallucinations and ataxia in one patient.

Theoretically, overdose may be manifested as an increase of antiestrogenic effects, such as hot flashes; estrogenic effects, such as vaginal bleeding; or nervous system disorders, such as vertigo, dizziness, ataxia, and nausea. There is no specific antidote and the treatment is symptomatic.


How should I store and handle Fareston?

FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.FARESTON Tablets, containing toremifene citrate in an amount equivalent to 60 mg of toremifene, are round, convex, unscored, uncoated, and white, or almost white.FARESTON Tablets are identified with TO 60 embossed on one side.FARESTON Tablets are available as:     NDC 42747-327-30 bottles of 30     NDC 42747-327-72 samples of 7Store at 25°C (77°F).Excursions permitted to 15-30°C (59-86°F)[See USP Controlled Room Temperature.]Protect from heat and light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Toremifene is a nonsteroidal triphenylethylene derivative. Toremifene binds to estrogen receptors and may exert estrogenic, antiestrogenic, or both activities, depending upon the duration of treatment, animal species, gender, target organ, or endpoint selected. In general, however, nonsteroidal triphenylethylene derivatives are predominantly antiestrogenic in rats and humans and estrogenic in mice. In rats, toremifene causes regression of established dimethylbenzanthracene (DMBA)-induced mammary tumors. The antitumor effect of toremifene in breast cancer is believed to be mainly due to its antiestrogenic effects, i.e., its ability to compete with estrogen for binding sites in the cancer, blocking the growth-stimulating effects of estrogen in the tumor.

Non-Clinical Toxicology
Hypersensitivity to the drug ()

QT Prolongation, Hypokalemia, Hypomagnesemia ()

FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided .









































Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner . Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death.

Toremifene should be avoided in patients with long QT syndrome. Caution should be exercised in patients with congestive heart failure, hepatic impairment and electrolyte abnormalities. Hypokalemia or hypomagnesemia must be corrected prior to initiating toremifene and these electrolytes should be monitored periodically during therapy. Drugs that prolong the QT interval should be avoided. In patients at increased risk, electrocardiograms (ECGs) should be obtained at baseline and as clinically indicated and .

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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