Product Training

Endocrinology

Formet XR
Dialiptin
Dimerol MR
Limpet 2
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What are Diabetes Mellitus?

Diabetes is a chronic (long-lasting) health condition that affects how your body turns food into energy.

Your body breaks down most of the food you eat into sugar (glucose) and releases it into your bloodstream.
When your blood sugar goes up, it signals your pancreas to release insulin. Insulin acts like a key to let the
blood sugar into your body’s cells for use as energy.

With diabetes, your body doesn’t make enough insulin or can’t use it as well as it should. When there isn’t
enough insulin or cells stop responding to insulin, too much blood sugar stays in your bloodstream. Over
time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease.
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Types of DM?
Type 1 Diabetes
Type 1 diabetes is thought to be caused by an autoimmune reaction (the body attacks itself by mistake). This
reaction stops your body from making insulin. Approximately 5-10% of the people who have diabetes have type
1. Symptoms of type 1 diabetes often develop quickly. It’s usually diagnosed in children, teens, and young
adults. If you have type 1 diabetes, you’ll need to take insulin every day to survive. Currently, no one knows how
to prevent type 1 diabetes.

Type 2 Diabetes
With type 2 diabetes, your body doesn’t use insulin well and can’t keep blood sugar at normal levels. About 90-
95% of people with diabetes have type 2. It develops over many years and is usually diagnosed in adults (but
more and more in children, teens, and young adults). You may not notice any symptoms, so it’s important to get
your blood sugar tested if you’re at risk. Type 2 diabetes can be prevented or delayed with healthy lifestyle
changes, such as: Losing weight. Eating healthy food. Being active.

Gestational Diabetes
Gestational diabetes develops in pregnant women who have never had diabetes. If you have gestational
diabetes, your baby could be at higher risk for health problems. Gestational diabetes usually goes away after
your baby is born. However, it increases your risk for type 2 diabetes later in life. Your baby is more likely to
have obesity as a child or teen and develop type 2 diabetes later in life.
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Classification of Antidiabetics

• Insulin
• Oral Antidiabetics
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Classification of Oral Antidiabetics

• Sulfonylureas (gliclazide, glimepiride, glipizide, glyburide)

• Meglitinides (nateglinide, repaglinide)
• Biguanides (metformin)
• Thiazolidinediones (pioglitazone, rosiglitazone)
• Alpha Glucosidase inhibitors (miglitol, voglibose, acarbose)
• Incretin enhancers ( vildagliptin)
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Classification of Oral Antidiabetics

• (1) the secretagogues (sulfonylureas, meglitinides), which increase

insulin availability;
• (2) the biguanides (metformin), which suppress excessive hepatic
glucose release;
• (3) the thiazolidinediones or glitazones (rosiglitazone, pioglitazone),
which improve insulin sensitivity; and
• (4) the α-glucosidase inhibitors (acarbose, miglitol), which delay GI
glucose absorption
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 Formet XR 850

 Composition : Metformin Hydrochloride extended release tablet

 Pack size : 5 x 10 tablets
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 Formet XR 850
 Indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary

management and exercise alone does not result in adequate glycemic control.
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 Formet XR 850

 Dosage and Administration

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or
chew.
• Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal.
Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once
daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal.

• Children: Metformin extended release tablet has not been studied in children

• Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73
m2. Asses risk/benefit of counting if eGFR falls below 45 L/min/1.73 m2.
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 Formet XR 850
 Side effects
Blood and lymphatic system disorders: Not known: Hemolytic anemia
Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a
decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a
patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12
deficiency have been reported in post-marketing experience (frequency not known)
Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy
Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea,
abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of
therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken
in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal
tolerability.
Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving
upon metformin discontinuation.
Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
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 Formet XR 850
 Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis.
• Severe renal failure (GFR <30 mL/min).
• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
• Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent
myocardial infarction, shock, Hepatic insufficiency, acute alcohol intoxication, alcoholism.
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 Formet XR 850

 Key messages/ Unique Selling Points

Increases peripheral insulin sensitivity

Does not increase basal or meal induced insulin secretion
Improves lipid profile of body by reducing hypertriglyceridemia.
Provides weight stabilization or reduction.
Reduces hepatic glucose production
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 Formet XR 850

 Focus Doctors

• Endocrinologists,
• Physicians,
• Cardiac,
• Neuro,
• GPs,
• Rheumatologists,
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 Dialiptin

 Composition : Vildagliptin INN 50mg

 Pack size : 2 x 10 tablets
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 Dialiptin

 Indications

For the treatment of type 2 diabetes mellitus (in combination with metformin or with a
sulphonylurea or with a thiazolidinedione
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 Dialiptin

 Dosage and Administration

Adult over 18 years: Vildagliptin administered in combination with metformin or a

thiazolidinedione, 50mg twice daily; in combination with a sulphonylurea, 50mg daily in the
morning. Or as directed by the registered physician.
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 Dialiptin
 Side effects
The most common side effects associated with Vildagliptin therapy include headache, tremor,
dizziness, nausea and asthenia.
Less commonly constipation, hypoglycemia.
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 Dialiptin
 Contraindications

It is contraindicated for patients with diabetic ketoacidosis, hepatic impairment, kidney dysfunction
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 Dialiptin

 Key messages/ Unique Selling Points

Rapidly absorbed & high bioavailability (85%) offer oral administration

Inhibits rapid degradation of endogenous GLP-1
Increases a-cell and -cell responsiveness to glucose, thereby improving
glycemic control in T2DM
Ensures lower risk of hypoglycemia and edema
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 Dialiptin

 Focus Doctors

• Endocrinologists,
• Physicians,
• Cardiac
• Neuro,
• GPs,
• Rheumatologists,
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 Limpet 2

 Composition : Glimepiride BP 2 mg
 Pack size : 5 x 10 tablets
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 Limpet 2

 Indications

Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with
noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by
diet and exercise alone. Glimepiride may be used concomitantly with metformin when diet, exercise,
and Glimepiride or metformin alone does not result in adequate glycemic control.

Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients
whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral
hypoglycemic agent. Combined use of Glimepiride and insulin may increase the potential for
hypoglycemia.
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 Limpet 2
 Dosage and Administration
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired
metabolic control.

The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also
serves to detect either primary or secondary failure of therapy.

Initial dose and dose titration : the usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar
monitoring, and should be gradual, i.e. at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg 2 mg 3 mg 4 mg 6 mg.

Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily. Distribution of doses: Timing and
distribution of doses are decided by the physician, in consideration of the patient\'s current life-style. Normally, a single daily dose is sufficient. This should be taken
immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment : As control of diabetes improves, sensitivity to insulin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To
avoid hypoglycemia, timely dose reduction or cessation of Glimepiride therapy must be considered.

A dose adjustment must also be considered whenever the patient\'s weight or life-style changes, or other factors arise which cause an increased susceptibility to hypo or
hyperglycemia.

Changeover from other oral anti-diabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When
substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering
agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration. Consideration must be given to the potency and duration of
action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycemia.
Administration: Glimepiride tablet must be swallowed with sufficient amount of liquid.
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 Limpet 2
 Side effects and Precautions
Hypoglycemia, temporary visual impairment, nausea, vomiting, diarrhea, abdominal pain, urticarial,
fall in blood pressure.

Precautions
In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates careful
monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride.
Hypoglycemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or
sugar).
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 Limpet 2
 Pregnancy & Lactation
Pregnancy : Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary.
Patients planning a pregnancy must inform their physician, and should changeover to insulin.

Lactation : Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore,
Glimepiride must not be taken by breast-feeding women. Either a changeover or a complete
discontinuation of breast-feeding is necessary.
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 Limpet 2

 Key messages/ Unique Selling Points

Rapidly absorbed & high bioavailability (85%) offer oral administration

Inhibits rapid degradation of endogenous GLP-1
Increases a-cell and -cell responsiveness to glucose, thereby improving
glycemic control in T2DM
Ensures lower risk of hypoglycemia and edema
 Product Training
 Limpet 2

 Focus Doctors

• Endocrinologists,
• Physicians,
• Cardiac
• Neuro,
• GPs,
• Rheumatologists,
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 Dimerol MR

 Composition : Miconazole base BP 2%w/w

 Pack size : 15gm per tube
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 Dimerol MR

 Indications
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 Dimerol MR

 Dosage and Administration

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 Dimerol MR
 Side effects
 Product Training
 Dimerol MR
 Contraindications
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 Dimerol MR

 Key messages/ Unique Selling Points

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 Dimerol MR

 Focus Doctors
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Thank you
&
Any Questions?