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Antidiabetic Agents

Glimepiride STADA® 2 mg

 

Pack size:

Box of 3 blisters x 10 tablets.


Composition:

Each tablet contains glimepiride 2 mg.


Shelf-ife:

24 months from the date of manufacturing.

Store in a well-closed container, in dry place. Do not store above 30oC.
 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.
     
  • The drug usually is orally administered as a single daily dose given each morning with breakfast or with the first main meal.
     
  • Initial dosage in previously untreated patients:
    The usual initial adult dosage of glimepiride is 1 - 2 mg once daily. In debilitated, malnourished, or geriatric patients and in patients with hepatic or renal impairment and other patients at increased risk of hypoglycemia, the initial dosage of glimepiride should be 1 mg once daily.
  • Initial dosage in patients transferred from other antidiabetic agents:
    For the switch over to glimepiride, the strength and the half-life of the previous medicinal product has to be taken into account. In some cases, especially in antidiabetics with along half-life (e.g. chlorpropamide), a wash out period of a few days is advisable in order to minimize the risk of hypoglycaemic reactions due to the additive effect. The initial dosage of glimepiride should be 1 - 2 mg once daily. The maximum dosage should not exceed 2 mg daily.
  • Maintenance dosage:
    The usual maintenance dosage of glimepiride from 1 - 4 mg once daily. In patients receiving 1 mg of glimepiride daily, the dosage may be increased to 2 mg daily if adequate glycemic control has not been achieved after 1 - 2 weeks. After reaching the 2 mg dosage, subsequent dosage should be adjusted according to the patient's tolerance and therapeutic response, increasing the dosage in increments of no more than 2 mg daily at 1- to 2-week intervals. The maximum recommended dosage of glimepiride is 8 mg daily.


Or as prescribed by physicians.

 

  • Hypersensitivity to glimepiride, other sulfonylureas or sulfonamides or excipients in the tablet.
  • Insulin dependent diabetes, diabetic coma, ketoacidosis.
  • Severe renal or hepatic function disorders: a change over to insulin is required.
  • Pregnancy and lactation.

     

  • The most significant adverse reaction is hypoglycemia.

Common

  • Dizziness, fainting, headache.
  • Nausea, vomiting, epigastric distension, abdominal pain, diarrhea.
  • Visual disturbance, transient, may occur especially on initiation of treatment, due to changes in blood glucose levels.

Uncommon

  • Allergic or false allergic reactions, rash, urticaria, pruritus.

Rarely

  • Hepatic enzymes increased, jaundice, hepatic failure.
  • Thrombocytopenia (mild or severe), hemolytic anemia, erythropenia, leukopenia, granulocytopenia.
  • Leukocytoclastic vasculitis.
  • Photosensitivity.

     

  • The patient should be informed of the potential risks and advantages of glimepiride and of alternative modes of therapy.
  • Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia.
    Patients with impaired renal function may be more sensitive to the glucose-lowering effect of glimepiride.
    Debilitated or malnourished patients and those with hepatic, adrenal, or pituitary insufficiency are particularly susceptible to the hypoglycemic action. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs or other sympatholytic agents.
    Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
    Combined use of glimepiride with insulin or metformin may increase the potential for hypoglycemia.
  • Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with glimepiride or even use insulin monotherapy.
  • Fasting blood glucose should be monitored periodically to determine therapeutic response. Glycosylated hemoglobin should also be monitored, usually every 3 to 6 months, to more precisely assess long-term glycemic control.
  • Hypersensitivity reactions: There have been reports of hypersensitivity reactions in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome. If a hypersensitivity reaction is suspected, promptly discontinue glimepiride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.
  • Hemolytic anemia: Sulfonylureas can cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Because glimepiride is a sulfonylurea, use caution in patient with G6PD deficiency and consider the use of a non-sulfonylurea alternative. There are also reports of hemolytic anemia in patients receiving glimepiride who did not have known G6PD deficiency.
  • Increased risk of cardiovascular mortality with sulfonylureas: The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. The patients should be informed of the potential risks and advantages of glimepiride and of alternative modes of therapy.
  • Pregnancy: Studies in animals show that drug has toxicity on embryo causing fetotoxicity and can cause congenital abnormalities. Therefore, glimepiride is contraindicated for pregnant women. People taking glimepiride were pregnant, immediately notify the physician to switch over to insulin therapy and insulin dose should be adjusted to keep blood glucose levels as normal.
  • Lactation: Glimepiride is excreted in breast milk. Therefore, glimepiride is contraindicated for breast-feeding women; insulin therapy should be used as an alternative mode. If glimepiride is required to use, they have to stop breastfeeding.
  • Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or visual impairment. Patients should be advised to take precautions to drive or operate machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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