Proxym-MR

Proxym-MR is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties. Its therapeutic effects are due to its ability to inhibit prostaglandin synthesis. It is indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.

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

Proxym-MR (Proxym-MR capsules and tablets) is indicated:

• For acute and long-term use in the management of signs and symptoms of the following:
  1. Osteoarthritis
  2. Rheumatoid arthritis
• For the management of acute pain

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

Proxym-MR is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.

Proxym-MR may also be used for purposes not listed in this medication guide.

Carefully consider the potential benefits and risks of Proxym-MR capsules and other treatment options before deciding to use Proxym-MR capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Proxym-MR capsules, the dose and frequency should be adjusted to suit an individual patient's needs.

Dosage adjustment of Proxym-MR capsules is generally not required in patients with mild to moderate renal impairment. Proxym-MR capsules should be used with caution in such patients, because, as with other NSAIDs, they may further decrease renal function in some patients with impaired renal function.

Analgesia

The recommended total daily dose of Proxym-MR capsules for acute pain is up to 1000 mg, given as 200 to 400 mg every 6 to 8 hours. Doses of Proxym-MR greater than 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

Osteoarthritis And Rheumatoid Arthritis

The recommended starting dose of Proxym-MR capsules for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

In chronic conditions, a therapeutic response to therapy with Proxym-MR capsules is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

How supplied

Proxym-MR capsules USP, 300 mg are available as opaque, dark red body and cap, hard gelatin capsules supplied as

NDC 63629-1376-1 bottles of 20

NDC 63629-1376-2 bottles of 60

NDC 63629-1376-3 bottles of 30

NDC 63629-1376-4 bottles of 45

NDC 63629-1376-5 bottles of 42

NDC 63629-1376-6 bottles of 120

NDC 63629-1376-7 bottles of 90

NDC 63629-1376-8 bottles of 25

NDC 63629-1376-9 bottles of 21

Store at 20° to 25°C (68° to 77°F), protected from moisture.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep container tightly closed.

Manufactured In Canada By: NOVOPHARM LIMITED, Toronto, Canada M1B 2K9. Distributed by: Bryant Ranch Prepack, 12623 Sherman Way, North Hollywood, CA 91605. Voice (877) 885-0882 Fax (877) 277-7552. Revised: Oct 2012

See also:
What is the most important information I should know about Proxym-MR?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Proxym-MR. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Proxym-MR. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Proxym-MR (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking Proxym-MR. Alcohol can increase the risk of stomach bleeding caused by Proxym-MR.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Proxym-MR can make your skin more sensitive to sunlight and sunburn may result.

Use Proxym-MR extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Proxym-MR extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Proxym-MR extended-release tablets refilled.
• Take Proxym-MR extended-release tablets by mouth with or without food. 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.
• Swallow Proxym-MR extended-release tablets whole. Do not break, crush, or chew before swallowing.
• Take Proxym-MR extended-release tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Proxym-MR extended-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 the proper use of Proxym-MR extended-release tablets.

Proxym-MR is used to relieve painful conditions of the bone, joints and soft tissues such as inflammatory arthritis (rheumatoid arthritis) and advanced osteoarthritis.

See also:
What other drugs will affect Proxym-MR?

Drug Interactions ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Antacids

The concomitant administration of antacids has no apparent effect on the extent of absorption of Proxym-MR. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak.

Aspirin

When Proxym-MR is administered with aspirin, its protein binding is reduced, although the clearance of free Proxym-MR is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Proxym-MR and aspirin is not generally recommended because of the potential of increased adverse effects.

Cyclosporine, Digoxin, Methotrexate

Proxym-MR, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increase toxicity. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given Proxym-MR, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Diuretics

Proxym-MR has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as post marketing observations have shown that Proxym-MR can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for sings of renal failure, as well as to assure diuretic efficacy.

Glyburide

Proxym-MR has no apparent pharmacokinetic interaction when administered with glyburide.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Phenylbutazone

Phenylbutazone causes increase (by about 80%) in the free fraction of Proxym-MR. Although in vivo studies have not been done to see if Proxym-MR clearance is changed by coadministration of phylbutazone, it is not recommended that they be coadministered.

Phenytoin

Proxym-MR has no apparent pharmacokinetic interaction when administered with phenytoin.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that of users of either drug alone. Short-term pharmacokinetic studies have demonstrated that concomitant administration of warfarin and Proxym-MR results in reduced protein binding of warfarin, but there was no change in the clearance of free warfarin. There was no significant difference in the pharmacodynamic effect of warfarin administered alone and warfarin administered with Proxym-MR as measured by prothrombin time. Thus, concomitant therapy with warfarin and Proxym-MR should not require dosage adjustment of either drug. However, caution should be exercised because there have been a few spontaneous reports of prolonged prothrombin times, with or without bleeding, in Proxym-MR-treated patients receiving concomitant warfarin therapy.

Drug/Laboratory Test Interactions

The urine of patients who take Proxym-MR can give a false-positive reaction for urinary bilirubin (urobilin) due to the presence of phenolic metabolites of Proxym-MR. Diagnostic dip-stick methodology, used to detect ketone bodies in urine, has resulted in false-positive findings in some patients treated with Proxym-MR. Generally, this phenomenon has not been associated with other clinically significant events. No dose relationship has been observed.

Proxym-MR treatment is associated with a small decrease in serum uric acid levels. In clinical trials, mean decreases of 1 to 2 mg/dL were observed in arthritic patients receiving Proxym-MR (600 mg to 1000 mg/day) after 4 weeks of therapy. These levels then remained stable for up to 1 year of therapy.

See also:
What are the possible side effects of Proxym-MR?

In patients taking Proxym-MR or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting.

Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus.

Adverse-reaction information for Proxym-MR was derived from 2,629 arthritic patients treated with Proxym-MR (Proxym-MR capsules and tablets) in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with Proxym-MR.

New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of Proxym-MR b.i.d. (i.e., 600 to 1000 mg/day).

Incidence Greater Than Or Equal To 1%—Probably Causally Related

Body as a whole—Chills and fever.

Digestive system—Dyspepsia (10%), abdominal pain1, diarrhea1, flatulence1, nausea1, constipation, gastritis, melena, vomiting.

Nervous system—Asthenia/malaise1, dizziness1, depression, nervousness.

Skin and appendages—Pruritus, rash.

Special senses—Blurred vision, tinnitus.

Urogenital system—Dysuria, urinary frequency.

Incidence Less Than 1%—Probably Causally Related

(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)

Body as a whole—Allergic reaction, anaphylactic/anaphylactoid reactions (including shock).

Cardiovascular system—Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic).

Digestive system—Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.

Hemic and lymphatic system—Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, leukopenia, neutropenia, pancytopenia.

Metabolic and nutritional—Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.

Nervous system—Insomnia, somnolence.

Respiratory system—Asthma, pulmonary infiltration with eosinophilia.

Skin and appendages—Angioedema, sweating, urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, hyperpigmentation, erythema multiforme.

Special senses—Photophobia, transient visual disturbances.

Urogenital system—Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.

Incidence Less Than 1%—Causal Relationship Unknown

(Medical events occurring under circumstances where causal relationship to Proxym-MR is uncertain. These reactions are listed as alerting information for physicians.)

Body as a whole—Infection, headache.

Cardiovascular system—Arrhythmias, myocardial infarction, cerebrovascular accident.

Digestive system—Esophagitis with or without stricture or cardiospasm, colitis.

Metabolic and nutritional—Change in weight.

Nervous system—Paresthesia, confusion.

Respiratory system— Bronchitis, dyspnea, pharyngitis, rhinitis, sinusitis.

Skin and appendages—Alopecia, maculopapular rash, photosensitivity, skin peeling.

Special senses—Conjunctivitis, deafness, taste perversion.

Urogenital system—Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities.

Additional Adverse Reactions Reported with NSAIDS

Body as a whole—Sepsis, death

Cardiovascular system—Tachycardia

Digestive system—Gastric ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis

Hemic and lymphatic system—Lymphadenopathy

Nervous system—Anxiety, dream abnormalities, convulsions, coma, hallucinations, meningitis, tremors, vertigo

Respiratory system—Respiratory depression, pneumonia

Urogenital system—Oliguria/polyuria, proteinuria