Metform ER 500Tablet

Generic

Metformin Hydrochloride

Indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.

• In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
• In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

Pharmacology

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

Dosage & Administration

Metformin immediate release 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.

tablet: Dosage of Metformin Hydrochloride must be individualized on

Interaction

Carbonic anhydrase (Topiramate, Zonisamide) co-administration may raise the risk of lactic acidosis. Drugs that decrease Metformin clearance (Ranolazine, Dolutegravir, Cimetidine) may cause Metformin buildup. Metformin's effect on lactate metabolism can be amplified by alcohol.

Contraindications

• Hypersensitivity to the active ingredient or any excipient.
• Acute metabolic acidosis of any kind (such as lactic acidosis, diabetic ketoacidosis).
• Renal failure with a GFR of less than 30 mL/min.
• Dehydration, severe infection, and shock are examples of acute diseases that might affect renal function.
• Acute or chronic conditions that produce tissue hypoxia, such as cardiac or respiratory failure, recent myocardial infarction, shock, etc. Hepatic insufficiency, acute alcohol intoxication, and alcoholism are all examples of hepatic insufficiency.

Side Effects

Blood and lymphatic system diseases: unknown: hemolytic anemia

Metabolism and nutritional disorders: very rare: lactic acidosis. During the long-term use of metformin, the absorption of vitamin B12 decreases and the serum level decreases. If the patient has megaloblastic anemia, it is recommended to consider this cause. In post-marketing experience, cases of peripheral neuropathy have been reported in patients with vitamin B12 deficiency (frequency unknown)

Nervous system diseases: common: dysgeusia. Unknown: encephalopathy

Gastrointestinal diseases: very common: gastrointestinal diseases such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These adverse reactions occur most frequently during the initiation of treatment and, in most cases, will resolve on their own. To prevent them, it is recommended to take metformin 2 or 3 times a day during or after meals. Slowly increasing the dose can also improve gastrointestinal tolerance.

Hepatobiliary disease: very rare: isolated reports of abnormal liver function tests or resolution of hepatitis after discontinuation of metformin.

Diseases of the skin and subcutaneous tissue: very rare: skin reactions such as erythema, itching, urticaria.

Pregnancy & Lactation

Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.

Precautions & Warnings

Metformin Hydrochloride is known to be eliminated in large amounts via the kidneys, and the danger of Metformin buildup and lactic acidosis rises as renal function declines. Metformin has been linked to a reduction in vitamin B12 levels. When combined with insulin or an insulin secretagogue, it 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

ACI Limited