METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are contraindicated in patients with: 1.  Severe renal impairment (eGFR below 30 mL/min/1.73m 2  (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.

Product summary:

Metformin Hydrochloride Tablets, USP Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film-coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. Unit of use Bottles of 60: 500 mg (NDC 68645-539-59) Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film-coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows. Unit of use Bottles of 60: 850 mg (NDC 68645-549-59) Store at 20° - 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers. All trademarks are the property of Zydus Group. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 05/17 Revision Date: 2017/05/31 Distributed by: Wal-Mart Bentonville, AR 72716 Packaged by: Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
Legacy Pharmaceutical Packaging, LLC
----------
PATIENT INFORMATION
Metformin Hydrochloride Tablets, USP
Metformin Hydrochloride Extended-release Tablets, USP
Rx only
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 AND METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS?
Metformin hydrochloride tablets and metformin hydrochloride
extended-release 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 or
metformin hydrochloride extended-release
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 and metformin hydrochloride
extended-release tablets have the same active
ingredient. However, metformin hydrochloride extended-release tablets
work longer in your body. Both of
these me

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
DESCRIPTION
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets 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, USP is a white crystalline powder with a
molecular formula of C
H
N
•
HCl and a molecular weight of 165.63. Metformin hydrochloride is
freely soluble in water, slightly
soluble in alcohol and is practically insoluble in acetone and
methylene chloride. The pK
of metformin
is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is
6.68.
Metformin hydrochloride tablets contain 500 mg or 850 mg or 1000 mg of
metformin hydrochloride.
Each tablet contains the inactive ingredients colloidal silicon
dioxide, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone
and sodium starch glycolate.
Metformin hydrochloride extended-release tablets contain 500 mg or 750
mg of metformin
hydrochloride as the active ingredient.
Metformin hydrochloride extended-release tablets 500 mg and 750 mg
contain the inactive ingredients
glyceryl behenate, hypromellose, microcrystalline cellulose and
povidone.
SYSTEM COMPONENTS AND PERFORMANCE:
Metformin hydrochloride extended-release tablets comprise a monolithic
hydrophilic polymer matrix
system. Metformin hydrochloride is combined with a drug
release-controlling polymer to form the core
of the matrix. After administration fluid from the Gastro Intestinal
tract (GI tract) enters the tablet
causing the polymers to hydrate and swell. Due to hydration and
swelling of the polymer, the size of the
tablet in the stomach increases. As