Glimepiride/metformin hydrochloride Side effects
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 Glimepiride/metformin hydrochloride.
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 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. 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, metformin, other sulfonylureas, other sulfonamides or any of the excipients of Glimepiride/metformin hydrochloride.
Glimepiride: No experience has been gained concerning the use of glimepiride 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: Glimepiride 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 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.
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Information checked by Dr. Sachin Kumar, MD Pharmacology