Caxfila OS Oral Suspension Megestrol Acetate Oral Suspension

Chinese Name: Megestrol Acetate Oral Suspension

Brand Name: Caxfila OS Oral Suspension

Generic Name: Megestrol Acetate Oral Suspension

Dosage Form: Oral Suspension

Specification: 40 mg/mL (240 mL bottle)

Manufacturer: Adley Formulations

2. Composition and Description

Active Ingredient: Megestrol Acetate 40 mg/mL

Excipients: Sucrose, purified water, flavoring agents, preservatives, etc. (refer to the original manufacturer's package insert for details)

Description: A white to off-white suspension with a sweet taste.

3. Pharmacological Classification

Progestogen (Synthetic Progestin)

Mechanism of Action:

Inhibits the hypothalamic-pituitary-gonadal axis, thereby reducing the release of gonadotropins.

Exerts a direct inhibitory effect on hormone-dependent tumors (e.g., breast cancer, endometrial cancer).

Potently stimulates appetite and promotes weight gain (indicated for cachexia and anorexia).

4. Indications (Officially Approved)

1. Tumor-related Anorexia/Cachexia

Severe loss of appetite, weight loss, and cachexia in patients with cancer (particularly lung cancer, gastrointestinal cancers, and breast cancer).

2. AIDS-related Wasting

Anorexia and severe weight loss in patients with AIDS.

3. Hormone-dependent Tumors

Advanced breast cancer (second-line or third-line endocrine therapy).

Endometrial cancer (in cases of recurrence, metastasis, or inoperable disease).

5. Dosage and Administration (Adults)

Administration: Oral use. Shake well before use. May be taken with food or on an empty stomach. Dosage (Standard):

Anorexia/Cachexia:

400–800 mg (10–20 mL) once daily

Onset of action is approximately 2–4 weeks; once effective, the dosage may be reduced for maintenance therapy.

Breast Cancer/Endometrial Cancer:

400–800 mg/day, or as directed by a physician.

Pediatric Patients: Not recommended for children under 12 years of age.

6. Contraindications

Hypersensitivity to megestrol acetate or to any of the excipients in this product.

Severe thromboembolic disease (history of deep vein thrombosis, pulmonary embolism, or stroke).

Severe hepatic or renal impairment.

Pregnancy or lactation.

Unexplained vaginal bleeding.

Male breast cancer (generally not applicable).

7. Warnings and Precautions

Thromboembolic Risk: May increase the risk of deep vein thrombosis, pulmonary embolism, and stroke; contraindicated in patients with a history of thromboembolic events.

Diabetes/Hyperglycemia: May elevate blood glucose levels; blood glucose monitoring is required for diabetic patients.

Adrenal Suppression: Long-term use may suppress adrenocortical function; gradual dosage reduction is required upon discontinuation.

Hypertension: May exacerbate hypertension; blood pressure should be monitored regularly.

Hepatic Function: Liver function should be monitored periodically during long-term use.

Pregnancy/Contraception: Contraindicated in pregnant women; effective contraception must be used during treatment.

Pediatric/Geriatric Patients:

Pediatric: Safety and efficacy have not been established; not recommended.

Geriatric: Use with caution due to increased susceptibility to thromboembolic events and blood glucose abnormalities.

8. Adverse Reactions (Common)

Very Common (>10%)

Increased appetite, weight gain (intended therapeutic effect)

Elevated blood glucose, dry mouth, constipation, abdominal distension

Common (1–10%)

Fatigue, dizziness, insomnia, mood changes

Hypertension, edema, shortness of breath

Nausea, diarrhea, rash, alopecia (hair loss)

Males: Impotence, decreased libido

Serious (Rare)

Deep vein thrombosis, pulmonary embolism, stroke

Adrenal insufficiency

Severe hepatic injury

9. Drug Interactions

Anticoagulants (e.g., Warfarin): May potentiate anticoagulant effects and increase the risk of bleeding; close monitoring is required. INR

Antidiabetic Agents: Megestrol acetate may elevate blood glucose levels; doses of hypoglycemic agents may need to be increased.

Corticosteroids: Increased risk of thrombosis and infection.

Hepatic Enzyme Inducers (e.g., phenytoin, carbamazepine, rifampin): May reduce megestrol acetate concentrations.

10. Special Populations

Pregnant Women (Category D): Contraindicated; may be teratogenic.

Breastfeeding Women: Contraindicated; may be excreted into breast milk.

Hepatic Impairment: Use with caution in mild to moderate cases; contraindicated in severe cases.

Renal Impairment: Standard dosing may be used in mild to moderate cases; use with caution in severe cases.

Elderly Patients: Reduce dosage and increase monitoring.

11. Management of Overdosage

Symptoms: Drowsiness, nausea, edema, hyperglycemia, hypertension.

Management: Discontinue the medication; provide symptomatic and supportive care (no specific antidote available).

12. Storage

Keep tightly sealed; store in a cool, dry place.

Avoid freezing.

Use within 3 months after opening.

Product Specifications

Product Name: Megestrol Acetate Oral Suspension 240 mL/bottle (Caxfila OS)

Common Name: Megestrol Acetate Oral Suspension

Composition: Megestrol Acetate 40 mg/mL

Dosage Form: Oral Suspension

Specification: 40 mg/mL (240 mL bottle)

Manufacturer: Adley Formulations

Indications: 1. Cancer-related Anorexia/Cachexia

Severe loss of appetite, weight loss, and cachexia in patients with cancer (particularly lung, gastrointestinal, or breast cancer).

2. AIDS-related Wasting

Anorexia and severe weight loss in patients with AIDS.

3. Hormone-dependent Tumors

Advanced breast cancer (second-line/third-line endocrine therapy).

Endometrial carcinoma (in cases of recurrence, metastasis, or inoperable disease).

Dosage and Administration: Administration: For oral use. Shake well before use. May be taken with food or on an empty stomach. Dosage (Standard):

Anorexia/Cachexia:

400–800 mg (10–20 mL) once daily

Onset of action occurs in approximately 2–4 weeks; once effective, the dosage may be reduced for maintenance.

Breast Cancer/Endometrial Cancer:

400–800 mg/day, or as directed by a physician.

Pediatric: Not recommended for children under 12 years of age.