Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3797
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Feldene (Capsule)
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Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . After observing the response to initial therapy with FELDENE, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of rheumatoid arthritis and osteoarthritis, the recommended dose is 20 mg given orally once per day. If desired, the daily dose may be divided. Because of the long half-life of FELDENE, steady-state blood levels are not reached for 7���12 days. Therefore, although the therapeutic effects of FELDENE are evident early in treatment, there is a progressive increase in response over several weeks and the effect of therapy should not be assessed for two weeks.
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FELDENE contains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral administration. The chemical name for piroxicam is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3-carboxamide 1,1-dioxide. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weaklybasic pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam is 331.35. Its molecular formula is CHNOS and it has the following structural formula: The inactive ingredients in FELDENE capsules include: Blue 1, Red 3, lactose, magnesium stearate, sodium lauryl sulfate, starch.
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Pharmacodynamics: FELDENE is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of FELDENE, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.<br/>Pharmacokinetics:<br/>Absorption: FELDENE is well absorbed following oral administration. Drug plasma concentrations are proportional for 10 and 20 mg doses and generally peak within three to five hours after medication. The prolonged half-life (50 hours) results in the maintenance of relatively stable plasma concentrations throughout the day on once daily doses and to significant accumulation uponmultiple dosing. A single 20-mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/mL, while maximum drug plasma concentrations, after repeated daily ingestion of 20 mg FELDENE, usually stabilize at 3���8 mcg/mL. Most patients approximate steady state plasma levels within 7���12 days. Higher levels, which approximate steady state at two to three weeks, have been observed in patients in whom longer plasma half-lives of piroxicam occurred. With food there is a slight delay in the rate but not the extent of absorption following oral administration. The concomitant administration of antacids (aluminum hydroxide or aluminum hydroxide with magnesium hydroxide) have been shown to have no effect on the plasma levels of orally administered piroxicam.<br/>Distribution: The apparent volume of distribution of piroxicam is approximately 0.14 L/kg. Ninety-nine percent of plasma piroxicam is bound to plasma proteins. Piroxicam is excreted into human milk. The presence in breast milk has been determined during initial and long-term conditions (52 days). Piroxicam appeared in breast milk at about 1% to 3% of the maternal concentration. No accumulation ofpiroxicam occurred in milk relative to that in plasma during treatment.<br/>Metabolism: Metabolism of piroxicam occurs by hydroxylation at the 5 position of the pyridyl side chain and conjugation of this product; by cyclodehydration; and by a sequence of reactions involving hydrolysis of the amide linkage, decarboxylation, ring contraction and N-demethylation. The biotransformation products of piroxicam metabolism are reported to not have any anti-inflammatory activity.<br/>Excretion: FELDENE and its biotransformation products are excreted in urine and feces, with about twice as much appearing in the urine as in the feces. Approximately 5% of a FELDENE dose is excreted unchanged. The plasma half-life (T) for piroxicam is approximately 50 hours.<br/>Special Populations:<br/>Pediatric: FELDENE has not been investigated in pediatric patients.<br/>Race: Pharmacokinetic differences due to race have not been identified.<br/>Hepatic Insufficiency: The effects of hepatic disease on FELDENE pharmacokinetics have not been established. However, a substantial portion of FELDENE elimination occurs by hepatic metabolism. Consequently, patients with hepatic disease may require reduced doses of FELDENE as compared to patients with normal hepatic function.<br/>Renal Insufficiency: FELDENE pharmacokinetics have been investigated in patients with renal insufficiency. Studies indicate patients with mild to moderate renal impairment may not require dosing adjustments. However, the pharmacokinetic properties of FELDENE in patients with severe renal insufficiency or those receiving hemodialysis are not known.<br/>Other Information: In controlled clinical trials, the effectiveness of FELDENE has been established for both acute exacerbations and long-term management of rheumatoid arthritis and osteoarthritis. The therapeutic effects of FELDENE are evident early in the treatment of both diseases with a progressive increase in response over several (8���12) weeks. Efficacy is seen in terms of pain relief and, when present, subsidence of inflammation. Doses of 20 mg/day FELDENE display a therapeutic effect comparable to therapeutic doses of aspirin, with a lower incidence of minor gastrointestinal effects and tinnitus. FELDENE has been administered concomitantly with fixed doses of gold and corticosteroids. The existence of a "steroid-sparing" effect has not been adequately studied to date.
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FELDENE Capsules for oral administration: Bottles of 100: 10 mg (NDC 0069-3220-66) maroon and blue #322 Bottles of 100: 20 mg (NDC 0069-3230-66) maroon #323
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Cardiovascular Risk:<br/>Gastrointestinal Risk:
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Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60���100 g in adults, 1���2 g/kg in children) and/or osmotic cathartic may be indicated. The long plasma half-life of piroxicam should be considered when treating an overdose with piroxicam. Experiments in dogs have demonstrated that the use of multiple-dose treatments with activated charcoal could reduce the half-life of piroxicam by more than 50% and systemic bioavailability by as much as 37% when activated charcoal is given as late as 6 hours after ingestion of piroxicam. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
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piroxicam
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Feldene (Capsule)
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| dailymed-instance:adverseRe... |
In patients taking FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1���10% of patients are: Additional adverse experiences reported occasionally include: Other adverse reactions which occur rarely are:
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Carefully consider the potential benefits and risks of FELDENE and other treatment options before deciding to use FELDENE. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . FELDENE is indicated:
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Feldene
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