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DIABEX & DIABEX XL Back to Products
COMPOSITION Diabex: Each film coated, tablet contains 500mg Metformin Hydrochloride. Diabex XL: Each film coated tablet contains 1000mg Metformin hydrochloride as an extended release (XL) formulation.
INDICATIONS Diabex and Diabex XL are indicated as monotherapy or as adjunct to diet and exercise to improve glycemic control in patients with Type II diabetes. Diabex is indicated in patients that are 10 years of age and older, and Diabex XL is indicated in patients that are 17 years of age and older. Diabex and Diabex XL may be used concomitantly with sulfonylurea or insulin to improve glycemic control in diabetic patients.
There is no fixed dosage regimen for the management of hyperglycemia in patients with Type II diabetes with Diabex or Diabex XL. Dosage of Diabex or Diabex XL must be individualized on the basis of both effectiveness and tolerance, whilst not exceeding the maximum recommended daily dose. The maximum recommended daily dose of Diabex is 2550mg in adults and 2000mg in younger patients (10-16 years); the maximum recommended daily dose of Diabex XL in adults is 2000mg. Diabex should be given in divided doses with meals while Diabex XL should generally be given once daily with the evening meal. Diabex or Diabex XL should be started at a low dose, with gradual increase in dose, both to reduce gastrointestinal side effect and to permit identification of the minimum dose required for adequate glycemic control of the patient.
Recommended Dosing Schedule In general, clinically significant responses are not seen at doses below 1500mg/day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of Diabex is 500mg twice a day given with meals. Dosage increases should be made in increments of 500mg weekly, up to a total of 2000mg/day, given in divided doses. For those patients requiring additional glycemic control, Diabex may be given to a maximum daily dose of 2550mg/day. Doses above 2000mg may be better tolerated given 3 times a day with meals. The usual starting dose of Diabex XL is 1000mg once daily with evening meals. This could be increased up to a maximum of 2000mg once daily with evening meal. If glycemic control is not achieved with Diabex XL 2000mg, a trial of Diabex XL 1000mg twice daily should be considered. Patients currently receiving Diabex could be switched to Diabex XL at the total daily dose, following a switch from Diabex to Diabex XL, glycemic control should be closely monitored.
Transfer from other antidiabetic drugs When transferring from standard oral hypoglycemic drugs other than chlorpropamide to Diabex or Diabex XL, no transition period is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, which may lead to overlapping drug effects and possible hypoglycemia.
Concomitant Diabex or Diabex XL and Oral Sulfonylurea. If patients have not responded to 4 weeks of the maximum dose of Diabex or Diabex XL monotherapy, consideration should be given to a gradual addition of an oral sulfonylurea while continuing Diabex or Diabex XL at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacological drug-drug interaction data are currently available only for Diabex and Glibenclamide. With concomitant Diabex or Diabex XL and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug.
Concomitant Diabex or Diabex XL and Insulin Therapy The current insulin dose should be continued upon initiation of Diabex or Diabex XL therapy. Diabex or Diabex XL should be initiated at lowest dose, for patients not responding adequately, the dose should increased after a week, and increment could be done weekly until adequate glycemic control is achieved. The recommended maximum daily dosage for Diabex should not be exceeded.
SIDE EFFECTS Diabex is generally well tolerated. Diarrhea, nausea, vomiting, flatulence, abdominal discomfort and headache have been reported following treatment with Diabex. Other side effect includes metallic taste, decreased vitamin B12 absorption, lactic acidosis (rare).
PREGNANCY & NURSING MOTHERS Metformin or Metformin XL are not recommended for use in pregnancy in lactation.
PRESENTATION Diabex Tablet 500mg, pack of 30’s and 100’s Diabex XL Tablets 1000mg, pack of 30’s and 100’s
For more information, please contact productmanager@solidumpharma.com Back to top |
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Diabex
contains Metformin hydrochloride, a biguanide antidiabetic drug used
in the management of Type II diabetes mellitus. 
DOSAGE AND
ADMINISTRATION