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:

ReadyMeds

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 1000 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin HCl Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin HCl, 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 HCl, USP. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin HCl, 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 alteration of renal function. (See also PRECAUTIONS .)

Product summary:

Metformin HCl Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, film-coated tablets debossed “IP 218” on obverse and “500” on the reverse. They are available as follows: Bottles of 100:                        NDC 65162-218-10 Bottles of 500:                        NDC 65162-218-50 Bottles of 1000:          NDC 65162-218-11 Metformin HCl Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, film-coated tablets debossed “IP 219” on obverse and “850” on the reverse. They are available as follows: Bottles of 100:                        NDC 65162-219-10 Bottles of 500:                        NDC 65162-219-50 Bottles of 1000:          NDC 65162-219-11 Metformin HCl Tablets, USP 1000 mg are blackberry flavored, white to off-white, oval, biconvex, bisected, film-coated tablets debossed “IP 220” on obverse and “1000” on the reverse. They are available as follows: Bottles of 100:                        NDC 65162-220-10 Bottles of 500:                        NDC 65162-220-50 Bottles of 1000:          NDC 65162-220-11 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: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Repackaged By: ReadyMeds Dothan, AL 36301 Rev. 04-2014-00

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
ReadyMeds
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PATIENT INFORMATION
Metformin Hydrochloride Tablets
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 is Metformin HCl?
Metformin HCl is used to treat type 2 diabetes. This is also known as
noninsulin- 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 HCl, 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 HCl 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 HCl
does 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

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
READYMEDS
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Metformin Hydrochloride (HCl) Tablets, USP is an oral
antihyperglycemic drug used in the
management of type 2 diabetes. Metformin HCl, USP
(_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 HCl, USP is a white to off-white crystalline compound with a
molecular formula of
C H N • HCl and a molecular weight of 165.62. Metformin HCl, USP 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 HCl, USP is 6.68.
Metformin HCl Tablets, USP, contains 500 mg, 850 mg, or 1000 mg of
metformin HCl, USP. Each
tablet contains the inactive ingredients povidone, microcrystalline
cellulose, croscarmellose sodium
and magnesium stearate. In addition, the coating for the 500 mg, 850
mg and 1000 mg tablets contain
polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, gum
acacia, maltodextrin, propylene
glycol and natural flavors.
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