Metformin (met FOR min)

Generic Name: metformin (met FOR min)

Brand Names: Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

Metformin is an oral diabetes medicine that helps control blood sugar levels.
Metformin is used to improve blood sugar control in people with type 2
diabetes. It is sometimes used in combination with insulin or other
medications, but this medicine is not for treating type 1 diabetes.
Metformin may also be used for purposes not listed in this medication guide.

Important information
You should not use metformin if you have severe kidney disease, or if you are
in a state of diabetic ketoacidosis (call your doctor for treatment with
insulin).
If you need to have any type of x-ray or CT scan using a dye that is injected
into your veins, you will need to temporarily stop taking metformin.
This medicine may cause a serious condition called lactic acidosis. Get
emergency medical help if you have even mild symptoms such as: muscle
pain or weakness, numb or cold feeling in your arms and legs, trouble
breathing, stomach pain, nausea with vomiting, slow or uneven heart rate,
dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use metformin if you are allergic to it, or if you have:

severe kidney disease; or

if you are in a state of diabetic ketoacidosis (call your doctor for
treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected
into your veins, you will need to temporarily stop taking metformin.

To make sure metformin is safe for you, tell your doctor if you have:

kidney disease;

liver disease;

a history of heart disease or recent heart attack;

if you have recently taken chlorpropamide; or

if you are over 80 years old and have not recently had your kidney
function checked.

Some people taking metformin develop a serious condition called lactic

acidosis. This may be more likely if you have liver or kidney disease,
congestive heart failure, a severe infection, if you are dehydrated, or if you
drink large amounts of alcohol. Talk with your doctor about your risk.
It is not known whether this medicine will harm an unborn baby. Tell your
doctor if you are pregnant or plan to become pregnant while using this
medicine.
It is not known whether metformin passes into breast milk or if it could harm
a nursing baby. You should not breast-feed while using this medicine.
Metformin should not be given to a child younger than 10 years
old. Extended-release formulations (Glucophage XR, Glumetza,
Fortamet) are not approved for use by anyone younger than 18 years old.

How should I take metformin?

Take metformin exactly as prescribed by your doctor. Follow all directions on
your prescription label. Your doctor may occasionally change your dose to
make sure you get the best results. Do not use this medicine in larger or
smaller amounts or for longer than recommended.
Take metformin with a meal, unless your doctor tells you otherwise. Some
forms of metformin are taken only once daily with the evening meal. Follow
your doctor's instructions.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other
blood tests at your doctor's office.
Low blood sugar (hypoglycemia) can happen to everyone who has
diabetes. Symptoms include headache, hunger, sweating, confusion,
irritability, dizziness, or feeling shaky. Always keep a source of sugar with you
in case you have low blood sugar. Sugar sources include fruit juice, hard
candy, crackers, raisins, and non-diet soda. Be sure your family and close
friends know how to help you in an emergency.
If you have severe hypoglycemia and cannot eat or drink, use a glucagon
injection. Your doctor can prescribe a glucagon emergency injection kit and
tell you how to use it.
Check your blood sugar carefully during times of stress, travel, illness,
surgery or medical emergency, vigorous exercise, or if you drink alcohol or
skip meals. These things can affect your glucose levels and your dose needs
may also change. Do not change your medication dose or schedule
without your doctor's advice.
Metformin is only part of a complete treatment program that may also
include diet, exercise, weight control, and special medical care. Follow your
doctor's instructions very closely.
Your doctor may have you take extra vitamin B12 while you are taking
metformin. Take only the amount of vitamin B12 that your doctor has
prescribed.
Store at room temperature away from moisture, heat, and light.
See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the
medicine with food). Skip the missed dose if it is almost time for your next
scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-2221222. An overdose of metformin may cause lactic acidosis, which
may be fatal.

What should I avoid while taking metformin?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of
lactic acidosis while taking metformin.

Metformin side effects

Get emergency medical help if you have signs of an allergic reaction to
metformin: hives; difficult breathing; swelling of your face, lips, tongue, or
throat.
Some people develop lactic acidosis while taking metformin. Early symptoms
may get worse over time and this condition can be fatal. Get emergency
medical help if you have even mild symptoms such as:

muscle pain or weakness;

numb or cold feeling in your arms and legs;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, nausea with vomiting; or

slow or uneven heart rate.

Common metformin side effects may include:

nausea, vomiting, upset stomach; or

diarrhea.

This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Metformin dosing information

Usual Adult Dose for Diabetes Type 2:
Immediate-release:
Initial dose: 500 mg orally twice a day or 850 mg orally once a day
Dose titration: Increase in 500 mg weekly increments or 850 mg every 2
weeks as tolerated
Maintenance dose: 2000 mg daily
Maximum dose: 2550 mg daily
Comments: Take in divided doses 2 to 3 times a day with meals. Titrate
slowly to minimize gastrointestinal side effects. In general, significant
responses are not observed with doses less than 1500 mg/day.
Extended-release:
Initial dose: 500 to 1000 mg orally once a day
Dose titration: Increase in 500 mg weekly increments as tolerated
Maintenance dose: 2000 mg daily
Maximum dose: 2500 mg daily
Comments: If glycemic control is not achieved with once a day
administration of an extended-release product, consider dividing doses. If
higher doses are required, may switch to immediate-release product.
Use: To improve glycemic control in adults with type 2 diabetes mellitus as
an adjunct to diet and exercise.
Usual Pediatric Dose for Diabetes Type 2:
10 years or older:
Immediate-release:
Initial dose: 500 mg orally twice a day
Dose titration: Increase in 500 mg weekly increments as tolerated
Maintenance dose: 2000 mg daily
Maximum dose: 2000 mg daily
Comments: Take in divided doses 2 to 3 times a day with meals. Titrate

slowly to minimize gastrointestinal side effects.

Safety and effectiveness of metformin extended-release has not been
established in pediatric patients less than 18 years of age.
Use: To improve glycemic control in children with type 2 diabetes mellitus as
an adjunct to diet and exercise.

What other drugs will affect metformin?

Tell your doctor about all your current medicines and any you start or stop
using, especially:

digoxin; or

furosemide.

You may be more likely to have hyperglycemia (high blood sugar) if you take
metformin with other drugs that can raise blood sugar, such as:

phenytoin;

birth control pills or hormone replacement therapy;

diet pills or medicines to treat asthma, colds or allergies;

a diuretic or "water pill";

heart or blood pressure medication;

niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

phenothiazines (Compazine and others);

steroid medicine (prednisone, dexamethasone, and others); or

thyroid medicine (Synthroid and others).

This list is not complete. Other drugs may increase or decrease the effects of
metformin on lowering your blood sugar. Tell your doctor about all
medications you use. This includes prescription and over-the-counter
medicines, vitamins, and herbal products. Not all possible interactions are
listed in this medication guide.

Metformin Side Effects

In Summary
Commonly reported side effects of metformin include: lactic acidosis,
diarrhea, nausea, nausea and vomiting, vomiting, and flatulence. Other side
effects include: diarrhea, nausea, vomiting, decreased vitamin b12 serum
concentrate, and weakness. See below for a comprehensive list of adverse
effects.

For the Consumer

Applies to metformin: oral solution, oral tablet, oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by
metformin. In the event that any of these side effects do occur, they may
require medical attention.
Major Side Effects

You should check with your doctor immediately if any of these side
effects occur when taking metformin:
More common:

Abdominal or stomach discomfort

cough or hoarseness

decreased appetite

diarrhea

fast or shallow breathing

fever or chills

general feeling of discomfort

lower back or side pain

muscle pain or cramping

painful or difficult urination

sleepiness

Less common:

Anxiety

blurred vision

chest discomfort

cold sweats

coma

confusion

cool, pale skin

depression

difficult or labored breathing

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

headache

increased hunger

increased sweating

nausea

nervousness

nightmares

redness of the face, neck, arms, and occasionally, upper chest

seizures

shakiness

shortness of breath

slurred speech

tightness in the chest

unusual tiredness or weakness

wheezing

Rare

Behavior change similar to being drunk

difficulty with concentrating

drowsiness

lack or loss of strength

restless sleep

unusual sleepiness

Minor Side Effects

Some of the side effects that can occur with metformin may not need
medical attention. As your body adjusts to the medicine during treatment
these side effects may go away. Your health care professional may also be
able to tell you about ways to reduce or prevent some of these side effects. If
any of the following side effects continue, are bothersome or if you have any
questions about them, check with your health care professional:
More common:

Acid or sour stomach

belching

bloated

excess air or gas in the stomach or intestines

full feeling

heartburn

indigestion

loss of appetite

metallic taste in the mouth

passing of gas

stomachache

stomach upset or pain

vomiting

weight loss

Less common:

Abnormal stools

bad, unusual, or unpleasant (after) taste

change in taste

difficulty with moving

discoloration of the fingernails or toenails

flu-like symptoms

joint pain

rash

runny nose

sneezing

stuffy nose

swollen joints

For Healthcare Professionals

Applies to metformin: compounding powder, oral solution, oral tablet, oral
tablet extended release
General

Gastrointestinal events such as nausea, vomiting, diarrhea, abdominal pain,

and loss of appetite have been frequently reported during therapy initiation
and resolve spontaneously in most cases.
Adverse events in the pediatric population appear to be similar in nature and
severity to that published in adults.[Ref]
Metabolic

Common (1% to 10%): Hypoglycemia

Very rare (less than 0.01%): Lactic acidosis[Ref]
Gastrointestinal

Very common (10% or more): Diarrhea (53.2%), nausea/vomiting (25.5%),

flatulence (12.1%)
Common (1% to 10%): Indigestion, abdominal discomfort, abnormal stools,
dyspepsia, loss of appetite[Ref]

Hematologic

Very rare (less than 0.01%): Subnormal vitamin B12 levels[Ref]

Other

Common (1% to 10%): Asthenia, chills, flu syndrome, accidental injury [Ref]
Hepatic

Very rare (less than 0.01%): Liver function test abnormalities, hepatitis [Ref]
Cardiovascular

Common (1% to 10%): Chest discomfort, flushing, palpitation[Ref]

Dermatologic

Common (1% to 10%): Rash, nail disorder, increased sweating

Very rare (less than 0.01%): Erythema, pruritus, urticaria[Ref]
Endocrine

Frequency not reported: Reduction in thyrotropin (TSH) levels[Ref]

Immunologic

Very common (10% or more): Infection (20.5%)[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia[Ref]

Nervous system

Common (1% to 10%): Lightheadedness, taste disturbances[Ref]

Psychiatric

Common (1% to 10%): Headache[Ref]

Respiratory

Common (1% to 10%): Rhinitis[Ref]

References
1. "Product Information. Glucophage (metformin)." Bristol-Myers Squibb,
Princeton, NJ.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Fortamet (metFORMIN)." Physicians Total Care, Tulsa,
OK.
4. Cerner Multum, Inc. "Australian Product Information." O 0
5. "Product Information. Riomet (metFORMIN)." Ranbaxy Pharmaceuticals,
Jacksonville, FL.
6. "Product Information. Glumetza (metFORMIN)." Biovail Pharmaceuticals
Canada, Mississauga, IA.
Not all side effects for metformin may be reported. You should always consult
a doctor or healthcare professional for medical advice. Side effects can be
reported to the FDA.

Metformin Dosage
Applies to the following strength(s): 500 mg ; 750 mg ; 850 mg ; 1000 mg ; 500 mg/5
mL
The information at Drugs.com is not a substitute for medical advice. Always consult your
doctor or pharmacist.

Usual Adult Dose for:

Diabetes Type 2

Usual Pediatric Dose for:

Diabetes Type 2

Additional dosage information:

Renal Dose Adjustments

Liver Dose Adjustments

Dose Adjustments

Precautions

Dialysis

Other Comments

Usual Adult Dose for Diabetes Type 2

Immediate-release:
Initial dose: 500 mg orally twice a day or 850 mg orally once a day
Dose titration: Increase in 500 mg weekly increments or 850 mg every 2
weeks as tolerated
Maintenance dose: 2000 mg daily
Maximum dose: 2550 mg daily
Comments: Take in divided doses 2 to 3 times a day with meals. Titrate
slowly to minimize gastrointestinal side effects. In general, significant
responses are not observed with doses less than 1500 mg/day.
Extended-release:
Initial dose: 500 to 1000 mg orally once a day
Dose titration: Increase in 500 mg weekly increments as tolerated
Maintenance dose: 2000 mg daily
Maximum dose: 2500 mg daily
Comments: If glycemic control is not achieved with once a day
administration of an extended-release product, consider dividing doses. If
higher doses are required, may switch to immediate-release product.
Use: To improve glycemic control in adults with type 2 diabetes mellitus as
an adjunct to diet and exercise.

Usual Pediatric Dose for Diabetes Type 2

10 years or older:
Immediate-release:
Initial dose: 500 mg orally twice a day
Dose titration: Increase in 500 mg weekly increments as tolerated

Maintenance dose: 2000 mg daily

Maximum dose: 2000 mg daily
Comments: Take in divided doses 2 to 3 times a day with meals. Titrate
slowly to minimize gastrointestinal side effects.
Safety and effectiveness of metformin extended-release has not been
established in pediatric patients less than 18 years of age.
Use: To improve glycemic control in children with type 2 diabetes mellitus as
an adjunct to diet and exercise.

Renal Dose Adjustments

Obtain eGFR prior to initiating therapy:
-eGFR less than 30 mL/min/1.73 m2: Use is contraindicated
-eGFR 30 to 45 mL/min/1.73 m2: Initiating therapy is not recommended
-eGFR that falls below 30 mL/min/1.73 m2 during therapy: Discontinue
therapy
-eGFR that falls below 45 mL/min/1.73 m2 during therapy: Assess risks
versus benefit of continued therapy
-eGFR greater than 45 mL/min/1.73 m2: No dose adjustments recommended
IODINATED CONTRAST PROCEDURE:
-For patients with eGFR between 30 and 60 mL/min/1.73 m2: Stop this drug
at the time of, or before imaging procedure; re-evaluate eGFR 48 hours after
procedure; restart therapy only if renal function is stable.

Liver Dose Adjustments

Not recommended in patients with liver impairment.

Dose Adjustments
-Elderly, debilitated, and malnourished patients: Titration to the maximum
dose is generally not recommended.
-Concomitant Insulin therapy: When initiating treatment in patients currently
receiving insulin, metformin should be started at 500 mg orally once a day

and titrated in 500 mg increments weekly. When fasting blood glucose levels
decrease to less than 120 mg/dL, consider decreasing the insulin dose by
10% to 25%.
Therapeutic drug monitoring/range: Steady-state plasma concentrations are
achieved within 24 to 48 hours and are generally less than 1 mcg/mL.
Metformin levels greater than 5 mcg/mL have been implicated as the cause
of lactic acidosis.

Precautions
US BOXED WARNING: Lactic Acidosis
-Lactic acidosis is a rare, but serious complication that may occur due to
metformin accumulation.
-Increased risk is associated with renal impairment, sepsis, dehydration,
excess alcohol intake, hepatic impairment, and acute congestive heart
failure.
-Onset is often subtle, accompanied by nonspecific symptoms such as
malaise, myalgia, respiratory distress, increasing somnolence, and
nonspecific gastrointestinal distress.
-Laboratory abnormalities include low pH, increased anion gap, and elevated
blood lactate.
-If acidosis is suspected, immediately discontinue drug and hospitalize
patient.
Safety and efficacy have not been established in patients younger than 10
years.
Consult WARNINGS section for additional precautions.

Dialysis
Data not available.

Other Comments
Administration advice:
-Take with meals
-Gastrointestinal tolerability may be improved by a slow increase in dosage.

-Extended-release product: Take with evening meal; swallow whole; do not

crush, cut, dissolve, or chew
General:
-Not for use in patients with type 1 diabetes or diabetic ketoacidosis.
-Temporarily stop treatment prior to radiologic studies utilizing iodinated
contrast materials and for surgical procedures when restricted food or fluid
intake is expected; may resume once adequate renal function is confirmed.
Monitoring:
Renal: Assess renal function baseline, repeat at least annually and more
often as clinically indicated.
Hematologic: Measure hematologic parameters annually
-Monitor glycemic control
Patient advice:
-Tablet shells may appear in feces, and this should not cause alarm.
-Inform patients about the risk of lactic acidosis, conditions that might
predispose them to its occurrence, and symptoms to watch for and report.
-Advise patient that this drug will need to be temporarily stopped if
undergoing radiologic studies with intravascular iodinated contrast materials
or surgical procedures that will limit food or fluid intake.
-Advise patients on the risks of excessive alcohol intake.
-Tell patients that while gastrointestinal symptoms might be common when
initiating treatment, gastrointestinal problems after initiation should be
reported.