Best Selling Apetiz (Megestrol Acetate)

Apetiz (Megestrol Acetate)

Therapeutic Group : Antineoplastic

Presentation:

Apetiz Tablet: Each film coated tablet contains Megestrol Acetate USP 160 mg.

Pharmacology:

The precise mechanism by which Megestrol Acetate produces effects in anorexia and cachexia is unknown at the present time. Absorption of Megestrol Acetate is well. Metabolism is primarily hepatic and the major route of drug elimination in humans is urine. After administration of 4 to 90 mg Megestrol Acetate in human, the urinary excretion within 10 days ranged from 56.5% to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7% to 30.3% (mean 19.8%). The elimination half-life of Megestrol Acetate ranges from 20 to 50 hours.

Indications:

Apetiz is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosis with Acquired Immunodeficiency Syndrome (AIDS). Apetiz is also indicated for the palliative treatment of advanced carcinoma of the breast (i.e. recurrent, inoperable or metastatic diseases). It should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy.

Dosage & Administration:

Anorexia-cachexia syndrome: The recommended dose of Apetiz is 400 to 800 mg/day (10 to 20 ml/day) for at least two months and could be taken without regard to the meal.

Breast cancer: The recommended dose of Apetiz is 160 mg/day in single or divided doses. Shake the bottle well before use.

No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day for 6 months or more.

Contrainidications:

History of hypersensitivity to Megestrol Acetate or any component of the formulation and in case of known or suspected pregnancy.

 

Warning & Precautions:

History of thromboembolic disease. Monitor for signs/symptoms of adrenal insufficiency; consider empiric therapy if occurs. Diabetes, renal impairment, elderly, fetal toxicity, obtain (-) pregnancy test prior to initiation. Advise females of reproductive potential to use effective contraception during therapy and for nursing mothers\\\\\\\’ it is not recommended.

 

Side effects:

Some common adverse events which occurred in at least 5% of patients are diarrhea, impotence, rash, flatulence, hypertension, asthenia, insomnia, nausea, anemia, fever, decreased libido, dyspepsia, hyperglycemia, headache, pain, vomiting, pneumonia & urinary frequency. Some other adverse events also occurred in 1% to 3% of all patients are abdominal pain, chest pain, infection, moniliasis and sarcoma, cardiomyopathy and palpitation, constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis, leukopenia, increased LDH, edema & peripheral edema, paresthesia, confusion, convulsion, depression, neuropathy, hyperesthesia & abnormal thinking, dyspnea, cough,
pharyngitis & lung disorder, alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder, amblyopia, albuminuria, urinary incontinence, urinary tract infection and gynecomastia. A rarely encountered side effect of prolonged administration of Megestrol Acetate is urticaria.

 

Drug interaction:

Pharmacokinetic studies show that there is no significant alteration in pharmacokinetic parameters of Zidovudine or Rifabutin to warrant dosage
adjustment when Megestrol Acetate is administered with these drugs.

 

Use in special groups:

Use in Pregnancy & Lactation
No adequate animal teratology information is available at clinically relevant doses. Because of the potential for adverse effects on the newborn, nursing should be discontinued if Megestrol Acetate is required.

Use In Children & Adolescents (<18 Years Of Age)
Safety and effectiveness in pediatric patients have not been established. Megestrol Acetate is not recommended for use in children.

Geriatric Use (>65 Years Of Age)
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Overdose
No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day for 6 months or more.

Storage:

Apetiz Tablet: Store within 30º C. Protect from light.

Packing:

Apetiz Tablet: Each box contains 10/30 tablets in alu-alu blister pack.

 

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FAQ : 

  1. What is megestrol acetate used for?

Answer : Megestrol suspension is used to treat loss of appetite, malnutrition, and severe weight loss in patients with acquired immunodeficiency syndrome (AIDS). Megestrol should not be used to prevent loss of appetite and severe weight loss in patients who have not yet developed this condition.

 

2. Is megestrol acetate safe?

Answer : No. Megestrol acetate (MA) is neither safe nor effective for stimulating appetite in malnourished nursing home residents.

 

3.  Is megestrol a chemotherapy medicine?

Answer : Megestrol (Megace®) is a hormonal therapy drug used to treat breast and womb cancer that has spread to other parts of the body. This is called secondary cancer. It may also be used to treat breast and womb cancer that has come back after treatment (recurrent). Megestrol can also be used to improve your appetite.

 

4. Is megestrol acetate a steroid?

Answer : synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy) 6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 μg per mL, solubility in plasma is 24 μg per mL. Its molecular weight is 384.51.

 

5. Why would a man take megestrol?

Answer : It is a man made version of the hormone progesterone. Progesterone is one of the female hormones but men also produce a small amount of it. Megestrol acetate is a treatment for the following cancers that have come back or spread from where they started. It is also a treatment for poor appetite.

 

6. Is megestrol acetate a birth control?

Answer : Megestrol acetate (MGA), marketed under the brand name Megace, among others, is a progestin drug that is used primarily as an appetite stimulant to treat waste syndromes such as cachexia. It is also used to treat breast cancer and endometrial cancer and has been used for birth control.

 

7. What is the side effect of megestrol?

Answer : Trouble sleeping, fever, gas, decreased sexual ability/desire, weight gain, changes in appetite, or upset stomach may occur. Women may have changes in their menstrual periods, including unpredictable bleeding. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

 

8. How long does it take megestrol to work?

Answer : Patients will typically improve their appetite within the first few weeks after starting the drug. Weight gain, often in the form of fat, may take longer. Resistance exercise traing coupled with the weight gain may lead to improved lean muscle mass. A typical treatment duration may be 12 weeks.

 

9. Why is megestrol a high risk medication?

Answer : Use of megestrol acetate results in minimal improvements in appetite and weight gain, no improvement in quality of life or survival, and increased risk of thrombotic events, fluid retention, and death.

 

10. Does megestrol lower your immune system?

Answer : Megace (megestrol) is good for treating appetite and weight loss in people with advanced cancer or AIDS, without causing the side effects of steroids. Calms down your immune system.

 

11. Is megace bad for kidneys?

Answer : Oral megestrol acetate (MA) should be used with caution in the management of protein-energy wasting in patients with chronic kidney disease (CKD) and only when other treatment options are unavailable, researchers concluded from a systematic literature review.

 

12. Can megestrol cause hair loss?

Answer : Your hair may become thin, brittle, or may fall out. This typically begins two to three weeks after treatment starts. This hair loss can be all body hair, including pubic, underarm, legs/arms, eyelashes, and nose hairs.

 

13. Is megestrol acetate over the counter?

Answer : Megace is a prescription medicine used to treat the symptoms of loss of appetite and wasting syndrome in people AIDS-Related Cachexia, breast cancer or endometrial cancer.

 

14. What type of drug is megestrol?

Answer : Drug type: Megestrol is a hormone therapy. This medication is classified as a “progesterone.” (For more detail, see “How this drug works” section below).

 

15. Can you drink alcohol while taking megestrol?

Answer : The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of megestrol. It is not known if megestrol affects fertility in men and women. If you plan to have children, discuss this with your doctor before being treated with megestrol. control while being treated with megestrol.

 

16. Can men use megestrol acetate?

Answer : Indeed, in older men, use of MA results in near-castrate levels of testosterone. MA has also been used to suppress estrogen levels in women with breast cancer (5).

 

17. How long can you be on megestrol?

Answer : Conclusions: A substantial proportion of patients continue to use megestrol acetate for periods of up to 3 years or longer with continued control of hot flashes. This treatment appears to be relatively well tolerated.

 

 

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