DRUGS & SUPPLEMENTS

Megace

Name: Megace drug & pharmaceuticals. Megace available forms, doses, prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Megace uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
Storage
Special handling
Megace reviews

Indications and Usage

Megace acetate is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.

Contraindications

History of hypersensitivity to Megace acetate or any component of the formulation.

Warnings

Megace acetate may cause fetal harm when administered to a pregnant woman. Fertility and reproduction studies with high doses of Megace acetate have shown a reversible feminizing effect on some male rat fetuses. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

The use of Megace in other types of neoplastic disease is not recommended.

The glucocorticoid activity of Megace acetate tablets has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megace. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megace therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic Megace therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megace therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic Megace therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (eg., surgery, infection).

Precautions

General

Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.

Use in Diabetics

Exacerbation of pre-existing diabetes with increased insulin requirements has been reported in association with the use of Megace acetate.

Information for the Patients

Patients using Megace acetate should receive the following instructions:

This medication is to be used as directed by the physician.
Report any adverse reaction experiences while taking this medication.

Laboratory Tests

Breast malignancies in which estrogen and/or progesterone receptors are positive are more likely to respond to Megace.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Administration of Megace acetate to female dogs for up to 7 years is associated with an increased incidence of both benign and malignant tumors of the breast. Comparable studies in rats and studies in monkeys are not associated with an increased incidence of tumors. The relationship of the dog tumors to humans is unknown but should be considered in assessing the benefit-to-risk ratio when prescribing Megace acetate and in surveillance of patients on therapy.

Pregnancy

Pregnancy Category D

Nursing Mothers

Because of the potential for adverse effects on the newborn, nursing should be discontinued if Megace is required for treatment of cancer.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Insufficient data from clinical studies of Megace acetate tablets are available for patients 65 years of age and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. 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.

Megace 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.

Adverse Reactions

Weight Gain

Weight gain is a frequent side effect of Megace. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.

Thromboembolic Phenomena

Thromboembolic phenomena including thrombophlebitis and pulmonary embolism have been reported.

Glucocorticoid Effects

Other Adverse Reactions

Heart failure, nausea and vomiting, edema, breakthrough menstrual bleeding, dyspnea, tumor flare (with or without hypercalcemia), hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.

Overdosage

No serious unexpected side effects have resulted from studies involving Megace acetate administered in dosages as high as 1600 mg/day. Oral administration of large, single doses of Megace acetate (5 g/kg) did not produce toxic effects in mice. Megace acetate has not been tested for dialyzability; however, due to its low solubility it is postulated that this would not be an effective means of treating overdose.

Dosage and Administration

Breast Cancer: 160 mg/day (40 mg q.i.d.).

Endometrial Carcinoma: 40 mg/day to 320 mg/day in divided doses.

At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megace acetate.

How Supplied

Megace Acetate Tablets USP

20 mg tablets are supplied as a white, flat faced, round tablet; scored on one side and product identification “54 763” debossed on the other side.

NDC 0054-8603-25: 10x10 Unit-Dose Tablets

NDC 0054-4603-25: Bottle of 100 Tablets

40 mg tablets are supplied as a white, flat faced, round tablet; scored on one side and product identification “54 352” debossed on the other side.

NDC 0054-8604-25: 10x10 Unit-Dose Tablets

NDC 0054-4604-25: Bottle of 100 Tablets

Dispense in a tight, child-resistant container as defined in the USP/NF.

STORAGE

Store at 20° to 25°C (68° to 77°F).

Protect from temperatures above 40°C (104°F).

SPECIAL HANDLING

Health Hazard Data

There is no threshold limit value established by OSHA, NIOSH, or ACGIH.

Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above. Women at risk of pregnancy should avoid such exposure.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

4056065//07

Revised May 2016

fpl-carton-20mg-100tab-04.jpg fpl-carton-40mg-100tab-04.jpg

Megace pharmaceutical active ingredients containing related brand and generic drugs:

Megestrol Acetate

Megace available forms, composition, doses:

Suspension; Oral; Megestrol Acetate 40 mg / ml
Tablets; Oral; Megestrol Acetate 160 mg
Tablets; Oral; Megestrol Acetate 20 mg
Tablets; Oral; Megestrol Acetate 40 mg

Megace destination | category:

Human:
Antineoplastic agents

Megace Anatomical Therapeutic Chemical codes:

G03AC05 - Megestrol
G03DB02 - Megestrol
L02AB01 - Megestrol

Megace pharmaceutical companies:

References

Dailymed."MEGESTROL ACETATE TABLET [WEST-WARD PHARMACEUTICALS CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."MEGESTROL ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"MEGESTROL ACETATE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Megace?

Depending on the reaction of the Megace after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Megace not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Megace addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Megace, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Megace consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.