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)
A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. [2012]
retrograde cholangiopancreatography (ERCP)... CONCLUSIONS: Among patients at high risk for post-ERCP pancreatitis, rectal
Fluid restriction and prophylactic indomethacin versus prophylactic indomethacin alone for prevention of morbidity and mortality in extremely low birth weight infants. [2011.07.06]
CONCLUSIONS: We found no randomized controlled trials to investigate the possible interaction between fluid restriction and indomethacin prophylaxis versus indomethacin prophylaxis alone in ELBW infants. A well-designed randomized trial is needed to address this question.
Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. [2011.07]
OBJECTIVE: To examine whether treatment with antenatal corticosteroids modifies the immediate and long-term effects of prophylactic indomethacin sodium trihydrate in extremely low-birth-weight infants... CONCLUSION: We find little evidence that the effects of prophylactic indomethacin vary in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. Trial Registration clinicaltrials.gov Identifier: NCT00009646.
Postoperative analgesia with tramadol and indomethacin for diagnostic curettage and early termination of pregnancy. [2011.07]
BACKGROUND: The postoperative analgesic effects of rectal indomethacin and tramadol were compared in patients undergoing elective termination of first trimester pregnancy and diagnostic dilatation and curettage... CONCLUSION: When compared to indomethacin 100 mg, preoperative administration of tramadol 100 mg provides superior postoperative analgesia with minimal adverse effects. Copyright (c) 2011. Published by Elsevier Ltd.
Comparison of the efficacy and adverse effects of nifedipine and indomethacin for the treatment of preterm labor. [2011.06]
OBJECTIVE: To compare the effectiveness and adverse effects of nifedipine versus indomethacin in the treatment of preterm labor... CONCLUSION: Indomethacin was less effective than nifedipine for the fast treatment of preterm labor. For women who responded to treatment within 2 hours, however, the delaying of delivery by indomethacin was similar to that by nifedipine. Copyright (c) 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Clinical Trials Related to Indocin I.V. (Indomethacin)
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
Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA) [Not yet recruiting]
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation,
however persistence of ductal patency postnatally may have significant adverse hemodynamic
effects in the neonate. Medical therapy for PDA predominantly involves the administration of
one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these
therapies have been shown to be successful in mediating ductal closure in approximately 70%
of treated infants.
However, the need for a second course of treatment for PDA closure remains quite common. The
investigators hypothesize that, because of small differences between the two drugs, a
greater percentage of infants who did not respond to a first course of therapy with
indomethacin will respond to a second course with ibuprofen than to a repeat course of
indomethacin.
As such, the investigators aim to compare secondary therapy with a repeat course of
indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent
after a first course of therapy with indomethacin.
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.
Indomethacin Versus Nifedipine for Preterm Labor Tocolysis [Recruiting]
Indomethacin and Nifedipine are commonly used medications for treatment of pre term labor.
This study will compare the efficacy and adverse outcomes of oral nifedipine versus oral
indomethacin for preterm labor tocolysis in an effort to identify which drug is most
effective.
Patients diagnosed with preterm labor who grant consent will be randomized by the pharmacy
to receive oral nifedipine or oral indomethacin. Both the patient and primary medical
provider will be blinded to the identity of the study drug. An abdominal ultrasound will be
performed in the labor and delivery unit prior to the administration of the tocolytic in
order to assess fetal position and fluid level, and to document fetal cardiac activity and
movement, and will be repeated at 48 hours post-randomization. Following randomization, the
patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills
each containing 10 mg oral nifedipine for a total of 30 mg. The patients will then receive
either 25 mg of oral indomethacin every 6 hours for 48 hours, or 20 mg of oral nifedipine
every 6 hours for 48 hours. Tocolysis beyond 48 hours will not be used.
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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