GLUMETZA Film coated tablet, extended release (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Santarus, Inc.

Λέξεις κλειδιά

68012-002 68012-003 68012-004

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BOXED WARNING SECTION

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

1. Indications and Usage

GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

2. Dosage and Administration

2.1 Adult Dosage and Administration The recommended starting dose of GLUMETZA is 500 mg orally once daily with the evening meal. Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis ...

3. Dosage Forms and Strengths

GLUMETZA is available as: Extended-release tablets: 500 mg white, film-coated, oval-shaped tablets with M500 on one side. Extended-release tablets: 1,000 mg white, film-coated, oval-shaped ...

4. Contraindications

GLUMETZA is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/minute/1.73 m²) [see Warnings and Precautions (5.1)]. Known hypersensitivity to metformin. Acute or chronic ...

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 ...

6.1. Clinical Trials Experience

The following adverse reactions are discussed in more detail in other sections of the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] Vitamin B12 Deficiency ...

6.2. Postmarketing Experience

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

7. Drug Interactions

Table 2 presents clinically significant drug interactions with GLUMETZA. Table 2. Clinically Significant Drug Interactions with GLUMETZA: Carbonic Anhydrase Inhibitors Clinical Impact: ...

8.1. Pregnancy

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

8.2. Lactation

Risk Summary Limited published studies report that metformin is present in human milk [see Data]. 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 GLUMETZA may result in ovulation in some anovulatory women.

8.4. Pediatric Use

Safety and effectiveness of GLUMETZA in pediatric patients have not been established.

8.5. Geriatric Use

Clinical studies of GLUMETZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly ...

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. GLUMETZA is contraindicated in severe renal ...

8.7. Hepatic Impairment

Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. GLUMETZA is not recommended in patients with hepatic impairment [see Warnings and Precautions ...

10. Overdosage

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

11. Description

GLUMETZA contains the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. ...

12.1. Mechanism of Action

Metformin is a biguanide that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases ...

12.3. Pharmacokinetics

Absorption Following a single oral dose of 1,000 mg (2x500 mg tablets) GLUMETZA after a meal, the time to reach maximum plasma metformin concentration (Tmax) is achieved at approximately 7-8 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies have been performed in Sprague Dawley rats at doses of 150, 300, and 450 mg/kg/day in males and 150, 450, 900, and 1,200 mg/kg/day in females. These doses are approximately ...

14. Clinical Studies

In a multicenter, randomized, double-blind, active-controlled, dose-ranging, parallel group study conducted in patients type 2 diabetes mellitus, GLUMETZA 1,500 mg once daily, GLUMETZA 1,500 per day in ...

16.1. How Supplied

GLUMETZA is supplied as: 500 mg Bottles of 100 NDC 68012-004-50 white, film-coated, oval-shaped, extended-releasetablets with M500 on one side. 1,000 mg Bottles of 90 NDC 68012-003-16 white, film-coated, ...

16.2. Storage and Handling

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].

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. ...