NEOFORM 500 Metformin Hydrochloride 500mg Film-Coated Tablet 1's
RXDRUG-DR-XY39435-100-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Metformin hydrochloride is a biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus.
Dosage/Direction for Use
Adults: Initial dose is 500 mg two or three times daily or 850 mg once or twice daily, with or after meals, gradually increased if necessary to a maximum of 2 to 3 g daily, or as prescribed by a physician.
Overdosage
High overdose of metformin or concomitant risks may lead to lactic acidosis. In such cases, medical emergency is required and must be treated in hospital. The most effective way to remove Lactate and Metformin is hemodialysis.
Administration
Should be taken with food: Take w/ or after meals.
Contraindications
Metformin hydrochloride 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.
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 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.
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
Lactic acidosis.
Use In Pregnancy & Lactation
Metformin hydrochloride should not be given to pregnant or lactating women since it is excreted in breast milk.
Adverse Reactions
Nervous System Disorder: Anorexia.
Gastrointestinal System Disorders: Nausea, Vomiting, Diarrhea, absorption of various substances including vitamin B12 may be impaired.
Digestive System Disorder: Patients may experience taste disturbance and there may be weight loss. Lactic acidosis, sometimes fatal, has occurred with biguanides, primarily with phenformin.
Excretory System Disorder: Skin reactions have been reported rarely. When it has occurred with metformin most cases have been in patients whose condition contraindicated the use of the drug, particularly those with renal impairment.
Endocrine System Disorder: Hypoglycemia is rare with a biguanide given alone, although it may occur if other contributing factors or drugs are present.
Circulatory System Disorders: Phenformin has been implicated in the controversial reports of excessive cardiovascular mortality associated with oral hypoglycaemic therapy.
Gastrointestinal System Disorders: Nausea, Vomiting, Diarrhea, absorption of various substances including vitamin B12 may be impaired.
Digestive System Disorder: Patients may experience taste disturbance and there may be weight loss. Lactic acidosis, sometimes fatal, has occurred with biguanides, primarily with phenformin.
Excretory System Disorder: Skin reactions have been reported rarely. When it has occurred with metformin most cases have been in patients whose condition contraindicated the use of the drug, particularly those with renal impairment.
Endocrine System Disorder: Hypoglycemia is rare with a biguanide given alone, although it may occur if other contributing factors or drugs are present.
Circulatory System Disorders: Phenformin has been implicated in the controversial reports of excessive cardiovascular mortality associated with oral hypoglycaemic therapy.
Drug Interactions
Use of a biguanide with other drugs that lower blood-glucose concentrations increase the risk of hypoglycaemia, while drugs that increase blood glucose may reduce the effect of biguanide therapy.
In general fewer drug interactions have been reported with biguanides than with sulfonylureas. Alcohol may increase the risk of lactic acidosis as well as of hypoglycaemia. Care should be taken if biguanides are given with drugs that may impair renal function.
In general fewer drug interactions have been reported with biguanides than with sulfonylureas. Alcohol may increase the risk of lactic acidosis as well as of hypoglycaemia. Care should be taken if biguanides are given with drugs that may impair renal function.
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 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. Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Pharmacokinetics: Metformin hydrochloride 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. Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
MedsGo Class
Antidiabetic Agents
Features
Brand
Neoform 500
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Metformin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Metformin Hydrochloride
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY39435
Drug Classification
Prescription Drug (RX)
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