Type 2 diabetes mellitus when diet, exercise and the single agent (Glimepiride (Zoryl-M)/Metformin (Zoryl-M)) do not result in adequate glycaemic control.
Each tablet contains Glimepiride (Zoryl-M) 2 mg and Metformin (Zoryl-M) 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 Zoryl-M is governed by the desired blood glucose level. The starting dose of Zoryl-M is 1 tab once a day before or with breakfast or first main meal. The dosage of Zoryl-M must be the lowest which is sufficient to achieve the desired metabolic control.
During treatment with Zoryl-M, 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 (Zoryl-M) requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Zoryl-M therapy must therefore be considered.
The highest recommended dose per day should be Glimepiride (Zoryl-M) 8 mg and Metformin (Zoryl-M) 2000 mg.
Daily doses of Glimepiride (Zoryl-M) of >6 mg are more effective only in a minority of patients.
In order to avoid hypoglycaemia, the starting dose of Zoryl-M should not exceed the daily doses of Glimepiride (Zoryl-M) or Metformin (Zoryl-M) already being taken.
When switching from combination therapy of Glimepiride (Zoryl-M) plus Metformin (Zoryl-M) as separate tablets, Zoryl-M 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 Zoryl-M is normally a long-term therapy.
Administration: Zoryl-M should be administered once per day during breakfast or at the first main meal. Due to the sustained-release formulation, Zoryl-M must be swallowed whole and not crushed or chewed.
Cimetidine: Metformin (Zoryl-M) interacts with cimetidine. Therefore, the dose of Metformin (Zoryl-M) 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 (Zoryl-M), and in such cases, the glycemic control should be closely monitored.
Alcohol: Alcohol potentiates the action of Metformin (Zoryl-M) on lactate metabolism as well as the antihyperglycemic effect. Hence, patients treated with Metformin (Zoryl-M) 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 (Zoryl-M) levels. However, no such changes were found with propranolol and ibuprofen.
The absorption of Metformin (Zoryl-M) may be reduced by acarbose and guar gum. Hypoglycemia due to interaction with Glimepiride (Zoryl-M) 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 (Zoryl-M) 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 (Zoryl-M) 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 (Zoryl-M).
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 Zoryl-M.
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 (Zoryl-M) 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 (Zoryl-M) 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 (Zoryl-M) therapy resolving upon discontinuation of Metformin (Zoryl-M).
Endocrine Effects: Hypoglycemia may occur when Metformin (Zoryl-M) 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 (Zoryl-M) 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 (Zoryl-M). 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 (Zoryl-M), Metformin (Zoryl-M), other sulfonylureas, other sulfonamides or any of the excipients of Zoryl-M.
Glimepiride (Zoryl-M): No experience has been gained concerning the use of Glimepiride (Zoryl-M) 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 (Zoryl-M): 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 (Zoryl-M): Glimepiride (Zoryl-M) 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 (Zoryl-M) must not be taken by breastfeeding women. If necessary, the patient must changeover to insulin or must stop breastfeeding.
Metformin (Zoryl-M): 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 (Zoryl-M) 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 (Zoryl-M) 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 (Zoryl-M), taking into account the importance of the compound to the mother.
Glimepiride/metformin hydrochloride in India.
|Unit description / dosage (Manufacturer)||Price, USD|
|Zoryl-M Glimepiride 2 mg, Metformin500 mg. TAB / 10||$ 0.79|
|Zoryl-M Metformin 500 mg, Glimepiride1 mg TAB / 10||$ 1.26|
|ZORYL-M 2 TABLET 1 strip / 15 tablets each (Intas Pharmaceuticals Ltd)||$ 2.22|
|ZORYL-M tab 15's (Intas)||$ 1.87|
|ZORYL-M film-coated tab 15's (Intas)||$ 1.34|
|ZORYL-M tab 10's (Intas)||$ 1.89|
List of Zoryl-M substitutes (brand and generic names):
|ZORGLIM M 2MG TABLET 1 strip / 10 tablets each (Instanz Life Sciences Pvt Ltd)||$ 1.10|
|Zorglim M 2mg/500mg Tablet (Instanz Life Sciences Pvt Ltd)||$ 0.11|
|Zoryl M Capsule/ Tablet / 1mg-500mg / 10 units (Intas Laboratories Pvt Ltd)||$ 0.71|
|Zoryl M Capsule/ Tablet / 2mg-500mg / 10 units (Intas Laboratories Pvt Ltd)||$ 0.97|
|Zoryl M Glimepiride 2mg, Metformin500mg TAB / 10 (Intas Laboratories Pvt Ltd)||$ 0.79|
|Zoryl M Glimepiride 1mg, Metformin500mg TAB / 10 (Intas Laboratories Pvt Ltd)||$ 0.56|
|10's (Intas Laboratories Pvt Ltd)||$ 0.56|
|Zoryl M 2+500 Tablet (Intas Laboratories Pvt Ltd)||$ 0.10|
|Zoryl M 1+500 Tablet (Intas Laboratories Pvt Ltd)||$ 0.08|
|ZORYL M 0.5 MG/500 MG TABLET 1 strip / 15 tablets each (Intas Laboratories Pvt Ltd)||$ 0.59|
|ZORYL M 1 MG/500 MG TABLET SR 1 strip / 15 tablet srs each (Intas Laboratories Pvt Ltd)||$ 1.59|
|ZORYL M - 2 FORTE TABLET 1 strip / 10 tablets each (Intas Laboratories Pvt Ltd)||$ 1.44|
|ZORYL M 3 MG/500 MG TABLET SR 1 strip / 10 tablet srs each (Intas Laboratories Pvt Ltd)||$ 1.68|
|ZORYL M 4 MG/500 MG TABLET SR 1 strip / 10 tablet srs each (Intas Laboratories Pvt Ltd)||$ 2.24|
|ZORYL M FORTE 1 MG/1000 MG TABLET 1 strip / 10 tablets each (Intas Laboratories Pvt Ltd)||$ 1.07|
|ZORYL M FORTE 3 MG/1000 MG TABLET 1 strip / 10 tablets each (Intas Laboratories Pvt Ltd)||$ 1.65|
|ZORYL M FORTE 4 MG/1000 MG TABLET 1 strip / 10 tablets each (Intas Laboratories Pvt Ltd)||$ 2.07|
|Zoryl M 0.5 Tablet (Intas Laboratories Pvt Ltd)||$ 0.04|
|Zoryl M 1 Forte Tablet SR (Intas Laboratories Pvt Ltd)||$ 0.12|
|Zoryl M 1 Tablet ER (Intas Laboratories Pvt Ltd)||$ 0.12|
|Zoryl M 2 Tablet ER (Intas Laboratories Pvt Ltd)||$ 0.16|
|Zoryl M 3 Forte Tablet SR (Intas Laboratories Pvt Ltd)||$ 0.18|
|Zoryl M 3mg/500mg Tablet SR (Intas Laboratories Pvt Ltd)||$ 0.18|
|Zoryl M 4 Forte Tablet SR (Intas Laboratories Pvt Ltd)||$ 0.21|
|Zoryl-M Forte (India)|
|Zoryl-M Forte Glimepiride 1 mg, Metformin 1g. TAB / 10 (Intas)||$ 0.72|
|Zoryl-M Forte Glimepiride 2 mg, Metformin 1g. TAB / 10 (Intas)||$ 0.97|
|ZORYL-M FORTE tab 10's (Intas)||$ 1.90|
|Zoryl-M4 Tablet SR|
|Zoryl-M4 Tablet SR (Intas Pharmaceuticals Ltd)||$ 0.22|
|ZORYL-MF 2 MG/850 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd)||$ 1.06|
|Zoryl-MP Glimepiride 2 mg, pioglitazone15 mg, metformin hydrochloride/ ER 500 mg. Bilayered MR-TAB / 10 (Intas)||$ 1.38|
|ZORYL-MP bilayer coated tab 10's (Intas)||$ 1.38|
|ZORYL-MP bilayer coated tab 15's (Intas)||$ 1.91|
|ZULIP-G tab 10's (Corazon)||$ 0.75|
|ZYROMET G1 TABLET 1 strip / 10 tablets each (Aagam Life Sciences Pvt Ltd)||$ 0.68|
|Zyromet G 1 Tablet (Aagam Life Sciences Pvt Ltd)||$ 0.07|
|ZYROMET G 2 TABLET|
|ZYROMET G 2 TABLET 1 strip / 10 tablets each (Aagam Life Sciences Pvt Ltd)||$ 0.95|
|Zyvana M 1 Tablet SR (Converge Biotech)||$ 0.08|
|Zyvana M 2mg/400mg Tablet (Converge Biotech)||$ 0.09|
|Zyvana M Forte 1mg/1000mg Tablet (Converge Biotech)||$ 0.10|
|Zyvana M Forte 2mg/1000mg Tablet (Converge Biotech)||$ 0.12|
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Information checked by Dr. Sachin Kumar, MD Pharmacology