Etodolac (Etodolac)

Trade Name : Etodolac

Eon Labs, Inc.

TABLET, COATED

Strength 400 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 Eon Labs, Inc.. It is available in strength of 400 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

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About GNH

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Cardiovascular Thrombotic Events
Gastrointestinal Risk

Etodolac tablets, USP are a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac, USP is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP 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 CHNO and it has the following structural formula:
Each tablet, for oral administration contains 400 mg and 500 mg of etodolac, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), talc and titanium dioxide.

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Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Etodolac tablets are indicated:

Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac.
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 , and , ).
In the setting of coronary artery bypass graft (CABG) surgery (see ).
Etodolac tablets are contraindicated in the setting of the coronary artery bypass graft (CABG) surgery (see ).

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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 post-marketing 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 mg to 500 mg of etodolac b.i.d. (i.e., 600 mg/day to 1000 mg/day).
Incidence Greater Than Or Equal To 1% - Probably Causally Related
Arrayn- Body as a Whole
Chills and fever.
Arrayn- Digestive System
Dyspepsia (10%), abdominal pain, diarrhea, flatulence, nausea, abdominal distension, epigastric pain, abnormal stools, constipation, gastritis, melena, vomiting.
Arrayn- Nervous System
Asthenia/malaise, dizziness, depression, nervousness, fatigue.
Arrayn- Skin and Appendages
Pruritus, rash.
Arrayn- Special Senses
Blurred vision, tinnitus.
Arrayn- Urogenital System
Dysuria, urinary frequency.
Arrayn- Musculoskeletal
Arthralgia
Drug-related patient complaints occurring in fewer than 3%, but more than 1%, are unmarked.
Incidence Less Than 1% - Probably Causally Related
(Adverse reactions reported only in worldwide post-marketing experience, not seen in clinical trials, are considered rarer and are italicized.)
Body as a Whole: n
Cardiovascular System: Hypertension, congestive heart failure, flushing, palpitations, syncope, n
Digestive System: Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, hepatitis, peptic ulcer with or without bleeding and/or perforationn
Hemic and Lymphatic System: Ecchymosis, anemia, thrombocytopenia, bleeding time increased, n
Metabolic and Nutritional: Edema, serum creatinine increase, n
Nervous System: Insomnia, somnolence.
Respiratory System: Asthma, n
Skin and Appendages: Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, , leukocytoclastic vasculitis, hyperpigmentationn
Special Senses: Photophobia, transient visual disturbances.
Urogenital System: n
Incidence Less Than 1% - Causal Relationship Unknown
(Medical events occurring under circumstances where causal relationship to etodolac is uncertain. These reactions are listed as alerting information for physicians.)
Body as a Whole: Infection, headache.
Cardiovascular System: Arrhythmias, myocardial infarction, cerebrovascular accident.
Digestive System: Esophagitis with or without stricture or cardiospasm, colitis, GI discomfort, burning sensation, blood in stools, gastralgia, upper abdominal discomfort.
Metabolic and Nutritional: Change in weight.
Nervous System: Paresthesia, confusion, irritability.
Respiratory System: Bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis.
Skin and Appendages: Alopecia, maculopapular rash, photosensitivity, skin peeling.
Special Senses: Conjunctivitis, deafness, taste perversion, loss of taste.
Urogenital System: Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities, renal impairment.
Musculoskeletal: Muscle pain.
Additional Adverse Reactions Reported with NSAIDs
Body as a Whole: Sepsis, death
Cardiovascular System: Tachycardia
Digestive System: Gastric ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis
Hemic and Lymphatic System: Lymphadenopathy
Nervous System: Anxiety, dream abnormalities, convulsions, coma, hallucinations, meningitis, tremors, vertigo
Respiratory System: Respiratory depression, pneumonia
Urogenital System: Oliguria/polyuria, proteinuria

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, 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 g to 100 g in adults, 1 g/kg 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 tablets and other treatment options before deciding to use etodolac 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 tablets, the dose and frequency should be adjusted to suit an individual patientu2019s needs.
Dosage adjustment of etodolac tablets 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 , ).

Etodolac tablets USP, for oral administration, are available as:
Arrayn- E
NDC 0185-0675-01 bottles of 100
NDC 0185-0675-05 bottles of 500
NDC 0185-0675-10 bottles of 1000
Arrayn- E
NDC 0185-0687-01 bottles of 100
NDC 0185-0687-05 bottles of 500
NDC 0185-0687-10 bottles of 1000
Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature].
Store tablets in original container until ready to use.
KEEP TIGHTLY CLOSED.
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
KEEP OUT OF THE REACH OF CHILDREN.

Arrayn- For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Arrayn- Etodolac Tablets, USP
Arrayn- (ee-toe-DOE-lak)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Do not take NSAIDs right before or after a 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
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:
Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplementsn- Do not start taking any new medicine without talking to your healthcare provider first.
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)?u201d
Get emergency help right away if you get any of the following symptoms:
Stop taking your 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.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
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.
For more information, go to or call 1-800-525-8747.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sandoz Inc.
Princeton, NJ 08540
Rev 05/18
MF0675REV05/18

NDC 0185-0675-01
Etodolac Tablets USP
400 mg
PHARMACIST: Please dispense with Medication Guide provided separately.
Rx only
100 Tablets
Sandoz

NDC 0185-0687-01
Etodolac Tablets USP
500 mg
PHARMACIST:
Rx only
100 Tablets
Sandoz

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Etodolac (Etodolac)

Trade Name : Etodolac

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Etodolac (Etodolac)

Trade Name : Etodolac

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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