METFORMIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin Hydrochloride Tablets USP, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin Hydrochloride Tablets USP is 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 ). - 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 Hydrochloride Tablets USP 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 a

Product summary:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossing “H/102” on one side and plain on the other side. NDC 60760-973-30 BOTTLE OF 30 60760-973-60 BOTTLE OF 60 60760-973-90 BOTTLE OF 90 850 mg - White to off-white, round, biconvex, film coated tablets debossing “H/103” on one side and plain on the other side. NDC 60760-974-90 BOTTLE OF 90 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossing “H/104” on one side and plain on the other side. NDC 60760-975-60 BOTTLE OF 60 60760-975-90 BOTTLE OF 90 Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Manufactured for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 Call: 1.866.901.DRUG Manufactured by: Granules India Limited Ranga Reddy Dist., India 500-043 AP Iss. 04/09 Patient Information 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 USP? Metformin Hydrochloride Tablets USP 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 USP, 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 USP can 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 USP do not cause your body to make more insulin. Because of this, when taken alone, it rarely cause hypoglycemia (low blood sugar), and usually do 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 Hydrochloride Tablets USP 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 Hydrochloride Tablets USP. (See " What are the side effects of Metformin Hydrochloride Tablets USP? ") Who should not take Metformin Hydrochloride Tablets USP? Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis. Do not take Metformin Hydrochloride Tablets USP if you: Tell your doctor if you are pregnant or plan to become pregnant. Metformin Hydrochloride Tablets USP 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 USP be used in children? Metformin Hydrochloride Tablets USP has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin Hydrochloride Tablets USP has not been studied in children younger than 10 years old. Metformin Hydrochloride Tablets USP 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 USP in children, talk with your doctor or other healthcare provider. How should I take Metformin Hydrochloride Tablets USP? 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 USP with meals. Your doctor may have you take other medicines along with Metformin Hydrochloride Tablets USP to control your blood sugar. These medicines may include insulin shots. Taking Metformin Hydrochloride Tablets USP 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 USP. 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 USP causes harm to the liver or kidneys. Tell your doctor if you: What should I avoid while taking Metformin Hydrochloride Tablets USP? Do not drink a lot of alcoholic drinks while taking Metformin Hydrochloride Tablets USP. 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 USP? Lactic Acidosis . In rare cases, Metformin Hydrochloride Tablets USP can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This buildup can cause serious damage. Lactic acidosis caused by Metformin Hydrochloride Tablets USP 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 Hydrochloride Tablets USP 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 Hydrochloride Tablets USP. Your liver helps remove lactic acid from your blood. Make sure you tell your doctor before you use Metformin Hydrochloride Tablets USP if you have kidney or liver problems. You should also stop using Metformin Hydrochloride Tablets USP 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: If your medical condition suddenly changes, stop taking Metformin Hydrochloride Tablets USP 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 Hydrochloride Tablets USP 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 USP have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time. Metformin Hydrochlori

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
ST MARYS MEDICAL PARK PHARMACY
----------
METFORMIN HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
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 to off-white crystalline compound
with a molecular formula of C
H
N
• 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 pK
of metformin is 12.4. The pH of
a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg
of metformin
hydrochloride. Each tablet contains the inactive ingredients povidone
(K-30), povidone (K-90),
pregelatinized starch, and magnesium stearate. In addition, the
coating for the tablets contains artificial
blackberry flavor, hypromellose and polyethylene glycol.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patients with type 2
diabetes, lowering both basal and postprandial plasma glucose. Its
pharmacologic mechanisms of action
are different from other classes of oral antihyperglycemic agents.
Metformin decreases hepatic
glucose production, decreases intestinal absorption of glucose, and
improves insulin sensitivity by
increasing peripheral glucose uptake and utilization. Unlike
sulfonylureas, metformin does not produce
hypoglycemia in either patients with type 2 diabetes or normal
subjects (except in special
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With metformin therapy,
insulin secretion remains unchanged while fasting insulin levels and
day-long plasma insulin response
may actually decrease.
PHARMACOKINE