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Glucoform

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Antidiabetic agent

COMPOSITION:
Metformin HCl:    500 mg, 850 mg.


INDICATIONS:

  • Metformin is an oral biguanide antidiabetic agent. It is used to treat non-insulin-dependent diabetes mellitus uncontrolled by diet alone.
  • Metformin can be used as monotherapy or in combination with sulfonylureas, alpha-glucosidase inhibitors, or with insulin.

ADMINISTRATION AND DOSAGE:
Adults:

For mono-therapy: Initially, take 500 mg x 2 times daily with the morning and evening meals. If needed, the dosage can be gradually increased to 500 mg x 3 times daily after a week or two weeks. Maximum dosage is 2500 mg/day.

In combination with sulfonylureas, alpha-glucosidase inhibitors: The dose of each medicine will be determined by doctor.

In combination with Insulin: Continue current insulin dose Initially, take 500 mg, once a day. If needed, the dosage can be gradually increased to 500 mg x 2 times daily after a week or two weeks until adequate glycemic control achieved.

Children from 10 to 17 years:
Use and dose will be determined by doctor.


CONTRAINDICATIONS:

  • Known hypersensitivity to metformin.
  • Ceton acidosis, precoma due to diabetes.
  • Renal failure (serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females]) or abnormal creatinine clearance.
  • Hepatic failure, cardiovascular disease, severe respiratory disease with hypoxemia, chronic pulmonary diseases with oxygen deficiency.
  • Congestive heart failure, cardiac collapse, acute myocardial infarction.
  • Severe infection, blood infection.
  • Acute alcohol poisoning.
  • Pregnancy and lactation.

WARNINGS AND PRECAUTIONS:

  • Metformin can induce or promote the onset of a state of lactic acidosis. The incidence can be reduced by closely monitoring risk factors, renal function and by using the minimum effective dose of metformin.
  • Renal function should be assessed before initiation of metformin and annually.
  • Metformin should generally be avoided in patients with hepatic disease.
  • Metformin should be promptly withheld in presence of acute hypoxemia, acute cardiac disease, dehydration or sepsis.
  • Low blood glucose levels may slow your reaction time and affect your ability to drive and operate machinery. Drinking alcohol can make this worse. However, metformin by itself is unlikely to affect how you drive or operate machinery.
  • Metformin therapy should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids)
  • Metformin should be temporarily discontinued 2-3 days prior to radiologic studies involving the use of intravascular iodinated contrast materials the procedure, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.
  • Macrovascular outcomes:  There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with metformin or any other anti-diabetic drug.
  • Use metformin with caution in the elderly.
  • Children < 10 years: Safe and effective use has not been established

SIDE EFFECTS:

  • Common: Anorexia, nausea, vomiting, diarrhea, flatulence, dyspepsia.
  • Uncommon: Blood dyscrasia, aplastic anemia, hemolytic anemia, thrombocytopenia, agranulocytosis. Lactic acidosis is a rare complication but seriously.

INTERACTIONS:

  • During concomitant therapy with either sulfonylureas and repaglinide, blood glucose should be monitored because combined therapy may causes hypoglycaemia.
  • Furosemide increases the metformin plasma and blood maximum concentrations.
  • Concurrent administration of drugs eliminated by renal tubular secretion (cimetidine, ranitidine, digoxin, morphine, quinine, trimethoprim, vancomycin) may increase the risk of lactic acidosis.
  • Effect of metformin may decrease by concurrent administration of drugs which can promote hyperglycemia: Glucocorticosteroides, b2 stimulants and sympathomimetics.

PRESENTATION:

  • Box of 1 blister x 10 film-coated tablets
  • Box of 2 blisters x 10 film-coated tablets
 

Manufacturing facility:

Address: No. 27, 3A Street, Bien Hoa Industrial Zone II, Dong Nai Province, Vietnam.

Telephone: (84-61) 3 992 999, (84-61) 3 892 353.

Fax: (84-61) 3 892 344.

Website: opv.com.vn Email: opv.vietnam@opv.com.vn

HCM Offce - HANOI Office

- HCMC: Suite 1006,10 Floor, Citilight, No. 45 Vo Thi Sau Str, Dist 1, HCMC, Vietnam.

Telephone: (84-4) 38 205 337 (8 line). Fax: (08) 38 205 336.

- HANOI: 4 Floor, King Building, No. 7 Chua Boc Str, Dong Da Dist, Hanoi, Vietnam.

Telephone: (84-4) 3734 2774, (84-4) 3734 2775. Fax: (84-4) 3734 2773.