GLIRED 2

GLIRED 2

- Glimepiride is an oral hypoglycemic agent. It is a sulfonylureas antidiabetic. 
  Primarly, Glimepiride stimulates the release of insulin from functioning 
  pancreatic beta cells. In addition it increases sensitivity of peripheral tissues to 
  insulin.
- Glimepiride is completely absorbed from the gastrointestinal tract. Peak plasma 
  concentrations occur within 2 to 3 hours, and it is highly bound to plasma 
   proteins. 
- Glimepiride is completely metabolised  and the half-life after multiple doses is 
  about 9 hours.
- Nearly 60% of a dose is eliminated in the urine and 40% in the faeces.

- Each tablet of  Glired® 3     contains :       Glimepiride                 3mg
- Each tablet of  Glired® 2     contains:       Glimepiride                  2mg
- Each tablet of  Glired® 1     contains:       Glimepiride                  1mg   

* Glired® is contraindicated in :- 
- patients with known hypersensitivity to the Glimepiride ,other sulfonylurea or 
  sulfonamides.
      - diabetic ketoacidosis. 
      - insulin – dependent ( typeI) diabetes mellitus. 
      - serious renal or hepatic dysfunctions. 
      - dialysis patients. 

- 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, chloramphenical, 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, salicylate,sulfinpyrazone, 
  sulfonamides, tetracyclines, tritoqualine, trofosfamide, fluconazole.
- Weakening of the blood –sugar- lowering effect and thus, raised blood sugar 
  levels may occur when one of the following medicine is taken, for example: 
  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, phenytion, rifampicin, thyroid hormones.
- H2 receptor antagonists, clonidine and reserpine may lead to either 
  potentiation or weakening of the blood –sugar- lowering effect of Glimepiride 
  when administrated concomitantly.
- Beta-blockers decrease glucose tolerance. In patients with diabetes mellitus,   
  this may lead to deterioration of metabolic control. In addition, beta-blockers 
  may increase the tendency to hypoglycemia (due to impaired 
  counter-regulation).
- Under the influence of sympatholytic medicines such as beta-blockers, clonidine, 
  guanethidine and reserpine, the signs of adrenergic counter-regulation to 
  hypoglycemia may be reduced or absent. 
- Both acute and chronic alcohol intake may potentiate or weaken the 
  blood-sugar-lowering action of Glimepiride unpredictably. 
-The effect of coumarin derivatives may be potentiated or weakened by taken 
  Glired®.
 

- No adequate and well-controls studies in pregnant women, so Glired® should not 
  be used during pregnancy. 
- Significant concentrations of Glimepiride were observed in the breast milk, so 
  Glired® should not  be used during lactation. 

Pediatric Use :-
- Safety and effectiveness in pediatric patients have not been established. 
 

- The main adverse effect with Glired® is hypoglycemia. 
- Other side effects: dizziness, asthenia, headache and nausea. 
- Gastrointestinal reactions:- vomiting , GI pain and diarrhea.
- Dermatologic reactions:- allergic skin reactions, e.g, pruritus, urticaria,    
  erythema and reauptions.
- Hematologic reactions:- rarely leukopenia, agranulocytosis, thrombocytopenia, 
  hemolytic anemia, a plastic anemia and pancytopenia.
- Metabolic reactions: hepatic porphyria, hyponatremia or increase release of 
   ADH. 
- Other reactions: change in accommodation and/or  blurred vision.

Over Dosage :- 
* over dosage of Glired® can produce hypoglycemia. 
- mild hypoglycemia should be treated with oral glucose and adjustments in drug 
  dose and/ or meals. 
- severe hypoglycemic reactions with coma, seizure, or other neurologic 
  impairment, require immediate  hospitalization . The patient should be given a 
  rapid IV injection of concentration (50%) glucose solution, followed by infusion 
  of more dilute ( 10% ) glucose solution until the blood glucose concentration 
  becomes more than 100 mg/dl. 
 

-To achieve optimal control of blood sugar, a correct diet, regular and sufficient 
  physical exercise and, if necessary, reduction of body weight are just as 
  important as regular intake of Glired®   
  Clinical signs of hyperglycemia are, e.g increased urinary frequency, intense 
  thirst, dryness of the mouth, and dry skin.
- When starting treatment, the patients must be informed about the effects and
  risks of Glired® and about it’s role in conjunction with dietary measures and 
  physical exercise; the importance of adequate co-operation must also be stressed. 
  In the initial weeks of treatment, the risk of hypoglycemia may be increased and 
  necessitates especially careful monitoring.
- Factors favouring hypoglycemia include:
       •Unwillingness or (more commonly in older patients)incapacity of the 
         patient to co-operate,
       •Undernutrition, irregular mealtimes, or skipped meals, 
       •Imbalance between physical exertion and carbohydrate intake, 
       •Alterations of diet.
       •Consumption of alcohol, especially in combination with skipped meals.
       •Impaired renal function. 
       •Severe impairment of liver function. 
       •Overdosage with Glired®. 
       •Certain uncompensated disorders of the endocrine system affection 
         carbohydrate metabolism or counter-regulation of hypoglycemia (as, for 
         example, in certain disorders of thyroid function and in anterior pituitary   
         or adrenocortical insufficiency).
       •Concurrent administration of certain other medicines.
   If such risk factors for hypoglycemia are present, it may be necessary to adjust 
   the dosage of Glired® or the entire therapy.
- temporary change  to insulin in exceptional stress situations like trauma, surgery, 
   infections with fever.
- Alertness and reactions may be impaired due to hypo-or hyperglycemia, 
  especially when beginning or after altering treatment, or when Glired® is not 
  taken regularly. Such impairment may, for example, affect the ability to operate a 
  vehicle or machinery.  

- (blister of 15 tables, pack of two blisters )
 

 Store in a dry place at a temperature below 30°C.