Indomethacin: profile and news

Roxane Laboratories, Inc. Announces the Launch of Fluticasone ... Feb 23, 2006
COLUMBUS, OH - Feb. 22, 2006- Roxane Laboratories, Inc. today announced the approval of Fluticasone Propionate Nasal Spray, 50mcg. ... - PharmaLive.com (press release),

First Generic Version of Flonase Approved Feb 23, 2006
The Food and Drug Administration (FDA) approved Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase, giving American ... - Kansas City infoZine,

FDA Approves First Generic Version of Flonase Feb 22, 2006
February 22, 2006, The Food and Drug Administration (FDA) today approved Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug ... - WebWire (press release),

FDA Approves Generic Version Of Flonase Nasal Spray Feb 23, 2006
...(AHN) - The US Food and Drug Administration on Thursday approves Fluticasone Propionate Nasal Spray, the first generic version of the brand name drug Flonase. ... - All Headline News

First Generic of Glaxo's Flonase is Approved Feb 24, 2006
...allowing Roxane, a subsidiary of Boehringer Ingelheim, to apply for approval of its generic product containing the same active ingredient fluticasone propionate ... - International News Service,

FDA approves generic version of popular allergy drug Flonase Feb 28, 2006
...alternative. Fluticasone Propionate Nasal Spray is the first generic version of Flonase, which has annual sales of more than $1 billion. ... - Wilkes Barre Times-Leader,

First Generic Version of Flonase Approved Feb 23, 2006
Like GlaxoSmithKline's brand-name equivalent, the generic form called Fluticasone Propionate Nasal Spray is an inhaled corticosteroid. ... - Forbes

GSK blocks generic Flonase in USA, for now Feb 27, 2006
Flonase (fluticasone propionate) nasal spray brought in worldwide sales of £656 million ($1.14bn) last year, £506 million of which came from the US market ... - Pharma Times (subscription),

FDA OKs Generic Version of Flonase Feb 22, 2006
The generic product is called fluticasone propionate nasal spray. It's approved for use in adults and children who are at least 4 years old. ... - WebMD

FDA Approves First Generic Form of Flonase Feb 23, 2006
Like GlaxoSmithKline's brand-name equivalent, the new generic (Fluticasone Propionate Nasal Spray) is an inhaled corticosteroid approved for adults and ... - WFIE-TV,

GlaxoSmithKline blocks sales of competitor's generic Flonase Feb 27, 2006
The order applies to both Roxane Laboratories Inc.'s Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved Wednesday, and Par ... - Columbus Ledger-Enquirer,

GlaxoSmithKline blocks sales of generic competitor to its Flonase ... Feb 24, 2006
The order applies to both Columbus, Ohio-based Roxane Laboratories Inc.'s Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved ... - Akron Beacon Journal,

Par Pharmaceutical Reports Sales and Earnings for 2005 Feb 28, 2006
...earlier announced that it entered into a supply and distribution agreement with GlaxoSmithKline (GSK) in the US to distribute fluticasone propionate nasal spray ... - MSN Money

Generic Flonase Gets FDA OK Feb 23, 2006
...billion. The generic version of the drug (Fluticasone Propionate Nasal Spray) is made by Roxane Laboratories, of Columbus, Ohio. ... - Milwaukee Channel.com,

Par Pharmaceutical Halts Shipment of Generic Flonase(R) Feb 24, 2006
Administration's (FDA) final decision approving an abbreviated new drug application (ANDA) for a generic version of Flonase (fluticasone propionate) Nasal Spray ... - Finanzen.net,

Par Pharmaceutical Begins Shipment of Generic Flonase(R) Feb 23, 2006
...that it has entered into a supply and distribution agreement with GlaxoSmithKline (GSK) in the United States to distribute fluticasone propionate aqueous nasal ... - PR Newswire (press release),

Boehringer Ingelheim Announces 48-week Results from Aptivus(R) ... Feb 9, 2006
A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone propionate exposures. ... - PR Newswire (press release),

Generic Flonase blocked in court Feb 25, 2006
The order applies to both Roxane Laboratories' fluticasone propionate nasal spray, which the Food and Drug Administration approved Wednesday, and Par ... - Fort Worth Star Telegram,

Par Pharma halts generic Flonase shipments after GSK wins ... Feb 24, 2006
Spring Valley, Pa.-based Par Pharma said it has subsequently halted all shipments of fluticasone propionate nasal spray and will take other steps necessary to ... - Forbes

National Briefing Feb 24, 2006
...spokeswoman for the company. The order applies to the fluticasone propionate nasal spray made by Roxane Laboratories Inc. and a generic ... - New York Times,

FDA approves generic Flonase spray Feb 24, 2006
By JAN JARVIS. Fluticasone propionate nasal spray, a generic version of GlaxoSmithKline's Flonase, won approval Wednesday from the Food and Drug Administration. ... - Fort Worth Star Telegram,

Judge orders halt to sales of generic Flonase Feb 24, 2006
In a statement today, Par said it was halting shipments of its version of Flonase, known by the generic name fluticasone propionate, a nasal spray. ... - philly.com,

GlaxoSmithKline blocks sales of generic competitor to Flonase Feb 26, 2006
The order applies to Columbus (Ohio)-based Roxane Laboratories' Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved Wednesday. ... - Newswatch 50,

Lundergan group buys Continental Inn Feb 24, 2006
The order applies to both Roxane Laboratories Inc.’s Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved Wednesday, and Par ... - Kentucky.com,

Generic nasal spray sales blocked Feb 25, 2006
The order applies to both Roxane Laboratories’ Fluticasone Propionate Nasal Spray, which the Food and Drug Administration approved Wednesday, and Par ... - Sioux Falls Argus Leader,

Business notebook Feb 23, 2006
Generic: The Food and Drug Administration approved the first generic version of the allergy drug Flonase, fluticasone propionate nasal spray. ... - Boston Globe,

Cash relief in store for allergy sufferers Feb 24, 2006
...relief. The Food and Drug Administration has approved fluticasone propionate, a generic version of Flonase nasal spray. Normally ... - WFAA (subscription),

Glaxo Loses US Court Bid to Block Generic Flonase (Update1) 06 Mar 2006
Flonase also is different from many other nasal sprays because its active ingredient, fluticasone propionate, is held in a suspension, which is a solid ... - Bloomberg

National Briefing Feb 24, 2006
...spokeswoman for the company. The order applies to the fluticasone propionate nasal spray made by Roxane Laboratories Inc. and a generic ... - New York Times,

Business notebook Feb 23, 2006
Generic: The Food and Drug Administration approved the first generic version of the allergy drug Flonase, fluticasone propionate nasal spray. ... - Boston Globe,

Other information

Indication
For moderate to severe rheumatoid arthritis including acute flares of chronic disease, ankylosing spondylitis, osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.

Pharmacology
Indomethacin, a nonsteroidal antiinflammatory drug (NSAID) with analgesic and antipyretic properties, is used to treat osteoarthritis and control acute pain.

Mechanism Of Action
Antiinflammatory effects of Indomethacin are believed to be due to inhibition of cylooxygenase in platelets which leads to the blockage of prostaglandin synthesis. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation.

Drug Category
Tocolytic Agents; Cardiovascular Agents; Anti-inflammatory Agents; Nonsteroidal Antiinflammatory Agents (NSAIDs); ATC:S01BC; ATC:M01AB

Brand Names/Synonyms
Amuno; Apo-Indomethacin; Argun; Arthrexin; Artracin; Artrinovo; Artrivia; Bonidin; Bonidon; Bonidon Gel; CCRIS 3502; Catlep; Chibro-Amuno; Chrono-Indicid; Chrono-Indocid; Confortid; Dolcidium; Dolcidium Pl; Dolovin; Durametacin; Elmetacin; Flexin Continus; HSDB 3101; Hicin; IMN; Idomethine; Imbrilon; Inacid; Indacin; Indameth; Indmethacine; Indo-Lemmon; Indo-Phlogont; Indo-Rectolmin; Indo-Spray; Indo-Tablinen; Indocid; Indocid Pda; Indocid Sr; Indocin; Indocin I.V; Indocin I.V.; Indocin Sr; Indolar Sr; Indomecol; Indomed; Indomee; Indometacin; Indometacine; Indometacyna; Indomethacin; Indomethacine; Indomethacinum; Indomethancin; Indomethazine; Indomethegan; Indomethine; Indometicina; Indomo; Indomod; Indoptic; Indoptol; Indorektal; Indoxen; Inflazon; Infrocin; Inteban Sp; Lausit; Liometacen [As Meglumine Salt]; Metacen; Metartril; Methazine; Metindol; Mezlin; Mezlocillin; Mezolin; Miametan; Mikametan; Mobilan; Novo-Methacin; Novomethacin; Nu-Indo; Reumacide; Rhemacin La; Rheumacin La; Sadoreum; Tannex; USAN; Vonum

Dosage Forms
CAPSULE

Absorption
Not Available

Interactions
Interactions for Indomethacin:

In normal volunteers receiving indomethacin, the administration of diflunisal decreased the renal clearance and significantly increased the plasma levels of indomethacin. In some patients, combined use of INDOCIN and diflunisal has been associated with fatal gastrointestinal hemorrhage. Therefore, diflunisal and INDOCIN should not be used concomitantly.

In a study in normal volunteers, it was found that chronic concurrent administration of 3.6 g of aspirin per day decreases indomethacin blood levels approximately 20%.

The concomitant use of INDOCIN with other NSAIDs is not recommended due to the increased possibility of gastrointestinal toxicity, with little or no increase in efficacy.

Clinical studies have shown that INDOCIN does not influence the hypoprothrombinemia produced by anticoagulants. However, when any additional drug, including INDOCIN, is added to the treatment of patients on anticoagulant therapy, the patients should be observed for alterations of the prothrombin time. In post-marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and INDOCIN. Caution should be exercised when INDOCIN and anticoagulants are administered concomitantly.

When INDOCIN is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased. Therefore, a lower total daily dosage of INDOCIN may produce a satisfactory therapeutic effect. When increases in the dose of INDOCIN are made, they should be made carefully and in small increments.

Caution should be used if INDOCIN is administered simultaneously with methotrexate. INDOCIN has been reported to decrease the tubular secretion of methotrexate and to potentiate its toxicity.

Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.

Capsules INDOCIN 50 mg t.i.d. produced a clinically relevant elevation of plasma lithium and reduction in renal lithium clearance in psychiatric patients and normal subjects with steady state plasma lithium concentrations. This effect has been attributed to inhibition of prostaglandin synthesis. As a consequence, when INDOCIN and lithium are given concomitantly, the patient should be carefully observed for signs of lithium toxicity. (Read circulars for lithium preparations before use of such concomitant therapy.) In addition, the frequency of monitoring serum lithium concentration should be increased at the outset of such combination drug treatment.

INDOCIN given concomitantly with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Therefore, when INDOCIN and digoxin are used concomitantly, serum digoxin levels should be closely monitored.

In some patients, the administration of INDOCIN can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics. Therefore, when INDOCIN and INDOCIN. (Indomethacin) diuretics are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

INDOCIN reduces basal plasma renin activity (PRA), as well as those elevations of PRA induced by furosemide administration, or salt or volume depletion. These facts should be considered when evaluating plasma renin activity in hypertensive patients.

It has been reported that the addition of triamterene to a maintenance schedule of INDOCIN resulted in reversible acute renal failure in two of four healthy volunteers. INDOCIN and triamterene should not be administered together.

INDOCIN and potassium-sparing diuretics each may be associated with increased serum potassium levels. The potential effects of INDOCIN and potassium-sparing diuretics on potassium kinetics and renal function should be considered when these agents are administered concurrently.

Most of the above effects concerning diuretics have been attributed, at least in part, to mechanisms involving inhibition of prostaglandin synthesis by INDOCIN.

Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by non-steroidal antiinflammatory drugs including INDOCIN has been reported. Therefore, when using these blocking agents to treat hypertension, patients should be observed carefully in order to confirm that the desired therapeutic effect has been obtained. INDOCIN can reduce the antihypertensive effects of captopril and losartan.

False-negative results in the dexamethasone suppression test (DST) in patients being treated with INDOCIN have been reported. Thus, results of the DST should be interpreted with caution in these patients.

Chemical IUPAC Name
2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]ethanoicacid

Chemical Formula
C19H16ClNO4

Half Life
4.5 hours

Drug Type
Approved Drug

# Accession No
APRD00109

CAS Registry Number
53-86-1