Proxalin

Each tablet contains Naproxen 200 mg and sodium 20 mg. It also contains the following inactive ingredients: Povidone, microcrystalline cellulose, talc, magnesium stearate, purified water and Opadry (blue) in the coating. It is lactose- and gluten-free.

The sodium content of Proxalin is low, similar to a slice of wheat bread.

Carefully consider the potential benefits and risks of Proxalin, EC-Proxalin or Proxalin Suspension and other treatment options before deciding to use Proxalin, EC-Proxalin or Proxalin Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Proxalin as Proxalin, EC-Proxalin or Proxalin Suspension is indicated:

• For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis
• For the relief of the signs and symptoms of juvenile arthritis

Proxalin as Proxalin Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Proxalin as Proxalin and Proxalin Suspension is also indicated:

• For relief of the signs and symptoms of tendonitis
• For relief of the signs and symptoms of bursitis
• For relief of the signs and symptoms of acute gout
• For the management of pain
• For the management of primary dysmenorrhea

EC-Proxalin is not recommended for initial treatment of acute pain because the absorption of Proxalin is delayed compared to absorption from other Proxalin-containing products.

Proxalin is a nonsteroidal anti-inflammatory drug (NSAID). Proxalin works by reducing hormones that cause inflammation and pain in the body.

Proxalin is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting forms of Proxalin that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of Proxalin will not work fast enough to treat acute pain.

Proxalin may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Ankylosing Spondylitis:

Initial: 250 mg to 500 mg (Proxalin) or 275 mg to 550 mg (Proxalin sodium) orally twice a day. The initial dose for Proxalin sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Proxalin) or 1650 mg (Proxalin sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Proxalin sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Osteoarthritis:

Initial: 250 mg to 500 mg (Proxalin) or 275 mg to 550 mg (Proxalin sodium) orally twice a day. The initial dose for Proxalin sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Proxalin) or 1650 mg (Proxalin sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Proxalin sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 250 mg to 500 mg (Proxalin) or 275 mg to 550 mg (Proxalin sodium) orally twice a day. The initial dose for Proxalin sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Proxalin) or 1650 mg (Proxalin sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Proxalin sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Acute Gout:

750 mg (Proxalin) or 825 mg (Proxalin sodium) orally one time, followed by 250 mg (Proxalin) or 275 mg (Proxalin sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of Proxalin sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided.

Usual Adult Dose for Bursitis:

550 mg Proxalin sodium orally once, followed by 550 mg Proxalin sodium every 12 hours, or 275 mg (Proxalin sodium)/250 mg (Proxalin) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Proxalin sodium or 1000 mg Proxalin. The recommended initial dose of Proxalin sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Tendonitis:

550 mg Proxalin sodium orally once, followed by 550 mg Proxalin sodium every 12 hours, or 275 mg (Proxalin sodium)/250 mg (Proxalin) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Proxalin sodium or 1000 mg Proxalin. The recommended initial dose of Proxalin sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Dysmenorrhea:

550 mg Proxalin sodium orally once, followed by 550 mg Proxalin sodium every 12 hours, or 275 mg (Proxalin sodium)/250 mg (Proxalin) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Proxalin sodium or 1000 mg Proxalin.

Over-the-counter preparation: Proxalin sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Proxalin sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Pain:

550 mg Proxalin sodium orally once, followed by 550 mg Proxalin sodium every 12 hours, or 275 mg (Proxalin sodium)/250 mg (Proxalin) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Proxalin sodium or 1000 mg Proxalin.

Over-the-counter preparation: Proxalin sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Proxalin sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Geriatric Dose for Pain:

Over-the-counter preparation - 220 mg (Proxalin sodium) orally every 12 hours or 250 mg (Proxalin) orally every 8 hours as needed.

Usual Pediatric Dose for Fever:

Dosage guidelines are based on Proxalin:

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Pain:

Dosage guidelines are based on Proxalin:

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Dosage guidelines are based on Proxalin:

Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.

See also:
What is the most important information I should know about Proxalin?

Proxalin, EC-Proxalin and Proxalin Suspension are contraindicated in patients with known hypersensitivity to Proxalin and Proxalin sodium.

Proxalin, EC-Proxalin and Proxalin Suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Proxalin, EC-Proxalin and Proxalin Suspension are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Use Proxalin sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Proxalin sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Proxalin sustained-release tablets refilled.
• Swallow Proxalin sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• Take Proxalin sustained-release tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Take Proxalin sustained-release tablets with a full glass of water (8 oz [240 mL]) as directed by your doctor.
• If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Proxalin sustained-release tablets.
• If you miss a dose of Proxalin sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Proxalin sustained-release tablets.

Proxalin is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

This form of Proxalin is absorbed slowly and should not be used for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist about using a different form of this drug or other medications for quick relief of pain.

How to use EC-Proxalin

Read the Medication Guide provided by your pharmacist before you start using Proxalin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily with or without food. Swallow this medication whole. Do not break, crush, or chew the tablets. Doing so can release the drug too quickly, increasing the risk of side effects. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.

For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.

Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Proxalin?

The use of NSAIDs in patients who are receiving ACE inhibitors may potentiate renal disease states.

In vitro studies have shown that Proxalin anion, because of its affinity for protein, may displace from their binding sites other drugs which are also albumin-bound.

Theoretically, the Proxalin anion itself could likewise be displaced. Short-term controlled studies failed to show that taking the drug significantly affects prothrombin times when administered to individuals on coumarin-type anticoagulants. Caution is advised nonetheless, since interactions have been seen with other nonsteroidal agents of this class. Similarly, patients receiving the drug and a hydantoin, sulfonamide or sulfonylurea should be observed for signs of toxicity to these drugs.

Concomitant administration of Proxalin and aspirin is not recommended because Proxalin is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations and peak plasma levels.

The natriuretic effect of furosemide has been reported to be inhibited by some drugs of this class. Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has also been reported. DL Proxalin and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.

Probenecid given concurrently increases Proxalin anion plasma levels and extends its plasma half-life significantly.

Caution should be used if Proxalin is administered concomitantly with methotrexate. DL Proxalin, Proxalin sodium and other NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model, possibly increasing the toxicity of methotrexate.

Drug/Laboratory Test Interactions

DL Proxalin may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined. The administration of Proxalin may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-dinitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with Proxalin be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.

DL Proxalin may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

See also:
What are the possible side effects of Proxalin?

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg Proxalin compared to those taking 750 mg Proxalin.

In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with Proxalin, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking Proxalin in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

Special Senses: tinnitus*, visual disturbances, hearing disturbances

Cardiovascular: edema*, palpitations

General: dyspnea*, thirst

*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in <1% of patients taking Proxalin during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gatrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some causes have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (Female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuri