DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. 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 sulindac, the dose and frequency should be adjusted to suit an individual patient’s needs.
Sulindac should be administered orally twice a day with food. The maximum dosage is 400 mg per day. Dosages above 400 mg per day are not recommended.
In osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, the recommended starting dosage is 150 mg twice a day. The dosage may be lowered or raised depending on the response.
A prompt response (within one week) can be expected in about one-half of patients with osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis. Others may require longer to respond.
In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. After a satisfactory response has been achieved, the dosage may be reduced according to the response. In acute painful shoulder, therapy for 7-14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate.
Sulindac Tablets USP 150 mg are round, convex, bright yellow color tablets which may be slightly mottled, engraved with “HP” above bisect and “5” below bisect on one side and plain on the other side. They are supplied as follows:
Bottles of 60 with CRC NDC 23155-005-06
Bottles of 100 with CRC NDC 23155-005-01
Bottles of 500 NDC 23155-005-05
Sulindac Tablets 200 mg are round, convex, bright yellow color tablets which may be slightly mottled, engraved with “HP” above bisect and “6” below bisect and plain on the other side. They are supplied as follows:
Bottles of 60 with CRC NDC 23155-006-06
Bottles of 100 with CRC NDC 23155-006-01
Bottles of 500 NDC 23155-006-05
Store at 20° to 25°C (68-77ºF); excursions permitted to 15° to 30°C (59-86ºF) [See USP].
Dispense in a tight, light resistant container
*The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (Incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care).
** Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk.
Heritage Pharmaceuticals Inc.
Edison, NJ 08837
Amneal Pharmaceuticals, L.L.C.
Paterson, NJ 07504
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:
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: || Other side effects include: |
| • ||heart attack || • stomach pain |
| • ||stroke || • constipation |
| • ||high blood pressure || • diarrhea |
| • ||heart failure from body swelling |
| • gas |
| • heartburn |
| • ||kidney problems including |
| • nausea |
| • vomiting |
| • ||bleeding and ulcers in the stomach and intestine || • dizziness |
| • ||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 || |
Get emergency help right away if you have any of the following symptoms:
shortness of breath or trouble breathing
weakness in one part or side of your body
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:
more tired or weaker than usual
your skin or eyes look yellow
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.
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 |
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
|* 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-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole) |
|Oxaprozin ||Daypro |
|Piroxicam ||Feldene |
|Sulindac ||Clinoril |
|Tolmetin ||Tolectin, Tolectin DS, Tolectin 600 |