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(indomethacin for injection) for intravenous administration is lyophilized indomethacin for injection. Variations in the size of the lyophilized plug and the intensity of color have no relationship to the quality or amount of indomethacin present in the vial. Sterile INDOCIN I.V. Each vial contains indomethacin for injection equivalent to 1 mg indomethacin as a white to yellow lyophilized powder or plug.
The neonates treated with indomethacin for injection also had a significantly higher incidence of transient oliguria and elevations of serum creatinine (greater than or equal to 1.8 mg/dL) than did the neonates treated with placebo.
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Furthermore, in one study of premature infants treated with INDOCIN I.V. and also receiving either gentamicin or amikacin, both peak and trough levels of these aminoglycosides were significantly elevated. Because the half-life of digitalis (given frequently to pre-term infants with patent ductus arteriosus and associated cardiac failure) may be prolonged when given concomitantly with indomethacin, the neonate should be observed closely; frequent ECGs and serum digitalis levels may be required to prevent or detect digitalis toxicity early. Since renal function may be reduced by INDOCIN I.V., consideration should be given to reduction in dosage of those medications that rely on adequate renal function for their elimination.
The mean plasma half-life of indomethacin is 4.5 hours. Following intravenous administration in adults, indomethacin is eliminated via renal excretion, metabolism, and biliary excretion. Indomethacin undergoes appreciable enterohepatic circulation. In the absence of enterohepatic circulation, it is 90 minutes. Indomethacin has been found to cross the blood-brain barrier and the placenta.
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Please refer to the WARNINGS and PRECAUTIONS sections. No information provided.
has not been established: Cardiovascular: bradycardia. The following adverse reactions have also been reported in neonates treated with indomethacin, however, a causal relationship to therapy with INDOCIN I.V.
Therapy with indomethacin may blunt the natriuretic effect of furosemide. and furosemide had significantly higher urinary output, higher levels of sodium and chloride excretion, and higher glomerular filtration rates than did those receiving INDOCIN I.V. In a study of 19 premature infants with patent ductus arteriosus treated with either INDOCIN I.V. In this study, the data suggested that therapy with furosemide helped to maintain renal function in the premature infant when INDOCIN I.V. alone or a combination of INDOCIN I.V. This response has been attributed to inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs. was added to the treatment of patent ductus arteriosus. alone. and furosemide, results showed that neonates receiving both INDOCIN I.V.
Indocin I.V. (indomethacin) for Injection Sterile.
Pregnant rats, given 2.0 mg/kg/day and 4.0 mg/kg/day during the last trimester of gestation, delivered offspring whose pulmonary blood vessels were both reduced in number and excessively muscularized. No information provided. These findings are similar to those observed in the syndrome of persistent pulmonary hypertension of the neonate.
The drug should be administered carefully to avoid extravascular injection or leakage as the solution may be irritating to tissue.
INDOCIN I.V. is contraindicated in: neonates with proven or suspected infection that is untreated; neonates who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; neonates with thrombocytopenia ; neonates with coagulation defects; neonates with or who are suspected of having necrotizing enterocolitis; neonates with significant impairment of renal function; neonates with congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).
Gastrointestinal: gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis.
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Indomethacin usually does not influence the hypoprothrombinemia produced by anticoagulants. When indomethacin is added to anticoagulants, prothrombin time should be monitored closely. Caution should be exercised when INDOCIN I.V. In post marketing experience, bleeding has been reported in patients on concomitant treatment with anticoagulants and INDOCIN I.V. and anticoagulants are administered concomitantly.
The reconstituted solution is clear, slightly yellow and essentially free from visible particles.
If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of INDOCIN I.V., no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1-3 doses may be given, each dose separated by a 12-24 hour interval as described above.
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Further dilution with intravenous infusion solutions is not recommended. is not buffered. INDOCIN I.V.
had a 75 to 80 percent closure rate. In one of these studies, a multicenter study, involving 405 pre-term infants, later reopening of the ductus arteriosus occurred in 26 percent of neonates treated with INDOCIN I.V., however, 70 percent of these closed subsequently without the need for surgery or additional indomethacin. In double-blind, placebo-controlled studies of INDOCIN I.V. in 460 small pre-term infants, weighing 1750 g or less, the neonates treated with placebo had a ductus closure rate after 48 hours of 25 to 30 percent, whereas those treated with INDOCIN I.V.
Metabolic: hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention).
Similar decreases in mesenteric blood flow and velocity have been observed. The clinical significance of these effects has not been established. Studies in healthy young animals and in premature infants with patent ductus arteriosus indicated that, after the first dose of intravenous indomethacin, there was a transient reduction in cerebral blood flow velocity and cerebral blood flow.
Plaet aggregation returned to normal by the tenth day. Premature infants should be observed for signs of bleeding. may inhibit plaet aggregation. In one small study, plaet aggregation was grossly abnormal after indomethacin therapy (given orally to premature infants to close the ductus arteriosus ). INDOCIN I.V.
FOR INTRAVENOUS ADMINISTRATION ONLY.
Sterile INDOCIN I.V. is a lyophilized white to yellow powder or plug supplied as single dose vials containing indomethacin for injection, equivalent to 1 mg indomethacin. NDC.
Cardiovascular: intracranial bleeding**, pulmonary hypertension.
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Its empirical formula is C 19 H 15 ClNNaO 4 •3H 2 O and its structural formula is:. Its molecular weight is 433.82. Indomethacin for injection is designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid, sodium salt, trihydrate.
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The percent bound in neonates has not been studied. In adults, about 99 percent of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentrations. In controlled trials in premature infants, however, no evidence of bilirubin displacement has been observed as evidenced by increased incidence of bilirubin encephalopathy (kernicterus).
AGE at 1st dose DOSAGE (mg/kg) Less than 48 hours 1st 0.2 2nd 0.1 3rd 0.1 2-7 days 0.2 0.2 0.2 over 7 days 0.2 0.25 0.25.
Metabolic: acidosis/alkalosis. Respiratory: apnea, exacerbation of pre-existing pulmonary infection.
When this occurs, a significant reduction in serum sodium values (i.e., hyponatremia ) may result. in pre-term infants may suppress water excretion to a greater extent than sodium excretion. Neonates should have serum electrolyte determinations done during therapy with INDOCIN I.V. INDOCIN I.V. Renal function and serum electrolytes should be monitored (see PRECAUTIONS: DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION ).
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. INDOCIN I.V.
at or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc.
after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, STOP THE DRUG. If the neonate remains unresponsive to therapy with INDOCIN I.V.
Prematurity per se, is associated with an increased incidence of spontaneous intraventricular hemorrhage. (see CLINICAL PHARMACOLOGY ), the incidence of intraventricular hemorrhage in neonates treated with INDOCIN I.V. was not significantly higher than in the control neonates. However, in the large multicenter study of INDOCIN I.V. Because indomethacin may inhibit plaet aggregation, the potential for intraventricular bleeding may be increased.
Renal: renal failure, renal dysfunction in 41 percent of neonates, including one or more of the following: reduced urinary output; reduced urine sodium, chloride, or potassium, urine osmolality, free water clearance, or glomerular filtration rate; elevated serum creatinine or BUN; uremia.
Their relevance to the pre-term infant receiving indomethacin for patent ductus arteriosus is unknown, however, the possibility exists that these experiences may be associated with the use of INDOCIN I.V. A variety of additional adverse experiences have been reported in adults treated with oral indomethacin for moderate to severe rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute painful shoulder and acute gouty arthritis (see package insert for Capsules INDOCIN (indomethacin) for additional information concerning adverse reactions and other cautionary statements). in pre-term infants.
In some patients with compromised renal function, the co-administration of an NSAID and an ACE inhibitor or angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Severe hepatic reactions have been reported in adults treated chronically with oral indomethacin for arthritic disorders. should be discontinued. ] If clinical signs and symptoms consistent with liver disease develop in the neonate, or if systemic manifestations occur, INDOCIN I.V. [For further information, see package insert for Capsules INDOCIN (Indomethacin).
may cause significant reduction in urine output (50 percent or more) with concomitant elevations of blood urea nitrogen and creatinine, and reductions in glomerular filtration rate and creatinine clearance. These effects in most neonates are transient, disappearing with cessation of therapy with INDOCIN I.V. may precipitate renal insufficiency, including acute renal failure, especially in neonates with other conditions that may adversely affect renal function (e.g., extracellular volume depletion from any cause, congestive heart failure, sepsis, concomitant use of any nephrotoxic drug, hepatic dysfunction). INDOCIN I.V. However, because adequate renal function can depend upon renal prostaglandin synthesis, INDOCIN I.V. When significant suppression of urine volume occurs after a dose of INDOCIN I.V., no additional dose should be given until the urine output returns to normal levels.
Hematologic: disseminated intravascular coagulation, thrombocytopenia. Ophthalmic: retrolental fibroplasia.**.
The rates are calculated from a database which contains experience of 849 indomethacin-treated neonates reported in the medical literature, regardless of the route of administration. Reactions marked with a single asterisk (*) occurred in 3-9 percent of indomethacin-treated neonates; those marked with a double asterisk (**) occurred in 3-9 percent of both indomethacin-and placebo-treated neonates. The following additional adverse reactions in neonates have been reported from the collaborative study, anecdotal case reports, from other studies using rectal, oral, or intravenous indomethacin for treatment of patent ductus arteriosus or in marketed use. One year follow-up is available on 175 neonates and shows no long-term sequelae which could be attributed to indomethacin. Unmarked reactions occurred in less than 3 percent of neonates. than after placebo. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after INDOCIN I.V.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
However, minor gastrointestinal bleeding (i.e., chemical detection of blood in the stool ) was more commonly noted in those neonates treated with indomethacin. Severe gastrointestinal effects have been reported in adults with various arthritic disorders treated chronically with oral indomethacin. ]. [For further information, see package insert for Capsules INDOCIN (Indomethacin). In the collaborative study, major gastrointestinal bleeding was no more common in those neonates receiving indomethacin than in those neonates on placebo.
An increased incidence of neuronal necrosis in the diencephalon in the live-born fetuses was observed. At 2.0 mg/kg/day, no increase in neuronal necrosis was observed as compared to the control groups. Neonatal Effects: In rats and mice, oral indomethacin 4.0 mg/kg/day given during the last three days of gestation caused a decrease in maternal weight gain and some maternal and fetal deaths. Administration of 0.5 or 4.0 mg/kg/day during the first three days of life did not cause an increase in neuronal necrosis at either dose level.
Coagulation: decreased plaet aggregation (see PRECAUTIONS ).
INDOCIN (Indomethacin) may mask the usual signs and symptoms of infection. Therefore, the physician must be continually on the alert for this and should use the drug with extra care in the presence of existing controlled infection.
In a double-blind, placebo-controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, in those neonates treated with indomethacin (n=206), there was a statistically significantly greater incidence of bleeding problems, including gross or microscopic bleeding into the gastrointestinal tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy. There was no statistically significant difference between treatment groups with reference to intracranial hemorrhage.
Therefore, all diluents should be preservative-free. Once reconstituted, the indomethacin solution may be injected intravenously. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Any unused portion of the solution should be discarded because there is no preservative contained in the vial. The solution should be prepared only with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. A fresh solution should be prepared just prior to each administration. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20-30 minutes. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximay 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximay 0.05 mg/0.1 mL.
In one study, of 28 neonates who could be evaluated, the plasma half-life in those less than 7 days old averaged 20 hours (range: 3-60 hours, n=18). Even though the plasma half-life of indomethacin was variable among premature infants, it was shown to vary inversely with postnatal age and weight. Grouping the neonates by weight, mean plasma half-life in those weighing less than 1000 g was 21 hours (range: 9-60 hours, n=10); in those neonates weighing more than 1000 g, the mean plasma half-life was 15 hours (range: 3-52 hours, n=18). The disposition of indomethacin following intravenous administration (0.2 mg/kg) in pre-term neonates with patent ductus arteriosus has not been extensively evaluated. In neonates older than 7 days, the mean plasma half-life of indomethacin was 12 hours (range: 4-38 hours, n=10).
Dosage according to age is as follows:
For: Lundbeck Inc., Deerfield, IL 60015, U.S.A. Revised: October 2009. Manufactured by: Hollister-Stier Laboratories, LLC, Spokane, WA 99207, U.S.A.
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given at 12-24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output < 0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of INDOCIN I.V., no additional doses should be given until laboratory studies indicate that renal function has returned to normal (see WARNINGS, Renal Effects ). Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of INDOCIN I.V.
were no greater than in placebo controls and were statistically significantly lower than in surgically-treated neonates. The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with INDOCIN I.V.
In fetal and newborn lambs, E type prostaglandins have also been shown to maintain the patency of the ductus, and as in human newborns, indomethacin causes its constriction. Indomethacin has been shown to be a potent inhibitor of prostaglandin synthesis, both in vitro and in vivo. In human newborns with certain congenital heart malformations, PGE 1 dilates the ductus arteriosus. Although the exact mechanism of action through which indomethacin causes closure of a patent ductus arteriosus is not known, it is believed to be through inhibition of prostaglandin synthesis.
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