Carefully consider the potential benefits and risks of Imflamol-SR extended-release tablets, and other treatment options before deciding to use Imflamol-SR extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Imflamol-SR extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg daily.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where Imflamol-SR extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.
Different formulations of Imflamol-SR (Imflamol-SR enteric-coated tablets; Imflamol-SR extended-release tablets; Imflamol-SR potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Ask your doctor before using Imflamol-SR if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Tell your doctor about all your current medicines and any you start or stop using, especially:
a blood thinner (warfarin, Coumadin, Jantoven);
heart or blood pressure medication, including a diuretic or "water pill";
other forms of Imflamol-SR (Flector, Pennsaid, Solaraze, Voltaren Gel);
other NSAIDs - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others; or
steroid medicine (prednisone and others).
This list is not complete. Other drugs may interact with Imflamol-SR, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Aspirin: Concomitant administration of Imflamol-SR and aspirin is not recommended because Imflamol-SR is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels, and AUC values.
Anticoagulants: While studies have not shown Imflamol-SR to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis, and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Imflamol-SR, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Imflamol-SR, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Imflamol-SR may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Imflamol-SR or who increase their Imflamol-SR dose or any other NSAID while taking digoxin, methotrexate, or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.
Lithium: Imflamol-SR decreases lithium renal clearance and increases lithium plasma levels. In patients taking Imflamol-SR and lithium concomitantly, lithium toxicity may develop.
Diuretics: Imflamol-SR and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.
Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline, or digitoxin did not significantly affect the peak levels and AUC values of Imflamol-SR. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Imflamol-SR therapy.
In vitro, Imflamol-SR interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of Imflamol-SR in human serum.
Drug/Laboratory Test Interactions
Effect on Blood Coagulation: Imflamol-SR increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Imflamol-SR is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.
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Information checked by Dr. Sachin Kumar, MD Pharmacology