Ovazol tablet: Each coated tablet contains Letrozole USP 2.5 mg.
Ovazol ® is a preparation of Letrozole which is a highly specific nonsteroidal aromatase inhibitor. Growth of some breast cancers is stimulated by estrogens which are female sex hormones. In postmenopausal women estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens to estrone and estradiol. Ovazol® inhibits the conversion of androgens to estrogens by inhibiting the aromatase enzyme. Ovazol® inhibits the aromatase enzyme by competitively binding to the practical heme of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues.
Adult: The recommended dose of Ovazol ® is one 2.5 mg tablet administered once daily. Treatment should continue as long as tumor response is seen. The drug should be discontinued if tumor stops responding as judged by tumor progression.
Children: The safety and effectiveness in pediatric patients have not been established.
Elderly: No dosage adjustment is required for elderly patients. Patients treated with Ovazol ® do not require glucocorticoid or mineralocorticoid replacement therapy.
Patients with Hepatic impairment: No dosage adjustment is required for patients with mild to moderate hepatic impairment. The dose of Ovazol ® in patients with cirrhosis and severe hepatic dysfunction should be reduced by 50%. The recommended dose of Ovazol ® for such patients is 2.5 mg administered every other day.
Patients with Renal impairment: No dosage adjustment is required for patients with renal impairment if creatinine clearance is ≥ 10 ml/min.
Concomitant administration with tamoxifen or other anti-estrogens or estrogen-containing therapies reduces letrozole pharmacological efficacy; CYP2A6 and CYP2C19 inhibitors may alter clearance.
Letrozole is contraindicated in patients with known hypersensitivity to Letrozole or any of its components. It is also contraindicated in severe hepatic dysfunction.
Common: Musculoskeletal pain, arthralgia, headache, fatigue, nausea, dyspnea, peripheral edema, cough, constipation, vomiting, chest pain, diarrhea, rash, abdominal pain, dyspepsia, anorexia. Less Common: Dizziness, weight increase, pruritus.
Overdose
There is no clinical experience of overdosage. There is no specific antidote to Letrozole. Since, Letrozole is not highly protein bound, dialysis may be helpful. Emesis may be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs are also appropriate.
Category X (Contraindicated). Aromatase inhibitor; embryotoxic and fetotoxic; strictly contraindicated during pregnancy. Lactation: Excretion in human milk unknown; contraindicated in nursing mothers.
Store below 25°C in a cool, dry place protected from light. Keep out of the reach of children.