NAPROSYN, EC-NAPROSYN, ANAPROX DS Tablet, Delayed-release tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Canton Laboratories

Λέξεις κλειδιά

69437-316 69437-415 69437-416 69437-203

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BOXED WARNING SECTION

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which ...

1. Indications and Usage

NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis ...

2. Dosage and Administration

2.1 General Dosing Instructions Carefully consider the potential benefits and risks of NAPROSYN Tablets, EC-NAPROSYN and ANAPROX DS and other treatment options before deciding to use NAPROSYN Tablets, ...

3. Dosage Forms and Strengths

NAPROSYN (naproxen) tablets: 500 mg: yellow, capsule-shaped, engraved with NPR LE 500 on one side and scored on the other. EC-NAPROSYN (naproxen) delayed-release tablets: 375 mg: white, oval ...

4. Contraindications

NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration, ...

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 naproxen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

See Table 1 for clinically significant drug interactions with naproxen. Table 1. Clinically Significant Drug Interactions with naproxen: Drugs That Interfere with Hemostasis Clinical Impact: ...

8.1. Pregnancy

Risk Summary Use of NSAIDs, including NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, ...

8.2. Lactation

Risk Summary The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. The developmental and health ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS, may delay or prevent rupture of ovarian follicles, ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled ...

8.5. Geriatric Use

The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. Of the patients studied, 98 patients were age 65 and older ...

8.6. Hepatic Impairment

Caution is advised when high doses are required and some adjustment of dosage may be required in these patients. It is prudent to use the lowest effective dose [see Clinical Pharmacology (12.3) ...

8.7. Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) [see Warnings and Precautions (5.6), Clinical ...

10. Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal ...

11. Description

NAPROSYN (naproxen) tablets, EC-NAPROSYN (naproxen) delayed-release tablets and ANAPROX DS (naproxen sodium) tablets are nonsteroidal anti-inflammatory drugs available as follows: NAPROSYN tablets are ...

12.1. Mechanism of Action

Naproxen has analgesic, anti-inflammatory, and antipyretic properties. ANAPROX DS (naproxen sodium) has been developed as a more rapidly absorbed formulation of naproxen for use as an analgesic. The mechanism ...

12.2. Pharmacodynamics

In a healthy volunteer study, 10 days of concomitant administration of naproxen 220 mg once-daily with low-dose immediate-release aspirin (81 mg) showed an interaction with the antiplatelet activity of ...

12.3. Pharmacokinetics

Naproxen and naproxen sodium are rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. The different dosage forms of NAPROSYN are bioequivalent in terms ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day (0.05, 0.1, and 0.16 times the maximum recommended human daily ...

14. Clinical Studies

Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout. Improvement ...

16.1. How Supplied

NAPROSYN (naproxen) tablets 500 mg: yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100. Supplied as: NDC 69437-316-01 ...

16.2. Storage and Handling

Store at 15° to 30°C (59° to 86°F) in well-closed containers.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information ...