Finished product reference
Piroxicam
Suppository · Rectal · 20 mg
- List code
- 2094
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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 .
What it is and how it works
Mechanism of Action Piroxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of piroxicam capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Piroxicam is a potent inhibitor of prostaglandin (PG) synthesis in vitro. Piroxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.
Mechanism class: Cyclooxygenase Inhibitors
Indications
Piroxicam capsules are indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated for •Relief of the signs and symptoms of osteoarthritis (OA) •Relief of the signs and symptoms of rheumatoid arthritis (RA)
Dosage and administration (summary)
Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ] . After observing the response to initial therapy with piroxicam capsules, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once per day. If desired, the daily dose may be divided.
Contraindications
Piroxicam capsules are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Warnings and precautions
• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Pregnancy
Pregnancy Risk Summary Use of NSAIDs, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester).
Storage and supply
Piroxicam Capsules, USP are available containing 20 mg of piroxicam, USP. The 20 mg capsules are hard gelatin capsules with a swedish orange opaque cap and swedish orange opaque body containing white to off-white powder. The capsules are imprinted with NP above 20 in black ink on the cap.
Source: Piroxicam (Piroxicam) — US FDA prescribing information, 2023-10-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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