Fenspan Uses

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What is Fenspan?

Fenspan is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Fenspan does not cure arthritis and will help you only as long as you continue to take it.

In addition, Fenspan can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

Fenspan is available both over-the-counter (OTC) and with your doctor's prescription.

Fenspan indications

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Carefully consider the potential benefits and risks of Fenspan

Oral Suspension and other treatment options before deciding to use Fenspan. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

In Pediatric Patients, Fenspan

Oral Suspension is indicated:

In Adults, Fenspan

Oral Suspension is indicated:

Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of Fenspan in conjunction with aspirin, the combination cannot be recommended.

How should I use Fenspan?

Use Fenspan capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about the proper use of Fenspan capsules.

Uses of Fenspan in details

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Use: Labeled Indications

Oral: Inflammatory diseases and rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, osteoarthritis

Fenspan injection (Caldolor): Management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics in adults and children 6 months and older; reduction of fever in adults and children 6 months and older.

Fenspan lysine injection (NeoProfen): Patent ductus arteriosus (PDA): To close a clinically significant PDA in premature infants weighing between 500-1500 g who are no more than 32 weeks of gestational age when usual medical management (eg, diuretics, fluid restriction, respiratory support) is ineffective.

OTC labeling: Reduction of fever; management of pain due to headache, migraine, sore throat, arthritis, physical or athletic overexertion (eg, sprains/strains), menstrual pain, dental pain, minor muscle/bone/joint pain, backache, pain due to the common cold and flu

Off Label Uses

Gout, acute flares

Clinical experience suggests the utility of Fenspan as an alternative option for acute gout flares.

Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDs are effective and recommended agents in the treatment of acute gout flares.

Pericarditis

Data from double-blind, placebo-controlled, multicenter trials indicate that colchicine in combination with aspirin or Fenspan significantly reduces the incidence of symptoms at 72 hours and the risk of recurrence in acute and recurrent pericarditis. Based on Brazilian Society of Cardiology guidelines for the management of myocarditis and pericarditis and European Society of Cardiology (ESC) guidelines for the management of pericardial diseases, nonsteroidal anti-inflammatory drugs (NSAIDs) (typically, aspirin or Fenspan) in combination with colchicine are recommended as first-line treatment to manage pain and resolve inflammation in idiopathic and viral acute and recurrent pericarditis.

Fenspan description

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Fenspan is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is a racemic mixture of [+]S- and [-]R-enantiomers.

The chemical name for Fenspan is (±)-2-(4-isobutylphenyl) propionic acid. It has a molecular weight of 206.28 and a molecular formula of C13H18O2.

Fenspan is a colorless, crystalline stable solid, with a melting point of 75-77°C. It is relatively insoluble in water but readily soluble in most organic solvents. Fenspan has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4.

Fenspan has shown analgesic, anti-inflammatory and antipyretic activity in both animal and human studies. These properties provide symptomatic relief of inflammation and pain.

Fenspan dosage

2.1 Recommended Dose

A course of therapy is three doses of Fenspan Lysine administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Fenspan Lysine, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of Fenspan Lysine, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Fenspan Lysine, alternative pharmacological therapy, or surgery may be necessary.

2.2 Directions for Use

For intravenous administration only.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use Fenspan Lysine if particulate matter is observed.

After the first withdrawal from the vial, any solution remaining must be discarded because Fenspan Lysine contains no preservative.

For administration, Fenspan Lysine should be diluted to an appropriate volume with dextrose or saline. Fenspan Lysine should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes. The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because Fenspan Lysine contains no preservative.

Since Fenspan Lysine is potentially irritating to tissues, it should be administered carefully to avoid extravasation.

Fenspan Lysine should not be simultaneously administered in the same intravenous line with Total

Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.

Fenspan interactions

See also:
What other drugs will affect Fenspan?

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Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that Fenspan significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when Fenspan and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering Fenspan to patients on anticoagulants.

Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including Fenspan, yields a net decrease in anti-inflammatory activity with lowered blood levels of the non-aspirin drug. Single dose bioavailability studies in normal volunteers have failed to wshow an effect of aspirin on Fenspan blood levels. Correlative clinical studies have not been performed.

Methotrexate: Apo-Fenspan, as well as other nonsteroidal anti-inflammatory drugs, probably reduces the tubular secretion of methotrexate based on in vitro studies in rabbit kidney slices. This may indicate that Fenspan could enhance the toxicity of methotrexate. Caution should be used if Fenspan is administered concomitantly with methotrexate.

H-2 Antagonists: In studies with human volunteers, co-administration of cimetidine or ranitidine with Fenspan had no substantive effect on Fenspan serum concentrations.

Furosemide: Clinical studies, as well as random observations, have shown that Fenspan can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with Fenspan, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium: Apo-Fenspan produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by Fenspan. Thus, when Fenspan and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy).

Fenspan side effects

See also:
What are the possible side effects of Fenspan?

6.1 Clinical Trials Experience

The most frequently reported adverse events with Fenspan Lysine were as shown in Table 1.

6.2 Renal Function

Compared to placebo, there was a small decrease in urinary output in the Fenspan group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in Fenspan treated infants.

6.3 Additional Adverse Events

The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.

6.4 Post-marketing Experience

The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, and pulmonary hypertension. 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.

Fenspan contraindications

See also:
What is the most important information I should know about Fenspan?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Fenspan just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Fenspan, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not take more of this medication than is recommended. An overdose of Fenspan can cause damage to your stomach or intestines. Use only the smallest amount of Fenspan needed to get relief from your pain, swelling, or fever.



Active ingredient matches for Fenspan:

Ibuprofen


List of Fenspan substitutes (brand and generic names)

Sort by popularity
Unit description / dosage (Manufacturer)Price, USD
Fenris 100 mg/5 mL x 60 mL (Interbat)$ 1.30
Fever-Free 200 mg x 60's
FeverFree 100 mg/5 mL x 60 mL (The United Drug)
FeverFree oral susp 100 mg/5 mL 60 mL x 1's (The United Drug)
Tablet; Oral; Ibuprofen
Tablets; Oral; Ibuprofen
Fla 4 400 mg Tablet (Pans Laboratories)$ 0.01
Flamofen 400+500 Tablet (Pans Laboratories)$ 0.02
Suspension; Oral; Naproxen Sodium 125 mg / 5 ml (Bayer)
Tablet; Oral; Naproxen Sodium 100 mg (Bayer)
Tablet; Oral; Naproxen Sodium 200 mg (Bayer)
Tablet; Oral; Naproxen Sodium 275 mg (Bayer)
Tablet; Oral; Naproxen Sodium 550 mg (Bayer)
Flanax 275 mg x 100's (Bayer)$ 21.96
Flanax 275 mg x 500's (Bayer)$ 109.76
Flanax Forte 550 mg x 50's (Bayer)$ 21.96
Flanax Forte 550 mg x 250's (Bayer)$ 109.76
Tablets; Oral; Naproxen Sodium 100 mg (Bayer)
Tablets; Oral; Naproxen Sodium 200 mg (Bayer)
Tablets; Oral; Naproxen Sodium 275 mg (Bayer)

References

  1. DailyMed. "IBUPROFEN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "ibuprofen". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ibuprofen". http://www.drugbank.ca/drugs/DB01050 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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