Amarax 2

Glimepiride.

Amarax 2 contains Glimepiride 2 mg/tablet.

Pharmacology: Pharmacodynamics: Glimepiride is a blood-sugar-lowering agent belonging to the sulfonylurea group. The decrease in blood sugar is achieved principally by means of the stimulation of insulin release from pancreatic beta cells. This effect is predominantly based on improved responsiveness of these cells to the physiological glucose stimulus. Glimepiride augments the normal action of insulin on peripheral glucose uptake. Moreover, it mimics such action as well as the glucose output of the liver.
In patients with insufficient response to the maximum dose, combine use with an additional oral antidiabetic containing metformin or with insulin.
Pharmacokinetics: Glimepiride is completely absorbed from the gastrointestinal tract. Peak plasma concentrations occur in 2 to 3 hours, and it is highly protein bound. The drug is extensively metabolized to two main metabolites, a hydroxy derivative and a carboxy derivative. The half-life after multiple doses is about 9 hours. Approximately 60% of a dose is eliminated in the urine and 40% in the faeces.

Management of type 2 diabetes mellitus (noninsulin dependent, NIDDM) as an adjunct to diet and exercise to lower blood glucose; may be used in combination with metformin or insulin in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with a single oral hypoglycemic agent.

Initial: 1-2 mg once daily, administered with breakfast or the first main meal.
Maintenance dose: 1-4 mg once daily; after a dose of 2 mg once daily, increase in increments of 2 mg at 1 to 2 week intervals based upon the patient's blood glucose response to a maximum of 8 mg once daily. If inadequate response to maximum dose, combination with metformin may be considered.
Combination with insulin therapy: Initial dose is 8 mg once daily with the first main meal or as prescribed by the physician.
Change over from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between glimepiride and other blood-sugar-lowering agents. When substituting glimepiride for others, the initial daily dose is 1 mg, this applies even changeovers from the maximum dose of another oral blood-sugar-lowering agent.
Geriatric use: The initial dosing, dose increment and maintenance dosage should be conservative based upon blood glucose levels prior to and after initiation of treatment to avoid hypoglycemic reactions.
Renal insufficiency: Starting dose of 1 mg of glimepiride may be given to Type 2 diabetic patients with kidney disease, and the dose may be titrated based on fasting blood glucose levels.
Hepatic insufficiency: No studies were performed in patients with hepatic insufficiency.

If the patient is conscious and presents within 1 hour of ingestion, the stomach should be emptied and/or activated charcoal should be given. Hypoglycemia should be treated with urgency, can usually be treated with oral carbohydrates. More severe episode hypoglycemia may be treated with glucagons or concentrated glucose solution (IV). The patient should be observed over several days in case hypoglycemia recurs.

Hypersensitivity to glimepiride or sulfonamides, diabetic ketoacidosis.

This medicine should be used under physician care. If dizziness occurs, the physician must be consulted.

All sulfonylurea drugs are capable of producing severe hypoglycemia which is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when more than one glucose-lowering drug is used. It is also more likely in elderly patients, malnourished patients and in patients with impaired renal or hepatic function, use with caution.
If such risk factors for hypoglycemia are present, it may be necessary to adjust the dosage of glimepiride or the entire therapy. This also applies whenever illness occurs during therapy or the patient's life-style changes.
Hypoglycemia can almost always be promptly controlled by immediate intake of sugar, e.g., in the form of glucose with them of this purpose (food or beverages containing artificial sweeteners - such as diet foods or drinks - are ineffective in controlling hypoglycemia).
During treatment with glimepiride, glucose levels in blood and urine must be checked regularly, as should, additionally, the proportion of glycated haemoglobin.
Alertness and reactions may be impaired due to hypo- or hyperglycemia, especially when beginning or after altering treatment, or when glimepiride is not taken regularly.
Caution use in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents as it can lead to hemolytic anemia.
Amarax 2 contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance should not take this medicine.
Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated, however, a risk of cross-reaction exists in patients with allergy to any of these compounds, avoid use when previous reaction has been severe.
Safety and efficacy have not been established in children.

Pregnancy: Pregnancy risk factor: C.
There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely was related to the pharmacologic action (hypoglycemia) of glimepiride.
Consequently, glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy.
Lactation: Excretion in breast milk unknown/not recommended.

The most common effect is dizziness, headache, hypoglycemia, nausea and weakness. Rare adverse effect such as agranulocytosis, anorexia, aplastic anemia, cholestatic jaundice, constipation, diuretic effect, edema.

Patients who take or discontinue taking certain other medicines while undergoing treatment with glimepiride may experience changes in blood sugar control.
Potentiation of the blood-sugar-lowering effect and, thus, in some instances hypoglycemia may occur when one of the following medicines is taken, for example: insulin and other, oral antidiabetics, 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, 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, for example: acetazolamine, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine and other sympathomimetic agents, glucagons, laxatives (after protracted use), nicotinic acid (in high dose). estrogens and progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones.

Store below 30°C in well-closed container, protect from light and moisture.

Antidiabetic Agents

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

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