Diaglip

DIAGLIP 1 MG TABLET: Each tablet contains Glimepiride 1 mg.
DIAGLIP 2 MG TABLET: Each tablet contains Glimepiride 2 mg.
DIAGLIP 3 MG TABLET: Each tablet contains Glimepiride 3 mg.
DIAGLIP 4 MG TABLET: Each tablet contains Glimepiride 4 mg.

Pharmacology: Pharmacodynamics: Glimepiride is a hypoglycemic agent of the sulfonylurea class. Glimepiride stimulates insulin release from the pancreatic beta cells. Glimepiride increases sensitivity of peripheral tissues to insulin.
Pharmacokinetics: Glimepiride is well absorbed from the gastrointestinal tract and peak plasma concentrations occur in 2 to 3 hours after oral administration. Duration of action is 24 hours. Glimepiride absorption is affected by food. Protein binding was greater than 99.5%. Glimepiride is metabolized by CYP2C9 and changed to be active metabolites. Urine excretion is major route, and fecal excretion is minor route. The half-life elimination of Glimepiride is about 5 to 9 hours.

As an adjunct to diet and exercise in non-insulin-dependent (type II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone. Moreover Glimepiride can be used in combination with insulin or with metformin.

Recommended dose: Treatment with Glimepiride is recommended to be initiated and monitored by a doctor. The dosage of Glimepiride must be the lowest and the dosage will be adjusted to be sufficient to achieve the glycemic control.
Mode of administration: Glimepiride should be taken with breakfast (the first main meal). Do not skip a meal after taking Glimepiride. In case of a dose is forgotten, do not take extra medicine to make up for a missed dose.
Initial dosage and dosage titration: orally 1 mg once daily.
If necessary, the daily dose can be raised. It is recommended that the dose be increased gradually, i.e. at intervals of one to two weeks and according to the following dose steps: 1 mg, 2 mg, 3 mg, 4 mg, 6 mg (and in exceptional cases 8 mg). It is recommended that the increase be guided by regular blood sugar monitoring. And glycated haemoglobin (HbA1c) level should be measured periodically every 3-6 months.
Dose range in patients with well-controlled diabetes: orally 1-4 mg once daily.
Only some patients benefit from daily doses of more than 6 mg. The maximum recommended dosage of the drug is 8 mg daily. The dose must be increased gradually. Any increase should be gradual based on regular blood sugar monitoring. And glycated haemoglobin (HbA1c) level should be measured periodically every 3-6 months.
Use in combination with insulin: Whenever blood sugar levels cannot be controlled adequately with the maximum daily dose of glimepiride, insulin may be given concomitantly. In this case, the current dose of glimepiride remains unchanged. Insulin treatment is started at a low dose, which is subsequently increased stepwise according to the desired blood sugar level. Combined treatment should be initiated under close medical supervision.
Use in combination with metformin: Combination therapy with Glimepiride and metformin may be used in patients who do not respond adequately to the maximal dose of Glimepiride and metformin for each medical product. In order to obtain the desired control blood level, the concomitant Glimepiride and metformin therapy may be used. In this case, the dose of previous medicinal product remains unchanged. The another medicinal product dose is started at a low dose, which is subsequently increased stepwise according to the desired blood sugar level. Combined treatment should be taken under close medical supervision.
Changeover from other oral hypoglycemic agents to DIAGLIP: There is no exact dosage relationship between Glimepiride and other oral blood-sugar-lowering agents. The recommended starting dose is 1 mg Glimepiride per day. After that the desired control of blood glucose may be obtained by adjusting the dose. Carefully monitoring should be taken. Consideration for changeover to Glimepiride the potency and duration of action of the previous blood-sugar-lowering agent has to be taken in order to avoid the risk of hypoglycemia.
Secondary dosage adjustment: Long term Glimepiride uses and control of diabetes improves. Secondary dosage adjustment should be considered by a physician. Owing to the sensitivity of insulin increases and to avoid an excessive reduction in blood sugar (hypoglycemia) then properly dose reduction or cessation of DIAGLIP therapy must be considered.
Hepatic impairment and renal impairment: Because Glimepiride is eliminated by renal excretion following metabolism in the liver. Initial dosing of the drug in patients with renal or hepatic impairment should be conservative to avoid hypoglycemic reaction; adults initially should receive 1 mg of Glimepiride once daily. The dosage may be titrated upward based on fasting glucose concentration.

Overdosage and treatment: Glimepiride overdose may lead to severe and sometimes life-threatening hypoglycemia and may require hospitalization in some cases. Serious symptoms of the drug overdoses are medical emergencies. The patients must be admitted in the hospital suddenly. Mild episodes of hypoglycemia can be treated with oral carbohydrates. Adjustments in dosage, meal patterns or physical activity may be necessary. More severe episodes with coma, seizure or other serious neurologic impairment may be treated with glucagons (intramuscular or subcutaneous) or concentrated glucose solution (intravenous). If life-threatening amounts have been ingested, detoxification (by, e.g. gastric lavage, activated charcoal) will be necessary. Sustained administration of carbohydrates may be needed. Closely observation is necessary because hypoglycemia may recur after apparent clinical recovery.

Hypersensitivity to Glimepiride.
Hypersensitivity to sulfonylureas and sulfonamide derivatives.
Type I diabetes mellitus.
Diabetic ketoacidosis with or without coma.
Severe impairment of renal or hepatic function.
Pregnancy and lactation.

Warnings (based on the Ministry of Public Health's Announcement): 1. Glimepiride is contraindicated in patients with known hypersensitivity to this drug.
2. Glimepiride is contraindicated in Type I diabetes mellitus patients, diabetic ketoacidosis patients, severe infection patients, severe accident patients.
3. Avoid using this drug in pregnant women. And use this drug with caution in breast-feeding women.
4. The intake of alcoholic beverages should be avoided during treatment with Glimepiride tablets.
5. Use the drug with caution because hypoglycemic symptoms can occur such as hunger, palpitation, sweating.
6. If the following symptoms occur during using this drug e.g. skin rash, blisters, detachment of skin and epithelial lining in oral cavity, throat, nose, genital organ and conjunctivitis, stop using this drug and consult the doctor immediately as this may be Stevens-Johnson syndrome.
7. Use the drug with caution in patients with renal impairment.

Patients should be advised that they should not neglect dietary restrictions, or disregard instructions about exercise, body-weight control, hygiene including regular intake of drug and avoidance of infection alcohol ingestion, stress so that the blood sugar level was controlled properly.
The drug should not be discontinued without physician consultation.
Patients who take Glimepiride tablet may have manifestation symptoms as following: Hypoglycemia: possible symptoms of hypoglycemia e.g. headache, nausea, vomiting, ravenous hunger, lassitude, sleepiness, sweating, disordered sleep, restlessness, impaired concentration, aggressiveness, palpitation, confusion, depression, difficulty in speaking, visual disorder, tremor, paresis, cerebral convulsions, coma.
Hyperglycemia: possible symptoms of hyperglycemia e.g. intense thirst, increased urinary frequency, dryness of the mouth and dry skin, fever, sore throat, rash and irregular bleeding.
The doctor should be informed promptly about hypoglycemic and hyperglycemic episodes. In case of mild hypoglycemia can be controlled by immediate intake of sugar e.g. in the form of glucose or sugar cubes.
Patients should be monitored glucose concentration in plasma and urine regularly including glycated haemoglobin (HbA1c).

Studied in pregnant animals have revealed that Glimepiride might have adverse effects on the fetus and also the insufficient studies in pregnant women. To avoid risk of harm to the child, Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary.
It is not known if Glimepiride is excreted in breast milk. Therefore, this drug must not be taken by breast-feeding women due to there are the potential for hypoglycemia in the nursing infants.

Adverse reactions of Glimepiride must be considered: Hypoglycemia, especially in the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates especially careful monitoring. Factors favouring hypoglycemia include: Irregular intake of the dug, or overdosage with the drug, or concomitant administration of certain other medicines; Undernutrition, or irregular meal times, or alterations of diet; Severe or prolonged exercise; Consumption of alcohol, combination with skipped meal; Severe impairment of renal and/or hepatic function; Certain uncompensated disorders of the endocrine system affecting carbohydrate metabolism, for example, certain disorders of thyroid function and in anterior pituitary or adrenocortical insufficient.
Symptoms of hypoglycemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, alertness and reactions, depression, confusion, difficult in speaking and even speech loss, visual disorders, tremor, paresis, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and coma, shallow respiration and slow heart rate. In addition, signs may be present such as sweating, clammy skin, anxiety, rapid heart rate, hypertension, palpitations, angina pectoris, and cardiac arrhythmias. The clinical picture of a severe hypoglycemia may resemble that of a stroke. The symptoms of hypoglycemia nearly always subside when hypoglycemia is corrected.
Central Nervous System: drowsiness, nervousness, tremor, insomnia, depression, confusion, headache, fatigue, weakness, paresthesia, visual disorder, sensory disturbances.
Dermatologic: pruritus, urticaria, eczema.
Gastrointestinal: nausea, vomiting, sensation of pressure, fullness in the epigastrium, abdominal pain, diarrhea.
Hematologic: leucopenia, thrombocytopenia, hemolytic anemia.
Others: a decrease in serum sodium, hypersensitivity of skin to light, dyspnea, a fall in blood pressure, liver failure and sometimes progressing to shock.
If sudden or severe adverse reactions occur, inform a doctor immediately. The patient must be for under the supervision and suggestion of the doctor.

Concomitant use of Glimepiride and other sulfonylureas, the following interactions must be considered: Potentiation of the blood-sugar lowering effect and, thus, in some instances hypoglycemia may occur when one of the following medicines is taken, i.e. insulin, oral antidiabetic drugs, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamides, tetracyclines, tritoqualine, trofosfamide.
Weakening of the blood-sugar-lowering effect and, thus, raised blood sugar levels may occur when one of the following medicines is taken, i.e. acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) and other sympathomimetic agents, glucagon, laxatives, (after protracted use), nicotinic acid (in high doses), oestrogens 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 decrease glucose tolerance. In patient with diabetes mellitus, this may lead to deterioration of metabolic control. Beta-blockers may increase the tendency to hypoglycemia.

Store below 30°C.

Antidiabetic Agents

A10BB12 - glimepiride ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.

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