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Metformin prescribing information

 



Full prescription information or package insert for Metformin

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Metformin

Why is this drug prescribed? Glucophage is an oral antidiabetic medication used to treat type 2 non-insulin-dependent) diabetes. Diabetes develops when the body proves unable to burn sugar and the unused sugar builds up in the bloodstream. Glucophage lowers the amount of sugar in your blood by decreasing sugar production and absorption and helping your body respond better to its own insulin, which promotes the burning of sugar. It does not, however, increase the body's production of insulin. Glucophage is sometimes prescribed along with insulin or certain other oral antidiabetic drugs such as Micronase or Glucotrol. It is also used alone. Standard Glucophage tablets are taken two or three times daily. An extended-release form (Glucophage XR) is available for once-daily dosing. Most important fact about this drug: Always remember that Glucophage is an aid to, not a substitute for, good diet and exercise. Failure to follow a sound diet and exercise plan can lead to serious complications such as dangerously high or low blood sugar levels. Remember, too, that Glucophage is not an oral form of insulin and cannot be used in place of insulin. How should you take this medication? Do not take more or less of this medication than directed by your doctor. The drug should be taken with food to reduce the possibility of nausea or diarrhea, especially during the first few weeks of therapy. If taking Glucophage XR, be sure to swallow the tablet whole; do not crush it or chew it. The inactive ingredients in the tablet may occasionally appear in the stool. This is not a cause for concern. • If you miss a dose... Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time. • Storage instructions... Store it at room temperature. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Glucophage. If side effects from Glucophage occur, they usually happen during the first few weeks of therapy. Most side effects are minor and will go away after you've taken Glucophage for a while. • More common side effects may include: Abdominal discomfort, diarrhea, gas, headache, indigestion, nausea, vomiting, weakness • Less common side effects may include: Abdominal distention, abnormal stools, altered sense of taste, chest discomfort, chills, constipation, dizziness, flu-like symptoms, flushing, increased sweating, low blood sugar, light-headedness, muscle pain, nail disorders, pounding heartbeat, rash, shortness of breath, upper respiratory infection Glucophage, unlike other oral antidiabetics, does not usually cause hypoglycemia (low blood sugar). However, hypoglycemia remains a possibility, especially in older, weak, and undernourished people and those with kidney, liver, adrenal, or pituitary gland problems. The risk of hypoglycemia increases when Glucophage is combined with other diabetes medications. The risk is also boosted by missed meals, alcohol, and excessive exercise. To avoid hypoglycemia, you should closely follow the dietary and exercise plan suggested by your physician. If you feel hypoglycemia coming on, get some fast-acting sugar, such as a 4 to 6 ounce glass of fruit juice. Glucophage can cause a serious side effect called lactic acidosis, a buildup of lactic acid in the blood. This problem is most likely to occur in people whose liver or kidneys are not working well, and in those who have multiple medical problems, take several medications, or have congestive heart failure. The risk also is higher if you are an older adult or drink alcohol. Although the condition is rare, it can be fatal. Lactic acidosis is a medical emergency that must be treated in a hospital. • Symptoms of lactic acidosis may include: Feeling very weak, tired, or uncomfortable, feeling cold, dizzy, or light-headed, increasing sleepiness, muscle pain, slow or irregular heartbeat, trouble breathing, unexpected or unusual stomach discomfort (especially if you already have been taking Glucophage for a while). If you notice these symptoms, stop taking Glucophage and call your doctor right away. Why should this drug not be prescribed? Avoid Glucophage if it has ever given you an allergic reaction. If you have congestive heart failure, do not take Glucophage. This condition increases your risk of developing lactic acidosis. Do not take Glucophage if you are suffering from acute or chronic metabolic acidosis, including diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath). You should not take Glucophage for 2 days before and after having an X-ray procedure with an injectable contrast agent (radioactive iodine). Also, if you are going to have surgery, except minor surgery, you should stop taking Glucophage. Once you have resumed normal food and fluid intake, your doctor will tell you when you can go back to therapy with Glucophage. If you have kidney or liver disease or develop serious conditions such as a heart attack, severe infection, or a stroke, do not take Glucophage. You should not take Glucophage if you are seriously dehydrated, having lost a large amount of fluid from severe vomiting, diarrhea, or high fever. If you lose control of your blood sugar due to the stress of a fever, injury, infection, or surgery, your doctor may temporarily take you off of Glucophage and ask you to take insulin instead. Special warnings about this medication: Before you start therapy with Glucophage, and at least once a year thereafter, your doctor will do a complete assessment of your kidney function. If you develop kidney problems while on Glucophage, your doctor will discontinue this medication. If you are an older person, you will need to have your kidney function monitored more frequently, and your doctor may want to start you at a lower dosage. If you are taking Glucophage, you should check your blood or urine periodically for abnormal sugar (glucose) levels. Your doctor will do annual blood checks to see if Glucophage is causing a vitamin B12 deficiency or any other blood problem. It's possible that drugs such as Glucophage may lead to more heart problems than diet treatment alone, or diet plus insulin. If you have a heart condition, you may want to discuss this with your doctor. The effectiveness of any oral antidiabetic, including Glucophage, may decrease with time. This may be due to either a diminished responsiveness to the medication or a worsening of the diabetes. Possible food and drug interactions when taking this medication: If Glucophage is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Glucophage with the following: Amiloride (Moduretic) Calcium channel blockers (heart medications) such as Calan, Isoptin, and Procardia Cimetidine (Tagamet) Decongestant, airway-opening drugs such as Sudafed and Ventolin Digoxin (Lanoxin) Estrogens such as Premarin Furosemide (Lasix) Isoniazid (Rifamate), a drug used for tuberculosis Major tranquilizers such as Thorazine Morphine Niacin (Niaspan) Oral contraceptives Phenytoin (Dilantin) Procainamide (Procanbid, Pronestyl) Quinidine (Quinidex) Quinine Ranitidine (Zantac) Steroids such as prednisone (Deltasone) Thyroid hormones (Synthroid) Triamterene (Dyazide, Dyrenium) Trimethoprim (Bactrim, Septra) Vancomycin (Vancocin) Water pills (diuretics) such as HydroDIURIL, Dyazide, and Moduretic Do not drink too much alcohol, since excessive alcohol consumption can cause low blood sugar and alcohol enhances some effects of this drug. Special information if you are pregnant or breastfeeding: If you are pregnant or plan to become pregnant, tell your doctor immediately. Glucophage should not be taken during pregnancy. Since studies suggest the importance of maintaining normal blood sugar (glucose) levels during pregnancy, your doctor may prescribe insulin injections instead. It is not known whether Glucophage appears in human breast milk. Therefore, women should discuss with their doctors whether to discontinue the medication or to stop breastfeeding. If the medication is discontinued and if diet alone does not control glucose levels, then your doctor may consider insulin injections. Recommended dosage Your doctor will tailor your dosage to your individual needs. ADULTS: Glucophage The usual starting dose is one 500-milligram tablet twice a day, taken with morning and evening meals. Your doctor may increase your daily dose by 500 milligrams at weekly intervals, based on your response up to a total of 2,000 milligrams. An alternative starting dose is one 850-milligram tablet a day, taken with the morning meal. Your doctor may increase this by 850 milligrams at 14-day intervals, to a maximum of 2,550 milligrams a day. The usual maintenance dose ranges from 1,500 to 2,550 milligrams daily. If you take more than 2,000 milligrams a day, your doctor may recommend that the medication be divided into three doses, taken with each meal. Glucophage XR The usual starting dose is one 500-milligram tablet once daily with the evening meal. Your doctor may increase your dose by 500 milligrams at weekly intervals, up to a maximum dosage of 2,000 milligrams a day. If a single 2,000-milligram dose fails to control your blood sugar, you may be asked to take 1,000-milligram doses twice a day. If you need more than 2,000 milligrams a day, the doctor will switch you to regular Glucophage. CHILDREN: Glucophage For children 10 to 16 years old, the usual starting dose is one 500-milligram tablet twice a day with meals. The dosage may be increased by 500 milligrams at weekly intervals up to a maximum of 2,000 milligrams daily. Glucophage has not been tested in children younger than 10. Glucophage XR This form of the drug has not been tested in children younger than 17. OLDER ADULTS: Older people and those who are malnourished or in a weakened state are generally given lower doses of Glucophage because their kidneys may be weaker, making side effects more likely. Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice. Metformin notes: This drug is used to treat the type 2 diabetes or more scientifically diabetes mellitus. Metformin effects in reducing blood sugar level and helps our body in energy generation. The intake of metformin during pregnancy or breastfeeding should be properly verified and discussed by the doctor. The dosage for adults can start with two tablets of 500 mg per day with meals and can be increased further gradually as prescribed by the doctor. And it remains the same for children at starting and can be increased weekly if required. Weak and malnourished people are given lower dosage of this glucophage as it can make them weaker. During the first period of treatment it may show some minor side effects like, headache, dizziness, nausea, vomiting, gas, diarrhea, weakness, weight loss etc. But the treatment should be avoided if it gives you allergic reactions at first. This metformin is used as an ingredient for the drugs like Adimet and Merckformin in some countries. Metformin dosage should be taken only after doctor’s advice. Metformin side effects can’t be anticipated. In case, it develops any side effects or transform in intensity, do not wait and immediately tell your doctor. Your doctor only can decide if it’s safe or not for you the continue intake of Glucophage. Metformin 500 mg is usually prescribed by the physicians. Metformin and pregnancy should be taken care of. If any side effects occur from the intake of Glucophage, they generally happen for some weeks of the therapy. Lots of side effects are small as well as they will go when you have taken Glucophage. Usual starting dosage of metformin is 500 mg twice in a day. Metformin weight loss can be seen while taking these drugs. It is always advisable to take these drugs when required to protect yourself from any kind of harm in the future. PLoS One. 2010 Jan 18;5(1):e8758. Metformin induces a dietary restriction-like state and the oxidative stress response to extend C. elegans Healthspan via AMPK, LKB1, and SKN-1. Onken B, Driscoll M. Department of Molecular Biology and Biochemistry, Rutgers University, Piscataway, New Jersey, United States of America. Abstract Metformin, a biguanide drug commonly used to treat type-2 diabetes, has been noted to extend healthspan of nondiabetic mice, but this outcome, and the molecular mechanisms that underlie it, have received relatively little experimental attention. To develop a genetic model for study of biguanide effects on healthspan, we investigated metformin impact on aging Caenorhabditis elegans. We found that metformin increases nematode healthspan, slowing lipofuscin accumulation, extending median lifespan, and prolonging youthful locomotory ability in a dose-dependent manner. Genetic data suggest that metformin acts through a mechanism similar to that operative in eating-impaired dietary restriction (DR) mutants, but independent of the insulin signaling pathway. Energy sensor AMPK and AMPK-activating kinase LKB1, which are activated in mammals by metformin treatment, are essential for health benefits in C. elegans, suggesting that metformin engages a metabolic loop conserved across phyla. We also show that the conserved oxidative stress-responsive transcription factor SKN-1/Nrf2 is essential for metformin healthspan benefits in C. elegans, a mechanistic requirement not previously described in mammals. skn-1, which functions in nematode sensory neurons to promote DR longevity benefits and in intestines for oxidative stress resistance lifespan benefits, must be expressed in both neurons and intestines for metformin-promoted healthspan extension, supporting that metformin improves healthy middle-life aging by activating both DR and antioxidant defense longevity pathways. In addition to defining molecular players operative in metformin healthspan benefits, our data suggest that metformin may be a plausible pharmacological intervention to promote healthy human aging.


Diabetes Care. 2010 Jul;33(7):1484-90.
Chatterjee R, Narayan KM, Lipscomb J, Phillips LS.
Corresponding author: Ranee Chatterjee, rchatte2@jhu.edu.

Screening adults for pre-diabetes and diabetes may be cost-saving.

OBJECTIVE The economic costs of hyperglycemia are substantial. Early detection would allow management to prevent or delay development of diabetes and diabetes-related complications. We investigated the economic justification for screening for pre-diabetes/diabetes. RESEARCH DESIGN AND METHODS We projected health system and societal costs over 3 years for 1,259 adults, comparing costs associated with five opportunistic screening tests. All subjects had measurements taken of random plasma and capillary glucose (RPG and RCG), A1C, and plasma and capillary glucose 1 h after a 50 g oral glucose challenge test without prior fasting (GCT-pl and GCT-cap), and a subsequent diagnostic 75 g oral glucose tolerance test (OGTT). RESULTS Assuming 70% specificity screening cutoffs, Medicare costs for testing, retail costs for generic metformin, and costs for false negatives as 10% of reported costs associated with pre-diabetes/diabetes, health system costs over 3 years for the different screening tests would be GCT-pl $180,635; GCT-cap $182,980; RPG $182,780; RCG $186,090; and A1C $192,261; all lower than costs for no screening, which would be $205,966. Under varying assumptions, projected health system costs for screening and treatment with metformin or lifestyle modification would be less than costs for no screening as long as disease prevalence is at least 70% of that of our population and false-negative costs are at least 10% of disease costs. Societal costs would equal or exceed costs of no screening depending on treatment type. CONCLUSIONS Screening appears to be cost-saving compared to no screening from a health system perspective, and potentially cost-neutral from a societal perspective. These data suggest that strong consideration should be given to screening-with preventive management-and that use of GCTs may be cost-effective.


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