Letrozol Tablets 2.5mg (30tabs/box)

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Dossier: Ctd
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  • Letrozol Tablets 2.5mg (30tabs/box)
  • Letrozol Tablets 2.5mg (30tabs/box)
  • Letrozol Tablets 2.5mg (30tabs/box)
  • Letrozol Tablets 2.5mg (30tabs/box)
  • Letrozol Tablets 2.5mg (30tabs/box)
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Basic Info.

Model NO.
tablets
Specification
2.5mg
Trademark
Sinolead
Origin
China

Product Description

 
 

Letrozol Tablets 2.5mg (30tabs/box)Letrozol Tablets 2.5mg (30tabs/box)
Basic Info.

 
Generic Name Letrozol Tablets 2.5mg
Strength 2.5mg
Packing 30tabs/box
Origin China

Component:
Letrozol.

Character:

This product is a film coated sheet, after removing the coating will appear white.


Indications:

Adjuvant therapy for postmenopausal patients with early breast cancer who are estrogen or progesterone receptor positive or whose receptor status is unknown.

Adjuvant therapy for postmenopausal patients with early breast cancer who have been receiving tamoxifen adjuvant therapy for 5 years and who are estrogen or progesterone receptor positive or have unknown receptor status.

Treatment of postmenopausal, estrogen receptor-positive progesterone receptor-positive or receptor status unknown advanced breast cancer patients, these patients should be natural menopause or artificially induced menopause.

 

Usage and dosage:

Adjuvant treatment with this product should be taken for 5 years or until the disease recurs.

In patients who have been receiving tamoxifen adjuvant therapy for 5 years, this product should be taken continuously until the disease recurred.

The recommended dose of this product is 2.5mg once daily. It is taken regardless of the time of eating (see Pharmacokinetics - absorption). For advanced breast cancer, treatment should continue until tumor progression is confirmed.

Dosage for patients with liver and/or renal insufficiency

Patients with hepatic and/or renal insufficiency (creatinine clearance ≥10ml/min) do not need to adjust the dose.


Matters needing attention:

Exercise caution with athletes

For patients with unknown menopausal status, the patient's LH, FSH, and/or estradiol levels should be checked before treatment to determine menopausal status.

This product should not be used in conjunction with other estrogen-containing drugs, as estrogens will counteract the pharmacological effects of this product.

This product can reduce the level of estrogen in the blood circulation, long-term use may lead to decreased bone density.

In women with or at risk for osteoporosis, bone density should be assessed using a bone density dosimeter prior to adjuvant treatment with this product, followed by regular check-ups.

It is recommended to test the overall bone health during treatment and at any time if necessary to prevent or treat osteoporosis, and patients with problems should be closely monitored.

Renal insufficiency

No creatinine clearance. Letrozole should be used in women at 10 mL/ min. The possible benefits of letrozole should be carefully weighed against the potential risks in these patients.

Liver dysfunction

Systemic drug concentrations and terminal half-lives of drugs are nearly twice as high in patients with severe hepatic insufficiency as in healthy volunteers, so these patients should be closely monitored (see pharmacokinetics). There is no clinical experience of repeated medication.

Effects on the ability to drive and operate machinery

Medication related fatigue and dizziness have been observed during the application of this product, and occasionally drowsiness has been observed, so patients should be reminded to pay attention when driving a vehicle or operating machinery.

Letrozol Tablets 2.5mg (30tabs/box)
Letrozol Tablets 2.5mg (30tabs/box)Letrozol Tablets 2.5mg (30tabs/box)Letrozol Tablets 2.5mg (30tabs/box)

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