- Approval Id
- b97e1c6385ae20c6
- Drug Name
- GLUCOBAY 50 TABLET 50 mg
- Product Name
- GLUCOBAY 50 TABLET 50 mg
- Approval Number
- SIN07861P
- Approval Date
- 1994-10-01
- Registrant
- BAYER (SOUTH EAST ASIA) PTE LTD
- Licence Holder
- BAYER (SOUTH EAST ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>Dosage And Method of Administration</strong></p>
<p><strong>Recommended usual dose for additional therapy in association with diet in patients with diabetes mellitus:</strong></p>
<p>The dosage must be adjusted by the doctor to suit each patient, because efficacy and tolerability vary from one individual to another.</p>
<p>Unless otherwise prescribed, the recommended dosage is as follows:</p>
<p>Initially 3 x 1 tablet of 50 mg Glucobay/day or 3 x ½ tablet of 100 mg Glucobay/day<br>
up to 3 x 2 tablets of 50 mg Glucobay/day or 3 x 1 tablet of 100 mg Glucobay/day</p>
<p>A further increase in dosage to 3 x 200 mg Glucobay/day may occasionally be necessary.</p>
<p>The dose may be increased after 4 – 8 weeks, and if patients show an inadequate clinical response in the later course of the treatment. If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further, and if necessary should be somewhat reduced. The average dose is 300 mg Glucobay/day (corresponding to 3 x 2 tablets of Glucobay tablets 50 mg/day, or 3 x 1 tablet Glucobay tablets 100 mg/day).</p>
<p><strong>Method of administration:</strong></p>
<p>Glucobay tablets are effective only if swallowed whole with a little liquid directly before the meal or be chewed with the first few mouthfuls of the meal.</p>
<p><strong>Special monitoring advice:</strong> see Special Warnings and Precautions for Use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><strong>Additional information on special populations</strong></p>
<p>Children and adolescents: see Special Warnings and Precautions for Use – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Geriatric patients:<br>
No alteration of dosage or dosing frequency is recommended with regard to the age of the patients.</p>
<p>Patients with renal impairment: see Contraindications.</p>
<p>Duration of use: It is not envisaged that there will be any time restriction in the use of Glucobay tablets.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
Additional therapy in association with diet in patients with diabetes mellitus.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul>
<li><p>Hypersensitivity to acarbose and/or to inactive constituents.</p></li>
<li><p>Chronic intestinal disorders associated with distinct disturbances of digestion and absorption.</p></li>
<li><p>States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld's syndrome, major hernias, intestinal obstructions, and intestinal ulcers).</p></li>
<li><p>Glucobay is contraindicated in patients with severe renal impairment (creatinine clearance < 25 ml/min).</p></li>
</ul>
- Atc Code
- A10BF01
- Atc Item Name
- acarbose
- Pharma Manufacturer Name
- BAYER (SOUTH EAST ASIA) PTE LTD
