Glucophage

Glucophage is part of the drug class:

• Biguanides

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix)
• estrogens
• insulins or other medicines for diabetes
• isoniazid (INH, Nydrazid)
• morphine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of Glucophage drug interactions. Ask your doctor or pharmacist for more information.

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Glucophage.

Take Glucophage exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting dose of Glucophage is 500 mg twice daily or 850 mg once a day (in people 17 and older), given with meals. The maximum recommended daily dose is 2000 mg in children (10 to 16 years of age) and 2550 mg in adults. The dosage should be increased slowly to avoid side effects.

The maximum total daily dose of Glucophage for people taking insulin is 2500 mg.

In the U.S.

• Fortamet
• Glucophage
• Glucophage XR
• Glumetza
• Riomet

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Solution

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

Use Glucophage as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals.
• Take with a full glass of water.
• This medicine may be used alone or with other high blood sugar (diabetes) drugs.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad belly pain.
• Fever or chills.
• Sore throat.
• It is common to have stomach problems like upset stomach, throwing up, or loose stools (diarrhea) when you start taking Glucophage. If you have stomach problems later during care, call your doctor right away. This may be a sign of an acid health problem in the blood (lactic acidosis).
• Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Glucophage (metformin hydrochloride) Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

Glucophage XR (metformin hydrochloride) Extended-Release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

Get emergency medical help if you have signs of an allergic reaction to Glucophage: 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 Glucophage 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.

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]

Some side effects of Glucophage may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.