Fenoprofen Calcium

Fenoprofen Calcium is an FDA-registered drug product whose active ingredient is FENOPROFEN CALCIUM. It is labelled by Misemer Pharmaceuticals, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0276-0501, application ANDA215548, label effective 20260820. It is one of 4 FDA drug label records sharing the active ingredient FENOPROFEN CALCIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FENOPROFEN CALCIUM are most often described in connection with: fenoprofen calcium, relief mild, moderate pain, symptoms rheumatoid, nonsteroidal anti-inflammatory, drug indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1. INDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for: • Relief of mild to moderate pain in adults • Relief of the signs and symptoms of rheumatoid arthritis • Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid arthritis. ( 1 ) Relief of the signs and symptoms of osteoarthritis. ( 1 )

2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ) Analgesia: For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed ( 2.2 ) Rheumatoid Arthritis and Osteoarthritis: For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg. ( 2.3 ) 2.1 General Dosing Carefully consider the potential benefits and risks of fenoprofen and other treatment options before deciding to use fenoprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals Use lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )]. Fenoprofen Calcium may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished. Patients with rheumatoid arthritis generally seem to require larger doses of Fenoprofen Calcium than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed. Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy. 2.2 Analgesia For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed. 2.3 Rheumatoid Arthritis and Osteoarthritis For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.

4. CONTRAINDICATIONS FENOPROFEN CALCIUM is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen 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. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] • Known hypersensitivity to fenoprofen 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 )

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 ( 5.12 )] Most common adverse reactions (incidence ≥ 5%) are Dyspepsia, headache, somnolence, nausea, dizziness, constipation, nervousness, asthenia, and peripheral edema. To report SUSPECTED ADVERSE REACTIONS, contact Misemer Pharmaceutical, Inc at 1-662-993-9625 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical studies for rheumatoid arthritis, osteoarthritis, or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions, and the following data emerged. These encompass observations in 6,786 patients, including 188 observed for at least 52 weeks. For comparison, data are also presented from complaints received from the 266 patients who received placebo in these same trials. During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies. Adverse Drug Reactions Reported in >1% of Patients During Clinical Trials Digestive System — During clinical trials with Fenoprofen Calcium, the most common adverse reactions were gastrointestinal in nature and occurred in 20.8% of patients receiving Fenoprofen Calcium as compared to 16.9% of patients receiving placebo. In descending order of frequency, these reactions included dyspepsia (10.3% Fenoprofen Calcium vs. 2.3% placebo), nausea (7.7% vs. 7.1%), constipation (7% vs. 1.5%), vomiting (2.6% vs. 1.9%), abdominal pain (2% vs. 1.1%), and diarrhea (1.8% vs. 4.1%). The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients during premarketing studies. Nervous System — The most frequent adverse neurologic reactions were headache (8.7% vs. 7.5%) and somnolence (8.5% vs. 6.4%). Dizziness (6.5% vs. 5.6%), tremor (2.2% vs. 0.4%), and confusion (1.4% vs. none) were noted less frequently. Fenoprofen Calcium was discontinued in less than 0.5% of patients because of these side effects during premarketing studies. Skin and Appendages — Increased sweating (4.6% vs. 0.4%), pruritus (4.2% vs. 0.8%), and rash (3.7% vs. 0.4%) were reported. Fenoprofen Calcium was discontinued in about 1% of patients because of an adverse effect related to the skin during premarketing studies. Special Senses — Tinnitus (4.5% vs. 0.4%), blurred vision (2.2% vs. none), and decreased hearing (1.6% vs. none) were reported. Fenoprofen Calcium was discontinued in less than 0.5% of patients because of adverse effects related to the special senses during premarketing studies. Cardiovascular — Palpitations (2.5% vs. 0.4%). Fenoprofen Calcium was discontinued in about 0.5% of patients because of adverse cardiovascular reactions during premarketing studies. Miscellaneous — Nervousness (5.7% vs. 1.5%), asthenia (5.4% vs. 0.4%), peripheral edema (5.0% vs. 0.4%), dyspnea (2.8% vs. none), fatigue (1.7% vs. 1.5%), upper respiratory infection (1.5% vs. 5.6%), and nasopharyngitis (1.2% vs. none). Adverse Drug Reactions Reported in <1% of Patients During Clinical Trials Digestive System —Gastritis, peptic ulcer with/without perforation, gastrointestinal hemorrhage, anorexia, flatulence, dry mouth, and blood in the stool. Increases in alkaline phosphatase, LDH, SGOT, jaundice, and cholestatic hepatitis, aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis. Cardiovascular —Atrial fibrillation, pulmonary edema, electrocardiographic changes, and supraventricular tachycardia. Genitourinary Tract —Renal failure, dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis, and papillary necrosis. Hypersensitivity —Angioedema (angioneurotic edema). Hematologic —Purpura, bruising, hemorrhage, thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, and pancytopenia. Nervous System —Depression, disorientation, seizures, and trigeminal neuralgia. Special Senses —Burning tongue, diplopia, and optic neuritis. Skin and Appendages —Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and alopecia. Miscellaneous —Anaphylaxis, urticaria, malaise, insomnia, tachycardia, personality change, lymphadenopathy, mastodynia, and fever. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of fenoprofen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).

FDA lists 4 drug label records with FENOPROFEN CALCIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Fenoprofen Calcium used for?
1. INDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for: • Relief of mild to moderate pain in adults • Relief of the signs and symptoms of rheumatoid arthritis • Relief of the signs and symptoms of osteoarthritis FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid …

Who makes Fenoprofen Calcium?
Misemer Pharmaceuticals, Inc. is the labeler of record for Fenoprofen Calcium. 4 FDA label records share the active ingredient FENOPROFEN CALCIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Fenoprofen Calcium come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Fenoprofen Calcium prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FENOPROFEN CALCIUM?
Yes. 4 FDA drug label records list FENOPROFEN CALCIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Fenoprofen Calcium been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.