Femzole 2.5 mg (Tablet)

Unit Price: ৳ 40.00 (1 x 5: ৳ 200.00)
Strip Price: ৳ 200.00

Medicine Details

Category Details
Generic Letrozole
Company Beximco pharmaceuticals ltd

Title and Categories

  • Femzole Tablets
  • Medicine
  • Hormonal Chemotherapy

Dimensions

  • N/A

Color Options

  • N/A

Functions

  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer
  • Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status
  • Pre-operative therapy in postmenopausal women with localized hormone receptor positive breast cancer

Materials

  • N/A

Technical Specifications

  • Potent and highly specific nonsteroidal aromatase inhibitor
  • Inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme
  • Reduction of estrogen biosynthesis in all tissues
  • Estrogens are derived mainly from the action of the aromatase enzyme in postmenopausal women
  • Suppression of estrogen biosynthesis achieved by specifically inhibiting the aromatase enzyme
  • Rapid and complete absorption from the gastrointestinal tract
  • Absolute bioavailability of 99.9%
  • Plasma protein binding of approximately 60%
  • Metabolic clearance to a pharmacologically inactive carbinol metabolite
  • Apparent terminal elimination half-life in plasma of about 2 days
  • Steady-state levels reached within 2 to 6 weeks after daily administration of 2.5mg

Design Elements

  • N/A

Usability Features

  • Recommended dose of Letrozole is 2.5 mg once daily
  • No dose adjustment required for elderly patients
  • No dosage adjustment required for patients with hepatic impairment or renal impairment
  • Treatment with Letrozole should continue for 5 years in adjuvant and extended adjuvant settings
  • Treatment should continue until tumor progression in metastatic disease
  • Keep below 30°C temperature, away from light & moisture
  • Keep out of the reach of children

Indications

  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • Extended adjuvant therapy for postmenopausal women with early breast cancer (positive or unknown hormone receptor status)
  • First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer
  • Treatment of advanced breast cancer in women with postmenopausal status
  • Pre-operative therapy in postmenopausal women with localized hormone receptor positive breast cancer

Mode of Action

  • Letrozole is a potent and highly specific nonsteroidal aromatase inhibitor
  • Inhibition of the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit
  • Reduction of estrogen biosynthesis in all tissues
  • Suppression of estrogen biosynthesis achieved by specifically inhibiting the aromatase enzyme
  • Rapid and complete absorption from the gastrointestinal tract
  • Steady-state levels reached within 2 to 6 weeks after daily administration of 2.5mg

Dosage & Administration

  • Recommended dose of Letrozole is 2.5 mg once daily
  • Treatment with Letrozole should continue for 5 years in adjuvant and extended adjuvant settings
  • No dose adjustment required for elderly patients
  • No dosage adjustment required for patients with hepatic impairment or renal impairment
  • Keep below 30°C temperature, away from light & moisture
  • Keep out of the reach of children

Interaction

  • Clinical interaction studies with cimetidine and warfarin indicated no clinically significant drug reactions with co-administration of Femzole

Contraindications

  • Contraindicated in known or suspected hypersensitivity to letrozole or other aromatase inhibitors
  • Contraindicated during pregnancy, lactation, and in pre-menopausal women
  • Contraindicated in severe hepatic dysfunction

Side Effects

  • Common side effects include hot flushes, increased cholesterol level, fatigue, increased sweating, joint pain, skin rash, headache, dizziness, gastrointestinal disorders, changes in appetite, muscle pain, osteoporosis, edema, depression, weight changes, high blood pressure, abdominal pain, dry skin, vaginal bleeding, heart palpitations, joint stiffness, chest pain
  • Rare side effects include nervous disorders, memory problems, eye disorders, itching, weight changes, urinary tract infection, cough, yellowing of skin and eyes, high blood levels of bilirubin

Pregnancy & Lactation

  • Teratogenicity and maternal toxicity seen in pregnant rats at certain doses
  • Not recommended for use in pregnant women
  • Not recommended for nursing women due to potential excretion in human milk

Precautions & Warnings

  • Caution recommended in breast cancer patients with moderate hepatic dysfunction since Femzole elimination depends mainly on intrinsic metabolic clearance
  • No dose adjustment necessary for renal impairment (calculated creatinine clearance: 20 to 50 ml/min)
  • Potential risks and benefits should be considered carefully before prescribing Femzole to patients with renal impairment
  • Fatigue and dizziness have been observed with the use of Femzole, patients should be advised regarding impaired physical and mental abilities

Overdose Effects

  • No clinical experience of overdosage
  • No specific antidote to Femzole
  • Dialysis may be helpful due to weak plasma protein binding
  • Emesis may be induced if the patient is alert
  • Supportive care and frequent monitoring of vital signs is appropriate

Therapeutic Class

  • Hormonal Chemotherapy

Storage Conditions

  • Keep below 30°C temperature, away from light & moisture
  • Keep out of the reach of children

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