- Approval Id
- 73dd583c8786c8ba
- Drug Name
- AMARYL 2.0 TABLETS 2 MG
- Product Name
- AMARYL 2.0 TABLETS 2 MG
- Approval Number
- SIN10459P
- Approval Date
- 1998-11-20
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>Posology and method of administration</strong><br>
For oral use<br>
The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet.</p>
<p><u>Posology</u><br>
Dose is determined by the results of blood and urinary glucose determinations.<br>
The starting dose is 1 mg glimepiride per day. If good control is achieved this dose should be used for maintenance therapy.<br>
For the different dose regimens appropriate strengths are available.<br>
If control is unsatisfactory the dose should be increased, based on the glycaemic 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.<br>
A dose of more than 4 mg glimepiride per day gives better results only in exceptional cases. The maximum recommended dose is 6 mg glimepiride per day.<br>
In patients not adequately controlled with the maximum daily dose of metformin alone, concomitant glimepiride therapy can be initiated.<br>
While maintaining the metformin dose, the glimepiride therapy is started at low dose, and is then titrated up depending on the desired level of metabolic control up to the maximum daily dose. The combination therapy should be initiated under close medical supervision.<br>
In patients not adequately controlled with the maximum daily dose of Amaryl, 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 desired level of metabolic control. The combination therapy should be initiated under close medical supervision.<br>
A single daily dose of glimepiride is usually sufficient. It is recommended that this dose be taken shortly before or during a substantial breakfast or - if none is taken – shortly before or during the first main meal.<br>
If a tablet is forgotten, this should not be corrected by increasing the next dose.<br>
If a patient has a hypoglycaemic reaction on 1 mg glimepiride daily, this indicates that they can be controlled by diet alone.<br>
In the course of treatment, as an improvement in control of diabetes is associated with higher insulin sensitivity, glimepiride requirements may fall. To avoid hypoglycaemia timely dose reduction or cessation of therapy must therefore be considered. Change in dose may also be necessary, if there are changes in weight or life style of the patient, or other factors that increase the risk of hypo- or hyperglycaemia.</p>
<ul>
<li><p><em><strong>Switch over from other oral antidiabetics agents to Amaryl</strong></em><br>
A switch over from other oral antidiabetics to glimepiride is generally possible. 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 a long half-life (e.g. chlorpropamide), a wash out period of a few days is advisable in order to minimise the risk of hypoglycaemic reactions due to the additive effect.<br>
The recommended starting dose is 1 mg glimepiride per day. Based on the response the glimepiride dose may be increased stepwise, as indicated above.</p></li>
<li><p><em><strong>Switch from Insulin to Amaryl</strong></em><br>
In exceptional cases, where type 2 diabetic patients are regulated on insulin, a changeover to Amaryl may be indicated. The changeover must be carried out under close medical supervision.</p></li>
<li><p><em><strong>Special Populations</strong></em><br>
Patients with renal or hepatic impairment: See section Contraindications.</p></li>
<li><p><em><strong>Paediatric population:</strong></em><br>
There is no data available on the use of glimepiride in patients under 8 years of age. For children aged 8 to 17 years, there is limited data on glimepiride as monotherapy.<br>
The available data on safety and efficacy is insufficient in the paediatric population and therefore such use is not recommended.</p></li>
</ul>
<p>Method of administration<br>
The tablets are taken unchewed with some liquid.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Non-insulin-dependent (type II) diabetes mellitus, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction alone. Amaryl may also be used in combination with an oral antidiabetic containing metformin or with insulin.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
must not be used in the following situations:</p>
<ul>
<li>hypersensitivity to glimepiride, other sulfonylureas or sulfonamides or to any of the excipients</li>
<li>insulin dependent diabetes,</li>
<li>diabetic coma,</li>
<li>ketoacidosis,</li>
<li>severe renal or hepatic impairment. In case of severe renal or hepatic impairment, a change over to insulin is required.</li>
</ul>
- Atc Code
- A10BB12
- Atc Item Name
- glimepiride
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
