Fezol 2.5 mg Tablet, 1 strip

Fezol 2.5 mg Tablet, 1 strip

Composition

Each film-coated tablet contains Letrozole USP 2.5 mg.

Pharmacology

Letrozole is a non-steroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. The suppression of estrogen biosynthesis in peripheral tissues and the cancer tissue itself can therefore be achieve by specially inhibiting the aromatase enzyme. Indication

Fezol (Letrozole) is indicated for the first line treatment of advanced / metastatic breast cancer in post menopausal women.

Dosage & Administration

Route of Administration : Orally.

The recommended dose is one tablet administered once a day. In patients with advanced disease, treatment with Fezol (Letrozole) should be continued until tumor progression is evident.

Treatment should be discontinued at tumor relapse.

No dose adjustment is required for elderly patients. Patients treated with Fezol (Letrozole) do not require glucocorticoid or mineralocorticoid replacement therapy.

Renal Impairment

No dosage adjustment is required for patients with renal impairment if Creatinine clearance is 10 ml/min.

Hepatic Impairment

No dosage adjustment is recommended for patients with mild to moderate hepatic impairment. The dese of Fezol (Letrozole) in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose for such patients is 2.5 mg Letrozole administered every other day.

OR AS DIRECTED BY THE PHYSICIAN.

Contraindication

Fezol (Letrozole) is contraindicated in known of suspected hypersensitivity to Letrozole. other aromatase inhibitors, or to any of their ingredients. It is contraindicated during pregnancy, lactation and in premenopausal women. It is contraindicated in severe hepatic dysfunction.

Warning & Precaution

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.

Side Effect

Common :

• CNS : Headache, Somnolence Dizziness, Depression

• Dermatologic : Hos flushes, Rash, Pruritus

• GI : Nausea, Vomiting, Constipation, Diarrhoea, abdominal Pain, Anorexia, Dyspepsia.

• Musculoskeletal : Arthralgia

• Respiratory : Dyspnea, Gough

• Others : Fatigue, chest pain, viral infection, hypertension, peripheral edema, weight gain, hypercholesterolemia, osteoporosis, hair loss, veginal bleeding.

Rare :

• Abnormal liver function • Hepatitis • Stroke • Ovarian Cyst

Use in Pregnancy & Lactation

Pregnancy : Pregnancy Category D.

Lactation : It not known if Letrozole is excreted in human milk. Caution should be exercised when Letrozole is administered to a nursing women.

Use in Children & Adolescents

Use in children is not recommended.

Drug Interaction

With Medicine : Clinical interaction studies with cimetidine and warfarin indicated that the co-administration of Letrozole with these drugs does not result in clinically significant drug reactions, even through cimetidine is a known inhibitor of one of the cytochrome P450 isoenzymes capable of metabolizing Letrozole in vitro.

With food & others: Food interaction is not known.

Overdose

There is no clinical experience of over dosage. There is no specific antidote to Letrozole. Since Letrozole is not highly protein bound, dialysis may be helpful Storage

Store below 300  C, protected from light & moisture. Keep all medicines out of reach of children.

Packing

Each box contains 1x5 tablets in blister strips.