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Etodolac (Etodolac)

Trade Name : Etodolac

NuCare Pharmaceuticals,Inc.

CAPSULE

Strength 300 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 NuCare Pharmaceuticals,Inc.. It is available in strength of 300 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.

Read more
  • No data
  • Arrayn- Cardiovascular Thrombotic Events
  • Gastrointestinal Risk
  • Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac 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. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is Cn n n Hn n n NOn n n , and it has the following structural formula:n nn
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n n n
  • Each etodolac capsule, USP is for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, black SW-9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
  • No data
  • No data
  • Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac.u00a0 Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see n n n ).n nn
  • Etodolac capsules are indicated:
  • u2022u00a0For acute and long-term use in the management of signs and symptoms of the following:
  • u2022u00a0For the management of acute pain
  • Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules.
  • Etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see n n n and n n n n n ).n nn
  • No data
  • No data
  • In patients taking etodolac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are:
  • Gastrointestinal experiences including
  • Other events including
  • Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with etodolac.
  • New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of etodolac b.i.d. (i.e., 600 to 1,000 mg/day).u00a0
  • 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 and coma has occurred following massive ibuprofen or mefenamic-acid overdose. Hypertension/hypotension, acute renal failure, and respiratory depression may occur but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following 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 would probably not be useful due to etodolacu2019s high protein binding.
  • Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see n n n ).u00a0n nn
  • After observing the response to initial therapy with etodolac, the dose and frequency should be adjusted to suit an individual patientu2019s needs.
  • Dosage adjustment of etodolac is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see n n n n n ).n nn
  • 300 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap. APO 040 is imprinted on each capsules in black ink)
  • NDC 66267-575-30
  • Store at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted from 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.
  • Dispense in tight, light-resistant container [see USP].
  • APOTEX INC.n- ETODOLAC CAPSULES, USPn- 200 mg and 300 mg
  • Revised: July 2016
  • Rev. 5
  • Arrayn- for
  • Arrayn- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
  • What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  • NSAIDs can cause serious side effects, including:n- Array
  • Arrayn- Do not take NSAIDs right before or after heart surgery called a u201ccoronary artery bypass graft (CABG)u201d. Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.n- Array
  • Arrayn- The risk of getting an ulcer or bleeding increases with
  • NSAIDs should only be used:
  • What are NSAIDs?
  • NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
  • Who should not take NSAIDs?
  • Do not take NSAIDs:
  • Arrayn- Before taking NSAIDs, tell n- your healthcare providern- about all of your medical conditions, including if you:
  • Arrayn- Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. n- u00a0n- Do not start taking any new medicine without talking to your healthcare provider first.n- Array
  • What are the possible side effects of NSAIDs?
  • NSAIDs can cause serious side effects including:
  • See u201cWhat is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  • Get emergency help right away if you get any of the following symptoms:
  • Stop taking NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • If you take too much of your NSAID, call your healthcare provider or get medical help right away.n- Array
  • These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.u00a0
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Other information about NSAIDs:
  • General information about the safe and effective use of NSAIDs
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised: July 2016
  • Array
  • No data

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Comparator Sourcing for Clinical Trials

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