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INDOCIN IV
CHF and arrhythmias
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Drug Name:

INDOCIN IV Rx

Generic Name and Formulations:
Indomethacin 1mg/vial; lyophilized pwd for IV infusion after reconstitution.

Company:
Recordati Rare Diseases, Inc.

Therapeutic Use:

Indications for INDOCIN IV:

Closure of hemodynamically significant patent ductus arteriosus in premature infants weighing 500‒1750g when after 48 hours of usual medical management is ineffective.

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.

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.

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.

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.

Pharmacological Class:

NSAID (indole deriv.).

Adverse Reactions:

Renal failure, electrolyte disturbances, GI bleeding, transient oliguria, elevated serum creatinine, decreased platelet aggregation.

How Supplied:

Single-dose vial—1

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