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Indications/Uses
Metformin Hydrochloride (Gludin) is a biguanide hypoglycemic agent used in the treatment of Non-Insulin-Dependent Diabetes Mellitus. It is given to patients who are no longer responding to sulphonylureas, either alone or in combination with sulphonylurea.
Dosage/Direction for Use
Adults: Monotherapy and combination with other oral antidiabetic agents: The usual starting dose is one tablet of Metformin 500 mg or Metformin 850 mg 2 - 3 times daily with or after meals. Metformin must be taken daily without interruption, except if specifically indicated by the doctor. If the patient has forgotten to take Metformin, the next dose should be taken at the usual time. Do not double the dose of Metformin. If the patients has taken more Metformin tablets than indicated, the doctor or pharmacist must be consulted immediately.
After 10 to 15 days, the dose may be slowly increased by an increment of one tablet depending on blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of Metformin is 3 g daily, taken as 3 divided doses.
If transfer from another oral antidiabetic is intended: discontinue the other agent and initiate Metformin at the dose indicated as previously mentioned.
Combination with insulin: Metformin and Insulin may be used in combination therapy to achieve better blood glucose control. Unless otherwise prescribed, Metformin is given at the usual starting dose of one tablet of Metformin 500 mg or Metformin 850 mg 2 - 3 times daily, while Insulin dosage is just adjusted on the basis of blood glucose measurements.
Elderly: Due to the potential for decreased renal function in elderly subjects, the Metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Children and adolescents: Monotherapy and combination with insulin: Metformin 500 mg tablet can be used in children from 10 years of age and adolescents.
The maximum recommended dose of Metformin is 2 g daily, taken as 2 or 3 divided doses.
After 10 to 15 days, the dose may be slowly increased by an increment of one tablet depending on blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of Metformin is 3 g daily, taken as 3 divided doses.
If transfer from another oral antidiabetic is intended: discontinue the other agent and initiate Metformin at the dose indicated as previously mentioned.
Combination with insulin: Metformin and Insulin may be used in combination therapy to achieve better blood glucose control. Unless otherwise prescribed, Metformin is given at the usual starting dose of one tablet of Metformin 500 mg or Metformin 850 mg 2 - 3 times daily, while Insulin dosage is just adjusted on the basis of blood glucose measurements.
Elderly: Due to the potential for decreased renal function in elderly subjects, the Metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Children and adolescents: Monotherapy and combination with insulin: Metformin 500 mg tablet can be used in children from 10 years of age and adolescents.
The maximum recommended dose of Metformin is 2 g daily, taken as 2 or 3 divided doses.
Overdosage
Overdosage may lead to Lactic Acidosis. In such cases, medical emergency is required and must be treated in a hospital. The most effective way to remove Lactate and Metformin in the blood is hemodialysis.
Administration
Should be taken with food: Take w/ or after meals.
Contraindications
Metformin Hydrochloride (Gludin) should not be used in Insulin-Dependent Diabetes Mellitus. Use in Non-Insulin-Dependent Diabetes Mellitus is contraindicated in patients with ketoacidosis and in those with severe infection, stress, trauma and other severe conditions where it is unlikely to control hyperglycemia.
Warnings
Lactic Acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that occurs due to accumulation of Metformin during treatment.
Special Precautions
It should not be given in severe impairment of renal or hepatic function because of an increased risk of hypoglycemia.
It should not be used in patients with heart failure, recent myocardial infarction, dehydration, acute or chronic alcoholism or any other condition likely to predispose to Lactic Acidosis.
It should not be used in patients with heart failure, recent myocardial infarction, dehydration, acute or chronic alcoholism or any other condition likely to predispose to Lactic Acidosis.
Use In Pregnancy & Lactation
Metformin Hydrochloride (Gludin) should not be given to pregnant or lactating women since it is excreted in breast milk.
Adverse Reactions
Metabolism and Nutrition disorder: Impaired absorption of various substances including Vitamin B12.
Nervous system disorders: Taste disturbance.
Gastrointestinal disorders: Nausea, Anorexia, Diarrhea.
Skin disorders: Pruritus, Erythema, Urticaria.
Nervous system disorders: Taste disturbance.
Gastrointestinal disorders: Nausea, Anorexia, Diarrhea.
Skin disorders: Pruritus, Erythema, Urticaria.
Drug Interactions
Dosage of Metformin Hydrochloride (Gludin) may be lowered in patients receiving Metformin Hydrochloride and Cimetidine to reduce the risk of Lactic Acidosis. Diuretics may increase the risk of Lactic Acidosis due to their potential to decrease renal function. Avoid consumption of alcohol and alcohol-containing medications, as it may cause increase risk of Lactic Acidosis.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Metformin is a biguanide hypoglycemic agent lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and as a result does not produce hypoglycemia.
Pharmacokinetics: Metformin Hydrochloride (Gludin) is slowly and incompletely absorbed from the gastrointestinal tract. A single 500 mg dose is reported to have a bioavailability of 50-60% (may be reduced in the presence of food). Plasma protein binding is negligible. It is excreted as unchanged drug in the urine. Plasma elimination half-life is reported to range about 2 to 6 hours after oral administration.
Pharmacokinetics: Metformin Hydrochloride (Gludin) is slowly and incompletely absorbed from the gastrointestinal tract. A single 500 mg dose is reported to have a bioavailability of 50-60% (may be reduced in the presence of food). Plasma protein binding is negligible. It is excreted as unchanged drug in the urine. Plasma elimination half-life is reported to range about 2 to 6 hours after oral administration.
MedsGo Class
Antidiabetic Agents
Features
Brand
Gludin
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Metformin
Drug Packaging
Film-Coated Tablet 100's
Generic Name
Metformin Hydrochloride
Dosage Form
Film-Coated Tablet
Registration Number
DRP-7736
Drug Classification
Prescription Drug (RX)