Metfo XR 500

Generic

Metformin Hydrochloride

 

Indications

Treatment of type 2 diabetes mellitus, especially in obese individuals, when food and exercise therapy alone do not result in sufficient glycemic control.

• Metformin can be used alone or in conjunction with other oral diabetes medications or insulin in adults.
• Metformin can be taken alone or in conjunction with insulin in children and adolescents as young as 10 years old.

Metformin as first-line treatment after diet failure has been demonstrated to reduce diabetes complications in overweight type 2 diabetic adult patients.

 

Pharmacology

Metformin is an oral antihyperglycemic medication of the biguanide class that is used to treat type 2 diabetes. It reduces both basal and postprandial plasma glucose levels. It has a different mode of action than sulfonylureas and does not cause hypoglycemia. Metformin reduces hepatic glucose synthesis, lowers intestinal glucose absorption, and increases insulin sensitivity by increasing peripheral glucose uptake and utilization.

 

Dosage & Administration

Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.

• Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
• Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.

• Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
• Children: Metformin extended release tablet has not been studied in children.
• Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m². Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m².

 

Interaction

Co-administration of topiramate and zonisamide with carbonic anhydrase may raise the risk of lactic acidosis. Metformin buildup may be increased by drugs that decrease Metformin clearance (Ranolazine, Dolutegravir, Cimetidine). Metformin's effect on lactate metabolism can be exacerbated by alcohol.

 

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients
• Acute metabolic acidosis of any sort (such as lactic acidosis, diabetic ketoacidosis).
• Severe renal failure (GFR less than 30 mL/min).
• Dehydration, severe infection, and shock are examples of acute situations that have the potential to impair renal function.
• Acute or chronic illness that can result in tissue hypoxia, such as cardiac or respiratory failure, recent myocardial infarction, shock, etc. Alcoholism, hepatic insufficiency, and acute alcohol intoxication.

 

Side Effects

Disorders of the circulatory and lymphatic systems: The following are unknown: Hemolytic anemia is a kind of anemia that occurs in the blood.

Disorders of metabolism and nutrition: Lactic acidosis is quite uncommon. Metformin usage causes a reduction in vitamin B12 absorption as well as a drop in blood levels. If a patient has megaloblastic anemia, such an etiology should be considered. In post-marketing experience, cases of peripheral neuropathy in individuals with vitamin B12 insufficiency have been recorded (frequency not known)

Taste disturbance is a common nervous system disease. The following are unknown: Encephalopathy

Gastrointestinal problems, such as nausea, vomiting, diarrhea, stomach discomfort, and loss of appetite, are quite frequent. These unfavorable effects occur most commonly over the course of therapy and, in most cases, disappear spontaneously. Metformin should be taken in two or three daily doses during or after meals to avoid them. A gradual increase in dosage may also help with gastrointestinal tolerability.

Hepatobiliary problems are extremely rare, with just a few isolated instances of liver function test abnormalities or hepatitis resolving after metformin cessation.

Skin and subcutaneous tissue disorders: Skin responses such as erythema, pruritus, and urticaria are quite uncommon.

 

Pregnancy & Lactation

Pregnancy: Uncontrolled diabetes (whether gestational or permanent) increases the risk of congenital malformations and perinatal death. When a patient intends to become pregnant or is pregnant, it is advised that diabetes not be treated with metformin, but that insulin be used to keep blood glucose levels as close to normal as possible in order to decrease the risk of foetal abnormalities.

Breastfeeding: Metformin can be found in human breast milk. There were no negative effects detected in breastfed newborns/infants. However, due to the scarcity of evidence, nursing is not advised with metformin medication. The choice to cease nursing should be taken after considering the benefits of breastfeeding as well as the potential danger of harmful consequences on the child.

 

Precautions & Warnings

Metformin Hydrochloride is significantly eliminated through the kidney, and the risk of Metformin buildup and lactic acidosis increases with the degree of renal function impairment. Metformin has been linked to a decrease in vitamin B12 levels. When used with insulin or an insulin secretagogue, it also raises the risk of hypoglycemia.

 

Therapeutic Class

Biguanides

 

Storage Conditions

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name

Pacific Pharmaceuticals Ltd.