Ovazol 2.5 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Letrozole |
| Company | Aci limited |
Title
- Ovazol
Categories
- Medicine
- Hormonal Chemotherapy
Description
Ovazol is indicated for adjuvant and extended adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer, first-line treatment in postmenopausal women with hormone-dependent advanced breast cancer, and treatment of advanced breast cancer in women with natural or induced postmenopausal status. It is also used in pre-operative therapy in postmenopausal women with localized hormone receptor positive breast cancer.
Indications
- 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
MechanismOfAction
Letrozole is a potent and highly specific nonsteroidal 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.
Pharmacokinetics
- Letrozole is rapidly and completely absorbed from the gastrointestinal tract
- Plasma protein binding of letrozole is approximately 60%
- The apparent terminal elimination half-life in plasma is about 2 days
- Steady-state levels are reached within 2 to 6 weeks after daily administration of 2.5mg of letrozole
DosageAndAdministration
The recommended dose of Letrozole is 2.5 mg once daily. In the adjutant and extended adjutant setting, treatment with Letrozole should continue for 5 years or until tumor relapse occurs, whichever comes first. In patients with metastatic disease, treatment with Letrozole should continue until tumor progression is evident.
Interaction
Clinical interaction studies with cimetidine and warfarin indicated that the co-administration of Ovazol with these drugs does not result in clinically significant drug reactions
Contraindications
- Known or suspected hypersensitivity to letrozole
- Pregnancy
- Lactation
- Severe hepatic dysfunction
SideEffects
- Plot flushes
- Increased sweating
- Pain in bones and joints
- Skin rash
- Gastrointestinal disorders
- Weight increase
- Depression
- Thinning or wasting of bones (osteoporosis)
- Swelling of arms, hands, feet, ankles (edema)
- Dry skin
- Vaginal bleeding
- Palpitations
- Joint stiffness (arthritis)
- Rare: Nervous disorders such as anxiety, nervousness, irritability
PregnancyAndLactation
- Oral administration of letrozole in pregnant rats resulted in teratogenicity and maternal toxicity
- Its use in pregnant women is not recommended
- Letrozole should not be administered to a nursing woman
PrecautionsAndWarnings
- No dosage adjustment is necessary in breast cancer patients with moderate hepatic dysfunction
- Renal impairment (calculated creatinine clearance) did not affect steady-state plasma letrozole concentration at a dose of 2.5 mg or 5 mg
OverdoseEffects
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.
TherapeuticClass
- Hormonal Chemotherapy
StorageConditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children