ETODOLAC tablet, film coated

Etodolac by

Drug Labeling and Warnings

Etodolac by is a Prescription medication manufactured, distributed, or labeled by Blenheim Pharmacal, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Incidence Less Than 1% - Probably Causally Related

(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)

Body as a whole - Allergic reaction, anaphylactic/anaphylactoid reactions (including shock).

Cardiovascular system - Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic).

Digestive system - Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.

Hemic and lymphatic system - Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, aplastic anemia, leukopenia, neutropenia, pancytopenia.

Metabolic and nutritional - Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.

Nervous system - Insomnia, somnolence.

Respiratory system - Asthma, pulmonary infiltration with eosinophilia.

Skin and appendages - Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis, hyperpigmentation, erythema multiforme.

Special senses - Photophobia, transient visual disturbances.

Urogenital system - Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.

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

  • OVERDOSAGE

    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 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 etodolac's high protein binding.

  • DOSAGE AND ADMINISTRATION

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

    After observing the response to initial therapy with etodolac capsules and tablets, USP, the dose and frequency should be adjusted to suit an individual patient's needs.

    Dosage adjustment of etodolac capsules and tablets, USP 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 WARNINGS, Renal Effects).

    Analgesia

    The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in wellcontrolled trials.

    Osteoarthritis and Rheumatoid Arthritis

    The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

    In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

  • HOW SUPPLIED

    Etodolac Capsules and Tablets, USP are available as:

    Etodolac Tablets, USP

    400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)

    - in bottles of 30, NDC: 10544-862-30
    - in bottles of 30, NDC: 10544-862-60

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Store tablets in original container until ready to use. Dispense in light-resistant container.

  • Medication Guide forNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    (See the end of this Medication Guide for a list of prescription NSAID medicines.)

    What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

    NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

    NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

    The chance of a person getting an ulcer or bleeding increases with:

    NSAID medicines should only be used:

    What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

    Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

    Do not take an NSAID medicine:

    Tell your healthcare provider:

    What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

    Serious side effects include:Other side effects include:
    • heart attack
    • stroke
    • high blood pressure
    • heart failure from body swelling (fluid retention)
    • kidney problems including kidney failure
    • bleeding and ulcers in the stomach and intestine
    • low red blood cells (anemia)
    • life-threatening skin reactions
    • life-threatening allergic reactions
    • liver problems including liver failure
    • asthma attacks in people who have asthma
    • stomach pain
    • constipation
    • diarrhea
    • gas
    • heartburn
    • nausea
    • vomiting
    • dizziness

    Get emergency help right away if you have any of the following symptoms:

    • shortness of breath or trouble breathing
    • chest pain
    • weakness in one part or side of your body
    • slurred speech
    • swelling of the face or throat

    Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

    • nausea
    • more tired or weaker than usual
    • itching
    • your skin or eyes look yellow
    • stomach pain
    • flu-like symptoms
    • vomit blood
    • there is blood in your bowel movement or it is black and sticky like tar
    • unusual weight gain
    • skin rash or blisters with fever
    • swelling of the arms and legs, hands and feet

    These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

    NSAID medicines that need a prescription

    Generic NameTradename
  • * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
  • Celecoxib

    Celebrex

    Diclofenac

    Cataflam, Voltaren, Arthrotec (combined with misoprostol)

    Diflunisal

    Dolobid

    Etodolac

    Lodine, Lodine XL

    Fenoprofen

    Nalfon, Nalfon 200

    Flurbiprofen

    Ansaid

    Ibuprofen

    Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)

    Indomethacin

    Indocin, Indocin SR, Indo-Lemmon, Indomethagan

    Ketoprofen

    Oruvail

    Ketorolac

    Toradol

    Mefenamic Acid

    Ponstel

    Meloxicam

    Mobic

    Nabumetone

    Relafen

    Naproxen

    Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole)

    Oxaprozin

    Daypro

    Piroxicam

    Feldene

    Sulindac

    Clinoril

    Tolmetin

    Tolectin, Tolectin DS, Tolectin 600

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110
    Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
    Marketed/ Packaged by: Blenheim Pharmacal, Inc., North Blenheim, NY 12131, (USA)


    Revised: February, 2010

    89927-0210-4

  • PRINCIPAL DISPLAY PANEL - 400 mg 30s

    NDC: 10544-862-30

    30 Tablets

    Etodolac Tablets USP,
    400 mg

    Sealed for your protection

    Blenheim Pharmacal, Inc.

    Rx only

    Label Graphic- Etodolac 400mg 30s Tablets
  • INGREDIENTS AND APPEARANCE
    ETODOLAC 
    etodolac tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 10544-862(NDC:51672-4018)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Etodolac (UNII: 2M36281008) (Etodolac - UNII:2M36281008) Etodolac400 mg
    Inactive Ingredients
    Ingredient NameStrength
    Hypromelloses (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINK (Peach) Scoreno score
    ShapeOVALSize19mm
    FlavorImprint Code T88
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 10544-862-3030 in 1 BOTTLE
    2NDC: 10544-862-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07507410/08/2013
    Labeler - Blenheim Pharmacal, Inc. (171434587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blenheim Pharmacal, Inc.171434587REPACK(10544-862) , RELABEL(10544-862)

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