Redorfin 500 Mg/850 Mg/1000 Mg Tablets

REDORFIN is indicated for Type II diabetes mellitus when diet has failed and especially if the patient is overweight.

REDORFIN can be given alone as initial therapy, or can be administered in combination with other oral antidiabetics, or insulin.

Adults: Initially, one 500 mg tablet three times a day, or one 850 mg or 1000 mg tablet twice a day, with or after food. After 10 to 15 days the dose should be adjusted according to blood glucose measurements. A slow increase in dose may improve gastro-intestinal tolerability. Good diabetic control may be achieved within a few days, but it is not unusual for the full effect to be delayed for up to two weeks. If control is incomplete a cautious increase in dosage to a maximum of 2550 mg daily is justified. Once control has been obtained it may be possible to reduce the dosage of REDORFIN.

Children and adolescents: REDORFIN is not recommended for use in type 1 diabetes mellitus. REDORFIN can be used in children from 12 years of age and adolescents. The usual starting dose is 500 mg or 850 mg once daily, given during meals or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase in dose may improve gastro-intestinal tolerability. The maximum recommended dose of REDORFIN is 2000 mg daily, taken as 2 or 3 divided doses.

Elderly: REDORFIN dose in the elderly should be adjusted based on renal function (See u201cSpecial Precautionsu201d).

Combination therapy: (See u201cSpecial Precautionsu201d).

• Hypersensitivity to metformin hydrochloride or to any of the excipients of REDORFIN.
• Diabetic ketoacidosis, diabetic pre-coma, or the history thereof.
• Renal failure or renal dysfunction (e.g. serum creatinine levels > 135 u03bcmol/l in males and >110 u03bcmol/l in females).
• Acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, intravascular administration of iodinated contrast agents.
• Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock, and pancreatitis.
• Chronic liver disease.
• History of or states associated with lactic acidosis such as shock or pulmonary insufficiency.
• Hepatic insufficiency, acute alcohol intoxication, alcoholism.
• Pregnancy and lactation.
• Children: as safety and efficacy have not been established.

Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment) metabolic complication that can occur due to REDORFIN accumulation. The incidence of lactic acidosis may be reduced by assessing other associated risk factors such as poorly controlled diabetes mellitus type 2, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings include decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, REDORFIN should be discontinued and the patient should be hospitalised immediately.

As REDORFIN is excreted by the kidneys, serum creatinine levels should be determined before initiating treatment and regularly thereafter:

• At least annually in patients with normal renal function.
• At least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and may be asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a NSAID.

As the intravascular administration of iodinated contrast materials in radiological studies can lead to renal failure, REDORFIN should be discontinued prior to, or at the time of the test and not re-instituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.

REDORFIN should be discontinued 48 hours before elective surgery with general anaesthesia and should not be resumed earlier than 48 hours afterwards.

Inadvisable combinations:

• Alcohol: Increased risk of lactic acidosis in acute alcohol intoxication, particularly in case of:
  • fasting or malnutrition,
  • hepatic insufficiency.
  Avoid consumption of alcohol and alcohol-containing medications.
• Iodinated contrast agents: Intravascular administration of iodinated contrast agents may lead to renal failure, resulting in REDORFIN accumulation and a risk of lactic acidosis. REDORFIN should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.
• Glucocorticoids (systemic and local routes), beta-2-agonists, and diuretics: have intrinsic hyperglycaemic activity. Medical practitioners should inform the patient and perform more frequent blood glucose monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of REDORFIN during therapy with the other medicines and upon its discontinuation.
• ACE-inhibitors may decrease the blood glucose levels. If necessary, adjust the dosage of REDORFIN during therapy with the other medicine and upon its discontinuation.
• Cimetidine: Reduced renal clearance of REDORFIN has been reported during cimetidine therapy, so a dose reduction should be considered.
• Anticoagulants: REDORFIN has been reported to diminish the activity of warfarin, and so dose adjustment of warfarin should be considered.
• Sulphonylurea: Concomitant therapy of REDORFIN with sulphonylurea may cause hypoglycaemia.
• Vitamins: Long-term treatment with REDORFIN may cause vitamin B12 mal-absorption in the gastrointestinal tract (see u201cSpecial Precautionsu201d).

The use of REDORFIN during pregnancy and lactation is contraindicated as the safety has not been established. Metformin (contained in REDORFIN) crosses the placenta and is distributed into breast milk in small amounts. Patients using REDORFIN should not breastfeed their infants.

There is no data to suggest that the ability to drive and operate heavy machinery may be impaired.

Side-Effects:

Blood and the lymphatic system disorders

• Less frequent: Megaloblastic anaemia.

Gastrointestinal disorders

• Frequent: Anorexia, nausea, vomiting, constipation, diarrhoea, metallic taste.
• Less frequent: Abdominal pain.

Hepato-biliary disorders

The following side effects have been reported but the frequencies are unknown: Severe cholestatic hepatitis, liver function abnormalities.

Immune system disorders

The following side effects have been reported but the frequencies are unknown: Hypersensitivity.

Investigations

• Less frequent: Hypoglycaemia.

Metabolic and nutrition disorders

• Less frequent: Hypoglycaemia and lactic acidosis (see u201cSpecial Precautionsu201d).
• Unknown frequency: Decreased absorption of Vitamin B12 and folic acid (see u201cSpecial Precautionsu201d).

Hypoglycaemia can occur when REDORFIN is given concomitantly with other oral antidiabetics, insulin or alcohol. In excessive doses, and particularly if there is a possibility of accumulation, lactic acidosis may develop. Lactic acidosis is a medical emergency and must be treated in hospital. Intense symptomatic and supportive therapy is recommended which should be particularly directed at correcting fluid loss and correcting blood glucose levels.

Treatment of Overdosage: There is no specific antidote for overdose with REDORFIN. Treatment is supportive and symptomatic and should be directed at correcting fluid loss and metabolic disturbances. Haemodialysis is the most effective way to remove lactate and metformin (REDORFIN).