Dosage and administration

Dosage considerations

The fasting blood glucose and HbA1C of the patient must be measured regularly to
determine the minimum effective dose of the patient; detection of primary failure, that is,
insufficient reduction of blood glucose at the maximum recommended drug dose; and
detection of secondary failure, that is, loss of enough after the beginning of the validity
period Response to lowering blood sugar. Glycosylated hemoglobin levels (HbA1c) should
be performed to monitor patients' response to treatment.

Usually in patients with good diet and exercise, taking AMARYL (glimepiride) for a short
period of time may be sufficient to relieve short-term glycemic control.

According to published literature, genetic polymorphisms of CYP2C9 may be associated

with an increased response to AMARYL. A lower dose regimen should be considered in poor
metabolizers (CYP2C9 * 3 variants), but a suitable dose regimen for this patient population
has not been established in clinical outcome trials (see Effects and Clinical Pharmacology,
Pharmacokinetics) .

Recommended dose and dose adjustment

Usual starting dose

The usual starting dose of AMARYL as an initial therapy is 1 mg once a day, taken with
breakfast or the first main meal. Those patients who may be more sensitive to
hypoglycemic drugs should be titrated carefully (see section "Warnings and Precautions").

Failure to follow proper dosage regimen may cause hypoglycemia. Patients who do not
follow prescribed diet, exercise, weight loss, and medication regimens are more likely to
show an unsatisfactory response to treatment.

Adjustment of the dose must also be considered whenever:

• patient's weight change,

• Changes in the patient's lifestyle and increased susceptibility to hypoglycemia or

hyperglycemia due to other factors (see section "Warnings and Precautions").

• AMARYL is used with other drugs (see "Drug Interactions" section)

Routine maintenance dose

The usual maintenance dose is 1 to 4 mg per day. The recommended maximum dose is 8
mg once daily. After reaching the 2 mg dose, the dose should be increased at intervals of 1-
2 weeks based on the patient's blood glucose response, and the increase should not exceed
1 mg. Long-term efficacy should be monitored by measuring HbA1C levels (for example,
every 3 to 6 months).

AMARYL-metformin combination therapy

The combination of AMARYL and metformin can be used in patients who are not fully
relieved by the maximum dose of AMARYL or in patients with secondary failure. With
AMARYL and metformin treatment, the desired glycemic control can be achieved by
adjusting the dosage of each drug. Attempts should be made to determine the minimum
effective dose of each drug to achieve this goal. Combined with AMARYL and metformin
treatment, the risk of hypoglycemia may increase. Take appropriate precautions.

AMARYL-insulin combination therapy

Patients with secondary failure can be treated with a combination of AMARYL and insulin.
The recommended AMARYL dose is 8 mg once daily with the first main meal. Starting with
low-dose insulin, insulin can be adjusted upwards about once a week, based on frequent
measurements of fasting blood glucose. Once stabilized, patients receiving combination
therapy should continuously monitor their capillary blood glucose, preferably once a day.
During maintenance, as indicated by glucose and HbA1C levels, regular adjustments to
insulin may also be required.

Specific patient populations

AMARYL is not recommended for pregnant, nursing mothers or children. For elderly,
debilitated or malnourished patients, or patients with renal or hepatic insufficiency, the
initial dose of the drug should be kept conservative, and the dose should be increased and
maintained to avoid hypoglycemia (see Actions and Clinical Pharmacology, Specific
Populations) And conditions as well as warnings and precautions, endocrinology and
metabolism).

Transition from other oral hypoglycemic agents

There is no exact dose relationship between AMARYL and other oral hypoglycemic agents.
When using AMARYL to replace other oral hypoglycemic agents, it is recommended that
the procedure be the same as the starting dose, which is 1 mg daily. The potency and
duration of previous hypoglycemic agents must be considered. Due to the long half-life of
sulfonylureas (such as chloropropionamide) when transferred to AMARYL, the patient's
hypoglycemia should be carefully observed (1-2 weeks) because the drug effects may
overlap. Medication may need to be discontinued to avoid any additive effects that could
lead to the risk of hypoglycemia.

management

AMARYL tablets must be swallowed with a sufficient amount of liquid (about ½ cup) and
not chewed.

Missed dose

Unless you miss the next dose, you should take the missed dose as soon as possible. Advise
patients not to take two doses at the same time