INDOCIN I.V. SUMMARY
STERILE INDOCIN® I.V.
(Indomethacin for Injection)
Sterile INDOCIN I.V. (Indomethacin for Injection) for intravenous administration is lyophilized indomethacin for injection.
INDOCIN I.V. is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 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 and pulmonary plethora on chest x-ray.
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INDOCIN I.V. NEWS HIGHLIGHTS
Published Studies Related to Indocin I.V. (Indomethacin)
Controlled indomethacin release from mucoadhesive film: in vitro and clinical evaluations. [2008.11]
To develop a film formulation allowing controlled release for long-term analgesia, we selected ethyl cellulose (EC) as a novel additive, prepared a film formulation using indomethacin [generic for Indocin I.V.] (IM film), and evaluated it in vitro and clinically. In the in vitro experiments, the effects of the EC concentration on the release rate of IM and on the adhesion force to the mucous membrane were investigated...
Ibuprofen versus continuous indomethacin in premature neonates with patent ductus arteriosus: is the difference in the mode of administration? [2008.09]
Ibuprofen has been proposed as a preferential alternative to indomethacin [generic for Indocin I.V.] in treating patent ductus arteriosus (PDA), because it is purported to have less renal, mesenteric, and cerebral vasoconstrictive effects. However, short and long-term safety concerns regarding ibuprofen remain... In conclusion, PDA treatment with either continuous indomethacin infusion or ibuprofen was equally devoid of adverse renal effects and/or peripheral vasoconstrictive effects.
Increased indomethacin dosing for persistent patent ductus arteriosus in preterm infants: a multicenter, randomized, controlled trial. [2008.08]
OBJECTIVE: We conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin [generic for Indocin I.V.] would improve the rate of patent ductus arteriosus (PDA) closure... CONCLUSION: Increasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.
Urinary prostaglandins and the effect of indomethacin on phosphate excretion in children with hypophosphatemic rickets. [2008.08]
We recently reported the urinary prostaglandin E(2)/creatinine ratio (PGE(2)/Cr) was markedly elevated in Hyp mice, the animal model for X-linked hypophosphatemia, compared with control mice... Indomethacin [generic for Indocin I.V.] had no significant effect on serum phosphorus or urinary phosphate excretion in children with HPR.
Increased Indomethacin Dosing for Persistent Patent Ductus Arteriosus in Preterm Infants: A Multicenter, Randomized, Controlled Trial. [2008.03.18]
OBJECTIVE: We conducted a multicenter, randomized, controlled trial to determine whether higher doses of indomethacin [generic for Indocin I.V.] would improve the rate of patent ductus arteriosus (PDA) closure... CONCLUSION: Increasing indomethacin concentrations above the levels achieved with a conventional dosing regimen had little effect on the rate of PDA closure but was associated with higher rates of moderate/severe ROP and renal compromise.
Clinical Trials Related to Indocin I.V. (Indomethacin)
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) [Completed]
This trial will determine whether giving low-dose indomethacin to infants weight 500 to 999
grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy
or developmental problems at 18 to 22 months of age.
An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants [Recruiting]
A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary
hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular
bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with
the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate
in infants weighing < 1000 gm. PDA ligation is associated with early postoperative
hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants.
The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to
be safe and decreased the need for PDA ligation without adverse effects in one observational
study. We hypothesize that the use of an escalated dose of intravenous indomethacin will
result in an increase in the probability of survival without need for surgical ligation of
PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational
age with persistent PDA.
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus [Completed]
The purpose of this study is to examine if a higher dose of indomethacin will increase the
rate of ductus arteriosus closure in extremely premature infants without increasing the side
effects. The long term objective is to find the optimal dosing of indomethacin for permanent
closure of the Ductus and prevent the morbidity related to PDA and the complications of
surgical ligation.
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants [Recruiting]
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen
therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding
intolerance and shorten the time period that infants need to tolerate full enteral nutrition.
We also hypothesize that this intervention will minimize the alterations in intestinal
permeability that occur with these drugs and will improve the infants' hemodynamic response
to enteral nutrition
A Double-Blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis [Recruiting]
The purpose of this research study is to determine if indomethacin, an anti-inflammatory
medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs)
can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography
(ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP
pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP,
patients will be randomized to receive a dose of indomethacin or placebo (an inactive
substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All
patients will be observed for 4 hours following ERCP which is part of routine clinical
practice. Patients with minimal pain will be discharged after this 4 hour observation period.
All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after
the ERCP has been completed. Patients who have significant abdominal pain will be
hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by
telephone the following day to ask them if they have had any complications of ERCP.
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