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FENOPROFEN CALCIUM
Overview
What is FENOPROFEN?
Fenoprofen (fenoprofen calcium, USP) capsules is a nonsteroidal, anti-inflammatory drug available in 200 mg and 400 mg capsule form for oral administration.
The 200 mg capsule is opaque yellow No. 97 cap and opaque white body, imprinted with “RX681” on the cap and body.
The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg" on the cap and “EP 123” on the body.
The chemical name is Benzenaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is CHCaO•2HO, and it has the following chemical structure.
Fenoprofen Calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.The pKa of fenoprofen calcium is 4.5 at 25°C.
Fenoprofen capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen.
Inactive ingredients in Fenoprofen capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and red iron oxide, and the 400 mg capsules contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, and titanium dioxide.
What does FENOPROFEN look like?
What are the available doses of FENOPROFEN?
Fenoprofen calcium (fenoprofen calcium, USP) capsules: 200 mg and 400 mg (3)
What should I talk to my health care provider before I take FENOPROFEN?
Pregnancy:
Infertility:
How should I use FENOPROFEN?
Fenoprofen is indicated for:
What interacts with FENOPROFEN?
Sorry No Records found
What are the warnings of FENOPROFEN?
Sorry No Records found
What are the precautions of FENOPROFEN?
Sorry No Records found
What are the side effects of FENOPROFEN?
Sorry No records found
What should I look out for while using FENOPROFEN?
Fenoprofen is contraindicated in the following patients:
What might happen if I take too much FENOPROFEN?
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ ].
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
How should I store and handle FENOPROFEN?
Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Fenoprofen® (fenoprofen calcium, USP) are available in capsule form for oral administration, and are supplied as following:● The 200 mg capsule has an opaque yellow No. 97 cap and an opaque white body, imprinted with "RX681" on the cap and body. NDC NDC 62250-691-02 Bottles of 100. Storage:Fenoprofen® (fenoprofen calcium, USP) are available in capsule form for oral administration, and are supplied as following:● The 200 mg capsule has an opaque yellow No. 97 cap and an opaque white body, imprinted with "RX681" on the cap and body. NDC NDC 62250-691-02 Bottles of 100. Storage:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fernoprofen has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of Fenoprofen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Fenoprofen is a potent inhibitor of prostaglandin synthesis in vitro. Fenoprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because fenoprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Non-Clinical Toxicology
Fenoprofen is contraindicated in the following patients:Metabolism of a number of medications, including antipsychotics, antidepressants, β-blockers, and antiarrhythmics, occurs through the cytochrome P450 2D6 isoenzyme (debrisoquine hydroxylase). Approximately 10% of the Caucasian population has reduced activity of this enzyme, so-called “poor” metabolizers. Among other populations the prevalence is not known. Poor metabolizers demonstrate higher plasma concentrations of antipsychotic drugs at usual doses, which may correlate with emergence of side effects. In one study of 45 elderly patients suffering from dementia treated with perphenazine, the 5 patients who were prospectively identified as poor P450 2D6 metabolizers had reported significantly greater side effects during the first 10 days of treatment than the 40 extensive metabolizers, following which the groups tended to converge. Prospective phenotyping of elderly patients prior to antipsychotic treatment may identify those at risk for adverse events.
The concomitant administration of other drugs that inhibit the activity of P450 2D6 may acutely increase plasma concentrations of antipsychotics. Among these are tricyclic antidepressants and selective serotonin reuptake inhibitors, e.g., fluoxetine, sertraline and paroxetine. When prescribing these drugs to patients already receiving antipsychotic therapy, close monitoring is essential and dose reduction may become necessary to avoid toxicity. Lower doses than usually prescribed for either the antipsychotic or the other drug may be required.
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the 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. The concurrent use of aspirin and an NSAID, such as fenoprofen, increases the risk of serious gastrointestinal (GI) events [ ].
Status Post Coronary Artery Bypass Graft (CABG) Surgery
see Contraindications ()
Post-MI Patients
Avoid the use of Fenoprofen in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Fenoprofen is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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