GLUMERIF 2

COMPOSITION:
Glimepiride .......................................... 2 mg
Excipients q.s.................................... 1 tablet
(Lactose monohydrate, FD & C Blue No 1 Alum lake, indigo carmine lake,
avicel M101 (microcrystalline cellulose M101), sodium starch glycolate, magnesium stearate, PVP K30).
DOSAGE FORM: Tablet.
PRESENTATIONS: Box of 3 blisters x 10 tablets.
PHARMACODYNAMICS: Glumerif is a new-generation hypoglycemic agent with active ingredient Glimepiride belonging to sulfonylureas. The action of glimepiride in lowering blood glucose appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride works by closing potassium channels dependent to ATP at beta cell membranes. Closing of potassium channels depolarizes in the membranes, increases the transfer of calcium to the cells. Increase in cellular calcium concentrations stimulates the release of insulin from the cell.
In addition, extrapancreatic effects may also play a role in the activity of glimepiride with the following mechanisms: 
- Glimepiride improves the sensitivity of peripheral tissues to insulin and reduces the withdrawal of hepatic insulin.
- Glimepiride accelerates the quantity of the active glucose-transporting substances in the muscular and fatty cell membranes, so the tolerance of glucose into muscular and adipose tissues.
- Hydroxy metabolites act on mild hypoglycemia.
Glimepiride has a synergistic action to metformin or insulin.
PHARMACOKINETICS: Bioavailability of glimepiride is high. The absorption of glimepiride is not significantly affected by food but the absorptive speed is slightly slow. Glimepiride binds extensively to plasma protein and has low clearance. The half-life of glimepiride is about 5 to 8 hours. Glimepiride is metabolized in the liver and eliminated in the urine and feaces. Glimepiride crosses the placenta barrier; poorly crosses the blood-brain barrier. Glimepiride is excreted in the milk for the animal.
INDICATIONS: Treatments of type 2 (non-insulin dependent) diabetes mellitus in adults whose blood glucose levels do not return to the normal after going on a diet, taking exercise and losing weight.
Glimepiride may be indicated for use in combination with metformin, glitazone, or insulin.
CONTRAINDICATIONS: Glumerif is contraindicated in patients with:
Hypersensitivity to any components of the drug. Known allergy, hypersensitivity to sulfonamide. Type 1 (insulin dependent) diabetes mellitus. Ketoacidosis, diabetic coma or pre-coma. Severe infections. History of allergy to sulfonamide and other sulfonylureas. Severe hepatic and renal impairment.
PRECAUTIONS: Glimepiride can cause hypoglycemia. Patients with poor nutrition, the elderly, those with adrenal insufficiency, hepatic impairment, hypopituitarism, particularly in patients getting hypotension easily when taking glimepiride.
Patients with stress, trauma, surgery, infections, high fever can become difficult to control blood sugar when administering glimepiride.
Blood sugar cannot be controlled when taking the drug for a long time.
PREGNANCY AND NURSING MOTHERS: The drug is contraindicated in pregnant and nursing women.
VEHICLE DRIVERS AND MACHINERY OPERATORS: The drug should be used with caution in vehicle drivers and machinery operators because of risk of hypotension.
INTERACTIONS: The hypoglycemic action of glimepiride may be potentiated by certain drugs, including insulin, other oral anti-diabetic drugs, chloramphenicol, coumarin derivative, cyclophosphamide, disopyramide, ifosfamide, MAO inhibitors, non-steroidal anti-inflammatory drugs (paraaminosalicylic acid, salycilates, phenylbutazone, oxyphenbutazone, azapropazone), probenecid, anti-fungal agents (miconazole,  fluconazole, ketoconazole), quinolones, sulfonamides, beta blockers, angiotensin converting enzyme inhibitors, anabolic steroids and male genital hormones, alcohols, tetracycline. If glimepiride is concurrently administered with one of above drugs, risk of hypoglycemia may have been dangerously reported. Adjustment of the dosage of glimepiride should be considered.
Certain drugs tend to produce hypoglycemia. These drug includes diuretics (thiazide), corticosteroids, diazoxide, catecholamine and others sympathomimetics, glucagons, nicotinic acid (high doses), estrogens, and estrogen-containing contraceptives, phenothiazines, phenytoin, thyroid hormone, rifampicin. The dosage of glimepiride should be adjusted.
ADVERSE EFFECTS: The most important adverse effect is hypoglycemia.
Frequent: Nerve: headache, dizziness. Digestion: nausea, vomiting, colic, diarrhea. Temporary vision disorders.
Less frequent: allergic reactions or pretence of allergy, rash, urticaria, itching.
Rare: Liver: elevated liver enzymes, jaundice, impaired hepatic function. Blood: thrombocytopenia, aglobulia, hypoleukocytosis, hemolytic anemia, agranulocytosis. Vessel: allergic vasculitis. Skin: sensitive to light.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Symptoms of hypoglycemia have been reported when overdosage including exhaustion, sweating, pale skin, polycardia, hypertension, nausea, vomiting, visual disorders, sensation disorders, confusion, unconsciousness leading to coma. Symptoms of severe hypoglycemia is the same as a stroke.
Mild hypoglycemic symptoms should be treated aggressively with oral glucose or 20 g to 30 g of sugar diluting with water. Patients should be closely monitored the blood glucose and take it every 15 minutes.
If severe hypoglycemic symptoms diagnosed or suspected, the patient should be given a rapid intravenous injection of 50 ml of concentrated (50%) glucose solution. This should be followed by a continuous infusion of more dilute (10% to 20%) glucose solution. If very severe cases, subdermal or muscular injection of 1 mg glucagon should be advised. Gastric lavage and administration of activated charcoal is instituted when glimepiride is given too much.
DOSAGE & ADMINISTRATION:
The usual starting dose of Glumerif 2 is 1 mg daily, then increasing increment every 1 to 2 weeks with therapeutic steps: 1 mg - 2 mg - 3 mg - 4 mg - 6 mg - (8mg).
The average dose is 1 to 4 mg daily.
Take Glumerif 2 by mouth once daily, with breakfast or the first main meal of the day.
Or as directed by the physician.
Read the directions carefully before use. Shelf-life: 36 months from the manufacturing date.
Consult the physician for more information. Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
This drug is for prescriptions only.  Specifications: Manufacturer's.