Letrozole (Letrozole)

Trade Name : Letrozole

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 2.5 mg/1

LETROZOLE Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Letrozole (Letrozole) which is also known as Letrozole and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Letrozole (Letrozole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Contraindications ()t7/2017
  • Warnings and Precautions, Embryo-Fetal Toxicity ()t7/2017
  • Letrozole tablets are an aromatase inhibitor indicated for:
  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer ()
  • Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy ()
  • First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer ()
  • Letrozole tablets are taken orally without regard to meals ():
  • Recommended dose: 2.5 mg once daily ()
  • Patients with cirrhosis or severe hepatic impairment: 2.5 mg every other day (, )
  • 2.5 mg tablets u2013 dark-yellow, standard convex round, unscored, film-coated tablet, debossed with u201cTEVAu201d on one side and u201cB1u201d on the other side of the tablet.
  • 2.5 mg tablets ()
  • No data
  • Pregnancy ()
  • Known hypersensitivity to the active substance, or to any of the excipients ()
  • This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
  • Decreases in bone mineral density may occur. Consider bone mineral density monitoring ()
  • Increases in total cholesterol may occur. Consider cholesterol monitoring. ()
  • Fatigue, dizziness and somnolence may occur. Exercise caution when operating machinery ()
  • Embryo-Fetal toxicity: Can cause fetal harm when administered to pregnant women. Obtain a pregnancy test in females of reproductive potential. Advise females of reproductive potential to use effective contraception (, 8.1, )
  • The following adverse reactions are discussed in greater detail in other sections of the labeling.
  • The most common adverse reactions (greater than 20%) were hot flashes, arthralgia; flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, bone pain; and musculoskeletal ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Arrayn- Tamoxifen
  • Coadministration of letrozole and tamoxifen 20 mg daily resulted in a reduction of letrozole plasma levels of 38% on average (study P015). Clinical experience in the second-line breast cancer trials (AR/BC2 and AR/BC3) indicates that the therapeutic effect of letrozole therapy is not impaired if letrozole is administered immediately after tamoxifen.
  • Arrayn- Cimetidine
  • A pharmacokinetic interaction study with cimetidine (study P004) showed no clinically significant effect on letrozole pharmacokinetics.
  • Arrayn- Warfarin
  • An interaction study (P017) with warfarin showed no clinically significant effect of letrozole on warfarin pharmacokinetics.
  • Arrayn- Other anticancer agents
  • There is no clinical experience to date on the use of letrozole in combination with other anticancer agents.
  • No data
  • Lactation: Advise not to breastfeed. ()
  • Isolated cases of letrozole overdose have been reported. In these instances, the highest single dose ingested was 62.5 mg or 25 tablets. While no serious adverse reactions were reported in these cases, because of the limited data available, no firm recommendations for treatment can be made. However, emesis could be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs are also appropriate. In single-dose studies, the highest dose used was 30 mg, which was well tolerated; in multiple-dose trials, the largest dose of 10 mg was well tolerated.
  • Lethality was observed in mice and rats following single oral doses that were equal to or greater than 2,000 mg/kg (about 4,000 to 8,000 times the daily maximum recommended human dose on a mg/mbasis); death was associated with reduced motor activity, ataxia and dyspnea. Lethality was observed in cats following single IV doses that were equal to or greater than 10 mg/kg (about 50 times the daily maximum recommended human dose on a mg/mbasis); death was preceded by depressed blood pressure and arrhythmias.
  • Letrozole Tablets USP for oral administration contain 2.5 mg of letrozole, USP, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1-1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural formula is:
  • CHN M.W. 285.31
  • Letrozole, USP is a white to yellowish fine powder, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a melting range of 184u00b0 to 185u00b0C.
  • Letrozole Tablets USP are available as 2.5 mg tablets for oral administration.
  • Inactive Ingredients: colloidal silicon dioxide, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, corn starch, talc, and titanium dioxide.
  • No data
  • A conventional carcinogenesis study in mice at doses of 0.6 to 60 mg/kg/day (about 1 to 100 times the daily maximum recommended human dose on a mg/mbasis) administered by oral gavage for up to 2 years revealed a dose-related increase in the incidence of benign ovarian stromal tumors. The incidence of combined hepatocellular adenoma and carcinoma showed a significant trend in females when the high dose group was excluded due to low survival. In a separate study, plasma AUC levels in mice at 60 mg/kg/day were 55 times higher than the AUC level in breast cancer patients at the recommended dose. The carcinogenicity study in rats at oral doses of 0.1 to 10 mg/kg/day (about 0.4 to 40 times the daily maximum recommended human dose on a mg/mbasis) for up to 2 years also produced an increase in the incidence of benign ovarian stromal tumors at 10 mg/kg/day. Ovarian hyperplasia was observed in females at doses equal to or greater than 0.1 mg/kg/day. At 10 mg/kg/day, plasma AUC levels in rats were 80 times higher than the level in breast cancer patients at the recommended dose. The benign ovarian stromal tumors observed in mice and rats were considered to be related to the pharmacological inhibition of estrogen synthesis and may be due to increased luteinizing hormone resulting from the decrease in circulating estrogen.
  • Letrozole was not mutagenic in tests (Ames and E.coli bacterial tests) but was observed to be a potential clastogen in assays (CHO K1 and CCL 61 Chinese hamster ovary cells). Letrozole was not clastogenic (micronucleus test in rats).
  • In a fertility and early embryonic development toxicity study in female rats, oral administration of letrozole starting 2 weeks before mating until pregnancy day 6 resulted in an increase in pre-implantation loss at doses u2265 0.03 mg/kg/day (approximately 0.1 times the maximum recommended human dose on a mg/m basis). In repeat-dose toxicity studies, administration of letrozole caused sexual inactivity in females and atrophy of the reproductive tract in males and females at doses of 0.6, 0.1 and 0.03 mg/kg in mice, rats and dogs, respectively (approximately 1, 0.4 and 0.4 times the daily maximum recommended human dose on a mg/m basis, respectively).
  • No data
  • Letrozole Tablets USP, 2.5 mg are available as follows:
  • 2.5 mg u2013 dark-yellow, standard convex round, unscored, film-coated tablets, debossed with u201cTEVAu201d on one side and u201cB1u201d on the other side of the tablet, in bottles of 30. (NDC 0093-7620-56)
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Embryo-Fetal Toxicity
  • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during letrozole therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with letrozole [].
  • Lactation
  • Advise women not to breastfeed during letrozole treatment and for at least 3 weeks after the last dose [].
  • Infertility
  • Advise females and males of reproductive potential of the potential for reduced fertility from letrozole [].
  • Fatigue and Dizziness
  • Since fatigue and dizziness have been observed with the use of letrozole and somnolence was uncommonly reported, caution is advised when driving or using machinery.
  • Bone Effects
  • Consideration should be given to monitoring bone mineral density.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. F 5/2018
  • No data

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