Apetiz Suspension (Megestrol Acetate)
Description
Apetiz is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss. It is also indicated for the palliative treatment of advanced carcinoma of the breast (i.e. recurrent, inoperable, or metastatic diseases).Apetiz Suspension is a powerful appetite stimulant and can be considered an antiemetic option for chemotherapy. Itis manufactured with US DMF certified raw material, which ensures the quality, safety & efficacy of the product. Apetiz Suspension is a lemon-flavored, tasty suspension- patients would love to take it.
Presentation
Apetiz Oral Suspension: Each ml suspension contains Megestrol Acetate USP 40 mg.
Indications
Apetiz is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed 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.
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:
Although the safety and effectiveness of Megestrol Acetate in pediatric patients have not been established, some clinical trials are found to use it safely in children of 8 months to 10 years at a median daily dose of 10 mg/kg body weight (range from 3.3 to 12 mg/kg body weight/day).
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.
Packing
Apetiz Oral Suspension: Each bottle contains 100 ml oral suspension.
