Indomethacin Injection

• It is used to treat patent ductus arteriosus (PDA).

• Tell all of your child's health care providers that your child is taking indomethacin injection. This includes your child's doctors, nurses, pharmacists, and dentists.
• To gain the most benefit, do not miss doses.
• Your child may bleed more easily. Talk with the doctor.

• WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Slow heartbeat.
• Long stops between breaths.
• This medicine may irritate the vein. It may burn the skin if the drug leaks from the vein when it is given. Tell your child's nurse if your child has any redness, burning, pain, swelling, or leaking of fluid where the drug is going into your child's body.

Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.  Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray.

Indomethacin for Injection is supplied in single dose vials containing 1 mg of indomethacin as a sterile lyophilized powder or plug for reconstitution.

Indomethacin for Injection is contraindicated in neonates:

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