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GLUCOPHAGE Tablet / Extended-release tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Bristol-Myers Squibb Company

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1. Indications and Usage

GLUCOPHAGE is 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. GLUCOPHAGE XR is indicated ...

2. Dosage and Administration

2.1 Adult Dosage <u>GLUCOPHAGE:</u> The recommended starting dose of GLUCOPHAGE is 500 mg orally twice a day or 850 mg once a day, given with meals. Increase the dose in increments of 500 mg weekly or ...

3. Dosage Forms and Strengths

GLUCOPHAGE is available as: <u>Tablets: 500 mg</u> round, white to off-white, film-coated debossed with BMS 6060 around the periphery on one side and 500 debossed across the face of the other side. <u> ...

4. Contraindications

GLUCOPHAGE and GLUCOPHAGE XR are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m²) <em>[see Warnings and Precautions (5.1)]</em>. Hypersensitivity to metformin. ...

5. Warnings and Precautions

5.1 Lactic Acidosis There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such ...

6. Adverse Reactions

The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis <em>[see Boxed Warning and Warnings and Precautions (5.1)]</em> Vitamin B<sub>12</sub> Deficiency <em>[see ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Table 3 presents clinically significant drug interactions with GLUCOPHAGE/GLUCOPHAGE XR. <b>Table 3. Clinically Significant Drug Interactions with GLUCOPHAGE/GLUCOPHAGE XR:</b> Carbonic Anhydrase Inhibitors ...

8.1. Pregnancy

Risk Summary Limited data with GLUCOPHAGE/GLUCOPHAGE XR in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin ...

8.2. Lactation

Risk Summary Limited published studies report that metformin is present in human milk <em>[see Data]</em>. However, there is insufficient information to determine the effects of metformin on the breastfed ...

8.3. Females and Males of Reproductive Potential

Discuss the potential for unintended pregnancy with premenopausal women as therapy with GLUCOPHAGE/GLUCOPHAGE XR may result in ovulation in some anovulatory women.

8.4. Pediatric Use

GLUCOPHAGE The safety and effectiveness of GLUCOPHAGE for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. Safety and effectiveness of GLUCOPHAGE ...

8.5. Geriatric Use

Controlled clinical studies of GLUCOPHAGE/GLUCOPHAGE XR did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. In general, dose selection ...

8.6. Renal Impairment

Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. GLUCOPHAGE/GLUCOPHAGE XR is contraindicated ...

8.7. Hepatic Impairment

Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. GLUCOPHAGE/GLUCOPHAGE XR is not recommended in patients with hepatic impairment <em>[see Warnings ...

10. Overdosage

Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin ...

11. Description

GLUCOPHAGE/GLUCOPHAGE XR contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is <em>N,N</em>-dimethylimidodicarbonimidic ...

12.1. Mechanism of Action

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose ...

12.3. Pharmacokinetics

Absorption The absolute bioavailability of a GLUCOPHAGE 500 mg tablet given under fasting conditions is approximately 50% to 60%. Studies using single oral doses of GLUCOPHAGE 500 to 1500 mg and 850 to ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively. ...

14. Clinical Studies

14.1 GLUCOPHAGE Adult Clinical Studies A double-blind, placebo-controlled, multicenter US clinical trial involving obese patients with type 2 diabetes mellitus whose hyperglycemia was not adequately controlled ...

16.1. How Supplied

<b>Table 12. GLUCOPHAGE/GLUCOPHAGE XR Available Strengths, Units, and Appearance:</b> GLUCOPHAGE Tablets 500 mg Bottles of 100 NDC 0087-6060-05 round, white to off-white, film-coated debossed with ...

16.2. Storage and Handling

Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. ...

BOXED WARNING SECTION

<b>WARNING: LACTIC ACIDOSIS</b> Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated ...
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