Metformin
Hydrochloride
Tablets
Rx only

/Metformin
Hydrochloride
Tablets
Rx only
Metformin
Hydrochloride
Tablets
Rx only
2018-09-06T09:12:40+00:00

Prescription Drug Name:

Metformin
Hydrochloride
Tablets
Rx only

ID:

A757F9F8-A925-4E47-9B83-131CCCF8E470

Code:

34391-3

DESCRIPTION


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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5• HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.Metformin hydrochloride tablets contain 500 mg, 850 mg or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone. In addition, the coating for each tablet contains hypromellose, lactose monohydrate, red iron oxide, titanium dioxide, triacetin, vanillin and yellow iron oxide.

INDICATIONS AND USAGE


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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin is indicated in patients 10 years of age and older.Metformin may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).

CONTRAINDICATIONS


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displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Metformin hydrochloride tablets are contraindicated in patients with:Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).Congestive heart failure requiring pharmacologic treatment.Known hypersensitivity to metformin hydrochloride.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS.)

ADVERSE REACTIONS


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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

In a U.S. double-blind clinical study of metformin in patients with type 2 diabetes, a total of 141 patients received metformin therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin patients, and that were more common in metformin- than placebo-treated patients, are listed in Table 7.

Table 7. Most Common Adverse Reactions (>5%) in a Placebo-Controlled Clinical Study of Metformin Monotherapy*
Metformin Monotherapy Placebo
n=141 n=145
* Reactions that were more common in metformin- than placebo-treated patients.
Adverse Reaction % of patients
Diarrhea 53.2 11.7
Nausea/Vomiting 25.5 8.3
Flatulence 12.1 5.5
Asthenia 9.2 5.5
Indigestion 7.1 4.1
Abdominal Discomfort 6.4 4.8
Headache 5.7 4.8
Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin. Additionally, the following adverse reactions were reported in ≥1 to ≤5% of metformin patients and were more commonly reported with metformin than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

OVERDOSAGE


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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS). Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

DOSAGE AND ADMINISTRATION


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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age).Metformin should be given in divided doses with meals and should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride tablets, either when used as monotherapy or in combination with a sulfonylurea or insulin.Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

HOW SUPPLIED


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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Metformin Hydrochloride Tablets 500 mg are unscored, capsule shaped, light peach film-coated tablets imprinted WPI on one side and 2713 on the other side and are supplied in bottles of 100, 500 and 1000.Metformin Hydrochloride Tablets 850 mg are unscored, capsule shaped, light peach film-coated tablets imprinted WPI on one side and 2775 on the other side and are supplied in bottles of 60, 100 and 250.Metformin Hydrochloride Tablets 1000 mg are capsule shaped, light peach film-coated tablets with a bisect line on both sides, imprinted WPI and WPI on one side and 2455 on the other side and are supplied in bottles of 100, 500 and 1000.StorageStore at controlled room temperature 20°-25°C (68°-77°F). [See USP.]Dispense in a light-resistant container.

PATIENT INFORMATION


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displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

METFORMIN HYDROCHLORIDE TABLETSRead this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.What is metformin?Metformin is used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness.Metformin helps control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin does not cause your body to make more insulin. Because of this, when taken alone, it rarely causes hypoglycemia (low blood sugar), and usually does not cause weight gain. However, when it is taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain.WARNING: A small number of people who have taken metformin have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take metformin. (See “What are the side effects of metformin?”)Who should not take metformin?Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take metformin. Most of the conditions listed below can increase your chance of getting lactic acidosis.Do not take metformin if you:have kidney problemshave liver problemshave heart failure that is treated with medicines, such as Lanoxin® (digoxin) or Lasix® (furosemide)drink a lot of alcohol. This means you binge drink for short periods or drink all the timeare seriously dehydrated (have lost a lot of water from your body)are going to have an x-ray procedure with injection of dyes (contrast agents)are going to have surgerydevelop a serious condition, such as heart attack, severe infection, or a strokeare 80 years or older and you have NOT had your kidney function testedTell your doctor if you are pregnant or plan to become pregnant. Metformin may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.Can metformin hydrochloride tablets be used in children?Metformin has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin has not been studied in children younger than 10 years old. Metformin hydrochloride tablets have not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of metformin hydrochloride tablets in children, talk with your doctor or other healthcare provider.How should I take metformin hydrochloride tablets?Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin with meals.Your doctor may have you take other medicines along with metformin to control your blood sugar. These medicines may include insulin shots. Taking metformin with insulin may help you better control your blood sugar while reducing the insulin dose.Continue your exercise and diet program and test your blood sugar regularly while taking metformin. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin causes harm to the liver or kidneys.Tell your doctor if you:have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin for a short time.plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking metformin hydrochloride tablets for a short time.start to take other medicines or change how you take a medicine. Metformin can affect how well other drugs work, and some drugs can affect how well metformin works. Some medicines may cause high blood sugar.What should I avoid while taking metformin hydrochloride tablets?Do not drink a lot of alcoholic drinks while taking metformin. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.What are the side effects of metformin?Lactic Acidosis. In rare cases, metformin can cause a serious side effect called lactic acidosis. This is caused by a build-up of lactic acid in your blood. This build-up can cause serious damage. Lactic acidosis caused by metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it.It is also important for your liver to be working normally when you take metformin. Your liver helps remove lactic acid from your blood.Make sure you tell your doctor before you use metformin if you have kidney or liver problems. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be
treated in a hospital.
Signs of lactic acidosis are:feeling very weak, tired, or uncomfortableunusual muscle paintrouble breathingunusual or unexpected stomach discomfortfeeling coldfeeling dizzy or lightheadedsuddenly developing a slow or irregular heartbeatIf your medical condition suddenly changes, stop taking metformin and call your doctor right away. This may be a sign of lactic acidosis or another serious side effect.Other Side Effects. Common side effects of metformin include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they’ve gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.About 3 out of every 100 people who take metformin have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.Metformin rarely causes hypoglycemia (low blood sugar) by itself. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.General advice about prescription medicinesIf you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about metformin that is written for healthcare professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use metformin for a condition for which it was not prescribed. Do not share your medicine with other people.Watson Laboratories, Inc.
Corona, CA 92880 USA