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NEW ZEALAND DATA SHEET METFORMIN 1 …

NEW ZEALAND data SHEETMETFORMINP lease refer to Medsafe website ( ) for the most recent datasheetPage 11 METFORMIN (500mg, 850mg and 1000mg tablets)2 QUALITATIVE AND QUANTITATIVE COMPOSITIONM etformin hydrochloride 500mgMetformin hydrochloride 850mgMetformin hydrochloride 1000mgExcipient of known effectPropylene GlycolThis excipient may cause skin a full list of excipients, see section PHARMACEUTICAL FORMM etformin 500 mg: White coloured, film coated, round, biconvex tablets embossed on one face with 500 METFORMIN 850 mg: White coloured, film coated, round, biconvex tablets embossed on one face with 850 METFORMIN 1000mg: White coloured, film coated oval shaped biconvex embossed on one face with 1000 .4 CLINICAL Therapeutic Indications Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, whendietary management and exercise alone does not result in adequate glycaemic control.

NEW ZEALAND DATA SHEET METFORMIN Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 1 METFORMIN (500mg, 850mg and 1000mg tablets)

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Transcription of NEW ZEALAND DATA SHEET METFORMIN 1 …

1 NEW ZEALAND data SHEETMETFORMINP lease refer to Medsafe website ( ) for the most recent datasheetPage 11 METFORMIN (500mg, 850mg and 1000mg tablets)2 QUALITATIVE AND QUANTITATIVE COMPOSITIONM etformin hydrochloride 500mgMetformin hydrochloride 850mgMetformin hydrochloride 1000mgExcipient of known effectPropylene GlycolThis excipient may cause skin a full list of excipients, see section PHARMACEUTICAL FORMM etformin 500 mg: White coloured, film coated, round, biconvex tablets embossed on one face with 500 METFORMIN 850 mg: White coloured, film coated, round, biconvex tablets embossed on one face with 850 METFORMIN 1000mg: White coloured, film coated oval shaped biconvex embossed on one face with 1000 .4 CLINICAL Therapeutic Indications Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, whendietary management and exercise alone does not result in adequate glycaemic control.

2 METFORMIN may be used as initial treatment or in sulfonylurea failures either alone or incombination with a sulfonylurea and other oral agents. Adjuvant therapy in insulin dependent diabetes especially if Dose and method of administrationLife threatening lactic acidosis can occur due to accumulation of METFORMIN . Risk factorsinclude renal impairment, old age and doses of METFORMIN above 2 g per day(see Specialwarnings and precautions for use).It is important that the tablets are taken in divided doses with and combination with other oral antidiabetic agents in adults with normal renalfunctionInitially 500 mg should be taken once or twice a day and, if necessary, increased over a few weeks upto a maximum of 1 g three times per day.

3 The dose should be titrated with gradual dose incrementsuntil the desired effect is obtained. 500 mg three times a day is often sufficient to obtain diabeticcontrol. Control may be attained within a few days but occasionally requires up to two weeks. Oncecontrol has been obtained, the dosage should be reviewed and reduced to the lowest maintenancelevel consistent with good diabetic maximum dose of 3g daily should only be used in patients with good renal function (ie creatinineclearance greater than 120ml/min).METFORMINP lease refer to Medsafe website ( ) for the most recent datasheetPage 2 The action of METFORMIN is progressive and no final assessment of the patient's real response shouldbe made before the 21st day of treatment; blood sugar estimations are recommended during the initial15 days of stabilisation.

4 METFORMIN will not produce a hypoglycaemic state when used alone, however,it increases insulin with insulin or sulphonylureas in adultsMetformin therapy with a sulphonylurea or insulin should be monitored by blood-sugar readingsbecause combined therapy may cause hypoglycaemia. If it is decided to stabilise diabetic patients withmetformin and insulin therapy, it is recommended that this is carried out in hospital because of thepossibility of hypoglycaemia until the correct ratio of the two medicines is ImpairmentThe risk of lactic acidosis is increased in patients with renal impairment. METFORMIN is contraindicatedin patients with renal failure (creatinine clearance <15mL/min), (see Contraindications). METFORMIN may be used in patients with stable renal impairment (but see Warnings and Precautions).

5 Where possible the dose should be titrated with gradual dose maximum daily dose for patients with creatinine clearance between 15-30mL/min is maximum daily dose for patients with creatinine clearance between 30-60mL/min is maximum daily dose for patients with creatinine clearance between 60-120mL/min is is recommended that METFORMIN concentrations are checked after steady state has been reached(after 48 hours) to ensure METFORMIN concentrations remain below 5 g/mL (5mg/L).Renal function should be closely monitored (every 3-6 months).If the creatinine clearance drops below 15mL/min METFORMIN must be initial and maintenance dosing of METFORMIN should be conservative in elderly patients, due to thepotential for decreased renal function in this population.

6 Any dosage adjustment should be based ona careful assessment of renal function. Generally, elderly patients should not be titrated to themaximum dose of or malnourished patientsThe dosing should be conservative and based on a careful assessment of renal is not recommended for use in ContraindicationsMetformin is contraindicated in the following conditions: Juvenile diabetes mellitus that is uncomplicated and well regulated on insulin Diabetes mellitus regulated by diet alone During or immediately following surgery where insulin is essential Hypersensitivity to METFORMIN hydrochloride and other biguanides, or to any of the excipients Diabetic ketoacidosis, diabetic precoma Renal failure (creatinine clearance < 15 mL/minute), patients with unstable renal function Acute conditions with the potential to alter renal function such as dehydration, severe infection,shock, intravascular administration of iodinated contrast agents (see Warnings andPrecautions)

7 Acute conditions which may cause tissue hypoxia such as cardiac failure, recent myocardialinfarction, respiratory failure, pulmonary embolism, acute significant blood loss, sepsis,gangrene, pancreatitisMETFORMINP lease refer to Medsafe website ( ) for the most recent datasheetPage 3 Severe hepatic insufficiency, acute alcohol intoxication, alcoholism History of lactic acidosis Lactation. Hypersensitivity to the active substance or to any of the excipients listed in section Special warnings and precautions for useLactic acidosisLactic acidosis is a rare but serious metabolic complication which can occur due to metforminaccumulation during treatment. When it occurs, it is fatal in more than 25% of cases. Lactic acidosisis a medical emergency and must be treated in hospital risk of lactic acidosis increases with the degree of renal dysfunction and the patient's cases have occurred primarily in diabetic patients with acute conditions causing a significantdecrease in renal function or tissue hypoxia (see Contraindications) Hepatic dysfunction is also a riskas lactate clearance is reduced (see Contraindications).

8 Patients with long-term stable conditionsshould be carefully assessed prior to treatment for risk factors for lactic acidosis such as: poorlycontrolled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency andconditions associated with hypoxia (see Contraindications).Particular caution should be paid in situations where renal function may become impaired such asdehydration, when starting therapy with a diuretic or when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). In these situations METFORMIN should be temporarily METFORMIN is implicated as the cause of lactic acidosis, METFORMIN plasma levels greater than5 g/mL (5mg/L) are generally found (see Pharmacokinetics).

9 DiagnosisThe risk of lactic acidosis must be considered in the event of non-specific signs such as malaise,myalgia, muscle cramps, respiratory distress, increasing somnolence and non-specific should be instructed to notify these signs to their physician lactic acidosis progresses there may be associated hypothermia, hypotension and resistantbradyarrhythmias with more marked acidosis. This can be followed by acidotic dyspnea and acidosis is characterised by acidosis (decreased blood pH), elevated lactate levels above5mmol/L with increased lactate/pyruvate ratio and electrolyte disturbances with an increased aniongap. If there is any suspicion of metabolic/lactic acidosis METFORMIN should be discontinued and thepatient hospitalised immediately.

10 Prompt haemodialysis is recommended to correct the acidosis andremove accumulated METFORMIN (see Overdose).Renal ImpairmentUnderlying renal disease, or a deterioration in renal function, result in reduced clearance of metforminand drug accumulation and are therefore major risk factors in lactic acidosis (see Dosage andAdministration). Creatinine clearance (this can be estimated from serum creatinine levels by using theCockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter: At least annually in patients with normal renal function At least twice a year in patients with impaired renal function and elderly patientsDecreased renal function in elderly subjects is frequent and therapy should be temporarily stopped in the presence of any condition associated withhypoxaemia or dehydration, in patients suffering from serious infections or trauma (particularly ifgastrointestinal disturbances are noted or acidosis is suspected) and in those undergoing refer to Medsafe website ( ) for the most recent datasheetPage 4 Prompt haemodialysis is recommended to correct the acidosis and remove accumulated METFORMIN (see Overdose).


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