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Zoleta

Form: Tablet

Strength: 2.5mg

Generic Name: Letrozole

Company: Nuvista Pharma Ltd

MRP:৳ 43.0   (Box=10)

Per Piece: ৳ 4.30  

Is Antibiotic: No

Indications

Zoleta is used to treat postmenopausal women with hormone receptor-positive early breast cancer. Zoleta is also used after 5 years of tamoxifen therapy in postmenopausal women with early breast cancer (whether the estrogen or progesterone receptor status is positive or unknown). Zoleta is a first-line treatment for postmenopausal women with advanced hormone-dependent breast cancer. Zoleta is also used for treating advanced breast cancer in women with natural or artificially induced postmenopausal status who have already been treated with antiestrogens. Additionally, Zoleta is used before surgery for postmenopausal women with localized hormone receptor-positive breast cancer to make breast-conserving surgery possible.

Pharmacology

Zoleta is a strong and specific nonsteroidal aromatase inhibitor. Zoleta works by blocking the aromatase enzyme, which reduces estrogen production in the body. This helps slow down or stop the growth of estrogen-dependent breast cancer cells. After menopause, estrogens mainly come from the aromatase enzyme, which converts other hormones (like testosterone and androstenedione) into estrogen. By blocking this enzyme, estrogen levels are lowered in both normal and cancerous tissues.

In healthy postmenopausal women, single doses of 0.1, 0.5, and 2.5mg reduce estrogen levels by up to 78%. The effect is maximum after 48-78 hours. In women with advanced breast cancer, daily doses of 0.1 to 5mg reduce estrogen levels by 78-95%. Letrozole has no effect on androgen levels, and Zoleta does not cause the accumulation of androgenic precursors. Zoleta is also not known to impair adrenal steroid production.

Dosage & Administration

Adult and Elderly Patients: The recommended dose is 2.5 mg once daily. Treatment should continue for 5 years or until the tumor relapses. For metastatic disease, treatment continues until the tumor progresses. No dosage adjustment is needed for elderly patients.

Patients with Liver or Kidney Problems: No dosage change is needed for patients with mild liver or kidney issues. However, patients with severe liver problems should be monitored closely.

Children: Zoleta is not applicable for children.

Interaction

Studies with cimetidine and warfarin show no significant interactions with letrozole, even though cimetidine is known to affect the enzymes that metabolize letrozole.

Contraindications

Zoleta is not suitable for people who are allergic to letrozole, other aromatase inhibitors, or any of its ingredients. Zoleta should not be used during pregnancy, breastfeeding, or in pre-menopausal women. Zoleta is also not recommended for patients with severe liver problems.

Side Effects

Common Side Effects: Hot flashes, increased cholesterol, fatigue, sweating, bone and joint pain, skin rashes, headaches, dizziness, feeling unwell, nausea, vomiting, indigestion, constipation, diarrhea, appetite changes, muscle pain, bone thinning (leading to fractures), swelling of limbs, depression, weight gain, hair loss, high blood pressure, abdominal pain, dry skin, vaginal bleeding, rapid heart rate, joint stiffness, chest pain.

Rare Side Effects: Anxiety, irritability, drowsiness, memory issues, sleep disturbances, carpal tunnel syndrome, blurred vision, eye irritation, itching, vaginal dryness, urinary tract infections, frequent urination, cough, yellowing of skin/eyes, high bilirubin levels.

Pregnancy & Lactation

Letrozole has been shown to cause birth defects in animal studies, so Zoleta should not be used during pregnancy. Zoleta is also not recommended for breastfeeding women as Zoleta may pass into breast milk.

Precautions & Warnings

Patients with moderate liver problems should be careful when using letrozole, although no dosage change is needed. Kidney impairment does not require dosage adjustments. Letrozole is weakly bound to plasma proteins, so Zoleta may be removed from the body through dialysis. Some patients may experience fatigue and dizziness, so caution is advised when driving or operating machinery.

Overdose Effects

There is no specific treatment for overdose. Since letrozole is not strongly protein-bound, dialysis may be helpful. If the patient is alert, vomiting may be induced. Supportive care and monitoring of vital signs are recommended.

Therapeutic Class

Zoleta is a hormonal chemotherapy drug.

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.

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