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Indomethacin For Injection Generic Name & Formulations
Legal Class
Rx
General Description
Indomethacin 1mg/vial; lyophilized pwd for IV infusion after reconstitution.
Pharmacological Class
NSAID (indole deriv.).
How Supplied
Contact supplier
Manufacturer
Indomethacin For Injection Indications
Indications
Closure of hemodynamically significant patent ductus arteriosus in premature infants weighing 500‒1750g when after 48 hours of usual medical management is ineffective.
Indomethacin For Injection Dosage and Administration
Adult
Not applicable.
Children
Give by IV infusion over 20‒30mins at 12‒24hr intervals for a total of 3 doses; monitor urinary output. Age <48hrs: initially 0.2mg/kg, then 0.1mg/kg for doses 2 and 3; 2‒7days old: 0.2mg/kg for all three doses; >7days old: initially 0.2mg/kg, then 0.25mg/kg for doses 2 and 3. If anuria or oliguria (urinary output <0.6mL/kg/hr) is evident at time of 2nd or 3rd dose, suspend therapy until renal function is normal. May give a second course of 1‒3 doses if ductus arteriosus re-opens. If unresponsive after 2 courses, surgery may be needed.
Indomethacin For Injection Contraindications
Contraindications
Untreated infection. Active intracranial hemorrhage or GI bleeding. Thrombocytopenia. Coagulations disorders. Necrotizing enterocolitis. Significant renal impairment. Congenital heart disease in which ductus arteriosus patency is necessary for satisfactory pulmonary or systemic blood flow.
Indomethacin For Injection Boxed Warnings
Not Applicable
Indomethacin For Injection Warnings/Precautions
Warnings/Precautions
Volume depletion. CHF. Sepsis. May mask signs of infection. Hepatic or renal impairment. Monitor serum electrolytes, hepatic, and renal function during therapy. Discontinue if liver dysfunction occurs. Monitor for signs of bleeding. Avoid extravasation.
Indomethacin For Injection Pharmacokinetics
See Literature
Indomethacin For Injection Interactions
Interactions
Caution with other nephrotoxic agents, anticoagulants (monitor). Concomitant ACE inhibitors or angiotensin II antagonists may worsen renal dysfunction. Potentiates aminoglycosides, digoxin (monitor for toxicity). Antagonizes furosemide.
Indomethacin For Injection Adverse Reactions
Adverse Reactions
Renal failure, electrolyte disturbances, GI bleeding, transient oliguria, elevated serum creatinine, decreased platelet aggregation, hyponatremia, elevated serum potassium.
Indomethacin For Injection Clinical Trials
See Literature
Indomethacin For Injection Note
Not Applicable
Indomethacin For Injection Patient Counseling
See Literature
