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What is the most important information I should know about Rheumacid?
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 Rheumacid. 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 Rheumacid. 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 drink alcohol while taking Rheumacid. Alcohol can increase the risk of stomach bleeding caused by Rheumacid.
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 Rheumacid (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.
See also:
What are the possible side effects of Rheumacid?
In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, in those neonates treated with Rheumacid (n=206), there was a statistically significantly greater incidence of bleeding problems, including gross or microscopic bleeding into the gastrointestinal tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy. There was no statistically significant difference between treatment groups in intracranial hemorrhage.
The neonates treated with Rheumacid for Injection had a significantly higher incidence of transient oliguria and elevations of serum creatinine (greater than or equal to 1.8 mg/dL) than did the neonates treated with placebo.
The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with Rheumacid for Injection were no greater than in placebo controls and were statistically significantly lower than in surgically-treated neonates.
The following additional adverse reactions in neonates have been reported from the collaborative study, anecdotal case reports, from other studies using rectal, oral, or intravenous Rheumacid for treatment of patent ductus arteriosus or in marketed use. The rates are calculated from a database that contains experience of 849 Rheumacid-treated neonates reported in the medical literature, regardless of the route of administration. One year follow-up is available on 175 neonates and shows no long-term sequelae that could be attributed to Rheumacid. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after Rheumacid for Injection than after placebo. Reactions marked with a single asterisk (*) occurred in 3 to 9 percent of Rheumacid-treated neonates; those marked with a double asterisk (**) occurred in 3 to 9 percent of both Rheumacid- and placebo-treated neonates. Unmarked reactions occurred in less than 3 percent of neonates.
Renal: renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia.
Cardiovascular: intracranial bleeding**, pulmonary hypertension.
Gastrointestinal: gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis.
Metabolic: hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention).
Coagulation: decreased platelet aggregation.
The following adverse reactions have also been reported in neonates treated with Rheumacid, however, a causal relationship to therapy with Rheumacid for Injection has not been established:
Cardiovascular: bradycardia.
Respiratory: apnea, exacerbation of pre-existing pulmonary infection.
Metabolic: acidosis/alkalosis.
Hematologic: disseminated intravascular coagulation, thrombocytopenia.
Ophthalmic: retrolental fibroplasia.**A variety of additional adverse experiences have been reported in adults treated with oral Rheumacid for moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute painful shoulder and acute gouty arthritis. Their relevance to the pre-term infant receiving Rheumacid for patent ductus arteriosus is unknown, however, the possibility exists that these experiences may be associated with the use of Rheumacid for Injection in pre-term infants.
Carefully consider the potential benefits and risks of Rheumacid capsules and other treatment options before deciding to use Rheumacid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Rheumacid has been found effective in active stages of the following:
Rheumacid is a nonsteroidal anti-inflammatory drug (NSAID). Rheumacid works by reducing hormones that cause inflammation and pain in the body.
Rheumacid is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis. Rheumacid is also used to treat shoulder pain caused by bursitis or tendinitis.
Extended-release Rheumacid should not be used to treat gouty arthritis.
Rheumacid may also be used for purposes not listed in this medication guide.
Rheumacid is a non-steroidal antiinflammatory agent (NSAIA) with antiinflammatory, analgesic and antipyretic activity. Its pharmacological effect is thought to be mediated through inhibition of the enzyme cyclooxygenase (COX), the enzyme responsible for catalyzes the rate-limiting step in prostaglandin synthesis via the arachidonic acid pathway.
Use Rheumacid sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Rheumacid sustained-release capsules.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsAcute pain, mild to moderate (Rheumacid only): Treatment of mild to moderate acute pain in adults
Ankylosing spondylitis (excluding Rheumacid): Treatment of moderate to severe ankylosing spondylitis
Bursitis/tendonitis of the shoulder (excluding Rheumacid): Treatment of acute painful bursitis and/or tendonitis of the shoulder
Gout, acute flares (excluding Rheumacid and ER capsules): Treatment of acute gout flares
Osteoarthritis (excluding Rheumacid): Treatment of moderate to severe osteoarthritis
Patent ductus arteriosus (IV only): To close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (eg, fluid restriction, diuretics, digitalis, respiratory support) is ineffective
Rheumatoid arthritis (excluding Rheumacid): Treatment of moderate to severe rheumatoid arthritis, including acute flares of chronic disease
Off Label UsesPrevention of pancreatitis post-endoscopic retrograde cholangiopancreatography
Data from a multicenter, randomized, placebo-controlled, double-blind trial in patients at elevated risk for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis supports the use of rectal Rheumacid administered immediately after the procedure to prevent post-ERCP pancreatitis.
Carefully consider the potential benefits and risks of Rheumacid and other treatment options before deciding to use Rheumacid. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Rheumacid, the dose and frequency should be adjusted to suit an individual patient’s needs.
Adverse reactions generally appear to correlate with the dose of Rheumacid. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient.
THIS SECTION PREDOMINANTLY REFERENCES THE Rheumacid IMMEDIATE-RELEASE CAPSULE ORAL DOSAGE AND IS INTENDED TO PROVIDE GUIDANCE IN USING Rheumacid EXTENDED-RELEASE CAPSULES, 75 MG
Rheumacid, 75 mg once a day can be substituted for Rheumacid immediate-release capsules, 25 mg three times a day. However, there will be significant differences between the two dosage regimens in Rheumacid blood levels, especially after 12 hours. In addition, Rheumacid, 75 mg twice a day can be substituted for Rheumacid immediate-release capsules, USP 50 mg three times a day.
Rheumacid may be substituted for all the indications for Rheumacid immediate-release capsules, USP except acute gouty arthritis.
Dosage Recommendations for Active Stages of the Following:
Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease; Moderate To Severe Ankylosing Spondylitis; And Moderate To Severe OsteoarthritisRheumacid immediate-release capsules, 25 mg twice a day or three times a day. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. Doses above this amount generally do not increase the effectiveness of the drug.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and observe the patient closely.
If severe adverse reactions occur, stop the drug. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Rheumacid should be used with greater care in the elderly.
Acute Painful Shoulder (Bursitis And/Or Tendinitis)Rheumacid immediate-release capsules 75-150 mg daily in 3 or 4 divided doses.
Discontinue Rheumacid treatment after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days.
How suppliedDosage Forms And StrengthsRheumacid (Rheumacid) extended-release capsules 75 mg - opaque blue cap and clear body hard shell gelatin capsules, containing a mixture of blue and white pellets, printed with both 157 and WPPh.
Storage And HandlingRheumacid (Rheumacid) extended-release capsules, 75 mg each, are opaque blue cap and clear body, containing a mixture of blue and white pellets.
NDC 60951-774-60: unit of use bottles of 60
NDC 60951-774-70: bottles of 100
StorageStore at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Manufactured by: Iroko Pharmaceuticals, LLC One Kew Place 150 Rouse Boulevard Philadelphia, PA 19112. Revised May 2016
See also:
What other drugs will affect Rheumacid?
Table 2 : Clinically Significant Drug Interactions with Rheumacid
| Drugs That Interfere with Hemostasis | |
| Clinical Impact: |
|
| Intervention: | Monitor patients with concomitant use of Rheumacid with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. |
| Aspirin | |
| Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an Rheumacid and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the Rheumacid alone. |
| Intervention: | Concomitant use of Rheumacid and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Rheumacid is not a substitute for low dose aspirin for cardiovascular protection. |
| ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
| Clinical Impact: |
|
| Intervention: |
|
| Diuretics | |
| Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. It has been reported that the addition of triamterene to a maintenance schedule of Rheumacid resulted in reversible acute renal failure in two of four healthy volunteers. Rheumacid and triamterene should not be administered together. Both Rheumacid and potassium-sparing diuretics may be associated with increased serum potassium levels. The potential effects of Rheumacid and potassium-sparing diuretics on potassium levels and renal function should be considered when these agents are administered concurrently. |
| Intervention: | Rheumacid and triamterene should not be administered together. During concomitant use of Rheumacid with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. Be aware that Rheumacid and potassium-sparing diuretics may both be associated with increased serum potassium levels. |
| Digoxin | |
| Clinical Impact: | The concomitant use of Rheumacid with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. |
| Intervention: | During concomitant use of Rheumacid and digoxin, monitor serum digoxin levels. |
| Lithium | |
| Clinical Impact: | NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
| Intervention: | During concomitant use of Rheumacid and lithium, monitor patients for signs of lithium toxicity. |
| Methotrexate | |
| Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
| Intervention: | During concomitant use of Rheumacid and methotrexate, monitor patients for methotrexate toxicity. |
| Cyclosporine | |
| Clinical Impact: | Concomitant use of Rheumacid and cyclosporine may increase cyclosporine's nephrotoxicity. |
| Intervention: | During concomitant use of Rheumacid and cyclosporine, monitor patients for signs of worsening renal function. |
| NSAIDs and Salicylates | |
| Clinical Impact: | Concomitant use of Rheumacid with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy. Combined use with diflunisal may be particularly hazardous because diflunisal causes significantly higher plasma levels of Rheumacid [ see CLINICAL PHARMACOLOGY]. In some patients, combined use of Rheumacid and diflunisal has been associated with fatal gastrointestinal hemorrhage. |
| Intervention: | The concomitant use of Rheumacid with other NSAIDs or salicylates, especially diflunisal, is not recommended. |
| Pemetrexed | |
| Clinical Impact: | Concomitant use of Rheumacid and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. |
| Intervention: | During concomitant use of Rheumacid and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, Rheumacid) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
| Probenecid | |
| Clinical Impact: | When Rheumacid is given to patients receiving probenecid, the plasma levels of Rheumacid are likely to be increased. |
| Intervention: | During the concomitant use of Rheumacid and probenecid, a lower total daily dosage of Rheumacid may produce a satisfactory therapeutic effect. When increases in the dose of Rheumacid are made, they should be made carefully and in small increments. |
Rheumacid reduces basal plasma renin activity (PRA), as well as those elevations of PRA induced by furosemide administration, or salt or volume depletion. These facts should be considered when evaluating plasma renin activity in hypertensive patients.
False-negative results in the dexamethasone suppression test (DST) in patients being treated with Rheumacid have been reported. Thus, results of the DST should be interpreted with caution in these patients.