Generic Name
Fenoprofen
Brand Names
Nalfon, Fenopron
FDA approval date: September 24, 2018
Classification: Nonsteroidal Anti-inflammatory Drug
Form: Tablet, Capsule
What is Nalfon (Fenoprofen)?
Carefully consider the potential benefits and risks of NALFON tablets, USP and other treatment options before deciding to use NALFON tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. NALFON tablets are indicated: For relief of mild to moderate pain in adults., For relief of the signs and symptoms of rheumatoid arthritis., For relief of the signs and symptoms of osteoarthritis.
Approved To Treat
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Brand Information
NALFON (Fenoprofen Calcium)
1DESCRIPTION
NALFON
Benzeneacetic acid, α-methyl-3-phenoxy-, calcium salt (2:1)-(±)-, dihydrate
Fenoprofen calcium, USP is a white crystalline powder, soluble in alcohol (95%) to the extent of approximately 15 mg/mL at 25°C, slightly soluble in water and insoluble in benzene.
The pKa of fenoprofen calcium is 4.5 at 25°C.
Film-coated NALFON tablets for oral administration are available containing fenoprofen calcium as the dihydrate equivalent to 600 mg of fenoprofen and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, titanium dioxide and FD&C Yellow No. 6 Aluminum Lake.
2CLINICAL PHARMACOLOGY
NALFON
Results in humans demonstrate that fenoprofen has both anti-inflammatory and analgesic actions. The emergence and degree of erythemic response were measured in adult male volunteers exposed to ultraviolet irradiation. The effects of fenoprofen, aspirin and indomethacin were each compared with those of a placebo. All three drugs demonstrated antierythemic activity.
In all patients with rheumatoid arthritis, the anti-inflammatory action of NALFON has been evidenced by relief of pain, increase in grip strength and reductions in joint swelling, duration of morning stiffness and disease activity (as assessed by both the investigator and the patient). The anti-inflammatory action of NALFON has also been evidenced by increased mobility (i.e., a decrease in the number of joints having limited motion).
The use of NALFON in combination with gold salts or corticosteroids has been studied in patients with rheumatoid arthritis. The studies, however, were inadequate in demonstrating whether further improvement is obtained by adding NALFON to maintenance therapy with gold salts or steroids. Whether or not NALFON used in conjunction with partially effective doses of a corticosteroid has a “steroid-sparing” effect is unknown.
In patients with osteoarthritis, the anti-inflammatory and analgesic effects of NALFON have been demonstrated by reduction in tenderness as a response to pressure and reductions in night pain, stiffness, swelling and overall disease activity (as assessed by both the patient and the investigator). These effects have also been demonstrated by relief of pain with motion and at rest and increased range of motion in involved joints.
In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with fenoprofen than in aspirin-treated patients. It is not known whether fenoprofen calcium causes less peptic ulceration than does aspirin.
In patients with pain, the analgesic action of NALFON has produced a reduction in pain intensity, an increase in pain relief, improvement in total analgesia scores and a sustained analgesic effect.
Under fasting conditions, fenoprofen is rapidly absorbed and peak plasma levels of 50 mcg/mL are achieved within 2 hours after oral administration of 600 mg doses. Good dose proportionality was observed between 200 mg and 600 mg doses in fasting male volunteers. The plasma half-life is approximately 3 hours. About 90% of a single oral dose is eliminated within 24 hours as fenoprofen glucuronide and 4’ hydroxy-fenoprofen glucuronide, the major urinary metabolites of fenoprofen. Fenoprofen is highly bound (99%) to albumin.
The concomitant administration of antacid (containing both aluminum and magnesium hydroxide) does not interfere with absorption of NALFON.
There is less suppression of collagen-induced platelet aggregation with single doses of fenoprofen calcium than there is with aspirin.
3INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of NALFON tablets, USP and other treatment options before deciding to use NALFON tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
NALFON tablets are indicated:
- For relief of mild to moderate pain in adults.
- For relief of the signs and symptoms of rheumatoid arthritis.
- For relief of the signs and symptoms of osteoarthritis.
4CONTRAINDICATIONS
NALFON tablets are contraindicated in patients who have shown hypersensitivity to fenoprofen calcium.
NALFON tablets should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see
NALFON is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see
NALFON is contraindicated in patients with a history of significantly impaired renal function (see
5ADVERSE REACTIONS
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.
5.1Adverse 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 as compared to 16.9% of patients receiving placebo. In descending order of frequency, these reactions included dyspepsia (10.3% fenoprofen 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 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 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 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 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% 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).
5.2Adverse 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 (see PRECAUTIONS).
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 (see WARNINGS).
Hyper sensitivity: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.
6DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of NALFON tablets and other treatment options before deciding to use NALFON tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
After observing the response to initial therapy with NALFON tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
6.1Analgesia
For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.
6.2Rheumatoid Arthritis and Osteoarthritis
For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 mg 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 3200 mg.
NALFON tablets 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 NALFON tablets 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.
7HOW SUPPLIED
NALFON (fenoprofen calcium tablets), USP are available containing fenoprofen calcium, USP equivalent to 600 mg fenoprofen.
The 600 mg tablet is an orange film-coated, capsule-shaped tablet debossed with
They are available as follows:
NDC 82804-129-90
bottles of 90 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
PHARMACIST:Dispense a Medication Guide with each prescription.
8Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs )
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Xspire Pharma LLC.
Ridgeland, MS 39157 U.S.A.
Ridgeland, MS 39157 U.S.A.
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Thousand Oaks, CA 91320
REVISED APRIL 2021
9PACKAGING
Rx only
Keep container tightly closed.
Keep this and all medication out of the reach of children.
Protect from light.
Usual Adult Dosage:See accompanying prescribing information.
