Gm Uses

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Gm indications

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Type 2 diabetes mellitus when diet, exercise and the single agent (Glimepiride (Gm)/Metformin (Gm)) do not result in adequate glycaemic control.

Gm description

Each tablet contains Glimepiride (Gm) 2 mg and Metformin (Gm) 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.

Gm dosage

In principle, the dosage of Gm is governed by the desired blood glucose level. The starting dose of Gm is 1 tab once a day before or with breakfast or first main meal. The dosage of Gm must be the lowest which is sufficient to achieve the desired metabolic control.

During treatment with Gm, 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 (Gm) requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Gm therapy must therefore be considered.

The highest recommended dose per day should be Glimepiride (Gm) 8 mg and Metformin (Gm) 2000 mg.

Daily doses of Glimepiride (Gm) of >6 mg are more effective only in a minority of patients.

In order to avoid hypoglycaemia, the starting dose of Gm should not exceed the daily doses of Glimepiride (Gm) or Metformin (Gm) already being taken.

When switching from combination therapy of Glimepiride (Gm) plus Metformin (Gm) as separate tablets, Gm 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 Gm is normally a long-term therapy.

Administration: Gm should be administered once per day during breakfast or at the first main meal. Due to the sustained-release formulation, Gm must be swallowed whole and not crushed or chewed.

Gm interactions

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The hypoglycaemic action of sulphonylurea drugs may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs that are highly protein bound. These include drugs eg, insulin and other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarins, cyclophosphamide, disopyramide, fenfluramine, fibrates, fluoxetine, guanethidine, iphosphamide, β-blockers, MAO inhibitors, miconazole, para-amino salicylic acid, pentoxifylline, (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulphonamides, tetracyclines, tritoqualine, trofosfamide.

Weakening of the blood sugar lowering effect and, thus, raised blood sugar levels may occur when one of the following medicines are taken concomitantly, eg, acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, adrenaline and other sympathomimetic agents, glucagon, laxatives (after protracted use), nicotinic acid (in high doses), oestrogen and progestogen, phenothiazines, phenytoin, rifampicin, thyroid hormones.

H2 receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood sugar lowering effect.

Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) which are eliminated by renal tubular secretion could have the potential for interaction with Metformin (Gm) by competing for common renal tubular transport systems.

Concomitant cimetidine leads to 60% increase in peak Metformin (Gm) plasma and whole blood concentrations.

Furosemide increased the Metformin (Gm) plasma and blood Cmax without altering Metformin (Gm) renal clearance in a single dose study. Nifedipine was reported to cause increases in plasma Metformin (Gm) Cmax and AUC.

Incompatibilities: None reported.

Gm side effects

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Metformin (Gm) 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 (Gm).

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 Gm.

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 (Gm) 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 (Gm) 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 (Gm) therapy resolving upon discontinuation of Metformin (Gm).

Endocrine Effects: Hypoglycemia may occur when Metformin (Gm) 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 (Gm) 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 (Gm). 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.

Gm contraindications

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Hypersensitivity to Metformin (Gm) HCl, Glimepiride (Gm), sulfonylureas, other sulfonamides or any of the excipients of Gm (risk of hypersensitivity reactions).

Gm is not suitable for the treatment of diabetes mellitus type 1 (eg, for the treatment of diabetics with a history of ketoacidosis) or of diabetic precoma or coma.

Impaired renal function; acute complications (severe infections, major operations and trauma); before x-ray examinations with iodinated contrast materials; liver damage; alcoholism; deficiencies of vitamin B12, folic acid and iron; ketosis-prone diabetes; severe cardiovascular or respiratory disease; general ill health (malnutrition, dehydration); diabetes with significant late complications (nephropathy, retinopathy).

Use in pregnancy: Pregnancy is generally regarded as a contraindication and insulin should be used in all pregnant diabetic women.

Active ingredient matches for Gm:

Glimepiride/Metformin

Glimepiride/metformin hydrochloride in India.


Unit description / dosage (Manufacturer)Price, USD
GM Glimepiride 2 mg, Metforminhydrochloride 500 mg. TAB / 10$ 0.48
10's$ 0.48
GM tab 10's (Beulah)$ 0.48

List of Gm substitutes (brand and generic names):

Glytab M 2 mg/500 mg Tablet (Elder Pharmaceuticals Ltd)$ 0.08
GM-SR Metformin hydrochloride 500mg, Glimepiride 1 mg. TAB / 10
GM-SR Metformin hydrochloride 500mg, Glimepiride 2 mg TAB / 10
10's
Gmac M 1mg/500mg Tablet (Macsys LifeSciences)$ 0.03
Gmac M 2mg/500mg Tablet (Macsys LifeSciences)$ 0.04
GMP M -1 TABLET 1 strip / 10 tablets each (Aretaeus Pharmaceuticals)$ 0.48
GMP M -2 TABLET 1 strip / 10 tablets each (Aretaeus Pharmaceuticals)$ 0.56
Gmp M 2 Tablet (Aretaeus Pharmaceuticals)$ 0.06
GMR M FORTE TABLET 1 strip / 10 tablets each (Signova Pharma Pvt Ltd)$ 0.83
GMR-M FORTE tab 10's (Signova)$ 0.87
GMR-M1 Glimepiride 1mg, Metformin/ SR 500mg TAB / 10 (Signova)$ 0.47
10's (Signova)$ 0.47
GMR-M1 tab 10's (Signova)$ 0.46
GMR-M2 Glimepiride 2mg, Metformin/ SR 500mg TAB / 10 (Signova)$ 0.65
10's (Signova)$ 0.65
GMR-M2 tab 10's (Signova)$ 0.54
GMT 1 MG/500 MG TABLET SR 1 strip / 10 tablet srs each (Indoco Remedies Ltd)$ 0.77
GMT 2 MG/500 MG TABLET SR 1 strip / 10 tablet srs each (Indoco Remedies Ltd)$ 1.20
Gmt 2 mg/500 mg Tablet SR (Indoco Remedies Ltd)$ 0.12
GMT-SR Capsule/ Tablet / 1mg-500mg / 10 units (Indoco Remedies)$ 0.42
GMT-SR Capsule/ Tablet / 2mg-500mg / 10 units (Indoco Remedies)$ 0.83
10's$ 0.75
GMT-SR Glimepiride 1mg, Metformin HCl500mg FC- TAB / 10$ 0.51
GMT-SR Glimepiride 2mg, MetforminHCl500mg FC- TAB / 10$ 0.75
GRID M 1 MG/500 MG TABLET 1 strip / 10 tablets each (Deys Medical)$ 0.48
GRID M 2 MG/500 MG TABLET 1 strip / 10 tablets each (Deys Medical)$ 0.54
Grid M 2 mg/500 mg Tablet (Deys Medical)$ 0.06
10's (East West)$ 0.50
Gride-M Glimepiride 1mg, Metformin/ SR 500mg TAB / 10 (East West)$ 0.50
GRIDE-M tab 10's (East West)$ 0.50
Gride-M Glimepiride 1mg, Metformin/ SR 500mg TAB / 10 (East West)$ 0.50
Gride-M Forte Glimepiride 2mg, Metformin/ SR 500mg TAB / 10 (East West)$ 0.75
10's (East West)$ 0.75
GRIDE-M FORTE tab 10's (East West)$ 0.75
HHGLIM M1 TABLET 1 strip / 15 tablets each (Hegde and Hegde Pharmaceutical LLP)$ 0.72
HHGLIM M2 TABLET 1 strip / 15 tablets each (Hegde and Hegde Pharmaceutical LLP)$ 0.84
Hhglim M2 Tablet (Hegde and Hegde Pharmaceutical LLP)$ 0.06
HILMET GM TABLET 1 MG/500 MG 1 strip / 10 tablets each (Heal All Pharmaceuticals (P) Ltd.)$ 0.47
HILMET GM TABLET 2 MG/500 MG 1 strip / 10 tablets each (Heal All Pharmaceuticals (P) Ltd.)$ 0.57

References

  1. DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "metformin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "glimepiride". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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