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Multiple-Visit-"Corticosteroid Paste"
Naproxen reduces pain, inflammation, and fever by inhibiting prostaglandin synthesis through COX-1 and COX-2 inhibition.
The Multiple-Visit "Corticosteroid Paste" is a marketed product developed by Istanbul Medipol University Hospital, primarily indicated for Rheumatoid Arthritis. The key strength of this product lies in its mechanism, where naproxen effectively reduces pain, inflammation, and fever by inhibiting prostaglandin synthesis through COX-1 and COX-2 inhibition. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | Multiple-Visit-"Corticosteroid Paste" |
|---|---|
| Also known as | Ledermix Paste |
| Sponsor | Istanbul Medipol University Hospital |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | cyclooxygenase (COX-1 and COX-2) |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Naproxen works by blocking the production of prostaglandins, which are chemicals that cause pain, inflammation, and fever. By inhibiting the enzymes COX-1 and COX-2, naproxen reduces the levels of these chemicals in the body, leading to relief of symptoms.
Approved indications
- Rheumatoid Arthritis
- Osteoarthritis
- Ankylosing Spondylitis
- Polyarticular Juvenile Idiopathic Arthritis
- Tendonitis
- Bursitis
- Acute Gout
- Pain Management
- Primary Dysmenorrhea
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions ( 5.1 ) ]. • Naproxen tablets and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. ( 5.1 ) • Naproxen tablets and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 )
Common side effects
Drug interactions
- anticoagulants (e.g., warfarin)
- antiplatelet agents (e.g., aspirin)
- selective serotonin reuptake inhibitors (SSRIs)
- serotonin norepinephrine reuptake inhibitors (SNRIs)
- low-dose immediate-release aspirin
- analgesic doses of aspirin
- angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and beta-blockers
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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