MedPath

Sulindac

Generic Name
Sulindac
Drug Type
Small Molecule
Chemical Formula
C20H17FO3S
CAS Number
38194-50-2
Unique Ingredient Identifier
184SNS8VUH

Overview

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) of the arylalkanoic acid class that is marketed by Merck under the brand name Clinoril. Like other NSAIDs, it may be used in the treatment of acute or chronic inflammatory conditions. Sulindac is a prodrug, derived from sulfinylindene, that is converted in vivo to an active sulfide compound by liver enzymes. There is evidence from some studies that sulindac may be associated with fewer gastrointestinal side effects than other NSAIDs, except for the cyclooxygenase-2 (COX-2) inhibitor drug class. This may be due to the sulfide metabolite undergoing enterohepatic circulation thus maintaining constant blood levels of the compound without inducing gastrointestinal effects, where the drug is excreted in the bile and then reabsorbed from the intestines. While its full mechanism of action is not fully understood, sulindac is thought to primarily mediate its action by inhibiting prostaglandin synthesis by inhibiting COX-1 and COX-2.

Indication

For acute or long-term use in the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis), and acute gouty arthritis.

Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Colorectal Adenomas
  • Gout
  • Osteoarthritis (OA)
  • Rheumatoid Arthritis
  • Tendonitis exacerbated
  • Acute Subacromial bursitis
  • Acute supraspinatus tendinitis

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-4976
ORAL
200 mg in 1 1
4/22/2019
State of Florida DOH Central Pharmacy
53808-0799
ORAL
150 mg in 1 1
4/13/2010
Bryant Ranch Prepack
71335-0413
ORAL
200 mg in 1 1
1/27/2022
A-S Medication Solutions
50090-2093
ORAL
200 mg in 1 1
4/26/2021
PuraCap Laboratories LLC dba Blu Pharmaceuticals
24658-771
ORAL
200 mg in 1 1
1/4/2019
Proficient Rx LP
71205-648
ORAL
200 mg in 1 1
3/1/2022
Major Pharmaceuticals
0904-7335
ORAL
200 mg in 1 1
7/28/2023
Actavis Pharma, Inc.
0591-5660
ORAL
200 mg in 1 1
5/22/2023
PD-Rx Pharmaceuticals, Inc.
72789-374
ORAL
200 mg in 1 1
1/25/2024
Epic Pharma, LLC
42806-011
ORAL
200 mg in 1 1
12/20/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Sulindac Capsules
国药准字H20010624
化学药品
胶囊剂
5/7/2020
Sulindac Tablets
国药准字H20033535
化学药品
片剂
2/3/2020
Sulindac Tablets
国药准字H33021627
化学药品
片剂
4/7/2020
Sulindac Tablets
国药准字H10940091
化学药品
片剂
4/21/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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