Fenoprofen

Fenoprofen is also used to treat ankylosing spondylitis (arthritis that mainly affects the spine) and gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints). It is also sometimes used to reduce fever. Talk to your doctor about the risks of using this medication to treat your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Fenoprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nervousness
• drowsiness
• sweating
• constipation
• ringing in the ears

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more fenoprofen until you speak to your doctor.

• blurred vision
• shaking of a part of the body that you cannot control
• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling in the abdomen, ankles, feet, or legs
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• upset stomach
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast or pounding heartbeat
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Fenoprofen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Nalfon 200

Fenoprofen is a prescription medication used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as arthritis, menstrual cramps, and other types of short-term pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with fenoprofen. See the “Drug Precautions” section.

Common side effects include:

• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting
• dizziness

This is not a complete list of fenoprofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take fenoprofen exactly as prescribed.

This medication comes in capsule and tablet forms, and is taken up to 6 times a day with food or milk to prevent upset stomach.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fenoprofen at the same time.

Fenoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Fenoprofen works by reducing hormones that cause inflammation and pain in the body.

Fenoprofen is used to treat mild to moderate pain, or to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

Fenoprofen may also be used for purposes not listed in this medication guide.

Fenoprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Fenoprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using fenoprofen, especially in older adults.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fenoprofen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fenoprofen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fenoprofen in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenoprofen in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving fenoprofen.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fenoprofen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fenoprofen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using fenoprofen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using fenoprofen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alacepril
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cilazapril
• Delapril
• Dicumarol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Imidapril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Pentopril
• Perindopril
• Pindolol
• Practolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Temocapril
• Timolol
• Trandolapril
• Valsartan
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fenoprofen. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Congestive heart failure or
• Dehydration or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Hypovolemia (low blood volume) or
• Kidney disease, history of or
• Liver disease (eg, hepatitis) or
• Stomach ulcers or bleeding or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of or
• Kidney disease, severe—Should not be used in patients with these conditions.

• Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

For safe and effective use of fenoprofen, do not use more of it, do not use it more often, and do not use it for a longer time than ordered by your doctor. Using too much of fenoprofen may increase the chance of unwanted effects, especially in elderly patients.

fenoprofen comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To lessen stomach upset, you may take fenoprofen with food or milk. .

Swallow the tablet whole. Do not break, crush, divide, or chew it. .

When used for severe or continuing arthritis, fenoprofen must be taken regularly as ordered by your doctor in order for it to help you. fenoprofen usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of fenoprofen. .

Dosing

The dose of fenoprofen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fenoprofen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For mild to moderate pain:
    • Adults—200 milligrams (mg) every 4 to 6 hours as needed.
    • Children—Use and dose must be determined by your doctor. .
  • For rheumatoid arthritis and osteoarthritis:
    • Adults—At first, 400 to 600 mg three or four times a day. Your doctor may increase or decrease your dose as needed. However, the dose usually is not more than 3200 mg per day.
    • Children—Use and dose must be determined by your doctor. .

Missed Dose

If you miss a dose of fenoprofen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Fenoprofen calcium is a nonsteroidal, anti-inflammatory, antiarthritic drug that also possesses analgesic and antipyretic activities. Its exact mode of action is unknown, but it is thought that prostaglandin synthetase inhibition is involved.

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 Fenoprofen 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 Fenoprofen has also been evidenced by increased mobility (i.e., a decrease in the number of joints having limited motion).

The use of Fenoprofen 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 Fenoprofen to maintenance therapy with gold salts or steroids. Whether or not Fenoprofen 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 Fenoprofen 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 Fenoprofen 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 Fenoprofen.

There is less suppression of collagen-induced platelet aggregation with single doses of Fenoprofen calcium than there is with aspirin.

Carefully consider the potential benefits and risks of Fenoprofen calcium tablets, USP and other treatment options before deciding to use Fenoprofen calcium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Fenoprofen calcium tablets are indicated:

• Fenortho
• Nalfon

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling. Not recommended in patients with advanced renal disease. Not removed by hemodialysis.

May be taken with food or milk.

Fenoprofen may interfere with Amerlex-M kit assay values; falsely elevated values of total and free triiodothyronine have been reported; may lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, nonclosure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for fenoprofen specifically states use should be avoided starting at 30-weeks gestation. Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women; however, use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bermas 2014; Bloor 2013).

If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Avoid use during third trimester of pregnancy. Prior to 30 weeks gestation: Use is not recommended unless clearly needed. US FDA pregnancy category: Not assigned. Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility. -If use prior to the third trimester is necessary, the dose should be kept low and duration of use as short as possible.

Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.