Medication info

Apitrol Oral Suspension (Megestrol Acetate)

Prescription medicationSuspensionApproval withdrawn
Ingredient · strength
Megestrol Acetate›4000mg
Manufacturer / importer
LG Chem, Ltd.
Appearance
This medication is a white or cream-colored, milk-like suspension contained in aluminum foil packaging that disperses easily when shaken. It has a lemon-lime or lemon scent and flavor.
Packaging
14 packets (10 mL, 20 mL/packet)
Approval status
Approval withdrawn

MFDS item code 200608270 · Notified 2006.08.09

This product's status changed to Approval withdrawn on 2025.07.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of cancer and AIDS (such as loss of appetite and cachexia); palliation of breast and endometrial cancer
Who uses it
Adults
Adult dosage
(Tablets) 1. Breast cancer: Administer megestrol acetate 160 mg orally in 4 divided doses daily (40 mg, 1 tablet per dose, 4 times daily). 2. Endometrial cancer: Administer 40~320 mg of this drug orally in divided doses daily. Treatment should be continued for at least 2 months, an adequate period for evaluating the effect of this drug. (Suspension) Shake well and take megestrol acetate 800 mg (20 mL) daily. Clinical efficacy was observed in clinical trials with this drug at doses of 400~800 mg (10∼20 mL) daily.

Ingredients

Manufacturer
LG Chem, Ltd.

Efficacy & effects

Treatment of symptoms of cancer and AIDS (such as loss of appetite and cachexia); palliation of breast and endometrial cancer

  • Recurrent breast cancer
  • metastatic breast cancer
  • inoperable breast cancer
  • endometrial cancer
  • loss of appetite
  • cachexia
  • significant unexplained weight loss.
View approved original text

This drug in tablet form is mainly used for alleviating the symptoms of recurrent or metastatic breast cancer and endometrial cancer patients where surgery is difficult. However, this drug should not be used as a substitute for surgical or radiation therapies. The suspension form helps in treating appetite loss, cachexia, or unexplained weight loss in cancer or AIDS patients. Both forms should be used appropriately according to their respective indications to assist in symptom relief and treatment.

Dosage and Administration

Adult dosage

(Tablets) 1. Breast cancer: Administer megestrol acetate 160 mg orally in 4 divided doses daily (40 mg, 1 tablet per dose, 4 times daily). 2. Endometrial cancer: Administer 40~320 mg of this drug orally in divided doses daily. Treatment should be continued for at least 2 months, an adequate period for evaluating the effect of this drug. (Suspension) Shake well and take megestrol acetate 800 mg (20 mL) daily. Clinical efficacy was observed in clinical trials with this drug at doses of 400~800 mg (10∼20 mL) daily.

Precautions

This medication should not be used during the first four months of pregnancy as it may cause serious damage to the fetus. Women of childbearing potential must practice contraception while using this medication as it may increase the risk of fetal malformation. Caution is advised as long-term use may lead to new-onset diabetes or worsen existing diabetes. Long-term use or abrupt discontinuation may lead to adrenal insufficiency, which can manifest as hypotension, nausea, dizziness, and other symptoms. It is important to consult healthcare providers if such symptoms occur for proper examination and treatment. Patients with a history of thromboembolic events or pulmonary embolism should be particularly cautious due to potential circulatory problems such as thrombosis. Women who are allergic to this medication or in the first four months of pregnancy should not use it. Nursing mothers should discontinue breastfeeding as this medication may pass into breast milk and harm the baby. Safety in pediatric patients has not been established, and it is advisable not to administer to children. Overdose usually does not result in severe reactions, but this drug is poorly soluble in the body and is difficult to remove through dialysis. Store this medication out of reach of children and do not transfer it to another container for safety. Accurate identification and treatment of the cause of weight loss are crucial during the use of this medication, and caution is also warranted as long-term use may increase the risk of respiratory infections.

Side effects

  • Thrombophlebitis
  • thromboembolic symptoms
  • pulmonary embolism
  • glucose intolerance
  • heart failure
  • nausea
  • vomiting
  • edema
  • sudden uterine bleeding
  • dyspnea
Show 68 more
  • tumor flushing
  • hyperglycemia
  • alopecia
  • hypertension
  • carpal tunnel syndrome
  • emotional changes
  • flushing
  • fatigue
  • weakness
  • drowsiness
  • sweating
  • rash
  • gynecomastia
  • hearing loss
  • pain
  • Cushing's face
  • diarrhea
  • erectile dysfunction
  • abdominal distension
  • hypertension
  • weakness
  • insomnia
  • anemia
  • fever
  • decreased libido
  • dyspepsia
  • headache
  • pneumonia
  • frequent urination
  • amblyopia
  • constipation
  • dry mouth
  • hepatomegaly
  • increased saliva secretion
  • oral candidiasis
  • cardiomyopathy
  • palpitations
  • cough
  • pharyngitis
  • pulmonary dysfunction
  • leukopenia
  • proteinuria
  • incontinence
  • urinary tract infection
  • abnormal sensations
  • confusion
  • seizures
  • depression
  • neuropathy
  • sensory loss
  • abnormal thoughts
  • herpes
  • itching
  • vesicular rash
  • skin disorders
  • elevated LDH
  • edema
  • peripheral edema
  • chest pain
  • abdominal pain
  • infection
  • candidiasis
  • sarcoma
  • sudden bleeding
  • anxiety
  • stomatitis
  • mucositis
  • shoulder pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 15 to 25 degrees Celsius.

Appearance and packaging

Appearance

This medication is a white or cream-colored, milk-like suspension contained in aluminum foil packaging that disperses easily when shaken. It has a lemon-lime or lemon scent and flavor.

Package unit

14 packets (10 mL, 20 mL/packet)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.