Oxaprozin
Generic Name: oxaprozin
Brand Names:
Oxaprozin
11 DESCRIPTION Oxaprozin is a nonsteroidal anti-inflammatory drug, available as tablets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its molecular formula is C 18 H 15 NO 3 , and it has the following chemical structure. Oxaprozin is a white to yellowish-white crystalline powder. It is sparingly soluble in methanol and in ethanol, slightly soluble in ether and practically insoluble in water.
Overview
11 DESCRIPTION Oxaprozin is a nonsteroidal anti-inflammatory drug, available as tablets of 600 mg for oral administration. The chemical name is 4,5-diphenyl-2-oxazole-propionic acid. The molecular weight is 293. Its molecular formula is C 18 H 15 NO 3 , and it has the following chemical structure. Oxaprozin is a white to yellowish-white crystalline powder. It is sparingly soluble in methanol and in ethanol, slightly soluble in ether and practically insoluble in water.
Uses
1 INDICATIONS AND USAGE Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) (1) Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)
Dosage
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1) OA: 1200 mg (two 600 mg tablets) given orally once a day ( 2.2 , 2.5 , 14.1 ) RA: 1200 mg (two 600 mg tablets) given orally once a day ( 2.3 , 2.5 , 14.2 ) JRA: 600 mg once daily in patients 22 to 31 kg. 900 mg once daily in patients 32 to 54 kg. 1200 mg once daily in patients ≥ 55 kg ( 2.4 , 2.5) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].
Side Effects
6 ADVERSE REACTIONS 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 ) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9) ] Hematologic Toxicity [see Warnings and Precautions (5.11) ] Most common adverse reactions (>3 %) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1) To report SUSPEC...
Interactions
7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with oxaprozin [see Clinical Pharmacology (12.3) ]. Table 2: Clinically Significant Drug Interactions with Oxaprozin Drugs That Interfere with Hemostasis Clinical Impact: Oxaprozin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of oxaprozin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
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)]. 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 oxaprozin 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 Oxaprozin is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Pregnancy
8.1 Pregnancy Risk Summary Use of NSAIDs, including oxaprozin, 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 oxaprozin use between about 20 and 30 weeks of gestation, and avoid oxaprozin use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Oxaprozin tablets USP, 600 mg are yellow, oval shaped, scored, film-coated tablets debossed “C” on one side and “01|70” on the other side. Supplied in: NDC 60760-382-14 BOTTLES OF 14 Storage Keep bottles tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Oxaprozin used for?▼
1 INDICATIONS AND USAGE Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) (1) Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)
What are the side effects of Oxaprozin?▼
6 ADVERSE REACTIONS 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 ) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9) ] Hematologic Toxicity [see Warnings and Precautions (5.11) ] Most common adverse reactions (>3 %) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1) To report SUSPEC...
Can I take Oxaprozin during pregnancy?▼
8.1 Pregnancy Risk Summary Use of NSAIDs, including oxaprozin, 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 oxaprozin use between about 20 and 30 weeks of gestation, and avoid oxaprozin use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data ).
What are the important warnings for Oxaprozin?▼
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)]. 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 oxaprozin 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 Oxaprozin is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
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Standardized Insect Venom Allergenic Extract [EPC]
OTC - PURPOSE SECTION
Landiolol
landiolol
11 DESCRIPTION RAPIBLYK (landiolol) for injection is a beta-1 adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 4 minutes). Landiolol is: [(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethylamino]propoxy]phenyl]propionate and has the following structure: The active pharmaceutical ingredient is the hydrochloride salt of landiolol, which has the empirical formula C 25 H 39 N 3 O 8 ∙ HCl and a.
Mucor Plumbeus
mucor plumbeus
Dosage form: INJECTION, SOLUTION. Route: SUBCUTANEOUS. Active ingredients: MUCOR PLUMBEUS (.1 g/mL). Category: BLA.
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.