METFORMIN HYDROCHLORIDE tablet, coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Megalith Pharmaceuticals Inc

INN (इंटरनेशनल नाम):

METFORMIN HYDROCHLORIDE

रचना:

METFORMIN HYDROCHLORIDE 500 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. Metformin hydrochloride tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (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. 

उत्पाद समीक्षा:

Metformin hydrochloride tablets USP, 500 mg are round white tablets, debossed with “500” on one side. They are available as follows: Bottles of 100 NDC 71717-104-10 Bottles of 500 NDC 71717-104-50 Bottles of 1000 NDC 71717-104-11 Metformin hydrochloride tablets USP, 850 mg are round white tablets, debossed with “850” on one side. They are available as follows: Bottles of 100 NDC 71717-105-10 Bottles of 500 NDC 71717-105-50 Bottles of 1000 NDC 71717-105-11 Metformin hydrochloride tablets USP, 1,000 mg are oval white tablets, debossed with “10|00” on one side. They are available as follows: Bottles of 100 NDC 71717-106-10 Bottles of 500 NDC 71717-106-50 Bottles of 1000 NDC 71717-106-11 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers. Manufactured by: CSPC Ouyi Pharmaceutical Co., Ltd. Shijiazhuang, Hebei, China 052160 Manufactured for: Megalith Pharmaceuticals Inc. Princeton, NJ 08540 Rev. 10/2017

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, COATED
MEGALITH PHARMACEUTICALS INC
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
RX ONLY
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.
PHARMACOKINETICS
_Absorption and Bioavailability_
The absolute bioavailability of a metformin hydrochloride 500 mg
tablet given under fasting conditions
is approximately 50% to 60%. Studies using single oral doses of
metformin hydrochloride tablets 500
mg to 1,500 mg, and 850 mg to 2,550 mg, indicate that there is a lack
of dose proportionality with
increasing doses, which is due to decreased absorption rather than an
alteration in elimination. Food
decreases the extent of and slightly delays the absorption of
metformin, as shown by approximately a
40% lower mean peak plasma concentration (C
), a 25% lower area under the plasma concentration
versus time curve (AUC), and a 35-minute prolongation of time to peak
plasma concentration (T
)
following administration of a single 850 mg tablet of metformin with
food, compared to the same tablet
strength administered fasting. The clinical relevance of these
decreases is unknown.
_Distribution_
The apparent volume of distribution (V/F) of metformin following
single oral doses of metformin
hydroc