Comet XR 500

Generic

Metformin Hydrochloride

 

Indications

Treatment of type 2 diabetes mellitus, especially in overweight people, when food and exercise alone are unable to provide appropriate glycemic control.

• Metformin can be used alone or in conjunction with other oral antidiabetic drugs or insulin in adults.
• Metformin can be taken alone or in conjunction with insulin in children and adolescents as young as ten years old.

In overweight type 2 diabetes adult patients treated with metformin as first-line treatment following diet failure, there was a decrease in diabetic complications.

 

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 Hydrochloride Dosage: Metformin Hydrochloride dosage should be customized based on efficacy and tolerance, while not exceeding the maximum suggested daily dosages.

• 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 should be swallowed whole, without being crushed, chopped, or chewed.

• 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

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 substance or to any of the excipients.
• Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
• Severe renal failure (GFR <30 mL/min).
• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
• Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.

 

Side Effects

Hemolytic anemia is a blood and lymphatic system disease that is not well understood.

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Taste disturbance is a common nervous system disease. Encephalopathy is a condition that is currently unknown.

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Isolated instances of liver function test problems or hepatitis resolving after metformin cessation are extremely rare.

Skin and subcutaneous tissue disorders: Erythema, pruritus, and urticaria are extremely infrequent.

 

Pregnancy & Lactation

Uncontrolled diabetes (gestational or permanent) during pregnancy is linked to an increased risk of congenital malformations and perinatal death. When a patient intends to become pregnant or is pregnant, it is advised that diabetes be managed with insulin rather than metformin to keep blood glucose levels as near to normal as possible, reducing the risk of foetal abnormalities.

Metformin is secreted in human breast milk during breastfeeding. In breastfed newborns/infants, no harmful effects were found. Breastfeeding is not suggested when using metformin since there is insufficient data. The benefits of nursing and the possible danger of harmful effects on the kid should be considered while deciding whether or not to stop breastfeeding.

 

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 the temperature below 30°C and away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.