Naproxen Sodium

Dosage Forms And Strengths

NAPRELAN (naproxen sodium) Controlled-Release Tablets are available as follows:

NAPRELAN 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.

NAPRELAN 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.

NAPRELAN 750: white, capsule-shaped tablet with “N” on one side and “750” on the reverse. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.

Storage And Handling

NAPRELAN (naproxen sodium) 375 mg, 500 mg, and 750 mg are controlled-release tablets supplied as:

NAPRELAN 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 52427-272-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen.

NAPRELAN 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 52427-273-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen.

NAPRELAN 750: white, capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; NDC 52427-274-30. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen.

Storage

Store at room temperature, 20° to 25° C (68° to 77° F), excursions permitted 15° to 30° C (59° to 86° F)[see USP Controlled Room Temperature]. PHARMACIST: Dispense in a well-closed container.

To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Almatica at 1-877-447-7979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Distributed by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA. Revised: Sep 2017

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death

The risk of getting an ulcer or bleeding increases with:

• past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
• taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
• increasing doses of NSAIDs
• older age
• longer use of NSAIDs
• poor health
• smoking
• advanced liver disease
• drinking alcohol
• bleeding problems

NSAIDs should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDs:

• if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
• are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

• shortness of breath or trouble breathing
• slurred speech
• chest pain
• swelling of the face or throat
• weakness in one part or side of your body

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

• nausea
• vomit blood
• more tired or weaker than usual
• there is blood in your bowel movement or
• diarrhea it is black and sticky like tar
• itching
• unusual weight gain
• your skin or eyes look yellow
• skin rash or blisters with fever
• indigestion or stomach pain
• swelling of the arms, legs, hands and feet
• flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

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 drug and may not reflect the rates observed in practice.

As with all drugs in this class, the frequency and severity of adverse events depends on several factors: the dose of the drug and duration of treatment; the age, the sex, physical condition of the patient; any concurrent medical diagnoses or individual risk factors. The following adverse reactions are divided into three parts based on frequency and whether or not the possibility exists of a causal relationship between drug usage and these adverse events. In those reactions listed as “Probable Causal Relationship” there is at least one case for each adverse reaction where there is evidence to suggest that there is a causal relationship between drug usage and the reported event. The adverse reactions reported were based on the results from two double-blind controlled clinical trials of three months duration with an additional nine month open-label extension. A total of 542 patients received NAPRELAN Tablets either in the double-blind period or in the nine month open-label extension. Of these 542 patients, 232 received NAPRELAN Tablets, 167 were initially treated with Naprosyn® and 143 were initially treated with placebo. Adverse reactions reported by patients who received NAPRELAN Tablets are shown by body system. Those adverse reactions observed with naproxen but not reported in controlled trials with NAPRELAN Tablets are italicized.

The most frequent adverse events from the double-blind and open-label clinical trials were headache (15%), followed by dyspepsia (14%), and flu syndrome (10%). The incidence of other adverse events occurring in 3% to 9% of the patients are marked with an asterisk.

Those reactions occurring in less than 3% of the patients are unmarked.

Incidence greater Than 1% (Probable Causal Relationship)

Body as a Whole - Pain (back)*, pain*, infection*, fever, injury (accident), asthenia, pain chest, headache (15%), flu syndrome (10%).

Gastrointestinal - Nausea*, diarrhea*, constipation*, abdominal pain*, flatulence, gastritis, vomiting, dysphagia, dyspepsia (14%), heartburn*, stomatitis.

Hematologic - Anemia, ecchymosis.

Respiratory - Pharyngitis*, rhinitis*, sinusitis*, bronchitis, cough increased.

Renal - Urinary tract infection*, cystitis.

Dermatologic - Skin rash*, skin eruptions*, ecchymoses*, purpura.

Metabolic and Nutrition - Peripheral edema, hyperglycemia.

Central Nervous System - Dizziness, paresthesia, insomnia, drowsiness*, lightheadedness.

Cardiovascular - Hypertension, edema*, dyspnea*, palpitations.

Musculoskeletal - Cramps (leg), myalgia, arthralgia, joint disorder, tendon disorder.

Special Senses - Tinnitus*, hearing disturbances, visual disturbances.

General - Thirst.

Incidence Less Than 1% (Probable Causal Relationship)

Body as a Whole - Abscess, monilia, neck rigid, pain neck, abdomen enlarged, carcinoma, cellulitis, edema general, LE syndrome, malaise, mucous membrane disorder, allergic reaction, pain pelvic.

Gastrointestinal - Anorexia, cholecystitis, cholelithiasis, eructation, GI hemorrhage, rectal hemorrhage, stomatitis aphthous, stomatitis ulcer, ulcer mouth, ulcer stomach, periodontal abscess, cardiospasm, colitis, esophagitis, gastroenteritis, GI disorder, rectal disorder, tooth disorder, hepatosplenomegaly, liver function abnormality, melena, ulcer esophagus, hematemesis, jaundice, pancreatitis, necrosis.

Renal - Dysmenorrhea, dysuria, kidney function abnormality, nocturia, prostate disorder, pyelonephritis, carcinoma breast, urinary incontinence, kidney calculus, kidney failure, menorrhagia, metrorrhagia, neoplasm breast, nephrosclerosis, hematuria, pain kidney, pyuria, urine abnormal, urinary frequency, urinary retention, uterine spasm, vaginitis, glomerular nephritis, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis.

Hematologic - Leukopenia, bleeding time increased, eosinophilia, abnormal RBC, abnormal WBC, thrombocytopenia, agranulocytosis, granulocytopenia.

Central Nervous System - Depression, anxiety, hypertonia, nervousness, neuralgia, neuritis, vertigo, amnesia, confusion, co-ordination, abnormal diplopia, emotional lability, hematoma subdural, paralysis, dream abnormalities, inability to concentrate, muscle weakness.

Dermatologic: Angiodermatitis, herpes simplex, dry skin, sweating, ulcer skin, acne, alopecia, dermatitis contact, eczema, herpes zoster, nail disorder, skin necrosis, subcutaneous nodule, pruritus, urticaria, neoplasm skin, photosensitive dermatitis, photosensitivity reactions resembling porphyria cutaneous tarda, epidermolysis bullosa.

Special Senses - Amblyopia, scleritis, cataract, conjunctivitis, deaf, ear disorder, keratoconjunctivitis, lacrimation disorder, otitis media, pain eye.

Cardiovascular - Angina pectoris, coronary artery disease, myocardial infarction, deep thrombophlebitis, vasodilation, vascular anomaly, arrhythmia, bundle branch block, abnormal ECG, heart failure right, hemorrhage, migraine, aortic stenosis, syncope, tachycardia, congestive heart failure.

Respiratory - Asthma, dyspnea, lung edema, laryngitis, lung disorder, epistaxis, pneumonia, respiratory distress, respiratory disorder, eosinophilic pneumonitis.

Musculoskeletal - Myasthenia, bone disorder, spontaneous bone fracture, fibrotendinitis, bone pain, ptosis, spasm general, bursitis.

Metabolic and Nutrition - Creatinine increase, glucosuria, hypercholesteremia, albuminuria, alkalosis, BUN increased, dehydration, edema, glucose tolerance decrease, hyperuricemia, hypokalemia, SGOT increase, SGPT increase, weight decrease.

General - Anaphylactoid reactions, angioneurotic edema, menstrual disorders, hypoglycemia, pyrexia (chills and fevers).

Incidence Less Than 1% (Causal Relationship Unknown)

Other adverse reactions listed in the naproxen package label, but not reported by those who received NAPRELAN Tablets are shown in italics. These observations are being listed as alerting information to the physician.

Hematologic - Aplastic anemia, hemolytic anemia.

Central Nervous System - Aseptic meningitis, cognitive dysfunction.

Dermatologic - Epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Gastrointestinal - Non-peptic GI ulceration, ulcerative stomatitis.

Cardiovascular - Vasculitis.

Read the entire FDA prescribing information for Naprelan (Naproxen Sodium)

Read More »

Prototypical NSAIA; propionic acid derivative.225 230

General

• Consider potential benefits and risks of naproxen therapy as well as alternative therapies before initiating therapy with the drug.225

Administration

Oral Administration

Formulation Considerations

Naproxen oral suspension is the preferred dosage form for children because of suitability for providing the calculated dosage.208 225

Naproxen sodium is preferred for management of acute painful conditions when prompt onset of pain relief is desired.225

Naproxen delayed-release preparations are not recommended for management of acute gout, tendinitis, bursitis, acute pain, or dysmenorrhea because of slow onset of action.225 267

Naproxen or Naproxen Sodium Conventional (Immediate-release) Tablets and Naproxen Suspension

Usually administered orally twice daily.225 When used for the management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, the morning and evening doses may be unequal in size.225

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Naproxen Delayed-release Tablets

Usually administered orally twice daily.225 When used for the management of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis, the morning and evening doses may be unequal in size.225

Do not break, crush, or chew naproxen delayed-release tablets.225

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Naproxen Sodium Extended-release Tablets

Administer orally once daily.230

Administration with meal, milk, or antacids may minimize adverse GI effects.a

Tablets Containing Delayed-release Naproxen and Immediate-release Esomeprazole

Administer orally twice daily.267

Swallow whole with liquid; do not split, chew, crush, or dissolve tablets.267

Administer at least 30 minutes before meals; patient may use antacids during therapy.267

Tablets Containing Naproxen Sodium and Sumatriptan

Administer with or without food; do not split, crush, or chew.268

Dosage

Available as naproxen or naproxen sodium; each 220, 275, 412.5, or 550 mg of naproxen sodium is approximately equivalent to 200, 250, 375, or 500 mg of naproxen, respectively.200 225 230

If changing from one strength to another or one dosage form to another, be aware that different dose strengths and formulations are not necessarily bioequivalent.225

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.225 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.225

Pediatric Patients

Inflammatory Diseases Juvenile Rheumatoid Arthritis Oral

Naproxen 10 mg/kg daily in 2 divided doses.104 204 205 225

Pain Oral

Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Fever Oral

Naproxen sodium self-medication in children ≥12 years of age: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Adults

Inflammatory Diseases Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis Oral

Preparation	Dosage
Naproxen conventional tablets, delayed-release tablets, or suspension	250–500 mg twice daily; may increase dosage to 1.5 g daily for up to 6 months225
Naproxen sodium conventional tablets	275–550 mg twice daily; may increase dosage to 1.65 g daily for up to 6 months225
Naproxen sodium extended-release tablets	825 mg or 1.1 g once daily; may increase dosage to 1.65 g daily for up to 6 months230
Tablets containing delayed-release naproxen and immediate-release esomeprazole	375 or 500 mg of naproxen (with esomeprazole 20 mg) twice daily267

Acute Tendinitis/Bursitis Oral

Preparation	Dosage
Naproxen conventional tablets or suspension	500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225
Naproxen sodium conventional tablets	550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225
Naproxen sodium extended-release tablets	1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Gout Oral

Preparation	Dosage
Naproxen conventional tablets or suspension	750 mg initially, followed by 250 mg every 8 hours until attack subsides225
Naproxen sodium conventional tablets	825 mg initially, followed by 275 mg every 8 hours until attack subsides225
Naproxen sodium extended-release tablets	1.1–1.65 g once on first day, followed by 1.1 g once daily until attack subsides230

Pain Oral

Preparation	Dosage
Naproxen conventional tablets or suspension	500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225
Naproxen sodium conventional tablets	550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225
Naproxen sodium extended-release tablets	1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Naproxen sodium for self-medication of minor aches and pain: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Acute Migraine Attack Oral

Naproxen sodium/sumatriptan fixed combination: Naproxen sodium 500 mg (with sumatriptan 85 mg) as a single dose.268 Efficacy of >1 dose not established.268 If a second dose is administered, allow ≥2 hours to elapse between the first and second doses.268

Dysmenorrhea Oral

Preparation	Dosage
Naproxen conventional tablets or suspension	500 mg initially, followed by 500 mg every 12 hours or 250 mg every 6–8 hours as needed225
Naproxen sodium conventional tablets	550 mg initially, followed by 550 mg every 12 hours or 275 mg every 6–8 hours as needed225
Naproxen sodium extended-release tablets	1.1 g once daily; may increase dosage to 1.65 g once daily for limited period230

Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Fever Oral

Naproxen sodium self-medication: Initially, 440 mg; usual dosage is 220 mg every 8–12 hours.200

Prescribing Limits

Pediatric Patients

Pain Oral

Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 10 days.200

Fever Oral

Naproxen sodium self-medication in children ≥12 years of age: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 3 days.200

Adults

Inflammatory Diseases Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis Oral

As naproxen, maximum 1.5 g daily.225

As naproxen sodium, maximum 1.65 g daily.230

Acute Tendinitis/Bursitis Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225 Maximum 1.5 g daily for limited period.230

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225 Maximum 1.65 g daily for limited period.230

Pain Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225 Maximum 1.5 g daily for limited period.230

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225 Maximum 1.65 g daily for limited period.230

Naproxen sodium for self-medication of minor aches and pain: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 10 days.200

Acute Migraine Attack Oral

Naproxen sodium/sumatriptan fixed combination: Maximum 2 doses (total sumatriptan dosage of 170 mg) in any 24-hour period.268 Safety of treating an average of >5 headaches per 30-day period not established.268

Dysmenorrhea Oral

As naproxen, maximum 1.25 g on the first day; thereafter, 1 g daily.225

As naproxen sodium, maximum 1.375 g on the first day; thereafter, 1.1 g daily.225

Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200

Fever Oral

Naproxen sodium self-medication: Maximum 440 mg in 8–12 hours; 660 mg in 24 hours.200 Self-medication should not exceed 3 days.200

Special Populations

Hepatic Impairment

Dosage adjustment may be needed if high doses required.225 Consider reduced initial dosage.225 Use lowest effective dosage.225 508

Tablets containing delayed-release naproxen and immediate-release esomeprazole not recommended for patients with severe hepatic impairment; an appropriate esomeprazole dosage is not available as a fixed-ratio preparation for twice-daily dosing.267

Do not use tablets containing naproxen sodium and sumatriptan in patients with hepatic impairment; sumatriptan dosage cannot be appropriately adjusted.268

Renal Impairment

Consider reduced initial dosage.225

Not recommended for use in patients with moderate to severe renal impairment (Clcr <30 mL/minute).225 267

Geriatric Patients

Dosage adjustment may be needed if high doses required.225 Consider reduced initial dosage.225 Use lowest effective dosage.225

Maximum for self-medication, naproxen sodium 220 mg twice daily unless otherwise directed by a clinician.200

• Inhibits cyclooxygenase-1 (COX-1) and COX-2.231 232 233 234 235 236

• Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.225 230

Consult your pharmacist.

How to use Naproxen Sodium Powder

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

No monograph available at this time.

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.