Femapirin Uses

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What is Femapirin?

Femapirin 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. Femapirin does not cure arthritis and will help you only as long as you continue to take it.

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

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

Femapirin indications

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Carefully consider the potential benefits and risks of Femapirin

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

In Pediatric Patients, Femapirin

Oral Suspension is indicated:

In Adults, Femapirin

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 Femapirin in conjunction with aspirin, the combination cannot be recommended.

How should I use Femapirin?

Use Femapirin 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 Femapirin capsules.

Uses of Femapirin in details

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Use: Labeled Indications

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

Femapirin 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.

Femapirin 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 Femapirin 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 Femapirin 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 Femapirin) in combination with colchicine are recommended as first-line treatment to manage pain and resolve inflammation in idiopathic and viral acute and recurrent pericarditis.

Femapirin description

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Femapirin 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 Femapirin is (±)-2-(4-isobutylphenyl) propionic acid. It has a molecular weight of 206.28 and a molecular formula of C13H18O2.

Femapirin 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. Femapirin has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4.

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

Femapirin dosage

2.1 Recommended Dose

A course of therapy is three doses of Femapirin 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 Femapirin 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 Femapirin Lysine, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Femapirin 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 Femapirin Lysine if particulate matter is observed.

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

For administration, Femapirin Lysine should be diluted to an appropriate volume with dextrose or saline. Femapirin 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 Femapirin Lysine contains no preservative.

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

Femapirin 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.

Femapirin interactions

See also:
What other drugs will affect Femapirin?

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Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that Femapirin 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 Femapirin and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering Femapirin to patients on anticoagulants.

Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including Femapirin, 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 Femapirin blood levels. Correlative clinical studies have not been performed.

Methotrexate: Apo-Femapirin, 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 Femapirin could enhance the toxicity of methotrexate. Caution should be used if Femapirin is administered concomitantly with methotrexate.

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

Furosemide: Clinical studies, as well as random observations, have shown that Femapirin 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 Femapirin, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium: Apo-Femapirin 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 Femapirin. Thus, when Femapirin 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).

Femapirin side effects

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

6.1 Clinical Trials Experience

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

6.2 Renal Function

Compared to placebo, there was a small decrease in urinary output in the Femapirin 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 Femapirin 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.

Femapirin contraindications

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

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 Femapirin 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 Femapirin, 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 Femapirin can cause damage to your stomach or intestines. Use only the smallest amount of Femapirin needed to get relief from your pain, swelling, or fever.



Active ingredient matches for Femapirin:

Ibuprofen in Netherlands.


List of Femapirin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Femidol 500+100+50 Tablet (West Coast Pharmaceuticals)$ 0.05
FEMIDOL 500 MG/250 MG TABLET 1 strip / 10 tablets each (West Coast Pharmaceuticals)$ 0.38
Femidol 500 mg/250 mg Tablet (West Coast Pharmaceuticals)$ 0.04
Fenatic 400 mg x 50's (Promed)$ 2.79
Fenatic 100 mg/5 mL x 60 mL x 1's (Promed)$ 1.49
Fencin A 400+325+50 Tablet (Suzikem Drugs Pvt. Ltd.)$ 0.00
Fencin MR 400+325+250 Tablet (Suzikem Drugs Pvt. Ltd.)$ 0.01
Fencin Plus 400+325 Tablet (Suzikem Drugs Pvt. Ltd.)$ 0.02
FENLONG 400 MG CAPSULE 1 strip / 10 capsules each (S H Pharmaceuticals Ltd)$ 0.33
Fenlong 200mg Tablet (SKN Organics)$ 0.02
Fenlong 400mg Capsule (S H Pharmaceuticals Ltd)$ 0.03
FENLONG MR TABLET 1 strip / 10 tablets each (SKN Organics)$ 0.47
FENLONG S TABLET 1 strip / 10 tablets each (SKN Organics)$ 0.61
Fenlur P 400+333 Tablet (Allure Remedies Pvt Ltd)$ 0.01
Suspension; Oral; Ibuprofen 100 mg / 5 ml (Pinewood)
Fenplus 60 ml Syrup (Healing Touch Pharmaceuticals)$ 0.01
Fenris 100 mg/5 mL x 60 mL (Interbat)$ 1.30

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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