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DRUGS & SUPPLEMENTS
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Megaplex
What are the side effects you encounter while taking this medicine? |
Megaplex uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Storage
- Special handling
Indications and Usage
Megaplex 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 Megaplex acetate or any component of the formulation.
Warnings
Megaplex acetate may cause fetal harm when administered to a pregnant woman. Fertility and reproduction studies with high doses of Megaplex 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 Megaplex in other types of neoplastic disease is not recommended.
The glucocorticoid activity of Megaplex 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 Megaplex. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megaplex therapy in the stressed and non-stressed state.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 Megaplex therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megaplex therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or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 Megaplex 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 Megaplex acetate.
Information for the Patients
Patients using Megaplex 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 Megaplex.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Administration of Megaplex 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 Megaplex 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 Megaplex 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 Megaplex 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.
Megaplex 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 Megaplex. 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 Megaplex acetate administered in dosages as high as 1600 mg/day. Oral administration of large, single doses of Megaplex acetate (5 g/kg) did not produce toxic effects in mice. Megaplex 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 Megaplex acetate.
How Supplied
Megaplex 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
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Megaplex pharmaceutical active ingredients containing related brand and generic drugs:
Megaplex available forms, composition, doses:
Megaplex destination | category:
Megaplex Anatomical Therapeutic Chemical codes:
Megaplex 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 Megaplex?Depending on the reaction of the Megaplex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Megaplex 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 Megaplex 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 Megaplex, 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 Megaplex 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.Visitor reports
One visitor reported useful
How is the drug Megaplex useful in reducing or relieving the symptoms? How useful is it?According to the survey conducted by the website sdrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
| Visitors | % | ||
|---|---|---|---|
| Useful | 1 | 100.0% | |
Visitor reported side effects
No survey data has been collected yetVisitor reported price estimates
No survey data has been collected yetVisitor reported frequency of use
No survey data has been collected yetTwo visitors reported doses
What is the dose of Megaplex drug you are taking?According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
| Visitors | % | ||
|---|---|---|---|
| 101-200mg | 1 | 50.0% | |
| 11-50mg | 1 | 50.0% | |
One visitor reported time for results
What is the time duration Megaplex drug must be taken for it to be effective or for it to reduce the symptoms?Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 month to notice the result from using Megaplex drug. The time needed to show improvement in health condition after using the medicine Megaplex need not be same for all the users. It varies based on other factors.
| Visitors | % | ||
|---|---|---|---|
| 1 month | 1 | 100.0% | |
Two visitors reported administration
The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Megaplex drug, before food or after food?Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
| Visitors | % | ||
|---|---|---|---|
| Before food | 1 | 50.0% | |
| After food | 1 | 50.0% | |
Visitor reported age
No survey data has been collected yetVisitor reviews
There are no reviews yet. Be the first to write one! |
The information was verified by Dr. Rachana Salvi, MD Pharmacology