Eudorlin Infantil Uses

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What is Eudorlin Infantil?

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

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

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

Eudorlin Infantil indications

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Carefully consider the potential benefits and risks of Eudorlin Infantil

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

In Pediatric Patients, Eudorlin Infantil

Oral Suspension is indicated:

In Adults, Eudorlin Infantil

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 Eudorlin Infantil in conjunction with aspirin, the combination cannot be recommended.

How should I use Eudorlin Infantil?

Use Eudorlin Infantil 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 Eudorlin Infantil capsules.

Uses of Eudorlin Infantil in details

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Use: Labeled Indications

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

Eudorlin Infantil 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.

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

Eudorlin Infantil description

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

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

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

Eudorlin Infantil dosage

2.1 Recommended Dose

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

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

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

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

Eudorlin Infantil 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.

Eudorlin Infantil interactions

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What other drugs will affect Eudorlin Infantil?

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

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

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

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

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

Lithium: Apo-Eudorlin Infantil 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 Eudorlin Infantil. Thus, when Eudorlin Infantil 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).

Eudorlin Infantil side effects

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What are the possible side effects of Eudorlin Infantil?

6.1 Clinical Trials Experience

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

6.2 Renal Function

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

Eudorlin Infantil contraindications

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What is the most important information I should know about Eudorlin Infantil?

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



Active ingredient matches for Eudorlin Infantil:

Ibuprofen in Spain.


List of Eudorlin Infantil substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablets, Film-Coated; Oral; Ibuprofen
Eufen 200 mg x 1's
Eufen 400 mg x 1's
Eufen 100 mg/5 mL x 1's
Capsule; Oral; Ibuprofen 400 mg
Capsules; Oral; Ibuprofen 400 mg
Tablet; Oral; Acetaminophen 300 mg; Caffeine Citrate 30 mg; Codeine Phosphate 15 mg
Tablet; Oral; Acetaminophen 300 mg; Caffeine Citrate 30 mg; Codeine Phosphate 30 mg
Tablet; Oral; Acetaminophen 300 mg; Caffeine Citrate 30 mg; Codeine Phosphate 8 mg
Tablet, Film-Coated; Oral; Ibuprofen 200 mg (Expanpharm)
Tablets, Film-Coated; Oral; Ibuprofen 200 mg (Expanpharm)
Tablet; Oral; Ibuprofen 400 mg
Extra Strength Ibuprofen tablet 400 mg (Vita Health Products Inc (Canada))
Capsule; Oral; Ibuprofen 400 mg
Capsules; Oral; Ibuprofen 400 mg
Extra Strength Ibuprofen Liquid Filled Capsules capsule 400 mg (Apotex Inc (Canada))
Fafen Forte 400 mg x 500's
Fafen Forte 400 mg x 50 x 10's
Fafen Paed 100 mg/5 mL x 60 mL
Fafen 200 mg x 1, 000's

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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