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Indocin IV

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Indocin IV

Indocin IV

Indocin IV Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Indocin (indomethacin) and Indocin, IV (indomethacin) for Injection Sterile is a nonsteroidal anti-inflammatory drug (NSAID) used to treat severe rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gouty arthritis, bursitis, and tendinitis. Indocin is available as a generic termed indomethacin. Common side effects of Indocin include GI symptoms (vomiting, diarrhea, and feeling of bowel fullness, constipation and rectal irritation), headache, and ringing in ears.

Indocin is available in capsules in strengths of 25 and 50 mg, in suspension strength of 25 mg per 5 ml and as a suppository in strength of 50 mg per suppository. Initial doses usually start at 25 mg three times daily. Indocin IV (indomethacin) for Injection Sterile Vial contains 1 mg Indocin and is used by specialists in infants to close a patent ductus arteriosus in the heart and is not commonly prescribed. Indocin (indomethacin) ordinarily should not be prescribed for pediatric patients under 15 years old. In late pregnancy, Indocin (indomethacin and other NSAIDs) should be avoided because it may cause premature closure of the ductus arteriosus. Serious side effects of Indocin may include heart attack, stroke, skin changes (paleness, blisters, rash, and hives), weight gain, swelling, shortness of breath, tachycardia, unusual bleeding (including GI bleeding), jaundice, stomach pain, and pain with urination, bloody urine, blurry vision, and back pain. Patients with asthma that are aspirin-sensitive should avoid use of this drug. Indocin may reduce the effectiveness of ACE inhibitors and increase lithium (Eskalith, Lithobid) levels; use with aspirin or similar agents is not recommended. Caution is advised as Indocin may react with a number of other drugs so the prescribing physician will need a list of current medications. Indocin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and infant; it is not recommended for use in breastfeeding women.

Our Indocin and Indocin, IV (indomethacin) for Injection Sterile Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Indocin IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

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.

The incidences of retrolental fibroplasia (grades III and IV) and pneumothorax in neonates treated with INDOCIN I.V. were no greater than in placebo controls and were statistically significantly lower than in surgically-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. 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. One year follow-up is available on 175 neonates and shows no long-term sequelae which could be attributed to indomethacin. In controlled clinical studies, only electrolyte imbalance and renal dysfunction (of the reactions listed below) occurred statistically significantly more frequently after INDOCIN I.V. than after placebo. 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. Unmarked reactions occurred in less than 3 percent of neonates.

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.

Cardiovascular: intracranial bleeding**, pulmonary hypertension.

Gastrointestinal: gastrointestinal bleeding*, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforation(s) of the small and/or large intestine, necrotizing enterocolitis.

Metabolic: hyponatremia*, elevated serum potassium*, reduction in blood sugar, including hypoglycemia, increased weight gain (fluid retention).

Coagulation: decreased platelet aggregation (see PRECAUTIONS).

The following adverse reactions have also been reported in neonates treated with indomethacin, however, a causal relationship to therapy with INDOCIN I.V. has not been established:

Cardiovascular: bradycardia.

Respiratory: apnea, exacerbation of pre-existing pulmonary infection.

Metabolic: acidosis/alkalosis.

Hematologic: disseminated intravascular coagulation, thrombocytopenia.

Ophthalmic: retrolental fibroplasia.**

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). 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. in pre-term infants.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Indocin IV (Indomethacin Inj) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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