METFORMIN HYDROCHLORIDE EXTENDED RELEASE- metformin hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TIME CAP LABORATORIES, INC

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE SUPPLIED: in bottles of 100 and 500 500 MG - White to Off-White capsule shaped no score imprint code 101 750 mg - White to Off-White capsule shaped no score imprint code 102

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE EXTENDED RELEASE- METFORMIN HYDROCHLORIDE
TABLET,
EXTENDED RELEASE
TIME CAP LABORATORIES, INC
----------
METFORMIN ER TABLETS
Metformin Hydrochloride Extended-Release Tablets, USP is indicated as
an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus.
HOW SUPPLIED
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS ARE SUPPLIED: in
bottles
of 100 and 500
500 MG - White to Off-White capsule shaped no score imprint code 101
750 mg - White to Off-White capsule shaped no score imprint code 102
There is no fixed dosage regimen for the management of hyperglycemia
in patients with type 2 diabetes
with metformin hydrochloride extended-release tablets or any other
pharmacologic agent. Dosage of
metformin hydrochloride extended-release tablets 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 extended-release
tablets in adults is 2000 mg.
Metformin hydrochloride extended-release tablets should generally be
given once daily with the
evening meal. Metformin hydrochloride extended-release 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 extended-
release 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 extended-release tablets,
either when used as monotherapy or in combi