METFORMIN HYDROCHLORIDE TABLETS USP, Rx only

/METFORMIN HYDROCHLORIDE TABLETS USP, Rx only
METFORMIN HYDROCHLORIDE TABLETS USP, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

METFORMIN HYDROCHLORIDE TABLETS USP, Rx only

ID:

ea2fa0a2-75bf-47f8-b0e6-5034d1af8283

Code:

34391-3

WARNING: LACTIC ACIDOSIS


id: c0a29582-160e-4f07-92eb-72ceae626061
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, 
hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often 
subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, 
somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated 
blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an 
increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL (see
PRECAUTIONS
).

DESCRIPTION


id: 3a38e53a-eb44-4b0c-8807-528153a9888c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs 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 crystalline compound with a molecular formula of C
4
H
11
N
5
.HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.

CLINICAL PHARMACOLOGY


id: 55c84278-4947-4f62-9110-e6e1bf8a9027
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

INDICATIONS AND USAGE


id: 1471c0fe-7c0f-4a00-9d74-e7585bd23d3b
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

​Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. 

CONTRAINDICATIONS


id: d975b5a4-0534-4f9c-9862-59327462fecd
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Metformin hydrochloride tablets are contraindicated in patients with:
1. Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (see WARNINGS and PRECAUTIONS ).
2. Known hypersensitivity to metformin hydrochloride.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Diabetic ketoacidosis should be treated with insulin.

WARNINGS


id: 0894cd3c-05b8-46f1-b486-40df90b88586
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

WARNING: LACTIC ACIDOSIS
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL (see PRECAUTIONS). Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and PRECAUTIONS ). If metformin-associated lactic acidosis is suspected, immediately discontinue metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ).

ADVERSE REACTIONS


id: 3c7dc66e-2e80-4a10-80b4-b77ec8445502
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

In a US 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 11.

Table 11: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of Metformin MonotherapyReactions that were more common in metformin- than placebo-treated patients.
Adverse Reaction Metformin Monotherapy

(n=141)

Placebo

(n=145)

% 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 >1.0% to <5.0% 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


id: 5b8e2c44-8061-434f-ad95-48098f624f8b
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


id: cd812670-de7c-4a6c-9db5-1ed366984b48
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 hydrochloride tablets is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age). Metformin hydrochloride tablets should be given in divided doses with meals. Metformin hydrochloride tablets 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 hydrochloride tablets 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 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


id: c38aee57-40e9-4904-892a-67ebb3b191f0
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Metformin Hydrochloride Tablets are available as follows:
500 mg:
Bottles of 100 NDC 71093-132-04
Bottles of 500 NDC 71093-132-05
Bottles of 1000 NDC 71093-132-06
850 mg:
Bottles of 100 NDC 71093-133-04
Bottles of 500 NDC 71093-133-05
1000 mg:
Bottles of 100 NDC 71093-134-04
Bottles of 500 NDC 71093-134-05
Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side. Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers Manufactured by:
ScieGen Pharmaceuticals, Inc.

Hauppauge NY 11788 Distributed by:
ACI Healthcare USA, Inc.

10100 W. Sample Road, Suite 406
Coral Springs, FL 33065 Rev: 12/17 Rx Only

Patient Information


id: 8799045f-952a-486f-afde-36d1240b4471
displayName: PATIENT MEDICATION INFORMATION SECTION
FDA Article Code: 68498-5

METFORMIN HYDROCHLORIDE TABLETS, USP Read 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 are metformin hydrochloride tablets? Metformin hydrochloride tablets are 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 hydrochloride tablets, 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 hydrochloride tablets help 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 hydrochloride tablets do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. Tell your doctor if you are pregnant or plan to become pregnant. Metformin hydrochloride tablets 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 hydrochloride tablets has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets has not been studied in children younger than 10 years old. Metformin hydrochloride tablets has 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 hydrochloride tablets with meals. Your doctor may have you take other medicines along with metformin hydrochloride tablets to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride tablets 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 hydrochloride tablets. 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 hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets can affect how well other drugs work, and some drugs can affect how well metformin hydrochloride tablets work. 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 hydrochloride tablets. 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 hydrochloride tablets?

• Lactic acidosis. Metformin, the active ingredient in metformin hydrochloride tablets, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: • you feel cold in your hands or feet
• you feel dizzy or lightheaded
• you have a slow or irregular heartbeat
• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you feel sleepy or drowsy
• you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with metformin if you:
• have severe kidney problems, or your kidneys are affected by certain x-ray tests that use injectable dye
• have liver problems
• drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids
• have surgery
• have a heart attack, severe infection, or stroke
The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your metformin hydrochloride tablets for a while if you have any of these things. Other Side Effects. Common side effects of metformin hydrochloride tablets 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 hydrochloride tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time. Metformin hydrochloride tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar. To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1-888-802-1213 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. General advice about prescription medicines If 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 hydrochloride tablets 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 hydrochloride tablets for a condition for which it was not prescribed. Do not share your medicine with other people. Manufactured by:
ScieGen Pharmaceuticals, Inc.

Hauppauge NY 11788 Distributed by:
ACI Healthcare USA, Inc.

10100 W. Sample Road, Suite 406
Coral Springs, FL 33065 Rev: 12/17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: e9088217-e130-40ef-b17c-85d928358d0a
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4


500 mg:
Bottles of 100 NDC 71093-132-04 850 mg:

Bottles of 100 NDC 71093-133-04 1000 mg:

Bottles of 100 NDC 71093-134-04