• Dosage of Febret in details
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Dosage of Febret in details

Febret Dosage

Applies to the following strength(s): 200 mg; 300 mg; 400 mg; 500 mg; 600 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

• Osteoarthritis
• Rheumatoid Arthritis
• Pain

Usual Pediatric Dose for:

• Juvenile Rheumatoid Arthritis

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Osteoarthritis

Capsules or tablets: 300 mg orally 2 to 3 times a day or 400 mg orally twice a day or 500 mg orally twice a day. Total daily dose should not exceed 1200 mg.

Extended-release tablets: 400 to 1200 mg orally, given once daily.

Usual Adult Dose for Rheumatoid Arthritis

Capsules or tablets: 300 mg orally 2 to 3 times a day or 400 mg orally twice a day or 500 mg orally twice a day. Total daily dose should not exceed 1200 mg.

Extended-release tablets: 400 to 1200 mg orally, given once daily.

Usual Adult Dose for Pain

Capsules or tablets: 200 to 400 mg orally every 6 to 8 hours. Total daily dose should not exceed 1200 mg.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Extended-release tablets:

6 to 16 years: dose based on weight, given orally once daily

For 20 to 30 kg, dose is 400 mg

For 31 to 45 kg, dose is 600 mg

For 46 to 60 kg, dose is 800 mg

For greater than 60 kg, dose is 1000 mg

Renal Dose Adjustments

Dosage adjustment of Febret is generally not required in patients with mild to moderate renal impairment. Monitoring of kidney function is advisable. Febret is not recommended in patients with advanced renal disease.

Liver Dose Adjustments

Febret should be used with caution in patients with mild to moderate hepatic disease.

Dose Adjustments

Patients weighing less than 60 kg should not exceed 20 mg/kg/day.

The dosage regimen should be adjusted based on patient response and tolerance to Febret. The lowest effective dose should be used for maintenance therapy.

Precautions

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of administration. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Prescribers and patients should remain vigilant for the development of such events, even in the absence of previous CV symptoms. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been shown that the incidence of upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Patients should be informed about the signs and symptoms of serious GI toxicities and the steps to take if they occur. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history of peptic ulcer disease, and/or GI bleeding, and who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Since elderly patients are at greater risk for serious GI events, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Febret is contraindicated for the treatment of perioperative pain in patients undergoing coronary artery bypass graft (CABG) surgery. Patients with a hypersensitivity (angioedema, bronchospasm, urticaria, or rhinitis) to aspirin or other NSAIDs may be cross sensitive to Febret. Patients with the "triad" of asthma, nasal polyps, and aspirin or other NSAID hypersensitivity are at particular risk. Fatal reactions have been reported in such patients. The use of Febret is considered contraindicated in these patients.

NSAIDs, including Febret, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to an increased incidence of CV events. NSAIDs, including Febret, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID therapy and throughout the course of therapy.

Fluid retention and edema have been observed in some patients taking NSAIDs, including Febret. Caution should be used when using Febret in patients with fluid retention, hypertension, or heart failure.

Long-term NSAIDs use has resulted in renal papillary necrosis and other renal injury. No information is available from controlled clinical trials regarding the use of Febret in patients with advanced renal disease. Therefore, treatment with Febret is not recommended in patients with advanced renal disease. Renal function may be further compromised by the use of Febret in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. If Febret must be used, periodic monitoring of renal function is recommended. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Caution is advised in patients with pre-existing kidney disease.

Patients who present with considerable dehydration should be rehydrated before starting therapy with Febret.

NSAIDs, including Febret, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Febret should not be used as a substitute for corticosteroids or to treat corticosteroid insufficiency.

Borderline elevations of one or more liver tests have been reported in patients treated with Febret. Elevations in ALT or AST (approximately three or more times the upper limit of normal) have been reported in clinical trials. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported. Febret should be discontinued if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (e.g., eosinophilia, rash, etc.).

Anemia has been reported in patients receiving NSAIDs, including Febret. This may due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Febret, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Patients receiving Febret who are also receiving anticoagulants or those who have coagulation disorders should be carefully monitored.

Patients receiving NSAIDs for long-term treatment should have their CBC and chemistry profile checked periodically.

Dialysis

Febret is not dialyzable.

Other Comments

If no improvement is seen within 2 to 4 weeks of therapy, an alternative NSAID should be considered.

More about Febret

• Side Effects
• During Pregnancy or Breastfeeding
• Dosage Information
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Consumer resources

• Febret
• Febret extended-release tablets
• Febret (Advanced Reading)

• Other brands: Febret, Febret XL

Professional resources

• Febret (AHFS Monograph)
• More (4) »

Related treatment guides

• Pain
• Juvenile Rheumatoid Arthritis
• Osteoarthritis
• Rheumatoid Arthritis

What other drugs will affect Febret?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with Febret may cause you to bruise or bleed easily.

Before taking Febret, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• digoxin (digitalis, Lanoxin);

• lithium (Eskalith, Lithobid);

• methotrexate (Rheumatrex, Trexall);

• a diuretic (water pills) such as furosemide (Lasix);

• steroids (prednisone and others);

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Cataflam, Voltaren), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with Febret. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Febret interactions

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 Febret. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak.

Aspirin

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

Cyclosporine, Digoxin, Methotrexate

Febret, 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 Febret, 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

Febret has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as post marketing observations have shown that Febret 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

Febret 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 Febret. Although in vivo studies have not been done to see if Febret clearance is changed by coadministration of phylbutazone, it is not recommended that they be coadministered.

Phenytoin

Febret 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 Febret 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 Febret as measured by prothrombin time. Thus, concomitant therapy with warfarin and Febret 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 Febret-treated patients receiving concomitant warfarin therapy.

Drug/Laboratory Test Interactions

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

Febret 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 Febret (600 mg to 1000 mg/day) after 4 weeks of therapy. These levels then remained stable for up to 1 year of therapy.

References

1. DailyMed. "ETODOLAC: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. MeSH. "Cyclooxygenase 2 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "(RS)-2-(1,8-Diethyl-4,9-dihydro-3H-pyrano[3,4-b]indol-1-yl)acetic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology