Ibuprofen

Neoprofen

20MG BASE/2ML injectableVereinigte StaatenIm HandelZugelassen am 13. Apr. 2006

Inhalt auf Englisch

Anwendungsgebiete

NeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

NeoProfen is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

( 1 )

Gegenanzeigen

NeoProfen is contraindicated in: Preterm infants with proven or suspected infection that is untreated; Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; Preterm infants with thrombocytopenia; Preterm infants with coagulation defects; Preterm infants with or who are suspected of having necrotizing enterocolitis; Preterm infants with significant impairment of renal function.

NeoProfen is contraindicated in preterm infants: With proven or suspected infection that is untreated ( 4 ) With congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow ( 4 ) With impaired renal function ( 4 ) With thrombocytopenia, coagulation defects or who are bleeding ( 4 ) With or who are suspected of having necrotizing enterocolitis ( 4 )

Anwendungsgebiete

( 1 )

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

NeoProfen has not been assessed for neurodevelopmental outcome and growth ( 5.1 ) NeoProfen may alter the usual signs of infection ( 5.2 ) NeoProfen can inhibit platelet aggregation, and has been shown to prolong bleeding time in normal adult subjects ( 5.3 ) Ibuprofen has been shown to displace bilirubin from albumin binding-sites ( 5.4 ) NeoProfen should be administered carefully to avoid extravascular injection or leakage ( 5.5 ) NeoProfen may cause serious skin reactions ( 5.6 )

5.1General

There are no long-term evaluations of the infants treated with ibuprofen at durations greater than the 36 weeks post-conceptual age observation period. Ibuprofen's effects on neurodevelopmental outcome and growth as well as disease processes associated with prematurity (such as retinopathy of prematurity and chronic lung disease) have not been assessed.

5.2Infection

NeoProfen may alter the usual signs of infection. The physician must be continually on the alert and should use the drug with extra care in the presence of controlled infection and in infants at risk of infection.

5.3Platelet Aggregation

NeoProfen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation. Preterm infants should be observed for signs of bleeding. Ibuprofen has been shown to prolong bleeding time (but within the normal range) in normal adult subjects. This effect may be exaggerated in patients with underlying hemostatic defects (see CONTRAINDICATIONS ).

5.4Bilirubin Displacement

Ibuprofen has been shown to displace bilirubin from albumin binding-sites; therefore, it should be used with caution in patients with elevated total bilirubin.

5.5Administration

NeoProfen should be administered carefully to avoid extravascular injection or leakage, as solution may be irritating to tissue.

5.6Serious Skin Reactions

NSAIDS, including ibuprofen, can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be fatal. Ibuprofen should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Nebenwirkungen

Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

The most frequently reported adverse events with NeoProfen were as shown in Table 1. Table 1. Adverse Events within 30 Days of Therapy in the Multicenter Study* Adverse Event % Incidence NeoProfen Placebo * Within 30 days of therapy, with an event rate greater on NeoProfen than on placebo, and greater than 2 events on NeoProfen. ** A given subject may have experienced more than one specific event within these adverse event categories.

Only the most severe grade of IVH counted for a given subject. Sepsis 43 37 Anemia 32 25 Total Bleeding** 32 29 Intraventricular Hemorrhage, Grades 1/2 15 13 Intraventricular Hemorrhage, Grades 3/4 15 10 Other Bleeding 6 13 Intraventricular Hemorrhage, All Grades 29 24 Apnea 28 26 Gastrointestinal Disorders 22 18 non-Necrotizing Enterocolitis Total Renal Events** 21 15 Renal Failure 1 3 Renal Insufficiency, Impairment 6 4 Urine Output Reduced 3 1 Blood Creatinine Increased 3 1 Blood Urea Increased with Hematuria 1 1 Blood Urea Increased 7 4 Respiratory Infection 19 13 Skin Lesion/Irritation 16 6 Hypoglycemia 12 6 Hypocalcemia 12 9 Respiratory Failure 10 4 Urinary Tract Infection 9 4 Adrenal Insufficiency 7 1 Hypernatremia 7 4 Edema 4 0 Atelectasis 4 1

6.2Renal Function Compared

to placebo, there was a small decrease in urinary output in the ibuprofen 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 ibuprofen treated infants.

6.3Additional 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.

6.4Postmarketing Experience

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. The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and pulmonary hypertension.

Neoprofen

Anwendungsgebiete

Gegenanzeigen

Zwei Arzneimittel in einer Frage?

Neoprofen

Anwendungsgebiete

Gegenanzeigen

Zwei Arzneimittel in einer Frage?

Warnhinweise und Vorsichtsmaßnahmen

5.1General

5.2Infection

5.3Platelet Aggregation

5.4Bilirubin Displacement

5.5Administration

5.6Serious Skin Reactions

Wechselwirkungen

Nebenwirkungen

6.1Clinical Trials Experience

6.2Renal Function Compared

6.3Additional Adverse Events

6.4Postmarketing Experience

In anderen Ländern

Packungen

Dokumente

Quellen und Lizenzen

Auf einen Blick