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 could be a biguanide sort verbal antihyperglycemic sedate utilized within the administration of sort 2 diabetes. It brings down both basal and postprandial plasma glucose. Its component of activity is distinctive from those of sulfonylureas and it does not deliver hypoglycemia. Metformin diminishes hepatic glucose generation, diminishes intestinal assimilation of glucose and moves forward affront affectability by an increment in fringe glucose take-up 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 with Carbonic anhydrase (Topiramate, Zonisamide) may increment hazard of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that decrease Metformin clearance may increment the collection of Metformin. Liquor can potentiate the impact of Metformin on lactate digestion system.

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 Effect

Blood and lymphatic framework disarranges: Not known: Hemolytic anemia Metabolism and sustenance disarranges: Exceptionally uncommon: Lactic acidosis. Diminish of vitamin B12 assimilation with a diminish of serum levels amid long-term utilize of metformin. Thought of such etiology is prescribed in case a persistent presents with megaloblastic frailty. Cases of fringe neuropathy in patients with vitamin B12 lack have been detailed in post-marketing involvement (recurrence not known) Nervous framework clutters: Common: Taste unsettling influence. Not known: Encephalopathy Gastrointestinal clutters: Exceptionally common: Gastrointestinal disarranges, such as queasiness, spewing, loose bowels, stomach torment, and misfortune of craving. These undesirable impacts happen most habitually amid the start of treatment and resolve suddenly in most cases. To avoid them, it is suggested that metformin be taken in 2 or 3 every day measurements amid or after dinners. A moderate increment of the dosage may too make strides gastrointestinal tolerability.

Pregnancy & Lactation

Pregnancy: Uncontrolled diabetes amid pregnancy (gestational or changeless) is related with an expanded hazard of intrinsic anomalies and perinatal mortality. When the persistent plans to ended up pregnant and amid pregnancy, it is prescribed that diabetes isn’t treated with metformin but insulin be utilized to preserve blood glucose levels as near to ordinary as conceivable, to decrease the hazard of deformities of the foetus. Breastfeeding: Metformin is excreted into human breast drain. No unfavorable efects were watched in breastfed newborns/infants. In any case, as only constrained information are accessible, breastfeeding isn’t suggested amid metformin treatment. A decision on whether to discontinue breastfeeding ought to be made, taking under consideration the advantage of breastfeeding and the potential chance to unfavorable impacts on the child.

Precautions & Warnings

Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.

Therapeutic Class

Biguanides

Storage Conditions

Store below 30° C in a cold, dry, and light-protected location. Keep out of children’s reach. Because touching the dropper tip to surfaces can contaminate the solution, avoid doing so. After 30 days from the date of initial opening, do not use.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.