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:
COURSE OF THERAPY IS THREE DOSES OF IBUPROFEN LYSINE INJECTION ADMINISTERED INTRAVENOUSLY. 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 IBUPROFEN 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 IBUPROFEN LYSINE, NO FURTHER DOSES ARE NECESSARY. IF DURING CONTINUED MEDICAL MANAGEMENT THE DUCTUS ARTERIOSUS FAILS TO CLOSE OR REOPENS, THEN A SECOND COURSE OF IBUPROFEN LYSINE, ALTERNATIVE PHARMACOLOGICAL THERAPY, OR SURGERY MAY BE NECESSARY.
Administration:
IBUPROFEN LYSINE INJECTION SHOULD BE DILUTED TO AN APPROPRIATE VOLUME WITH DEXTROSE OR SALINE 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 IBUPROFEN LYSINE INJECTION CONTAINS NO PRESERVATIVE.
IBUPROFEN LYSINE INJECTION 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.
CONTRAINDICATIONS:
* 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.