MG-40

MG-40 oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) or other unknown factors.

The recommended adult initial dosage of MG-40 is 800 mg daily (20 mL/day). Doses should be taken after meals. Daily dose is 400-800 mg.

No serious unexpected side effects have resulted.

Patients w/ a history of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.

Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss.

General: Therapy with MG-40 oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, and renal or psychiatric diseases.
Effects on HIV viral replication have not been determined.
Use with caution in patients with a history of thromboembolic disease.
Use In Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of MG-40.
Use in Women with HIV infections: Although megestrol acetate has been used extensively in women for the treatment of breast and endometrial cancer, however, its use in HIV-infected females has been limited.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Megesterol acetate may cause fetal harm when administered to pregnant women. If it is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to the fetus. Treatment of MG-40 oral suspension should be discontinued in nursing mothers as it has potency to develop side effects in newborns.

Body as a Whole: Abdominal pain, chest pain, infection, moniliasis and sarcoma.
Cardiovascular System: Cardiomyopathy and palpitation.
Gastro Intestinal System: Constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis.
Hemic and Lymphatic System: Leucopenia.
Metabolic and Nutritional: Increased LDH, edema and peripheral edema.
Nervous System: Paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking.
Respiratory System: Dyspnea, cough, pharyngitis and lung disorder.
Skin and Appendages: Alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder.
Special Senses: Amblyopia.
Urogenital System: Albuminuria, urinary incontinence, urinary tract infection and gynecomastia.

There are no significant alterations in pharmacokinetic parameters of zidovudine or with rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs.

Store the oral suspension below 30°C.

Cancer Hormone Therapy

L02AB01 - megestrol ; Belongs to the class of progestogens.

K