Piroxicam
Generic Name: piroxicam
Brand Names:
Piroxicam
11 DESCRIPTION Piroxicam Capsules USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue #10 mg capsules and maroon #20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl- N -2 pyridinyl-2 H -1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C 15 H 13 N 3 O 4 S, and it has the following chemical structure.
Overview
11 DESCRIPTION Piroxicam Capsules USP is a nonsteroidal anti-inflammatory drug, available as maroon and blue #10 mg capsules and maroon #20 mg capsules for oral administration. The chemical name is 4-hydroxyl-2-methyl- N -2 pyridinyl-2 H -1,2,-benzothiazine-3-carboxamide 1,1-dioxide. The molecular weight is 331.35. Its molecular formula is C 15 H 13 N 3 O 4 S, and it has the following chemical structure.
Uses
1 INDICATIONS AND USAGE Piroxicam Capsules are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of osteoarthritis (OA) (1) Relief of the signs and symptoms of rheumatoid arthritis (RA) (1) Piroxicam Capsules are indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.
Dosage
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2) OA and RA: 20 mg once daily (2) 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 (5)]. 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.
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions (incidence >2% from clinical trials) are: nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5 )] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphyl...
Interactions
7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors [SNRIs]): Monitor patients for bleeding who are concomitantly taking Piroxicam Capsules with drugs that interfere with hemostasis. Concomitant use of Piroxicam Capsules and analgesic doses of aspirin is not generally recommended (7) Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with Piroxicam Capsules may diminish the antihypertensive effect of these drugs.
Warnings
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. 5 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 (5.3) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7) Heart Failure and Edema: Avoid use of Piroxicam Capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5) Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. 4 CONTRAINDICATIONS Known hypersensitivity to piroxicam or any components of the drug product (4) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4) In the setting of CABG surgery (4) Piroxicam Capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or...
Pregnancy
8.1 Pregnancy Risk Summary Use of NSAIDs, including Piroxicam Capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Piroxicam Capsules use between about 20 and 30 weeks of gestation, and avoid Piroxicam Capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Piroxicam Capsules USP, 10mg are maroon opaque cap and blue opaque body imprinted with 'P10' on body, supplied as NDC Number Size 42291-953-01 Bottle of 100 Piroxicam Capsules USP, 20mg are maroon opaque cap and maroon opaque body imprinted with "P20" on body, supplied as NDC Number Size 42291-954-01 Bottle of 100 42291-954-50 Bottle of 500 Storage Store at roo...
Frequently Asked Questions
What is Piroxicam used for?▼
1 INDICATIONS AND USAGE Piroxicam Capsules are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of osteoarthritis (OA) (1) Relief of the signs and symptoms of rheumatoid arthritis (RA) (1) Piroxicam Capsules are indicated: For relief of the signs and symptoms of osteoarthritis. For relief of the signs and symptoms of rheumatoid arthritis.
What are the side effects of Piroxicam?▼
6 ADVERSE REACTIONS Most common adverse reactions (incidence >2% from clinical trials) are: nausea, constipation, flatulence, abdominal pain, diarrhea, headache, dizziness, edema, rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5 )] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphyl...
Can I take Piroxicam during pregnancy?▼
8.1 Pregnancy Risk Summary Use of NSAIDs, including Piroxicam Capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Piroxicam Capsules use between about 20 and 30 weeks of gestation, and avoid Piroxicam Capsules use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ).
What are the important warnings for Piroxicam?▼
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. 5 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 (5.3) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7) Heart Failure and Edema: Avoid use of Piroxicam Capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5) Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. 4 CONTRAINDICATIONS Known hypersensitivity to piroxicam or any components of the drug product (4) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4) In the setting of CABG surgery (4) Piroxicam Capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.