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GLUFAST should only be administered to patients who have been positively diagnosed with diabetes mellitus. Special attention should be paid to verify the diagnosis since, other than diabetes, some diseases (impaired glucose tolerance, urine sugar positive, etc.) show diabetes-like symptoms, such as renal diabetes, senile glycometabolic disorder and abnormal thyroid function.
In patients on the basic regimen for treatment of diabetes mellitus only with dietary treatment and exercise therapy alone or those on the regimen with α-glucosidase inhibitors in addition to diet and physical exercise, GLUFAST should be prescribed only when fasting blood glucose level ≥126 mg/dL or postprandial blood glucose level or ≥200 mg/dL within 1- or 2-hour period.
Careful Administration: GLUFAST should be administered with care in the following patients: Patients with hepatic dysfunction [Since GLUFAST is metabolized mainly in the liver, it may worsen hepatic dysfunction in those patients as well as result in hypoglycemia].
Patients with renal dysfunction. [Prolongation of elimination half-life for mitiglinide in plasma was observed in patients with chronic renal failure which may result in secondary hypoglycemia (See Pharmacology: Pharmacokinetics under Actions).]
Patients with the following conditions: Patients with ischemic heart disease [Myocardial infarction has been reported. See Adverse Reactions].
Patients with pituitary or adrenal insufficiency. [GLUFAST may cause hypoglycemia.]
Patients with gastroenteropathy such as diarrhoea and vomiting. [GLUFAST may cause hypoglycemia.]
Malnutrition, starvation, insufficient intake of foods, or debility. [GLUFAST may cause hypoglycemia.]
Strenuous physical exercise. [GLUFAST may cause hypoglycemia.]
Excessive ingestion of alcohol. [GLUFAST may cause hypoglycemia.]
Elderly. [Compromised physiological functions is generally observed in elderly people. See Use in the Elderly as follows.]
Important Precautions: Since GLUFAST may cause hypoglycemia, due care should be exercised for patients engaged in work at high elevations (risk of falling) or patients operating machinery or motor vehicles. When hypoglycemia symptoms are observed, patients should be treated appropriately with sucrose, glucose, or soft drinks containing adequate amounts of glucose. If hypoglycemia occurs on the concomitant use of α-glucosidase inhibitors, glucose should be administered instead of sucrose, since α-glucosidase inhibitors delay the digestion and absorption of disaccharides. In addition, the risks and management of hypoglycemia symptoms should be carefully explained to patients.
During maintenance of GLUFAST treatment, blood glucose level and condition should be monitored periodically. If satisfactory effect is not achieved after two to three months' treatment with GLUFAST, alternative treatments should be considered.
Sometimes during treatment, drug administration may be unnecessary, lowered doses may be required, or the effectiveness may be completely or partially impaired by patient's poor regimen management compliance or complications of infectious diseases. Therefore, the necessity of continuous treatment, the dose, the selection of appropriate drug, should always be determined considering patients' dietary habits, blood glucose level and infections.
GLUFAST has rapid onset of insulin secretagogue activity. The site of this action is the same as sulfonylurea-type agents, therefore since the additive/synergistic clinical effects and safety of interactions with sulfonylurea-type agents have not been confirmed, GLUFAST should not be used in combination with sulfonylurea-type agents. [See Pharmacology and Pharmacodynamics under Actions.]
Effectiveness and safety has not been confirmed for concomitant use of GLUFAST with insulin sensitizer (pioglitazone hydrochloride) or biguanides (metformin etc.).
Use in Children: The safety of GLUFAST in pediatric patients has not been established. [GLUFAST has not been administered to pediatric patients.]
Use in the Elderly: As physiological functions are generally compromised in the elderly, administration should be carefully performed taking into consideration blood glucose level or initiating treatment at a lower dose (5 mg each time).
