METFORMIN HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1) Severe renal impairment (eGFR below 30 mL/min/1.73 m 2) ( 4, 5.1) Hypersensitivity to metformin ( 4) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.( 4) Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. ( 8.3) Geriatric Use: Assess renal function more frequently. ( 8.5) Hepatic Impairment: Avoid use in patients with hepatic impairment. ( 8.7)

Tóm tắt sản phẩm:

Metformin Hydrochloride Tablets, USP 500 mg Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. NDC: 70518-3735-00 PACKAGING: 30 in 1 BLISTER PACK 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.] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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.]

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
METFORMIN HYDROCHLORIDE TABLETS.
METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
DOSAGE FORMS AND STRENGTHS
Metformin Hydrochloride Tablets, USP: 500 mg, 850 mg, and 1000 mg ( 3)
(1)
ADVERSE REACTIONS
For Metformin Hydrochloride Tablets, the most common adverse reactions
(>5.0%) are diarrhea,
nausea/vomiting, flatulence, asthenia, indigestion, abdominal
discomfort, and headache. ( 6.1) (2)
To report SUSPECTED ADVERSE REACTIONS, contact ScieGen at (855)
724-3436 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch (2)
DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION (12)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
3 DOSAGE FORMS AND STRENGTHS
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Metformin Hydrochloride Tablets
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*
Sections or subsections omitted from the full prescribing information
are not listed.
FULL PRESCRIBING INFORMATION
3 DOSAGE FORMS AND STRENGTHS
Metformin Hydrochloride Tablets, USP are available as:
Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored,
white to off-
white, round, biconvex, beveled edge film coated tablets, debossed
with ‘SG’ on one
side ‘105’ on other side.
Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored,
white to off-
white, round, biconvex, beveled edge film coated tablets, debossed
with ‘SG’ on one
s