Metformin (metformin hydrochloride)

The US label for metformin hydrochloride tablets lists use alongside diet and exercise to improve blood sugar control in type 2 diabetes.

It covers adults and children aged 10 years and older.

• Type 2 diabetes in adults
• Type 2 diabetes in children aged 10 and older

The label describes metformin as an antihyperglycaemic agent. It lowers blood sugar both between meals and after meals.

It works by reducing sugar made by the liver, reducing sugar absorbed from the gut, and helping the body use sugar better. The label says insulin release itself is not changed.

This page covers the US label for metformin hydrochloride tablets taken by mouth, with the adult dosing the label gives.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults, the label describes a starting dose of 500 mg twice a day or 850 mg once a day, with meals. The dose may be raised step by step, to a label maximum of 2,550 mg a day in divided doses.

For children aged 10 and older, the label describes 500 mg twice a day with meals, to a maximum of 2,000 mg a day.

Kidney function is checked before starting and periodically afterwards. The label says it may need to be paused around some contrast scans. Ask your doctor or pharmacist before any change.

• Taken with meals
• Dose is raised in steps on the prescriber's advice
• Kidney function checks before and during treatment
• May be paused around contrast imaging

It must not be used in severe kidney impairment, in people allergic to metformin, or in metabolic acidosis including diabetic ketoacidosis.

The label lists risk factors for lactic acidosis: kidney or liver impairment, age 65 and over, contrast scans, surgery, low-oxygen states such as acute heart failure, and heavy alcohol use.

The label says to avoid metformin in people with liver impairment and to check kidney function more often in older adults.

In pregnancy, the label says limited data cannot define the risk. It also notes metformin may restore ovulation in some women, so unplanned pregnancy is possible.

• Severe kidney impairment: do not use
• Liver impairment: avoid
• Age 65 and over: more frequent kidney checks
• Heavy alcohol use: raises lactic acidosis risk
• Before contrast scans or surgery: tell your doctor
• Pregnancy: ask your doctor

• Topiramate, zonisamide, acetazolamide
• Cimetidine, dolutegravir, ranolazine, vandetanib
• Alcohol
• Insulin and sulfonylureas: low blood sugar
• The label names carbonic anhydrase inhibitors such as topiramate, zonisamide and acetazolamide, which may raise the risk of lactic acidosis.
• Medicines that slow metformin clearance by the kidney, such as cimetidine, dolutegravir, ranolazine and vandetanib, can raise exposure.
• Alcohol increases the effect of metformin on lactate.
• Using insulin or sulfonylureas with metformin raises the risk of low blood sugar, and some other medicines can change blood sugar control.
• Tell your doctor and pharmacist about all your medicines.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says overdoses, including more than 50 grams, have occurred. About 32% of reported cases had lactic acidosis, and about 10% had low blood sugar.

Metformin can be removed by dialysis. Seek emergency care or contact a poison control centre.

The label text we reviewed gives only the packaging of this product and no storage temperature.

Follow the storage line on your own pack and keep medicines away from children.

We did not find metformin in the Drugs Rules schedule lists we checked, so we cannot state its prescription status from our sources. Ask your pharmacist or doctor.

It is on the National List of Essential Medicines 2022 as 500 mg and 1000 mg tablets and a 1000 mg modified-release tablet (page 97).

The Jan Aushadhi list we checked includes metformin tablets and sustained-release tablets, plus several combinations with glimepiride or voglibose. Metformin appears in 27 entries of the banned-combination list we checked, so check any combination product.

NPPA lists ceilings per tablet in two lists, shown above. They are ceilings, not the price you will always pay.

Jan Aushadhi lists metformin 500 mg tablets, sustained-release tablets of 500, 850 and 1000 mg, and combinations. Check the pack and the seller for the actual price.