DRUGS & SUPPLEMENTS
Indications and Usage
Meltonar 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.
History of hypersensitivity to Meltonar acetate or any component of the formulation.
Meltonar acetate may cause fetal harm when administered to a pregnant woman. Fertility and reproduction studies with high doses of Meltonar 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 Meltonar in other types of neoplastic disease is not recommended.
The glucocorticoid activity of Meltonar 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 Meltonar. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Meltonar therapy in the stressed and non-stressed state.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 Meltonar therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Meltonar therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or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 Finally, in patients who are receiving or being withdrawn from chronic Meltonar therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions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).
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 Meltonar acetate.
Information for the Patients
Patients using Meltonar acetate should receive the following instructions:
Breast malignancies in which estrogen and/or progesterone receptors are positive are more likely to respond to Meltonar.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Administration of Meltonar 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 Meltonar acetate and in surveillance of patients on therapy.
Pregnancy Category D
Because of the potential for adverse effects on the newborn, nursing should be discontinued if Meltonar is required for treatment of cancer.
Safety and effectiveness in pediatric patients have not been established.
Insufficient data from clinical studies of Meltonar 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.
Meltonar 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.
Weight gain is a frequent side effect of Meltonar. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.
Thromboembolic phenomena including thrombophlebitis and pulmonary embolism have been reported.
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.
No serious unexpected side effects have resulted from studies involving Meltonar acetate administered in dosages as high as 1600 mg/day. Oral administration of large, single doses of Meltonar acetate (5 g/kg) did not produce toxic effects in mice. Meltonar 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 Meltonar acetate.
Meltonar 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.
Store at 20° to 25°C (68° to 77°F).
Protect from temperatures above 40°C (104°F).
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
Eatontown, NJ 07724
Revised May 2016
Meltonar pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Meltonar available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Meltonar destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Meltonar Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Meltonar pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Meltonar?
Depending on the reaction of the Meltonar after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Meltonar 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 Meltonar 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.
ReviewsDrugs.com conducted a study on Meltonar, 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 Meltonar 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.
The information was verified by Dr. Arunabha Ray, MD Pharmacology