Apit 160 Tablet 1 Strip

Apit Tablet is used for the palliative treatment of advanced breast cancer and endometrial cancer, particularly in cases that are recurrent, inoperable, or metastatic. It is not intended to replace standard treatments such as surgery, radiotherapy, or chemotherapy.

Apit Oral Suspension is indicated for managing loss of appetite (anorexia), severe weight loss (cachexia), or unexplained significant weight loss in patients with AIDS or cancer.

Megestrol Acetate is a synthetic progestin with antineoplastic (anti-cancer) properties. Its exact mechanism in endometrial cancer is not fully understood, but it may reduce estrogen production by suppressing pituitary gonadotropins. In breast cancer, it acts by altering the effects of steroid hormones and may directly inhibit tumor cell growth.

After oral administration, peak blood levels are usually reached within 2–3 hours. The drug has a half-life of approximately 33–38 hours. Around 66% of the dose is eliminated through urine, while about 20% is excreted in feces.

Tablet:

• Breast cancer: 160 mg daily.
• Endometrial cancer: 40–320 mg daily in divided doses.
• Treatment should generally continue for at least 2 months before assessing effectiveness.

Oral Suspension:

• Recommended starting dose for adults: 800 mg daily (20 mL).

Always use the medication according to a physician’s instructions.

Drug Interactions

Specific drug interaction studies with Apit have not been conducted.

Estrogens and progestogens may cause fluid retention, especially at high doses or during long-term treatment. Patients with conditions associated with excess fluid retention should use the medication cautiously.

Contraindications

Apit should not be used in:

• Patients with known hypersensitivity to Megestrol Acetate or any component of the formulation.
• Women who are pregnant or suspected to be pregnant.

Side Effects

A common effect of Apit is weight gain, often due to increased appetite. This effect is beneficial in patients being treated for anorexia, cachexia, or significant weight loss.

Other reported side effects include:

• Nausea
• Vomiting
• Fluid retention (edema)
• Breakthrough uterine bleeding
• Gynecomastia (breast enlargement in males)
• Hearing loss
• Shortness of breath
• Heart failure
• High blood pressure
• Hot flashes
• Mood changes
• Elevated blood sugar
• Hair loss
• Carpal tunnel syndrome
• Skin rash

Serious thromboembolic events such as thrombophlebitis and pulmonary embolism, including fatal cases, have also been reported.

Pregnancy & Breastfeeding

Megestrol should not be used during pregnancy due to the potential risk of fetal abnormalities. Women of childbearing potential should avoid becoming pregnant while taking this medication.

Because Megestrol may pass into breast milk and could harm a nursing infant, breastfeeding should be discontinued during treatment.

Precautions & Warnings

Use Apit with caution in patients who:

• Have a history of thrombophlebitis or blood clots.
• Have severe liver impairment.
• Have reduced kidney function.
• Are elderly, as they may be more susceptible to adverse effects.

Regular monitoring by a healthcare professional is recommended during treatment. The drug may also affect adrenal gland function and requires careful observation.

Patients with rare hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid this medicine.

Use in Special Populations

Pediatric Use: Safety and effectiveness have not been established in children.

Geriatric Use: Elderly patients may require closer monitoring because of age-related declines in kidney, liver, or heart function and the presence of other medical conditions.

Overdose

Studies have shown no severe acute toxicity with doses up to 1600 mg daily for six months or longer. Reported overdose symptoms include:

• Diarrhea
• Nausea
• Abdominal pain
• Shortness of breath
• Cough
• Unsteady walking
• Lethargy
• Chest pain

There is no specific antidote. Treatment consists of supportive and symptomatic care.

Storage

Store below 30°C in a cool, dry place away from direct light and moisture. Keep out of the reach of children.