sulindac

Contraindicated in:

Hypersensitivity;
Cross-sensitivity may occur with other NSAIDs, including aspirin;
Active GI bleeding or ulcer disease;
Perioperative pain from coronary artery bypass graft surgery;
OB: Avoid use after 30 wk gestation;
Lactation: Lactation.

Use Cautiously in:

Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, MI, and stroke, especially with prolonged use or use of higher doses);
Severe renal impairment (dosage modification recommended);
Severe hepatic impairment (dosage modification recommended);
History of ulcer disease;
OB: Use at or after 20 wk gestation may cause fetal or neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible;
Pedi: Safety and effectiveness not established in children;
Geri: Appears on Beers list. ↑ risk GI bleeding or peptic ulcer disease in older adults. Avoid chronic use unless other alternatives are not effective and the patient can take a gastroprotective agent; avoid short-term use in combination with oral or parenteral corticosteroids, anticoagulants, or antiplatelet agents unless other alternatives are not effective and the patient can take a gastroprotective agent.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), EXFOLIATIVE DERMATITIS, photosensitivity, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: blurred vision, tinnitus

GI: constipation, diarrhea, dyspepsia, nausea, vomiting, anorexia, DRUG-INDUCED HEPATITIS, flatulence, GI BLEEDING, pancreatitis

GU: renal failure

Hemat: blood dyscrasias, prolonged bleeding time

Neuro: dizziness, headache, drowsiness, STROKE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use of aspirin may ↓ effectiveness.
↑risk of bleeding with anticoagulants, thrombolytic agents, tirofiban, eptifibatide, clopidogrel, cefotetan, or valproic acid.
↑adverse GI side effects with aspirin, corticosteroids, and other NSAIDs.
May ↓ response to antihypertensives or diuretics.
May ↑ levels and risk of toxicity from lithium.
May ↑ risk of hematologic toxicity from antineoplastics or radiation therapy.
May ↑ risk of adverse renal effects with cyclosporine or chronic use of acetaminophen.
May blunt the antihypertensive effect of and ↑ the risk of renal dysfunction associated with ACE inhibitors or angiotensin II antagonists.
Antacids↓ levels and decrease effectiveness of sulindac.
↑risk of photosensitivity reactions with other photosensitizing medications.
↑risk of hypoglycemia with insulins or oral hypoglycemic agents.
Should not be used concurrently with dimethyl sulfoxide because of ↑ risk of peripheral neuropathy and ↓ levels of sulindac and its metabolite.

Availability ⬆ ⬇

(Generic available)

Tablets: 150 mg; 200 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 150–200 mg twice daily (not to exceed 400 mg/day).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits prostaglandin synthesis.

Therapeutic effects:

Suppression of pain and inflammation.

Classifications ⬆ ⬇

Therapeutic Classification: antirheumatics, nonopioid analgesics

Pharmacologic Classification: nonsteroidal anti inflammatory drugs nsaids

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Converted by the liver to active drug. Minimal amounts excreted unchanged by the kidneys.

Half-Life: 7.8 hr (16.4 hr for active metabolite).

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO (analgesic)	1–2 days	unknown	12 hr
PO (anti-inflammatory)	few days–1 wk	2 wk or more	unknown

Patient/Family Teaching ⬆ ⬇

Advise patient to take this medication with a full glass of water and to remain in an upright position for 15–30 min after administration.
Instruct patient to take medication as directed. Take missed doses as soon as remembered but not if almost time for the next dose. Do not double doses.
May cause dizziness. Advise patient to avoid driving or other activities requiring alertness until response to the medication is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Caution patient to avoid the concurrent use of alcohol, aspirin, NSAIDs, or acetaminophen.
Advise patient to inform health care professional of medication regimen before treatment or surgery.
Advise patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Advise patient to consult health care professional if itching, visual disturbances, tinnitus, weight gain, edema, black stools, persistent headache, or influenza-like syndrome (chills, fever, muscle aches, pain) occurs.
Instruct patient to notify health care professional immediately if rash, shortness of breath, trouble breathing, slurred speech, chest pain, swelling of face or throat, or weakness in 1 part or side of your body occur.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise women to avoid sulindac in the 3rd trimester of pregnancy (after 29 wk); may cause premature closure of the fetal ductus arteriosus. Use of sulindac after 20 wk may cause fetal renal impairment leading to oligohydramnios.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0591- Actavis Pharma, Inc.
- 0591-5660-
  - 0591-5660-00- 29000 TABLET in 1 BAG (0591-5660-00)

0591- Actavis Pharma, Inc.
- 0591-5660- Sulindac
  - 0591-5660-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-5660-01)

0591- Actavis Pharma, Inc.
- 0591-5660- Sulindac
  - 0591-5660-05- 500 TABLET in 1 BOTTLE, PLASTIC (0591-5660-05)

0591- Actavis Pharma, Inc.
- 0591-5660-
  - 0591-5660-77- 35292 TABLET in 1 CONTAINER (0591-5660-77)

0591- Actavis Pharma, Inc.
- 0591-5661-
  - 0591-5661-00- 39000 TABLET in 1 BAG (0591-5661-00)

0591- Actavis Pharma, Inc.
- 0591-5661- Sulindac
  0591-5661-01- 100 TABLET in 1 BOTTLE, PLASTIC (0591-5661-01)

0591- Actavis Pharma, Inc.
- 0591-5661- Sulindac
  - 0591-5661-05- 500 TABLET in 1 BOTTLE, PLASTIC (0591-5661-05)

0591- Actavis Pharma, Inc.
- 0591-5661-
  - 0591-5661-77- 47064 TABLET in 1 CONTAINER (0591-5661-77)

0904- Major Pharmaceuticals
- 0904-7334- SULINDAC
  0904-7334-60- 100 TABLET in 1 BOTTLE, PLASTIC (0904-7334-60)

0904- Major Pharmaceuticals
- 0904-7335- SULINDAC
  - 0904-7335-60- 100 TABLET in 1 BOTTLE, PLASTIC (0904-7335-60)

17337- Olon SpA
- 17337-0541-
  - 17337-0541-0- 1 BAG in 1 DRUM (17337-0541-0) / 1 BAG in 1 BAG / 25 kg in 1 BAG

24658- PuraCap Laboratories LLC dba Blu Pharmaceuticals
- 24658-770- SULINDAC
  24658-770-01- 100 TABLET in 1 BOTTLE (24658-770-01)

24658- PuraCap Laboratories LLC dba Blu Pharmaceuticals
- 24658-770- SULINDAC
  - 24658-770-05- 500 TABLET in 1 BOTTLE (24658-770-05)

24658- PuraCap Laboratories LLC dba Blu Pharmaceuticals
- 24658-771- SULINDAC
  - 24658-771-01- 100 TABLET in 1 BOTTLE (24658-771-01)

24658- PuraCap Laboratories LLC dba Blu Pharmaceuticals
- 24658-771- SULINDAC
  - 24658-771-05- 500 TABLET in 1 BOTTLE (24658-771-05)

42806- Epic Pharma, LLC
- 42806-011- SULINDAC
  - 42806-011-01- 100 TABLET in 1 BOTTLE (42806-011-01)

42806- Epic Pharma, LLC
- 42806-011- SULINDAC
  - 42806-011-05- 500 TABLET in 1 BOTTLE (42806-011-05)

42806- Epic Pharma, LLC
- 42806-011- SULINDAC
  - 42806-011-10- 1000 TABLET in 1 BOTTLE (42806-011-10)

42806- Epic Pharma, LLC
- 42806-018- SULINDAC
  - 42806-018-01- 100 TABLET in 1 BOTTLE (42806-018-01)

42806- Epic Pharma, LLC
- 42806-018- SULINDAC
  - 42806-018-05- 500 TABLET in 1 BOTTLE (42806-018-05)

42806- Epic Pharma, LLC
- 42806-018- SULINDAC
  - 42806-018-10- 1000 TABLET in 1 BOTTLE (42806-018-10)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  - 49452-7583-1- 5 g in 1 BOTTLE (49452-7583-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  49452-7583-2- 25 g in 1 BOTTLE (49452-7583-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  49452-7583-3- 100 g in 1 BOTTLE (49452-7583-3)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  49452-7583-4- 1000 g in 1 BOTTLE (49452-7583-4)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  49452-7583-5- 500 g in 1 BOTTLE (49452-7583-5)

49452- Spectrum Laboratory Products, Inc.
- 49452-7583-
  49452-7583-6- 10000 g in 1 DRUM (49452-7583-6)

50090- A-S Medication Solutions
- 50090-2093- SULINDAC
  50090-2093-4- 60 TABLET in 1 BOTTLE (50090-2093-4)

52133- F.I.S. Fabbrica Italiana Sintetici S.P.A.
- 52133-0007-
  - 52133-0007-0- 50 kg in 1 DRUM (52133-0007-0)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  53489-478-01- 100 TABLET in 1 BOTTLE, PLASTIC (53489-478-01)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  - 53489-478-02- 50 TABLET in 1 BOTTLE, PLASTIC (53489-478-02)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  - 53489-478-03- 250 TABLET in 1 BOTTLE, PLASTIC (53489-478-03)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  - 53489-478-05- 500 TABLET in 1 BOTTLE, PLASTIC (53489-478-05)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  - 53489-478-06- 60 TABLET in 1 BOTTLE, PLASTIC (53489-478-06)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-478- SULINDAC
  - 53489-478-10- 1000 TABLET in 1 BOTTLE, PLASTIC (53489-478-10)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-01- 100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-02- 50 TABLET in 1 BOTTLE, PLASTIC (53489-479-02)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-03- 250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-05- 500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-06- 60 TABLET in 1 BOTTLE, PLASTIC (53489-479-06)

53489- Sun Pharmaceutical Industries, Inc.
- 53489-479- SULINDAC
  - 53489-479-10- 1000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10)

55111- Dr.Reddys Laboratories Limited
- 55111-059-
  - 55111-059-00- 1 kg in 1 DRUM (55111-059-00)

55289- PD-Rx Pharmaceuticals, Inc.
- 55289-930- Sulindac
  55289-930-10- 10 TABLET in 1 BOTTLE, PLASTIC (55289-930-10)

55289- PD-Rx Pharmaceuticals, Inc.
- 55289-930- Sulindac
  - 55289-930-20- 20 TABLET in 1 BOTTLE, PLASTIC (55289-930-20)

55289- PD-Rx Pharmaceuticals, Inc.
- 55289-930- Sulindac
  - 55289-930-30- 30 TABLET in 1 BOTTLE, PLASTIC (55289-930-30)

57821- Agno Pharma Jiangsu
- 57821-015-
  - 57821-015-01- 30 kg in 1 BAG (57821-015-01)

71205- Proficient Rx LP
- 71205-648- SULINDAC
  71205-648-30- 30 TABLET in 1 BOTTLE (71205-648-30)

71205- Proficient Rx LP
- 71205-648- SULINDAC
  - 71205-648-60- 60 TABLET in 1 BOTTLE (71205-648-60)

71205- Proficient Rx LP
- 71205-648- SULINDAC
  - 71205-648-90- 90 TABLET in 1 BOTTLE (71205-648-90)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-373- SULINDAC
  - 72789-373-01- 100 TABLET in 1 BOTTLE, PLASTIC (72789-373-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-373- SULINDAC
  - 72789-373-82- 500 TABLET in 1 BOTTLE, PLASTIC (72789-373-82)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-374- SULINDAC
  - 72789-374-01- 100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01)

72789- PD-Rx Pharmaceuticals, Inc.
- 72789-374- SULINDAC
  - 72789-374-82- 500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇