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Indocin I.V. (Indomethacin) - Summary



(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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Published Studies Related to Indocin I.V. (Indomethacin)

Randomized, double-blind, placebo-controlled clinical trial on the efficacy of 0.5% indomethacin eye drops in uveitic macular edema. [2014]
different etiology uveitis... CONCLUSIONS: The four times per day administration of 0.5% INDOM eye drops in

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.

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Clinical Trials Related to Indocin I.V. (Indomethacin)

Indomethacin and Cardiac Bypass Surgery [Completed]
Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.

Indomethacin Decreases Post-ERCP Pancreatitis [Completed]
Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3. 5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.

Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury [Recruiting]
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis [Recruiting]
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. A number of trials have evaluated that rectal NSAIDs (non-steroidal anti-inflammatory drug) can prevent post-ERCP pancreatitis (PEP) in high risk patients. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk factor patients, may preventing the PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional regimen.

Indomethacin for Tocolysis [Not yet recruiting]
Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy. Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.

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Page last updated: 2014-11-30

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