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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NEWS HIGHLIGHTS
Published Studies Related to Indocin I.V. (Indomethacin)
Oral prednisolone is more cost-effective than oral indomethacin for treating patients with acute gout-like arthritis. [2009.10]
OBJECTIVES: Acute gouty arthritis is often treated with NSAIDs, but recent studies have suggested that treatment with prednisolone has at least equivalent analgesic efficacy and fewer adverse effects. No formal economic analysis has been performed earlier. In this study, we aimed to compare the economic impact of oral indomethacin therapy and oral prednisolone therapy in the treatment of acute gout in patients presenting to an emergency department in Hong Kong... CONCLUSION: Treatment of acute gouty arthritis with a 5-day course of prednisolone is significantly more cost-effective than treatment with indomethacin.
Effects of indomethacin on cerebrovascular response to hypercapnea and hypocapnea in breath-hold diving and obstructive sleep apnea. [2009.05.15]
We tested whether breath hold divers (BHD) and obstructive sleep apnea (OSA) subjects had similar middle cerebral artery velocity (MCAV) responses to hypercapnea and hypocapnea.The blunted MCAV responses to hypercapnea with indomethacin in BHD, but not in OSA patients suggests that (a) the normal contribution of local vasodilating mechanisms to the cerebrovascular responses to hypercapnea is absent in OSA patients and (b) exposure to chronic/repeated apneas is not causal per se in limiting the contribution of vasodilating mechanisms to the cerebrovascular responses to hypercapnea in OSA.
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 (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 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 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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