Microsoft word - farma-feximet. inglés.doc

FEXIMET®
It should not be administered to patients with dehydration, diabetic coma or ketoacidosis, those with a serious infection or trauma, nor patients that will be subjected to a major FORMULA:
surgery. Patients that present conditions Each covered tablet of Feximet® 500 contains: associated to hypoxemia, hepatic lesions, lactic Metformin hydrochloride………….….500 mg acidosis, renal dysfunction; patients that present hypersensitivity to metformin. Pregnancy and Each covered tablet of Feximet® 500 contains: Metformin hydrochloride………….850 mg WARNINGS:
Metformin is distributed in breast milk. No appropriate studies have been performed in INDICATIONS:
pediatric patients, and its use is limited to children   over 10 years of age. In geriatric belonging to the group of biguanides, used for patients, the dosage must be adjusted gradually, the treatment of type II diabetes. It is used to or treatment should be discontinued according control hyperglycemia when it has not been to renal clearance and if they present peripheral controlled by the diet, exercise or weight loss. It vascular disease problems. The level of plasma is useful in overweight patients because it creatinine should be determined before starting reduces the risk of diabetic complications and treatment, and then, regularly. Metformin mortality. It may be used in monotherapy, or in interferes with the absorption of vitamin B12, combination with other oral anti-diabetics, or predisposed patients. If the patient is going to be subjected to a major surgery under general PHARMACOKINETICS
anesthesia, it must be interrupted 48 hours PHARMACODYNAMICS:
before, and continued only after 48 hours. Mechanism of action:
Treatment must be done with an adequate diet. Its mechanism of action is not known with certainty. It powers the effect of insulin; does SIDE EFFECTS AND ADVERSE REACTIONS:
not stimulate insulin secretion, but requires the It may produce anorexia, nausea, vomiting, presence of a little insulin to exert its diarrhea, dyspepsia, flatulence, abdominal pain, hypoglycemiant action. It is believed to headache, metallic taste and weight loss. In rare occasion it may produce hypoglycemia; increase sensibility to insulin, increasing lactic acidosis if used in patients with renal reuptake and use of peripheral glucose, retards dysfunction; diarrhea, megaloblastic anemia, glucose absorption; that is, its main action is based on the increase of glucose transportation through the cell membrane of the skeletal OVERDOSE AND TOXIC EFFECTS:
muscle. It also increases storage of hepatic Acute intoxication with doses up to 85 g. may glycogen in diabetic patients (not so in non- provoke development of lactic acidosis and hypoglycemia, glucose or glycogen may be Pharmacokinetics:
It is absorbed slowly and incompletely in the DRUG AND OTHER INTERACTIONS:
approximately 50-60%, although it is slightly With other drugs that affect metabolism or reduced if administered with food. After glycemic control. It should not be administered absorption, its union to plasma proteins is with alcohol, cimetidine, amiloride, nifedipine, insignificant and it is excreted without digoxine, morphine, procainamide, quinidine, modifications in urine. The average life of plasma elimination is between 2 and 6 hours vancomycin; furosemide; oral contraceptives containing estrogen, corticosteroids, tiazide CONTRAINDICATIONS:
chlorpromazine, phenytoin, sympathomimetic agents, thyroid hormones (may produce hyperglycemia); chlofibrates, MAO inhibitors, Maintenance: 500 or 850 mg, two or three times probenecid, propranolol, rifabutin, rifampicin, Maximum dosage in adults: 2550 mg a day. sulfonylureas (may cause hypoglycemia). Do Pediatric dosage:
DOSAGE AND ADMINISTRATION ROUTE:
Initial: 500 mg or 850 mg once a day, during or after meals. Dosage increments should be in 500-850 mg weekly intervals, up to a maximum Initial: 500 mg 1 or 2 times/day, taken with Maximum pediatric dosage: 2000 mg a day. 4.5 meals in the morning and night. Daily dose may be increased by 500 mg at weekly intervals if PRESENTATION:
necessary. An alternative dose of 850 mg a day increased by 850 mg at 45 day intervals. REFERENCES: 1. Hundal RS, Inzucchi SE. Metformin. New understandings, new uses. Drugs 2003;63(18):1879-1894. 2. Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Inter Med 2002;137:25-33. 3. Nathan DM, Buse JB,Davison MB, Ferrannini E, Holman R, Sherwin R, Zinman B. Medical Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjusment of therapy. Diabetes Care 2009; 32:193-203. 4. Martindale. Guía completa de consulta farmacoterapéutica. 1st Edition. 2003. Pages 444-445, 460. 5. USP DI. Drug Information for the Health Care Professional. 23rd Edition. Thompson Micromedex. U.S.A. 2003. Pages 1841-1845.

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