Metformin Hydrochloride Tablets | Oral Antihyperglycemic Therapy
Important Safety Information: Metformin Hydrochloride Tablets | Oral Antihyperglycemic Therapy
What is this?
This Important Safety Information summarizes key warnings and precautions for Metformin Hydrochloride Tablets, an oral biguanide medication used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus . Metformin works by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity. This summary does not include all available information. Always read your medication label and follow your healthcare provider’s instructions.
Most Serious Warnings
Product can cause:
Lactic acidosis, a rare but serious condition that can result in death
Elevated blood lactate levels with symptoms such as malaise, muscle pain, respiratory distress, somnolence, abdominal pain, hypotension, or irregular heartbeat
Increased risk of lactic acidosis in patients with renal impairment, age 65 years or older, contrast imaging exposure, surgery, hypoxic states, excessive alcohol intake, or hepatic impairment
Lactic acidosis is a medical emergency. If suspected, discontinue metformin and seek immediate medical care.
Who Should NOT Take Metformin
Do not take this medication if you:
Have severe renal impairment (eGFR below 30 mL/min/1.73 m²)
Have a known hypersensitivity to metformin
Have acute or chronic metabolic acidosis, including diabetic ketoacidosis
Before Taking Metformin, Tell Your Healthcare Provider if You:
Have kidney problems or reduced renal function
Have liver disease or hepatic impairment
Are over age 65
Consume alcohol regularly or engage in binge drinking
Are scheduled for surgery or iodinated contrast imaging procedures
Have heart failure, recent heart attack, severe infection, or other hypoxic conditions
Take insulin or insulin secretagogues, as dose adjustments may be required to reduce risk of hypoglycemia
Are pregnant, planning pregnancy, or breastfeeding
Take prescription, over the counter, or herbal medications, including carbonic anhydrase inhibitors or drugs that may reduce metformin clearance
Possible Side Effects
Common (mild to moderate):
Diarrhea
Nausea or vomiting
Flatulence
Abdominal discomfort or indigestion
Headache
Metformin may also lower vitamin B12 levels with long-term use. Periodic monitoring is recommended .
Serious (seek medical care immediately):
Symptoms of lactic acidosis such as weakness, unusual muscle pain, breathing difficulty, dizziness, feeling cold, irregular heartbeat, or severe abdominal pain
Severe allergic reactions
Signs of severe hypoglycemia when used with insulin or insulin secretagogues
While Taking Metformin
Tell your healthcare provider immediately if you:
Develop symptoms consistent with lactic acidosis
Experience dehydration, severe infection, or reduced food and fluid intake
Are scheduled for surgery or contrast imaging procedures
Experience persistent gastrointestinal symptoms or signs of vitamin B12 deficiency
Pregnancy and Lactation
Limited data in pregnancy are not sufficient to determine drug-associated risk. Metformin is present in human milk, but data are limited regarding infant risk. Discuss risks and benefits with your healthcare provider.
Overdose
Metformin overdose has been associated with hypoglycemia and lactic acidosis . If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.
Missed Dosage
If you miss a dose:
Take the next dose as prescribed
Do not double your next dose
Contact your healthcare provider if you are unsure how to resume therapy
Storage
Store at 20° to 25°C (68° to 77°F)
Dispense in tight, light-resistant containers with child-resistant closure
Keep out of reach of children
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains. Contact your pharmacy for disposal instructions.
Provider Oversight and Order Review
This prescription requires evaluation and ongoing monitoring by a licensed healthcare provider. Renal function should be assessed prior to initiation and periodically thereafter . Dose adjustments may be required based on kidney function, age, concomitant medications, or clinical response.
Telemedicine Disclosure
If this prescription was issued via telemedicine and you experience severe or concerning symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about Metformin Hydrochloride Tablets and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
