Humamet

Metformin HCl.

Metformin HCl is an oral antihyperglycemic drug. Metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride chemically. It is a white to off-white crystalline powder. It is freely soluble in water and is practically insoluble in acetone, chloroform and ether. Its molecular formula is C₄H₁₁N₅·HCl.

Pharmacology: Pharmacodynamics: Mechanism of Action: Metformin HCl is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes or non-insulin dependent diabetes mellitus (NIDDM), lowering both basal and postprandial plasma glucose. Metformin HCl decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics: Absorption, Bioavailability and Elimination: The absolute bioavailability of a metformin HCl 500-mg tablet given under fasting condition is approximately 50-60%. Absorption of metformin HCl occurs mainly from the small intestine. It is stable and does not bind to plasma proteins. It is excreted in the urine apparently unchanged.

To improve glycemic control in patients with non-insulin dependent diabetes mellitus (NIDDM) where there is poor diet control; primary and secondary failures to sulfonylurea treatment and those having a trend for increasing the body weight; diabetic with an exceeding body weight.
Humamet can be given alone as an initial treatment or to supplement treatment with a sulfonylurea. In patients with insulin-dependent diabetes mellitus (type I) who are not adequately controlled, Humamet can be added to their existing treatment regimen.

Recommended Dose: 500 mg 3 times daily or 850 mg twice daily, taken with meals.
The dosage of Humamet must be individualized based on both effectiveness and tolerance but should not exceed the maximum dose of 2,550 mg.
If in combination therapy with either a sulfonylurea or insulin, diabetic control should be checked by blood sugar readings because of the possibility of hypoglycemia.
The dose should be increased gradually. One 500-mg tablet, 3 times daily is often enough to give good diabetic control. This may be achieved within a few days, but it is not unusual for the full effect to be delayed for up to 2 weeks. If control is incomplete, a cautious increase in dosage to maximum of 3 g daily is justified. Once control has been obtained, it may be possible to reduce the dosage.
When combined with existing sulfonylurea therapy which is not giving adequate control, one 500-mg tablet should be added initially, the dosage of Humamet being gradually increased until optimal control is obtained. Often, the sulfonylurea may be reduced and in some patients, withdrawn. Humamet can then be continued as the sole therapy.

Hypoglycemia is not normally a problem encountered with Humamet when used alone. In combination therapy with a sulfonylurea or insulin with alcohol, hypoglycemia can occur.
In excessive dosage and particularly, if there is a possibility of accumulation, lactic acidosis should be suspected.
Intensive supportive therapy is recommended which should be particularly directed as correcting fluid loss and metabolic disturbance.

Hypersensitivity to metformin HCl or to any of the excipients of Humamet.
Patients with the following conditions: Renal disease or dysfunction, chronic liver disease, cardiac failure, recent myocardial infarction; acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. Diabetic ketoacidosis should be treated with insulin. History of, or states associated with lactic acidosis or hypoxemia, alcoholism.
The use of Humamet should be stopped 2-3 days before surgery or clinical investigations eg, IV urography and IV angiography. It should be resumed only after control of renal function has been regained.

Humamet is known to be excreted in the kidney thus, patients with impaired renal function should be caution. Regular monitoring of renal function is advisable in all diabetic patients. The use of Humamet is not advised in conditions which may cause dehydration or in patients suffering from serious infections or trauma.
Patients receiving Humamet should have their vitamin B₁₂ levels estimated annually since decreased vitamin B₁₂ absorption has been reported.
When used alone, Humamet is not prone to cause hypoglycemia. However, when given in combination with a sulfonylurea, blood glucose levels should be monitored.
Use in Pregnancy & Lactation: Safety in pregnant women and in nursing mothers has not been established. The use of Humamet during pregnancy or in breastfeeding is not advised.

Safety in pregnant women and in nursing mothers has not been established. The use of Humamet during pregnancy or in breastfeeding is not advised.

The most common adverse effects of Humamet are gastrointestinal disturbances eg, anorexia, nausea, vomiting, diarrhea, flatulence, metallic taste.
Very rarely, lactic acidosis has been associated with Humamet treatment. It is a serious metabolic complication due to accumulation of metformin. It may also occur in association with a number of pathophysiologic conditions including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels, decreased blood pH, electrolyte disturbances with an increase in anion gap and an increased lactate/pyruvate ratio. Lactic acidosis is a medical emergency that must be treated in a hospital immediately.

Interactions with cimetidine and anticoagulants have been reported.
In healthy subjects given single 500-mg doses of cefalexin and metformin, plasma metformin peak plasma concentration (C_max) and area under the curve (AUC) increased by an average of 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. No information is available about the interaction of cefalexin and metformin following multiple dose administration.

Store at controlled room temperatures between 15-30°C.

Antidiabetic Agents

A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.

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