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Fenoprofen Calcium (Tablet, Film Coated)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4186

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Fenoprofen Calcium (Tablet, Film Coated)
dailymed-instance:dosage
Carefully consider the potential benefits and risks of fenoprofen calcium tablets and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with fenoprofen, the dose and frequency should be adjusted to suit an individual patient's needs.<br/>Analgesia: For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.<br/>Rheumatoid Arthritis and Osteoarthritis: For the relief of rheumatoid arthritis or osteoarthritis the recommended dose is 300 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation ofdrug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3200 mg. Fenoprofen calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished. Patients with rheumatoid arthritis generally seem to require larger doses of fenoprofen calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed. Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy.
dailymed-instance:descripti...
Fenoprofen calcium is a non-steroidal, anti-inflammatory, antiarthritic drug. Chemically, fenoprofen calcium is an arylacetic acid derivative. The structural formula is as follows: Benzeneacetic acid,��-methyl-3-phenoxy-, calcium salt (2:1)-(��)-, dihydrate Fenoprofen calcium, USP is a white, crystalline powder, soluble in alcohol (95%) to the extent of approximately 15 mg/mL at 25��C, slightly soluble in water, and insoluble in benzene. The pKa of fenoprofen calcium is 4.5 at 25��C. Film-coated fenoprofen calcium tablets for oral administration are available containing fenoprofen calcium as the dihydrate equivalent to 600 mg of fenoprofen and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, titanium dioxide and FD&C Yellow No. 6 Aluminum Lake.
dailymed-instance:clinicalP...
Fenoprofen calcium is a non-steroidal, anti-inflammatory, antiarthritic drug that also possesses analgesic and antipyretic activities. Its exact mode of action is unknown, but it is thought that prostaglandin synthetase inhibition is involved. Fenoprofen has been shown to inhibit prostaglandin synthetase isolated from bovine seminal vesicles. Reproduction studies in rats have shown fenoprofen to be associated with prolonged labor and difficult parturition when given during late pregnancy. Evidence suggeststhat this may be due to decreased uterine contractility resulting from the inhibition of prostaglandin synthesis. Its action is not mediated through the adrenal gland. Fenoprofen shows anti-inflammatory effects in rodents by inhibiting the development of redness and edema in acute inflammatory conditions and by reducing soft-tissue swelling and bone damage associated with chronic inflammation. It exhibits analgesic activity in rodents by inhibiting the writhing response caused by the introduction of an irritant into the peritoneal cavities of mice and by elevating pain thresholds that are related to pressure in edematous hindpaws of rats. In rats made febrile by the subcutaneous administration of brewer's yeast, fenoprofen produces antipyretic action. These effects are characteristic of non-steroidal, antiinflammatory, antipyretic, analgesic drugs. The results in humans confirmed the anti-inflammatory and analgesic actions found in animals. The emergence and degree of erythemic response were measured in adult male volunteers exposed to ultraviolet irradiation. The effects of fenoprofen, aspirin and indomethacin were each compared with those of a placebo. All three drugs demonstrated antierythemic activity. In all patients with rheumatoid arthritis, the anti-inflammatory action of fenoprofen has been evidenced by relief of pain, increase in grip strength and reductions in joint swelling, duration of morning stiffness and disease activity (as assessed by both the investigator and the patient). The anti-inflammatory action of fenoprofen has also been evidenced by increased mobility (i.e., a decrease in the number of joints having limited motion). The use of fenoprofen in combination with gold salts or corticosteroids has been studied in patients with rheumatoid arthritis. The studies, however, were inadequate in demonstrating whether further improvement is obtained by adding fenoprofen to maintenance therapy with gold salts or steroids. Whether or not fenoprofen, used in conjunction with partially effective doses of a corticosteroid, has a "steroid-sparing" effect is unknown. In patients with osteoarthritis, the anti-inflammatory and analgesic effects of fenoprofen have been demonstrated by reduction in tenderness as a response to pressure and reductions in night pain, stiffness, swelling and overall disease activity (as assessed by both the patient and the investigator). These effects have also been demonstrated by relief of pain with motion and at rest and increased range of motion in involved joints. In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with fenoprofen than in aspirin-treated patients. It is not known whether fenoprofen calcium causes less peptic ulceration than does aspirin. In patients with pain, the analgesic action of fenoprofen has produced a reduction in pain intensity, an increase in pain relief, improvement in total analgesia scores, and a sustained analgesic effect. Under fasting conditions, fenoprofen is rapidly absorbed and peak plasma levels of 50 mcg/mL are achieved within 2 hours after oral administration of 600 mg doses. Good dose proportionality was observed between 200 mg and 600 mg doses in fasting male volunteers. The plasma half-life is approximately 3 hours. About 90% of a single oral dose is eliminated within 24 hours as fenoprofen glucuronide and 4'-hydroxy-fenoprofen glucuronide, the major urinary metabolites of fenoprofen. Fenoprofen is highly bound (99%) to albumin. The concomitant administration of antacid (containing both aluminum and magnesium hydroxide) does not interfere with absorption of fenoprofen. There is less suppression of collagen-induced platelet aggregation with single doses of fenoprofen calcium than there is with aspirin.
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Fenoprofen calcium tablets, USP are available containing fenoprofen calcium, USP equivalent to 600 mg fenoprofen. The 600 mg tablet is an orange, film-coated, capsule-shaped, tablet debossed with M471 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0471-01bottles of 100 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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Cardiovascular Risk Gastrointestinal Risk
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dailymed-instance:overdosag...
Signs and Symptoms: Symptoms of overdose appear within several hours and generally involve the gastrointestinal and central nervous systems. They include dyspepsia, nausea, vomiting, abdominal pain, dizziness, headache, ataxia, tinnitus, tremor, drowsiness and confusion. Hyperpyrexia, tachycardia, hypotension and acute renal failure may occur rarely following overdose. Respiratory depression and metabolic acidosis have also been reported following overdose with certain NSAIDs.<br/>Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient. Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. Alkalinization of the urine, forced diuresis, peritoneal dialysis, hemodialysis and charcoal hemoperfusion do not enhance systemic drug elimination.
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Fenoprofen Calcium
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Fenoprofen Calcium (Tablet, Film Coated)
dailymed-instance:adverseRe...
During clinical studies for rheumatoid arthritis, osteoarthritis or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions and the following data emerged. These encompass observations in 6,786 patients, including 188 observed for at least 52 weeks. For comparison, data are also presented from complaints received from the 266 patients who received placebo in these same trials. During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies.<br/>INCIDENCE GREATER THAN 1%:<br/>Probable Causal Relationship: Digestive System: During clinical trials with fenoprofen calcium, the most common adverse reactions were gastrointestinal in nature and occurred in about 20% of patients receiving fenoprofen as compared to 16% of patients receiving placebo. In descending order of frequency, these reactions included dyspepsia (10.3% fenoprofen vs. 2.3% placebo), nausea (7.7% vs. 7.1%), constipation (7% vs. 1.5%), vomiting (2.6% vs. 1.9%), abdominal pain (2% vs. 1.1%) and diarrhea (1.8% vs. 4.1%). The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients during premarketing studies. Nervous System: (8.7% vs. 7.5%) and somnolence (8.5% vs. 6.4%). Dizziness (6.5% vs. 5.6%), tremor (2.2% vs. 0.4%) and confusion (1.4% vs. none) were noted less frequently. Fenoprofen was discontinued in less than 0.5% of patients because of these side effects during premarketing studies. Skin and Appendages: Increased sweating (4.6% vs. 0.4%), pruritus (4.2% vs. 0.8%) and rash (3.7% vs. 0.4%) were reported. Fenoprofen was discontinued in about 1% of patients because of an adverse effect related to the skin during premarketing studies. Special Senses: Tinnitus (4.5% vs. 0.4%), blurred vision (2.2% vs. none), and decreased hearing (1.6% vs. none) were reported. Fenoprofen was discontinued in less than 0.5% of patients because of adverse effects related to the special senses during premarketing studies. Cardiovascular: Palpitations (2.5% vs. 0.4%). Fenoprofen was discontinued in about 0.5% of patients because of adverse cardiovascular reactions during premarketing studies. Miscellaneous: Nervousness (5.7% vs. 1.5%), asthenia (5.4% vs. 0.4%), peripheral edema (5.0% vs. 0.4%), dyspnea (2.8% vs. none), fatigue (1.7% vs. 1.5%), upper respiratory infection (1.5% vs. 5.6%) and nasopharyngitis (1.2 % vs. none).<br/>INCIDENCE LESS THAN 1%:<br/>Probable Causal Relationship: The following adverse reactions, occurring in less than 1% of patients, were reported in controlled clinical trials and voluntary reports made since fenoprofen was initially marketed. The probability of a causal relationship exists between fenoprofen and these adverse reactions: Digestive System: Gastritis, peptic ulcer with/without perforation, gastrointestinal hemorrhage, anorexia, flatulence, dry mouth and blood in the stool. Increases in alkaline phosphatase, LDH, SGOT, jaundice and cholestatic hepatitis were observed . Genitourinary Tract: Renal failure, dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis and papillary necrosis . Hypersensitivity: Angioedema (angioneurotic edema). Hematologic: Purpura, bruising, hemorrhage, thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis and pancytopenia. Miscellaneous: Anaphylaxis, urticaria, malaise, insomnia and tachycardia.<br/>INCIDENCE LESS THAN 1%:<br/>Causal Relationship Unknown: Other reactions, reported either in clinical trials or spontaneously, occurred in circumstances in which a causal relationship could not be established. However, with these rarely reported reactions, the possibility of such a relationship cannot be excluded. Therefore, these observations are listed to alert the physician. Skin and Appendages: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome and alopecia. Digestive System: Aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis. Cardiovascular: Atrial fibrillation, pulmonary edema, electrocardiographic changes, and supraventricular tachycardia. Nervous System: Depression, disorientation, seizures, and trigeminal neuralgia. Special Senses: Burning tongue, diplopia, and optic neuritis. Miscellaneous: Personality change, lymphadenopathy, mastodynia, and fever.
dailymed-instance:indicatio...
Carefully consider the potential benefits and risks of fenoprofen calcium tablets and other treatment options before deciding to use fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Fenoprofen calcium tablets are indicated:
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Fenoprofen Calcium