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Etodolac (Etodolac) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 WARNINGS).

Etodolac tablets are indicated:

• For acute and long-term use in the management of signs and symptoms of the following:

1. Osteoarthritis

2. Rheumatoid arthritis

• For the management of acute pain

DOSAGE AND ADMINISTRATION

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 WARNINGS).

After observing the response to initial therapy with etodolac, the dose and frequency should be adjusted to suit an individual patient’s 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 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 well-controlled clinical 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 Tablets, USP are available as follows:

400 mg — Each light gray, football shaped, film-coated tablet imprinted with

and 599 on one side and plain on the other side contains 400 mg of etodolac, USP. Tablets are supplied in bottles of 100 (NDC 0228-2599-11) and 500 (NDC 0228-2599-50).

500 mg — Each white, football shaped, film-coated tablet imprinted with

and 632 on one side and plain on the other side contains 500 mg of etodolac, USP. Tablets are supplied in bottles of 100 with a child-resistant closure (NDC 0228-2632-11).

Store at controlled room temperature 20°-25°C (68°-776°F), protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by: Actavis Elizabeth LLC

200 Elmora Avenue, Elizabeth, NJ 07207 USA

40-8821

Revised — March 2006

MEDICATION GUIDE FOR NON-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:

  • with longer use of NSAID medicines

  • in people who have heart disease

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:

  • can happen without warning symptoms

  • may cause death

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

  • taking medicines called “corticosteroids” and “anticoagulants”

  • longer use

  • smoking

  • drinking alcohol

  • older age

  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed

  • at the lowest dose possible for your treatment

  • for the shortest time needed

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:

  • different types of arthritis

  • menstrual cramps and other types of short-term pain

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

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all your medical conditions.

  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.

  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.

  • if you are breastfeeding. Talk to your doctor.

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

Serious side effects include: heart attackstrokehigh blood pressureheart failure from body swelling (fluid retention)kidney problems including kidney failurebleeding and ulcers in the stomach and intestinelow red blood cells (anemia)life-threatening skin reactionslife-threatening allergic reactionsliver problems including liver failureasthma attacks in people who have asthma Other side effects include: stomach painconstipationdiarrheagasheartburnnauseavomitingdizziness

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

shortness of breath or trouble breathingchest painweakness in one part or side of your bodyslurred speechswelling of the face or throat

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

nauseamore tired or weaker than usualitchingyour skin or eyes look yellowstomach painflu-like symptomsvomit bloodthere is blood in your bowel movement or it is black and sticky like tarunusual weight gainskin rash or blisters with feverswelling 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.

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

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
CelecoxibCelebrex
DiclofenacCataflam, Voltaren, Arthrotec (combined with misoprostol)
DiflunisalDolobid
EtodolacLodine, Lodine XL
FenoprofenNalfon, Nalfon 200
FlurbirofenAnsaid
IbuprofenMotrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
IndomethacinIndocin, Indocin SR, Indo-Lemmon, Indomethagan
KetoprofenOruvail
KetorolacToradol
Mefenamic AcidPonstel
Generic Name Tradename
MeloxicamMobic
NabumetoneRelafen
NaproxenNaprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
OxaprozinDaypro
PiroxicamFeldene
SulindacClinoril
TolmetinTolectin, Tolectin DS, Tolectin 600
This Medication Guide has been approved by the U.S. Food and Drug Administration.

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