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Glucophage XR – scripted patients only

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1. What is diabetes?

UNDERSTANDING DIABETES
Diabetes mellitus is a chronic condition characterised by increased levels of glucose in the bloodstream caused by dysfunctions in the production of, or use of, a hormone called insulin.
Insulin is normally produced by the pancreas and is responsible for the transport of glucose from the bloodstream into cells where it can be used for energy.
Therefore, any dysfunction in either insulin production or function
leads to high levels of glucose in the blood and ultimately diabetes.
The two most common types of diabetes are Type 1 and Type 2.

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2. What you need to know if you’ve just been diagnosed with Type 2 diabetes

The cornerstones to treating Type 2 diabetes are lifestyle changes, which include a healthy diet, being physically active, and to quit smoking. Due to the progressive nature of Type 2 diabetes and the difficulties in making lifestyle changes, some people may need to take oral medications to maintain blood glucose levels, in addition to making healthy lifestyle changes.

Metformin is the preferred initial treatment for newly diagnosed Type 2 diabetic patients. If Metformin alone is not able to adequately maintain blood glucose levels, there are a range of add-on therapies that can be safely given in addition to Metformin. When oral
medications are unable to keep blood glucose levels within normal levels, insulin injections may need to be used.

90-95% of people with diabetes, have type 2 diabetes

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3. Type 2 diabetes

Type 2 diabetes is the most common type of diabetes and was traditionally diagnosed in older adults, but is increasingly being diagnosed in children and adolescents due to the sharp rise in the rates of obesity, physical inactivity, and poor diets.

Type 2 diabetes is a progressive disease, transitioning from a state where the body does not respond effectively to insulin, termed insulin resistance, to a state where insulin secretion is decreased. Insulin resistance causes an increase in blood glucose levels and in response to this, the pancreas subsequently increases the amount of
insulin it produces.
Over time, exhaustion of the pancreas can occur leading to decreased insulin production and even greater levels of glucose in the bloodstream. Risk factors for Type 2 diabetes include, a family history of diabetes, obesity, poor diet and nutrition, physical inactivity, smoking, and increasing age.

5-10% of people with diabetes have type 1 diabetes

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4. Type 1 diabetes

Type 1 diabetes is caused by the body’s inability to produce insulin and is typically first diagnosed in children or adolescents.
Type 1 diabetes is an autoimmune disease where the body’s own immune system destroys the cells in the pancreas that are responsible for the production of insulin.
The exact reason for this autoimmune process is not known but may include risk factors such as genetic susceptibility and environmental triggers.

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5. How are glucose levels measured and interpreted?

CHECK YOUR BLOOD GLUCOSE LEVELS
Ensure that you check your blood glucose regularly as directed by your doctor, when
you are on any treatment, including Glucophage® XR, for your diabetes. If your
blood glucose measurements are very high or low, discuss these results with your
healthcare provider as your dosage or treatment regimen may need to be adjusted.

BLOOD TESTS USED TO MEASURE BLOOD GLUCOSE CONCENTRATIONS

What is HbA1c1,2?
The HbA1c test, also known as the haemoglobin A1c or glycated haemoglobin test, is an important blood test that gives a good indication of how well your diabetes is being controlled.
The HbA1c provides an indication of the avarage blood glucose over the past 2 to 3 months.
What is Fasting Plasma Glucose (FPG)?
The FPG measures a person’s blood glucose level after fasting or not eating anything for at least 8 hours.
Together with the HbA1c, the fasting plasma glucose test is one of the main ways in which type 2 diabetes is diagnosed.
What is Post Prandial Glucose (PPG)?
This test is done to see how your body responds after you eat a meal. As you digest the food in your stomach, blood glucose, or blood sugar, levels rise sharply. In response, your pancreas releases insulin to help move these sugars from the blood into the cells of muscles and other tissues to be used for fuel. Within two hours of eating, your insulin and blood glucose levels should return to normal.

Maintaining glucose levels to target levels may avoid serious health complications, such as, blindness, amputations, kidney failure, heart disease
and premature death.

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6. Blood Glucose and HbA1C Targets

Estimated average glucose levels in relation to HbA1c

HbA1c values greater than 7% increase your risk of serious diabetic complications

 

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7. HOW DO I AVOID THE QUICK PROGRESSION TO INSULIN?

 

 

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Exercise Tips

Both aerobic and resistance exercise have benefits for people with Type 2 diabetes.
People with Type 2 diabetes are encouraged to undertake 150 minutes of aerobic activities (cycling, brisk walking, jogging, swimming, gardening) spread throughout the week.

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Diet Tips

  • Choose water, unsweetened coffee or tea instead of fruit juice, soda or other sugar
    sweetened beverages
  • Choose nuts, fresh fruit, or unsweetened yoghurt as a snack
  • Limit alcohol intake to no more than two standard drinks per day
  • Choose whole-grain bread, brown rice, or whole-grain pasta instead of white bread, rice, or pasta
  • Choose lean cuts of white meat, poultry, or seafood
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8. How does Glucophage® XR work?

Mode of Action

The innovative GelShield Diffusion System™ ofGlucophage® XR provides prolonged release of Metformin

The Glucophage® XR tablets swell on hydration in the stomach and Metformin is released over an extended period of time

Gastric residence time is prolonged, allowing for a slower delivery of Metformin

Metformin is intended for adults with type 2 diabetes when diet and lifestyle modification does not keep blood glucose levels within target levels. Metformin works by increasing the uptake of glucose into cells and therefore reducing blood glucose levels. Only once glucose enters the cell can it be used for energy.
In addition to increasing glucose uptake, Metformin also prevents the production
of new glucose and delays the absorption of glucose from the intestine with the nett effect of reducing blood glucose levels.

Other formulations of Metformin need to be taken twice daily or even up to three times
a day when given at correct doses.

Merck, however, has specially developed Glucophage® XR with a novel tablet technology that allows the optimal dose of Metformin to be delivered in a once daily dose.

The GelShieldTM technology of Glucophage® XR delays the transit of the tablet through the stomach, enabling the release of Metformin over a longer period of time, and enabling a once a day dosing.

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9. How to take Glucophage® XR

Glucophage® XR 500 mg
The usual starting dose is one tablet daily taken with the evening meal.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastro-intestinal tolerability. The maximum recommended dosage is 4 tablets daily.

Dosage increases should be made in increments of 500 mg every 10 to 15 days, up to a maximum of 2000 mg once daily with an evening meal.

Glucophage® XR 1000 mg
Glucophage® XR 1000 mg is intended as maintenance therapy for patients already
treated with either 1000 mg (2 tablets of Glucophage® XR 500 mg) or 2000 mg
(4 tablets of Glucophage® XR 500 mg) of sustained release Metformin hydrochloride.

Switching patients already treated with Metformin tablets
In patients already treated with Metformin tablets, the starting dose of Glucophage® XR prolonged release tablets should be equivalent to the daily dose of Metformin
immediate release tablets.

Note
All medication should be taken as prescribed by your treating physician.

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10. INTERACTIONS

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 Glucophage® XR
accumulation and a risk of lactic acidosis.
Glucophage® XR 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.

Associations requiring precautions for use:

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, the dosage of the antidiabetic medicines should be adjusted
during therapy with the other medicine and upon its discontinuation.
ACE-inhibitors may decrease the blood glucose levels. If necessary, the dosage of the
antidiabetic medicine should be adjusted during therapy with the other medicine and
upon its discontinuation.
Cimetidine: Reduced renal clearance of Glucophage® XR has been reported during
cimetidine therapy, so a dose reduction should be considered.
Anticoagulants: Glucophage® XR has been reported to diminish the activity of
warfarin, and so dose adjustments and increased frequency of INR determinations
should be considered.
Sulphonylurea: Concomitant therapy of Glucophage® XR with sulphonylurea may
cause hypoglycaemia.
Vitamins: Long-term treatment with Glucophage® XR may cause vitamin B12
malabsorption in the gastro-intestinal tract, thus a dose reduction of Glucophage® XR
should be considered.

PREGNANCY AND LACTATION:
Speak to your Doctor if you are pregnant or breast feeding. The use of Glucophage® XR during pregnancy is not advised. There is no information available concerning the
safety of Glucophage® XR during lactation.

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11. Complications of Diabetes

If left untreated, diabetes can lead to serious health complications.
Diabetes is a leading cause of cardiovascular disease, blindness, kidney failure, and lower limb amputations 

Continuous elevations of blood glucose levels can cause damage to:

  • The heart
  • The blood vessels
  • The eyes
  • The kidneys
  • The nerves
  • And may lead to erectile dysfunction

Stroke

2 – 4 fold increase in cardiovascular events and stroke.

Diabetic Retinopathy

Leading cause of blindness in working-aged adults.

Cardiovascular Disease

Diabetes and impaired glucose tolerance increase cardivascular disease risk by 3 – 8 fold

Diabetic Nephropathy

Leading cause of end-stage renal disease.

Diabetic Neuropathy

Leading cause of non-traumatic lower extremity amputations.

 

NOTE: Maintaining blood glucose at target levels by implementing lifestyle modifications and taking all prescribed medications, may reduce the complications of diabetes

Medical References

  1. International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes
    Federation, 2017. 
  2. The Society for Endocrinology, Metabolism and Diabetes of South Africa, Type 2 Diabetes Guidelines
    Expert Committee. “Chapter 2: Definition and classification of diabetes mellitus” in 2017 SEMDSA Guideline for the
    Management of Type 2 Diabetes Guideline Committee. JEMDSA 2017; 21(1) (Supplement 1): S1-S196.
  3. International Diabetes Federation; 2019; 11November 2019; <https://idf.org/aboutdiabetes/type-2-diabetes.html>
  4. https://www.diabetes.co.uk/hba1c-test.html. 
  5. https://www.webmd.com/diabetes/guide/glycated-hemoglobin-test-hba1c
  6. https://www.webmd.com/diabetes/qa/what-is-the-fasting-plasma-glucose-fpg-test. 
  7. https://www.urmc.rochester.edu/encyclopedia/
    content.aspx?contenttypeid=167&contentid=glucose_two_hour_postprandial. 5. SEMDSA Type 2 Diabetes Guidelines Expert Committee JEMDSA 2017; 22(1)(Supplement 1): S1-S196
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