Fenoprofen (Progesic) is a non-selective NSAID (a non-steroidal anti-inflammatory drug) that is used to treat mild to moderate pain and inflammation in patients with Rheumatoid arthritis and osteoarthritis.

Fenoprofen (Progesic) Uses:

• Osteoarthritis:

  • Uses for the relief of the signs and symptoms of osteoarthritis.

• Pain:

  • Uses for the relief of mild to moderate pain in adults.

• Rheumatoid arthritis (RA):

  • Uses for the relief of the signs and symptoms of RA.

Fenoprofen (Progesic) Dose in Adults

Note: For the shortest possible duration use the lowest effective dose.

Fenoprofen (Progesic) Dose in Osteoarthritis and rheumatoid arthritis:

• Oral: 400 to 600 mg 3 to 4 times a day;
• Adjust the dose based on the patient's response;
• The maximum dose: 3,200 mg per day.

Fenoprofen (Progesic) Dose in the treatment of mild to moderate pain:

• Oral: 200 mg every 4 to 6 hours as needed.

Use in Children:

Not indicated.

Fenoprofen (Progesic) Pregnancy Category: C (D in the last trimester)

• Some studies have shown that birth defects can be caused by in utero NSAID use. However, the data is inconsistent.
• Following in utero NSAID treatment, nonteratogenic effects such as prenatal constriction, oligohydramnios and renal dysfunction or failure, necrotizing Enterocolitis, persistent pulmonary Hypertension of the Newborn, and intracranial bleeding have been observed in the fetus/neonate.
• Additionally, postnatal non-closure of ductus arteriosus may occur. This can be difficult to manage medically.
• Because NSAIDs can cause premature closing of the ductus Arteriosus, fenoprofen product labels specifically state that use should be stopped starting at 30 weeks gestation.
• NSAIDs may be used to treat mild rheumatoid-arthritis flares in pregnant women. However, it should be avoided or minimized early in pregnancy.
• Women of reproductive age who have been using NSAIDs for a long time may experience infertility. This can be reversed by stopping the medication.
• Women who have difficulty conceiving, or are undergoing fertility treatment should consider quitting NSAIDs. 
• There may be an increased chance of miscarriage if NSAIDs are used close to the time of conception.

Fenoprofen use during breastfeeding:

• Breast milk can contain fenoprofen.
• NSAIDs can be used by postpartum mothers who want to breastfeed. However, if a mother has platelet dysfunction or thrombocytopenia, NSAIDs should not be used.
• According to the manufacturer of the product, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks to infant exposure, the benefits to the infant and the benefits to the mother.

Dose in Kidney Disease:

Manufacturer’s labeling doesn't provide any dosage adjustments; use with caution. Not recommended in patients with advanced renal disease. ProFeno is contraindicated in patients with severe renal impairment.

• Dialysis: Not removed by hemodialysis.

Dose in Liver disease:

Manufacturer’s labeling doesn't provide any dosage adjustments; use with caution.

Side Effects of Fenoprofen (Progesic):

• Cardiovascular:

  • Palpitations
  • Peripheral Edema

• Central Nervous System:

  • Drowsiness
  • Confusion
  • Headache
  • Dizziness
  • Nervousness
  • Fatigue

• Dermatologic:

  • Pruritus
  • Skin Rash
  • Diaphoresis

• Gastrointestinal:

  • Constipation
  • Vomiting
  • Abdominal Pain
  • Dyspepsia
  • Nausea

• Neuromuscular & Skeletal:

  • Weakness
  • Tremor

• Ophthalmic:

  • Blurred Vision

• Otic:

  • Auditory Impairment
  • Tinnitus

• Respiratory:

  • Dyspnea
  • Nasopharyngitis

Contraindications to Fenoprofen (Progesic):

• Hypersensitivity to fenoprofen or any component of its formulation (For example, anaphylactic reactions and severe skin reactions).
• A history of asthma, urticaria or an allergic reaction to aspirin, NSAIDs, or any other NSAIDs.
• In the setting coronary artery bypass surgery (CABG).
• Only for severe renal impairment (ProFeno).

Warnings and precautions

• Anaphylactoid reactions

  • Patients who have bronchospasm or rhinitis or asthma and are receiving NSAIDs or aspirin therapy are advised to discontinue use.
  • Anaphylactoid reactions can occur even in patients who have never been exposed to anaphylactic substances. Patients with the "aspirin trifecta" (bronchial asthma and rhinitis, aspirin intolerance, or aspirin intolerance) could be at greater risk.

• Cardiovascular events: [US Boxed Warn]

  • The increased risk of severe (and possibly fatal) adverse cardiovascular events due to NSAIDs, such as stroke and MI, can be caused by NSAIDs.
  • This risk can occur during treatment, and it may increase as the use continues.
  • The relative risk seems to be the same in people with and without cardiovascular disease, or risk factors for it.
  • However, patients with known cardiovascular diseases or risk factors had a higher absolute rate of cardiovascular events.
  • Patients with edema may experience sodium and fluid retention.
  • Patients with heart disease should not use this product.
  • Patients with MI should not be used unless the benefits are greater than the risk to their cardiovascular health.
  • Exacerbation or new-onset hypertension can occur. NSAIDs could also affect the response to ACE inhibitors, thiazide or loop diuretics; may cause cardiovascular events. Monitor blood pressure.
  • To reduce cardiovascular events, use the lowest effective dose for the most time. Patients at high risk should consider alternate therapies.

• CNS effects

  • This may cause blurred vision, drowsiness, and dizziness. Patients should be cautious about driving or operating machinery that requires mental alertness.
  • Perform an ophthalmologic examination if you have any visual disturbances.

• GI events: [US Boxed Warning]

  • NSAIDs increase the risk of severe GI inflammation, ulceration and bleeding (may be fatal); patients older than 65 years old and those with a history peptic ulcer disease or GI bleeding are more at risk.
  • These events can occur without warning and at any time during therapy.
  • Patients with active GI bleeding should not be used.
  • To reduce the risk of GI adverse reactions, use the lowest effective dose for the shortest time. Patients at high risk should consider alternate treatments.
  • Concomitant use of aspirin can lead to a significant increase in the risk for GI complications (eg ulcers). Therefore, it is recommended that you take concomitant gastroprotective therapy, such as proton pump inhibitors, and concomitant aspirin.
  • Avoid non-aspirin NSAIDs in patients who have had a history or experience of severe lower GI bleeding.
  • Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in elderly or debilitated patients.

• Hematologic effects

  • Anemia can occur. Patients on long-term NSAID therapy need to be closely monitored.
  • Rarely, NSAIDs have been linked to potentially severe blood disorders (eg, thrombocytopenia or aplastic anemia)
  • Patients with coagulation disorders and those on anticoagulants need to be closely monitored for platelet adhesion or aggregation.

• Hepatic effects

  • Use has been associated with transaminase elevations; be sure to monitor any patients suffering from abnormal LFT.
  • Rare but sometimes fatal hepatic reactions have been linked to NSAIDs.
  • If you notice any signs or symptoms of hepatic diseases or systemic manifestations, stop taking the treatment immediately.

• Hyperkalemia:

  • Monitor potassium closely.
  • Patients who use NSAIDs are at greater risk for hyperkalemia, especially elderly patients, diabetics, kidney disease, and those who have used ACE-inhibitors or other agents that can induce hyperkalemia (eg, ACE inhibitors)

• Effects on the renal system:

  • Before starting treatment, hydrate the patient and monitor your renal function.
  • Long-term NSAID treatment may cause renal papillary necrosis or other injuries.
  • NSAIDs can cause impairment of renal function. Dose-dependent decreases may occur in prostaglandin synthesis due to NSAIDs. This may lead to reduced renal blood flow, which may lead to renal decompensation (usually reversible).
  • Patients with impaired renal function, hypovolemia and heart failure, as well as those who take diuretics and ACE inhibitors, are more at risk for renal toxicity.

• Reactions to skin:

  • NSAIDs can cause severe skin adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and exfoliative dermatitis (TEN) which may occur without warning.
  • You should stop using the treatment immediately you notice a skin rash or other hypersensitivity.

• Asthma

  • Patients with other forms or asthma should exercise caution
  • Patients with asthma that is aspirin-sensitive should not use this product. Severe bronchospasm can occur.

• Coronary bypass surgery for coronary artery bypass: [US Boxed Warn]

  • In the case of coronary bypass graft (CABG), surgery, it is not recommended to use.
  • Use of CABG surgery may increase the risk of stroke and MI.

• Hearing impairment:

  • During prolonged therapy, monitor the auditory function of patients with hearing impairment.

• Hepatic impairment

  • Patients with hepatic impairment should be cautious.
  • Patients suffering from advanced hepatic diseases are more at risk for GI bleeding when they use NSAIDs.

• Renal impairment

  • ProFeno is not recommended for patients with severe renal impairment.
  • Patients with advanced renal disease should be advised not to use this product.
  • Stop using if you have persistent or worsening abnormal kidney function tests.

Fenoprofen: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• CBC;
• Liver function tests;
• Renal function (urine output, BUN, creatinine);
• Chemistry profile (periodically during long-term therapy);
• Signs/symptoms of bleeding (occult or gross blood loss);
• Blood pressure (at initiation and during therapy);
• Signs/symptoms of fluid retention;
• Audiogram (in patients with baseline hearing impairment on long-term therapy).

How to administer Fenoprofen (Progesic)?

The drug may be administered with food or milk (peak blood levels are delayed and diminished, although the total amount absorbed is not affected).

Mechanism of action of Fenoprofen (Progesic):

• It inhibits cyclooxygenase-1 (COX-1) and 2 (COX-2), respectively, which causes decreased production of prostaglandin precursors.
• It is an antipyretic, analgesic and anti-inflammatory agent.
• Other mechanisms have not been fully explained (and may contribute to the anti-inflammatory effects to different degrees).
• It acts by inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

The onset of action: 

• A few days;
• full benefit: up to 2 to 3 weeks

Absorption:

• Rapid

Protein binding:

• 99%; to albumin

Metabolism:

• Extensively hepatic

Half-life elimination:

• About 3 hours

Time to peak, serum:

• About 2 hours

Excretion:

• Urine (~90% as metabolites)

International Brand Names of Fenoprofen:

• FeiLin
• Noprofen
• Progesic
• Fenopron
• Fepron
• Gompron
• Kimpron
• Nalfon
• Nalfosab
• Nalgesic
• Nonsic
• Fenortho
• Nalfon
• ProFeno
• Arthromax

Fenoprofen Brand Names in Pakistan:

There is no brand available in Pakistan.