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AMIRIDE

COMPOSITION:
Each AMIRIDE 2 tablet contains:
Active ingredient: Glimepiride…………………………..2 mg
Excipients: Avicel, Lactose, Kollidon K30, Sodium starch glycolate, Yellow iron oxyde, Magnesium stearate q.s for 1 tablet.
Each AMIRIDE 4 tablet contains:
Active ingredient:  Glimepiride…………………………..4 mg
Excipients: Avicel, Lactose, Kollidon K30, Sodium starch glycolate, Indigocarmine lake, Magnesium stearate q.s for 1 tablet.
 

PHARMACODYNAMICS:
Glimepiride is a sulfonylurea antidiabetic which is used in non-insulin dependent diabetes mellitus (type 2 diabetes mellitus).
Glimepiride acts mainly by stimulating the release of insulin from functioning pancreatic beta cells. As with other sulfonylureas, this effect is based on an increase of responsiveness of the pancreatic beta cells to the physiological glucose stimulus. In addition, glimepiride seems to have pronounced extrapancreatic effects which are for example an improvement of the sensitivity of the peripheral tissue for insulin and a decrease of the insulin uptake by the liver.
The effect of glimepiride is dose-dependent, and good metabolic control over 24 hours can be achieved with a single daily dose.


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 metabolised to two main metabolites, a hydroxy derivative and a carboxy derivative.
The half-life after multiple doses is about 9 hours. About 60% of a dose is eliminated in the urine and 40% in the faeces.
INDICATIONS:
Treatment of type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.
Combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
DOSAGE AND ADMINISTRATION:
Administration:
AMIRIDE is administered orally, immediately before a substantial breakfast or shortly before the first main meal. Tablets should be swallowed whole with approximate ½ glass of water. It is very important not to skip meals after taking glimepiride. A single daily dose of glimepiride is sufficient.
Tablets must be taken at the times and in the doses prescribed. If a dose is forgotten, this should not be corrected by increasing the next dose.
Dosage:
The starting dose is 1 mg glimepiride per day. If necessary, the dosage should be increased, based on the regular blood sugar control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2, 3 or 4 mg glimepiride per day.
The usual dose range in patients with well controlled is 1 to 4 mg once daily. Only some patients benefit from daily of more than 6 mg (maximum dose is 8 mg per day).
A dose adjustment must also be considered when an increased susceptibility to insulin after treatment period or the patient’s weight and/or lifestyle changes, and when other factors causing and increased susceptibility to hypoglycaemia or hyperglycaemia.
In patients not adequately controlled with the maximum daily dose of metformin, concomitant glimepiride therapy can be initiated. While maintaining the metformin dose, the glimepiride therapy is started with a low dose, and is then titrated up to the maximum daily dose, depending on the desired blood sugar level.
In patients not adequately controlled with the maximum daily dose of glimepiride, concomitant insulin therapy can be initiated if necessary. While maintaining the glimepiride dose, insulin treatment is started at low dose and titrated up depending on the blood sugar level.
CONTRAINDICATIONS:
Known hypersensitivity to glimepiride, other sulphonylureas, sulphonamides or any ingredient of the drug.
Insulin dependent diabetes mellitus (type 1 diabetes mellitus) (e.g. for the treatment of diabetics with a history of ketoacidosis), diabetic ketoacidosis, diabetic pre-coma and coma.
Pregnancy and lactation.
Severe renal or hepatic insufficiency.
PRECAUTIONS:
Oral antidiabetic drugs are capable of producing hypoglycaemia, particularly in the following conditions: elderly; glimepiride overdose; undernutrition, irregular mealtimes or missed meals; alterations in diet; imbalance between physical exertion and carbohydrate intake; consumption of alcohol, especially in combination with skipped meals; in patients with hepatic and/or renal impairment; in patients with thyroid disorders, hypopituitarism and adrenocortical insufficiency.
    Patient should be informed about the importance of dietary compliance, regular exercise and regular monitoring of their urinary and/or blood glucose.
In addition determination of the proportion of glycosylated haemoglobin is recommended.
In stress-situations (e.g. accidents, acute operations, infections with fever, etc.) a temporary switch to insulin may be indicated.
If treated for another disease or treated by different doctors, the patients must inform them of their diabetic condition and previous treatment.
DRUG INTERACTIONS:
Certain drugs tend to produce hypoglycaemia, including insulin and oral antidiabetic products, nonsteroidal anti-inflammatory drugs, salicylates, sulfonamides, chloramphenicol, quinolone, fibrates, ACE inhibitors, fluoxetine, miconazol, coumarins, probenecid, monoamine oxidase inhibitors, beta adrenergic blocking agents.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control, including the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, isoniazid, glucagon, barbiturates and rifampicin.
H2 antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Under the influence of sympatholytic medicine such as beta – blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter regulation to hypoglycaemia may be reduced or absent.
Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride.
Glimepiride may either potentiate or weaken the effects of coumarin derivatives.
ADVERSE EFFECTS:
Hypoglycaemia may occur and may also be prolonged with possible symptoms including headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, restlessness, impaired concentration, dizziness, loss of self-control, shallow respiration, bradycardia, somnolence and loss of consciousness up to coma. In addition, some signs may be present such as sweating, hypertension, palpitations, tachycardia, angina pectoris, cardiac arrhythmias, visual disorders…
Gastrointestinal: nausea, vomiting, abdominal distension, abdominal discomfort and abdominal pain, and diarrhea. Elevation of liver enzyme levels may occur. In isolated instances, impairment of liver function.
Dermatological: pruritus, rash, urticaria
Eyes: Visual disturbances, transient, may occur especially on initiation of treatment, due to changes in blood glucose levels.
Hematological: rarely thrombocytopenia, haemolytic anaemia, erythropenia, leukopenia, granulocytopenia, which are in general reversible upon discontinuation of medication.
Notify your physicians if you should experience any of adverse effects
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, especially when beginning or after altering treatment, or when glimepiride is not taken regularly. This may constitute a risk when driving a car or operating machinery.
PREGNANCY AND LACTATION:
Pregnancy: Glimepiride should not be used during pregnancy. Insulin is the drug of first choice for treatment of diabetes during pregnancy.
Lactation: Because sulphonylurea - derivatives like glimepiride pass into the breast milk, glimepiride must not be taken by breast-feeding women.
OVERDOSAGE:
Overdosage of glimepiride can produce hypoglycaemia and sometimes lead to life-threatening. In general observation in hospital is recommended.
Mild episodes of hypoglycaemia can usually treated with oral carbohydrates. More severe episodes with coma, seizure or neurological impairment occur, the patient should be given intramuscular or subcutaneous glucagons or a rapid intravenous injection of concentrated (50%) glucose solution, followed by a continuous infusion of a more dilute (10%) glucose solution that will maintain the blood glucose.
If large quantities have been ingested, gastric lavage and activated charcoal are necessary.
Blood glucose should be closely monitored.
STORAGE: In a dry place, below 25oC, protect from light.
SHELF-LIFE: 36 months from the date of manufacturing. Do not use after the expiry date.
PACKAGING: Box of 5 blisters x 10 tablets.
SPECIFICATIONS: Manufacturer’s specifications.
KEEP OUT OF REACH OF CHILDREN
USE ONLY AS DIRECTED BY YOUR PHYSICIAN
CAREFULLY READ THE PACKAGE INSERT BEFORE USE
FOR FURTHER INFORMATION, DO NOT HESISTATE TO ASK YOUR PHYSICIANS


Manufactured at:
BOSTON VIETNAM PHARMACEUTICAL JOINT STOCK COMPANY
No. 43, Street no. 8, VSIP, Thuan An, Binh Duong, Vietnam
Tel: 06503 769 606 - Fax: 06503 769 601

                                                                                  

 


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