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Etodolac (Etodolac)

Trade Name : Etodolac

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 600 mg/1

ETODOLAC Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Etodolac (Etodolac) which is also known as Etodolac and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 600 mg/1 per ml. Read more

Etodolac (Etodolac) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cardiovascular Thrombotic Events
  • cardiovascular thrombotic events, including myocardial infarction and stroke, which can
  • be fatal. This risk may occur early in treatment and may increase with duration of use
  • (seeand).
  • Gastrointestinal Risk
  • Etodolac extended-release tablets contain etodolac, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol.
  • The chemical name is (u00b1) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula:
  • CHNO M.W. 287.37
  • The inactive ingredients in etodolac extended-release tablets are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow.
  • No data
  • The use of etodolac extended-release tablets in managing the signs and symptoms of osteoarthritis of the knee and rheumatoid arthritis was assessed in double-blind, randomized, parallel, controlled clinical trials in 1552 patients. In these trials, etodolac extended-release tablets, given once daily, provided efficacy comparable to immediate-release etodolac.
  • The safety, efficacy, and pharmacokinetics of etodolac extended-release tablets were assessed in an open-label, 12 week clinical trial. Seventy-two (72) patients, 6 to 16 years of age, with juvenile rheumatoid arthritis, received etodolac extended-release tablets in doses of 400 to 1000 mg (13.3 to 21.3 mg/kg body weight) once daily. At these doses, etodolac extended-release tablets controlled the signs and symptoms of juvenile rheumatoid arthritis. Based on the results of this study, the safety profile of etodolac extended-release tablets (at doses not exceeding 20 mg/kg) appeared to be similar to that observed in the adult arthritic patients in clinical trials. (See .)
  • Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • Etodolac extended-release tablets are indicated:
  • * For relief of signs and symptoms of juvenile arthritis
  • * For relief of the signs and symptoms of rheumatoid arthritis
  • * For relief of the signs and symptoms of osteoarthritis
  • Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac.
  • Etodolac extended-release tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see and ).
  • Etodolac extended-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • No data
  • No data
  • A total of 1552 patients were exposed to etodolac extended-release tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment with etodolac extended-release tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy.
  • In patients taking NSAIDs, including etodolac extended-release tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are:
  • gastrointestinal experiences including:
  • other events including:
  • Symptoms following acute NSAID overdose 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 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of the urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
  • Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • After observing the response to initial therapy with etodolac extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
  • Etodolac extended-release tablets, 400 mg, are available as orange, film-coated, oval-shaped tablets, debossed u201c1122u201d on one side and u201c93u201d on the other. They are available in bottles of 100. NDC 0093-1122-01.
  • Etodolac extended-release tablets, 500 mg, are available as gray, film-coated, oval-shaped tablets, debossed u201c7172u201d on one side and u201c93u201d on the other. They are available in bottles of 100. NDC 0093-7172-01.
  • Etodolac extended-release tablets, 600 mg, are available as light blue, film-coated, oval-shaped tablets, debossed u201c1118u201d on one side and u201c93u201d on the other. They are available in bottles of 100. NDC 0093-1118-01.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Protect from excessive heat and humidity.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Manufactured In Israel By:n n Jerusalem, 9777402, IsraelManufactured For:n n North Wales, PA 19454
  • Rev. I 7/2015
  • No data
  • No data
  • No data
  • No data

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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