Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who have inadequate glycemic control with metformin or Glimepiride (Diaswich-M1) monotherapy or already treated with a combination of metformin and a sulfonylurea as separate tablets.
To maintain the efficacy of drug therapy, management of type 2 diabetes mellitus should also include nutritional counseling, appropriate exercise and weight reduction if obese or overweight. Secondary causes of poor glycemic control (eg, infection) should be investigated and treated prior to initiation or escalation of oral antidiabetic therapy.
Each tablet contains Glimepiride (Diaswich-M1) 2 mg and metformin HCl (in sustained-release form) 500 mg.
It also contains the following excipients: Hypromellose, sodium carboxymethyl cellulose, methacrylic acid copolymer dispersion, macrogol, povidone, magnesium stearate, purified water, sodium starch glycolate, lactose, titanium dioxide, microcrystalline cellulose, magnesium stearate and pregelatinized starch. Colors: Yellow ferric oxide and titanium dioxide.
In principle, the dosage of Diaswich-M1 is governed by the desired blood glucose level. The starting dose of Diaswich-M1 is 1 tab once a day before or with breakfast or first main meal. The dosage of Diaswich-M1 must be the lowest which is sufficient to achieve the desired metabolic control.
During treatment with Diaswich-M1, glucose levels in blood and urine must be measured regularly. In addition, it is recommended that regular determinations of the proportion of glycated haemoglobin be carried out.
Mistakes eg, forgetting to take a dose, must never be corrected by subsequently taking a larger dose.
Measures for dealing with such mistakes (in particular, forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between physician and patient beforehand.
As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, Glimepiride (Diaswich-M1) requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Diaswich-M1 therapy must therefore be considered.
The highest recommended dose per day should be Glimepiride (Diaswich-M1) 8 mg and metformin 2000 mg.
Daily doses of Glimepiride (Diaswich-M1) of >6 mg are more effective only in a minority of patients.
In order to avoid hypoglycaemia, the starting dose of Diaswich-M1 should not exceed the daily doses of Glimepiride (Diaswich-M1) or metformin already being taken.
When switching from combination therapy of Glimepiride (Diaswich-M1) plus metformin as separate tablets, Diaswich-M1 should be administered on the basis of dosage currently being taken.
Titration: The daily dose should be titrated in increments of 1 tab only, corresponding to the lowest strength (in case various strengths are available).
Duration of Treatment: Treatment with Diaswich-M1 is normally a long-term therapy.
Administration: Diaswich-M1 should be administered once per day during breakfast or at the first main meal. Due to the sustained-release formulation, Diaswich-M1 must be swallowed whole and not crushed or chewed.
Cimetidine: Metformin interacts with cimetidine. Therefore, the dose of metformin should be reduced if cimetidine is co-prescribed.
Hyperglycemic Agents: Drugs with hyperglycemic potential (eg, thiazides, corticosteroids and others) may partly offset the antihyperglycemic action of metformin, and in such cases, the glycemic control should be closely monitored.
Alcohol: Alcohol potentiates the action of metformin on lactate metabolism as well as the antihyperglycemic effect. Hence, patients treated with metformin should preferably avoid alcohol and alcoholism is a definite contraindication.
Other Interactions: Studies with furosemide and nifedipine suggest a possible interaction by increasing plasma metformin levels. However, no such changes were found with propranolol and ibuprofen.
The absorption of metformin may be reduced by acarbose and guar gum. Hypoglycemia due to interaction with Glimepiride (Diaswich-M1) may occur when one of the following medicines is taken eg, insulin and other oral antidiabetics, angiotensin-converting enzymes (ACE) inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, isofamide, monoamine oxidase (MAO) inhibitors, miconazole, para-aminosalicylic acid, pentoxifylline (high-dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines, tritoqualine, trofosfamide. Hyperglycemia due to interaction with Glimepiride (Diaswich-M1) may occur when one of the following medicines is taken eg, acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagons, laxatives (after protracted use), nicotinic acid (in high doses), estrogens and progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones. H2-receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood sugar-lowering effect. Beta-blockers may increase the tendency to hypoglycemia.
The effect of coumarin derivatives may be potentiated or weakened.
Metformin may provoke or augment lactic acidosis particularly if it is present in high concentrations in the blood. Some of the symptoms of lactic acidosis may mimic certain adverse effects of metformin.
Physicians should instruct their patients to recognize the onset of symptoms of lactic acidosis to avoid this adverse reaction.
There is a great potential risk for hypoglycemia to occur due to the sulfonylurea component of Diaswich-M1.
Possible symptoms include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impaired alertness and reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence, and loss of consciousness up to and including coma, shallow respiration and bradycardia.
Reported Adverse Events to Metformin are as Follows: Gastrointestinal: Adverse effects appear to be dose-related and include diarrhea, nausea, vomiting, abdominal discomfort (eg, abdominal cramps or pain), abnormal stools, constipation, abdominal distention, dyspepsia, epigastric discomfort, flatulence, viral gastroenteritis, taste disturbance specifically metallic taste in the mouth, toothache, tooth abscess. Most of these reactions are transient and can be controlled by taking metformin with meals or by a temporary reduction in dosage.
Body as a Whole: Chills, flu syndrome, fatigue, lethargy, asthenia, accidental injury, headache, infection
Cardiovascular: Chest discomfort/pain, hypertension, palpitations
Hematologic: Vitamin B12 and folate malabsorption, thrombocytopenia, neutropenia and rare reports of megaloblastic anemia
Hepatic: Severe acute hepatitis associated with liver function tests abnormalities and cholestasis have been associated with long-term metformin therapy resolving upon discontinuation of metformin.
Endocrine Effects: Hypoglycemia may occur when metformin is given concomitantly with sulfonylureas and/or alcohol; hyperglycemia (NOS) and sexual dysfunction.
Musculoskeletal: Asthenia, muscle cramp, muscle strain, myalgia, pain in limb.
Nervous System: Agitation, dizziness, migraine, paresthesia, syncope, sinus headache, hypoesthesia, lightheadedness, tremor.
Respiratory: Dyspnea, flu syndrome, nasal congestion, sinus congestion, rhinorrhea, rhinitis, tonsillitis, upper respiratory infection.
Skin and Appendages: Rash, erythema, pruritus, urticaria, increased sweating, contusion.
Others: Pneumonitis with vasculitis, aggravated edema, peripheral edema, ear pain, blurred vision, fungal infection, flushing, nail disorder and seasonal allergy.
The profile of adverse reactions in pediatric patients is similar to those observed in adults.
Laboratory Findings: Decreased blood glucose, abnormal liver function tests and increased white blood cell count.
Reported Adverse Events to Glimepiride (Diaswich-M1) are as Follows: Metabolic-Nutritional: Hypoglycemia, hyperglycemia, hyponatremia, increased appetite, dyspepsia, anorexia.
Gastrointestinal (GI): Diarrhea, nausea, vomiting, abdominal discomfort, abdominal distention, sensation of fullness.
Cardiovascular: Hypertension, tachycardia, bradycardia, palpitations, angina pectoris, cardiac arrhythmias, vasodilation.
Hematologic: Hemolytic and aplastic anemia, leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, pancytopenia due to myelosuppression, eosinophilia, erythrocytopenia, granulocytopenia.
Central Nervous System: Disulfiram-like reactions, headache, dizziness, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, alertness and reaction time, depression, confusion, aphasia, tremor, paresis, sensory disturbance, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma.
Hepatobiliary: Cholestasis, jaundice, abnormal liver function, hepatitis which may lead to liver failure or hepatic dysfunction, hepatic porphyria reactions, increased liver enzyme levels, granulomatous hepatitis, bilirubinemia.
Skin and Subcutaneous Tissue Disorders: Allergic or pseudo-allergic skin reactions (eg, pruritus, erythema, urticaria, vasculitis, and morbilliform or maculopapular eruptions). Such mild reactions may develop into serious reactions with dyspnea and hypotension, sometimes progressing to shock. These may be transient and may disappear despite continued use of Glimepiride (Diaswich-M1). If skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions and clammy skin were also observed.
Miscellaneous: Asthenia, allergic vasculitis, sweating, impaired speech disorder, visual disturbance/abnormal vision, dyspnea, increased urinary frequency.
Patients hypersensitive to Glimepiride (Diaswich-M1), metformin, other sulfonylureas, other sulfonamides or any of the excipients of Diaswich-M1.
Glimepiride (Diaswich-M1): No experience has been gained concerning the use of Glimepiride (Diaswich-M1) in patients with severe impairment of liver function and in dialysis patients. In patients with severe impairment of hepatic function, changeover to insulin is indicated, not least to achieve optimal metabolic control.
Metformin: Diabetic ketoacidosis, diabetic pre-coma.
Renal failure or renal dysfunction (eg, serum creatinine levels >135 micromol/L in males and >110 micromol/L in females).
Acute conditions with the potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents.
Acute or chronic disease which may cause tissue hypoxia eg, cardiac or respiratory failure, recent myocardial infarction, shock.
Hepatic insufficiency; acute alcohol intoxication, alcoholism.
Use in pregnancy & lactation: Glimepiride (Diaswich-M1): Glimepiride (Diaswich-M1) must not be taken during pregnancy. Otherwise, there is risk of harm to the child. The patient must changeover to insulin during pregnancy.
Patients planning a pregnancy must inform their physician. It is recommended that such patients changeover to insulin.
To prevent possible ingestion with the breast milk and possible harm to the child, Glimepiride (Diaswich-M1) must not be taken by breastfeeding women. If necessary, the patient must changeover to insulin or must stop breastfeeding.
Metformin: To date, no relevant epidemiological data are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fetal development, parturition or postnatal development.
When the patient plans to become pregnant and during pregnancy, diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of fetal malformations associated with abnormal blood glucose levels.
Metformin is excreted into milk in lactating rats. Similar data are not available in humans and a decision should be made whether to discontinue nursing or to discontinue metformin, taking into account the importance of the compound to the mother.
Glimepiride/metformin hydrochloride in India.
|Unit description / dosage (Manufacturer)||Price, USD|
|Diaswich-M1 Glimepiride 1 mg, Metforminhydrochloride 500 mg. TAB / 10||$ 0.43|
|DIASWICH-M1 tab 10's (Jagsonpal)||$ 0.43|
|Diaswich-M1 Glimepiride 1 mg, Metforminhydrochloride 500 mg. TAB / 10||$ 0.43|
List of Diaswich-M1 substitutes (brand and generic names):
|Diaset-M SR (India)|
|DIASET-M SR tab 10's (Stadmed)||$ 0.87|
|Diaswich-M2 Glimepiride 2 mg, Metforminhydrochloride 500 mg. TAB / 10 (Jagsonpal)||$ 0.70|
|10's (Jagsonpal)||$ 0.70|
|DIASWICH-M2 tab 10's (Jagsonpal)||$ 0.70|
|Diazero-M Glimepiride 2mg, Metformin/ SR500mg TAB / 10 (Minova)||$ 0.79|
|10's (Minova)||$ 0.79|
|DIAZERO-M tab 10's (Minova)||$ 0.79|
|Diazero-PM Glimepiride 2 mg, Metformin/ SR 500 mg, Pioglitazone 15mg. TAB / 10 (Minova)||$ 1.04|
|10's (Minova)||$ 1.04|
|DIAZERO-PM tab 10's (Minova)||$ 1.19|
|DIOR-G tab 10's (Sain)||$ 0.78|
|10's (Daksh)||$ 0.59|
|Dipride-M Glimepiride 2mg, Metformin/ ER 500mg TAB / 10 (Daksh)||$ 0.59|
|DIPRIDE-M tab 10's (Daksh)||$ 0.59|
|Dipride-M Glimepiride 2mg, Metformin/ ER 500mg TAB / 10 (Daksh)||$ 0.59|
|Dipride-M Plus (India)|
|Dipride-M Plus Glimepiride 2mg, Metformin500mg TAB / 10 (Daksh)||$ 0.65|
|10's (Daksh)||$ 0.65|
|DIPRIDE-M PLUS tab 10's (Daksh)||$ 0.71|
|Dymeryl M (South Korea)|
|EASYAID 1 MG/1000 MG TABLET 1 strip / 10 tablets each (AN Pharmaceuticals Pvt Ltd)||$ 1.33|
|EASYAID 2 MG/1000 MG TABLET 1 strip / 10 tablets each (AN Pharmaceuticals Pvt Ltd)||$ 2.16|
|EASYAID 3 MG/1000 MG TABLET 1 strip / 10 tablets each (AN Pharmaceuticals Pvt Ltd)||$ 2.87|
|Easyaid -2 Tablet (AN Pharmaceuticals Pvt Ltd)||$ 0.22|
|Easyaid 3 mg/1000 mg Tablet (AN Pharmaceuticals Pvt Ltd)||$ 0.29|
|ECOPRIDE-FM tab 10's (CE-Biotec)||$ 1.19|
|ECOPRIDE-M tab 10's (CE-Biotec)||$ 0.71|
|Efinex Met (El Salvador, Guatemala, Honduras, Nicaragua)|
|EMPERIDE M 1 MG/500 MG TABLET 1 strip / 10 tablets each (Emcure Pharmaceuticals Ltd)||$ 0.68|
|Endial Met (Argentina)|
|ENDOFORMIN G 1 MG/500 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 0.86|
|ENDOFORMIN G 2 MG/500 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 1.27|
|Endoformin G 1mg/500mg Tablet (Precia Pharma)||$ 0.09|
|Endoformin G 2mg/500mg Tablet (Precia Pharma)||$ 0.14|
|ENDOFORMIN G FORTE|
|ENDOFORMIN G FORTE 1 MG/1000 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 1.03|
|ENDOFORMIN G FORTE 2 MG/1000 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 1.03|
|ENDOFORMIN G FORTE 3 MG/1000 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 1.16|
|ENDOFORMIN G FORTE 4 MG/1000 MG TABLET 1 strip / 10 tablets each (Precia Pharma)||$ 1.16|
|Endoformin G Forte 1mg/1000mg Tablet (Precia Pharma)||$ 0.11|
|Endoformin G Forte 2mg/1000mg Tablet (Precia Pharma)||$ 0.11|
|Endoformin G Forte 3mg/1000mg Tablet (Precia Pharma)||$ 0.12|
|Endoformin G Forte 4mg/1000mg Tablet (Precia Pharma)||$ 0.12|
|ENRISTAS MF 2MG TABLET 1 strip / 10 tablets each (Anthem Biopharma)||$ 1.51|
|> 3 month||1||100.0%|
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Information checked by Dr. Sachin Kumar, MD Pharmacology