about Indomethacin class, uses, side effects contraindications
Indomethacin
Short Description
Indomethacin is a nonsteroidal anti-inflammatory drug that relieves pain, relieving stiffness and inflammation.
Category
Chemical class: Indoleacetic acid derivative
Therapeutic class: Antigout, antiinflammatory, antirheumatic
Pregnancy category: Not rated
Indications
To relieve symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis , ORAL SUSPENSION
Adults.25 to 50 mg b.i.d. to q.i.d., increased by 25 or 50 mg daily every wk, if needed. Maximum: 200 mg daily. After adequate response, dosage reduced as low as possible. (ANTIRHEUMATIC)
Adults.75 mg daily, increased to 75 mg b.i.d, if needed. SUPPOSITORIES
Adults.50 mg up to q.i.d. To relieve symptoms of acute gouty arthritis , ORAL SUSPENSION
Adults.Initial: 100 mg. Increased up to 50 mg t.i.d. Maximum: 200 mg daily. After pain is relieved, dosage tapered until drug is discontinued. SUPPOSITORIES
Adults. 50 mg up to q.i.d. Maximum: 200 mg daily. To treat inflammation and relieve acute shoulder pain from bursitis or tendinitis , ORAL SUSPENSION
Adults. 75 to 150 mg daily in divided doses t.i.d. or q.i.d. for 7 to 14 days. SUPPOSITORIES
Adults.50 mg up to q.i.d. Maximum: 200 mg daily.
DOSAGE ADJUSTMENT Dosage reduced for elderly patients. To treat hemodynamically significant patent ductus arteriosus in premature infants weighing 500 to 1,750 g (1 to 3.9 lb)
I.V.INJECTION Infants over age 7 days. Initial: 200 mcg/kg (0.2 mg/kg) over 5 to 10 sec; 1 or 2 additional doses of 250 mcg/kg (0.25 mg/kg) given at 12to 24-hr intervals, if needed. Neonates ages 2 to 7 days. Initial: 200 mcg/ kg (0.2 mg/kg) over 5 to 10 sec; 1 or 2 additional doses of 200 mcg/kg (0.2 mg/kg) given at 12to 24-hr intervals, if needed. Neonates under age 48 hours. Initial: 200 mcg/kg (0.2 mg/kg) over 5 to 10 sec; 1 or 2 additional doses of 100 mcg/kg (0.1 mg/kg) given at 12to 24-hr intervals, if needed. Route Onset Peak Duration P.O.* 2–4 hr 2–5 days Unknown P.O. 30 min Unknown 4–6 hr P.O. In 7 days 1–2 wk Unknown
Mechanism of Action
Blocks activity of cyclooxygenase, the enzyme needed to synthesize prostaglandins, which mediate inflammatory response and cause local vasodilation, swelling, and pain. By blocking cyclooxygenase and inhibiting prostaglandins, this NSAID reduces inflammatory symptoms and helps relieve pain.
Incompatibilities
Don’t give indomethacin suspension with alkaline antacids or liquids. Don’t mix reconstituted indomethacin sodium with I.V. infusion solutions.
Contraindications
Allergy or hypersensitivity to aspirin, indomethacin, iodides, other NSAIDs, or their components; history of proctitis or recent rectal bleeding (suppositories) indomethacin 530 * For antigout effects. For anti-inflammatory effects. For antirheumatic effects.
Interactions
Note: All effects listed are for oral forms and suppositories unless indicated. acetaminophen: Increased risk of adverse renal effects (long-term use of both ) aluminumand magnesium-containing antacids: Possibly decreased blood indomethacin level aminoglycosides: Increased risk of aminoglycoside toxicity antihypertensives: Decreased effectiveness of these aspirin, other
NSAIDs: Increased risk of adverse GI effects and non-GI bleeding bone marrow depressants: Possibly increased leukopenic or thrombocytopenic effects of these cefamandole, cefoperazone, cefotetan: Increased risk of hypoprothrombinemia and bleeding colchicine, platelet aggregation inhibitors: Increased risk of GI bleeding, hemorrhage, and ulcers corticosteroids, potassium supplements: Increased risk of adverse GI effects cyclosporine: Increased risk of nephrotoxicity from both , increased blood cyclosporine level diflunisal: Increased blood indomethacin level and risk of GI bleeding digoxin: Increased blood digoxin level and risk of digitalis toxicity (all forms) diuretics (thiazide, loop, and potassiumsparing): Decreased diuretic and antihypertensive effects gold compounds, nephrotoxic : Increased risk of adverse renal effects heparin, oral anticoagulants, thrombolytics: Possibly increased anticoagulant effects and risk of hemorrhage lithium: Increased blood lithium level and risk of toxicity methotrexate: Increased risk of methotrexate toxicity plicamycin,
valproic acid: Increased risk of hypoprothrombinemia and GI bleeding, hemorrhage, and ulcers probenecid: Increased blood level and effectiveness of indomethacin, increased risk of indomethacin toxicity zidovudine: Increased blood zidovudine level and risk of toxicity, increased risk of indomethacin toxicity
alcohol use: Increased risk of adverse GI effects
Side Efect
Note: All reactions are for oral forms and suppositories unless indicated.
CNS: Confusion, depression, dizziness, drowsiness, fatigue, hallucinations, headache, intraventricular hemorrhage (I.V.), peripheral neuropathy, seizures, stroke, syncope, vertigo
CV: Arrhythmias, chest pain, edema, fluid retention (all forms), heart failure, hypertension, MI, pulmonary hypertension (I.V.), tachycardia
EENT: Blurred vision, corneal and retinal damage, epistaxis, hearing loss, tinnitus
ENDO: Hypoglycemia (I.V.)
GI: Abdominal cramps or pain, abdominal distention (I.V.), anorexia, constipation, diarrhea, diverticulitis, dyspepsia, dysphagia, epigastric discomfort, esophagitis, gastric perforation, gastritis, gastroenteritis, gastroesophageal reflux disease, GI bleeding and ulceration (all forms), hemorrhoids, hepatic dysfunction (I.V.), hepatic failure, hiatal hernia, ileus (I.V.), indigestion, melena, nausea, necrotizing enterocolitis (I.V.), pancreatitis, peptic ulcer, perforation of stomach or intestine, stomatitis, vomiting (all forms)
GU: Acute renal falure, hematuria, interstitial nephritis, nephrotic syndrome, oliguria (I.V.), proteinuria, renal dysfunction (I.V.), vaginal bleeding
HEME: Agranulocytosis, anemia, aplastic anemia, bone marrow depression, disseminated intravascular coagulation, hemolytic anemia, iron deficiency anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, unusual bleeding or bruising (all forms)
RESP: Asthma, respiratory depression
SKIN: Ecchymosis, erythema multiforme, erythema nodosum, photosensitivity, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Other: Anaphylaxis, angioedema, hyperkalemia (I.V.), hyponatremia (I.V.), injection site irritation
Cautions
Use indomethacin with extreme caution in patients with history of ulcer disease or GI indomethacin 531 G H I bleeding because NSAIDs such as indomethacin increase risk of GI bleeding and ulceration. Expect to use drug for shortest time possible in these patients. Be aware that serious GI tract ulceration, bleeding, and perforation may occur without
WARNING symptoms. Elderly patients are at greater risk. To minimize risk, give oral indomethacin with food, a full glass of water (not suspension), or an antacid to reduce GI distress. If GI distress occurs, withhold drug and notify prescriber immediately. Use indomethacin cautiously in patients with hypertension, and monitor blood pressure closely throughout therapy. Drug may cause hypertension or worsen it. Shake suspension well before giving it. For arthritis, give up to 100 mg of daily dose (not capsules) at bedtime to reduce nighttime pain and morning stiffness. Make sure suppository stays in rectum at least 1 hour to improve absorption. To reconstitute I.V. form, add 1 to 2 ml of preservative-free sodium chloride for injection or preservative-free sterile water to vial. Solution made with 1 ml diluent contains 100 mcg (0.1 mg) indomethacin/0.1 ml. Solution made with 2 ml diluent contains 50 mcg (0.05 mg) indomethacin/0.1 ml. Use solution immediately because it contains no preservatives. Discard unused portion. Be aware that scheduled I.V. doses may be withheld if infant or neonate has anuria or a significant decrease in urine output (less than 0.6 ml/kg/hr). When using I.V. form, avoid extravasation to protect surrounding tissue. Anticipate a second course (3 more doses) of I.V. indomethacin if patent ductus arteriosus fails to close or reopens. After two courses, surgery may be performed.
WARNING Monitor patient closely for thrombotic events, including MI and stroke, because NSAIDs increase the risk. Monitor patient—especially if he’s elderly or receiving long-term indomethacin therapy—for less common but serious adverse GI reactions, including anorexia, constipation, diverticulitis, dysphagia, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux disease, hemorrhoids, hiatal hernia, melena, stomatitis, and vomiting. Monitor liver function test results because, rarely, elevations may progress to severe hepatic reactions, including fatal hepatitis, liver necrosis, and hepatic failure. Monitor BUN and serum creatinine levels in elderly patients, those taking diuretics or ACE inhibitors, and those with heart failure, impaired renal function, or hepatic dysfunction; drug may cause renal failure. Monitor CBC for decreased hemoglobin and hematocrit. Drug may worsen anemia.
WARNING If patient has bone marrow suppression or is receiving an antineoplastic drug, monitor laboratory results (including WBC count), and watch for evidence of infection because anti-inflammatory and antipyretic actions of indomethacin may mask signs and symptoms, such as fever and pain. Assess patient’s skin regularly for signs of rash or other hypersensitivity reaction because indomethacin is an NSAID and may cause serious skin reactions without
WARNING, even in patients with no history of NSAID sensitivity. At first sign of reaction, stop drug and notify prescriber. Because indomethacin causes sodium retention, monitor weight and blood pressure, especially if patient has hypertension. When drug is used to treat gouty arthritis, expect its action to peak in 24 to 36 hours and significant swelling to gradually disappear over 3 to 5 days. Be aware that form shouldn’t be used to treat gouty arthritis. Expect to use suppositories for patients who can’t swallow oral form. To evaluate drug effectiveness, assess for reduced pain and inflammation and improved joint mobility. Expect patient to have intermittent checkups during long-term therapy and an ophthalmologic examination if vision changes. PATIENT SAFTY
Urge patient to take indomethacin capsules with full glass of water and to avoid lying down for 15 to 30 minutes afterward. This helps prevent drug from lodging in esophagus and causing irritation. Caution patient not to open or crush capsules. Instruct patient to take drug with food or an antacid to reduce GI distress. Instruct patient to make sure suppository indomethacin 532 stays in rectum at least 1 hour. Urge patient to avoid alcohol during indomethacin therapy. Remind patient that improvement may not occur for 2 to 4 weeks after starting indomethacin and that he should continue taking drug, as prescribed. Inform breast-feeding patient that indomethacin appears in breast milk and may cause seizures in infants. Urge her to use another feeding method during therapy. Caution against prolonged sun exposure during therapy. Urge patient to notify prescriber immediately about changes in vision or hearing, fever, itching, rash, sore throat, swelling in arms or legs, and weight gain. Stress importance of having ordered laboratory tests and eye examinations during long-term therapy. Caution pregnant patient not to take NSAIDs such as indomethacin during last trimester because they may cause premature closure of the ductus arteriosus. Explain that indomethacin may increase risk of serious adverse cardiovascular reactions; urge patient to seek immediate medical attention if signs or symptoms arise, such as chest pain, shortness of breath, weakness, and slurring of speech. Explain that indomethacin may increase risk of serious adverse GI reactions; stress need to seek immediate medical attention for such signs and symptoms as epigastric or abdominal pain, indigestion, black or tarry stools, or vomiting blood or material that looks like coffee grounds. Alert patient to rare but serious skin reactions. Urge him to seek immediate medical attention for rash, blisters, itching, fever, or other indications of hypersensitivity.
Trade Name & Company Name
effect of Indomethacin in Pregnancy, Fetal Health
and Breast feeding
Pregnancy
. Indomethacin is used off-label for the treatment of presumed preterm labor. In that scenario, it significantly prolongs gestation (48-72h), a degree similar to b-mimetic agents and, in small trials, magnesium sulfate. The latter is relevant since in meta-analyses magnesium sulfate is no better than placebo for tocolysis. The interval is adequate for the administration of corticosteroids to enhance fetal lung maturity. Indomethacin is no better and likely inferior to calcium channel blockers such as nifedipine, which has a stronger safety profile. Continuing indomethacin after the successful treatment of presumed preterm labor does not further delay delivery or enhance outcome and should not be condoned. Similarly, indomethacin is advocated for the treatment of the sonographically detected short cervix. Here, too, there is little quality evidence to support the practice. It does not appear to delay preterm delivery of women with a dilated cervix independent of cerclage. Indomethacin has multiple non?prostaglandin-related actions, including the inhibition of MMPs 2 and 9 in amnion, chorion, and decidua. Such actions may contribute to its 505 anti-inflammatory effect. Indomethacin reduces renal free water clearance and can cause abrupt maternal weight gain and edema when first initiated. Indomethacin should probably be avoided in women at risk for delivery within 24h, as a 50mg dose reproducibly prolongs the maternal bleeding time, in half of which cases will reach abnormal levels. Fetal Health
Indomethacin crosses the placenta, and fetal sequelae are common. Fetal levels are dependent on maternal, as NSAIDs are not metabolized by the fetal kidney. A third of fetuses exposed to indomethacin for 1w or more develop oligohydramnios or evidence of ductal constriction. These adverse effects are completely avoidable as there are no demonstrable benefits over the long term for the indication of preterm labor or incompetent cervix. Other prostaglandin synthase inhibitors reputedly have a lower incidence of fetal sequelae when used as a tocolytic agent, though the quantity of clinical experience is much smaller than that for indomethacin. These differences are clear in the neonate when comparing ibuprofen to indomethacin for the closure of a PDA. Because of its effect on fetal urine output, indomethacin is used to treat idiopathic polyhydramnios. It should not, however, be used in twin gestations complicated by the so-called stuck twin, or the ??oligo-polyhydramnios sequence.?? In this scenario, there is no evidence that indomethacin prolongs gestation, and it can lead to fetal renal shutdown. The effects of indomethacin on the fetal kidneys are dose- and duration-dependent. Stopping it typically results in reversal of the abnormal sonographic findings. Indomethacin is used postnatally for the pharmacologic closure of a PDA. Constriction of the fetal ductus is common when indomethacin is used for the treatment of preterm labor. It, too, reverses with cessation, and the long-term impact of in utero ductal constriction on the otherwise healthy fetus is currently unknown. A short course (<48h) of indomethacin for the treatment of preterm labor does not alter the newborn?s responsiveness to indomethacin postnatally. In uncontrolled trials, indomethacin tocolysis was associated with an increased risk of IVH and NEC in the neonate. These reports remain to be confirmed. In other uncontrolled studies, neurodevelopment was unaffected by antenatal exposure. Breastfeeding
There are no adequate reports or well-controlled studies in nursing women. The quantity of indomethacin excreted into human breast milk is low, such that the breastfed neonate would ingest <1% of the maternal dose per day. Neonatal plasma levels are typically below detection.
the follwing drugs will increse Indomethacin by inhepiting cyp450
armodafinil ; chloramphenicol ; cimetidine ; citalopram ; esomeprazole ; felbamate ; fluconazole ; fluoxetine ; fluvoxamine ; isoniazid ; ketoconazole ; luliconazole ; modafinil ; omeprazole ; oral contraceptives ; oritavancin ; pantoprazole ; quercetin ; ticlopidine ; topiramate ; voriconazole ;
the follwing drugs will decrease Indomethacin by inhancing cyp450
carbamazepine ; efavirenz ; enzalutamide ; letermovir ; norethindrone ; prednisone ; rifampicin ; ritonavir ;
trad drugs based on Indomethacin
| Gen name | Trade name | Catagory name |
| indomethacin | Indocin | Nonsteroidal anti-inflammatory drugs |
| indomethacin | Indocin SR | Nonsteroidal anti-inflammatory drugs |
| indomethacin | Tivorbex | Nonsteroidal anti-inflammatory drugs |
| Indomethacin | CONFORTID 25MG CAPS | |
| Indomethacin | CONFORTID 50MG SUPPOSITORY | |
| Indomethacin | CONFORTID INJ IV 50MG | |
| Indomethacin | CONFORTID SUPPOSITORIES 100 MG. | |
| Indomethacin | CONFORTID SYRUP 5MG-ML | |
| Indomethacin | INDOCID 100MG SUPPOSITORIES | |
| Indomethacin | INDOGESIC CAP 25MG | |
| Indomethacin | INDOMETHACIN CAPS 25MG | |
| Indomethacin | INDOMIN 100MG SUPP | |
| Indomethacin | INDOMIN CAP 25MG | |
| Indomethacin | METHACIN CAPS.?25MG | |
| Indomethacin | METHACIN SUPP.?100 MG | |
| Indomethacin | ROTHACIN 100MG SUPPOSITORIES | |
| Indomethacin | ROTHACIN CAPS 25 MG | |
other drugs from same cataogory
| Gen name | trade name | catogry |
| ketorolac | Toradol | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Voltaren | Nonsteroidal anti-inflammatory drugs |
| naproxen | Aleve | Nonsteroidal anti-inflammatory drugs |
| meloxicam | Mobic | Nonsteroidal anti-inflammatory drugs |
| ketorolac | Sprix | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Cambia | Nonsteroidal anti-inflammatory drugs |
| esomeprazole / naproxen | Vimovo | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Cataflam | Nonsteroidal anti-inflammatory drugs |
| diclofenac / misoprostol | Arthrotec | Nonsteroidal anti-inflammatory drugs |
| famotidine / ibuprofen | Duexis | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Advil | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Zipsor | Nonsteroidal anti-inflammatory drugs |
| nabumetone | Relafen | Nonsteroidal anti-inflammatory drugs |
| naproxen | Naprosyn | Nonsteroidal anti-inflammatory drugs |
| indomethacin | Indocin | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Zorvolex | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Advil Liqui-Gels | Nonsteroidal anti-inflammatory drugs |
| ketorolac | Toradol IV/IM | Nonsteroidal anti-inflammatory drugs |
| mefenamic acid | Ponstel | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Motrin | Nonsteroidal anti-inflammatory drugs |
| naproxen | Naprelan | Nonsteroidal anti-inflammatory drugs |
| etodolac | Lodine | Nonsteroidal anti-inflammatory drugs |
| piroxicam | Feldene | Nonsteroidal anti-inflammatory drugs |
| naproxen | Anaprox | Nonsteroidal anti-inflammatory drugs |
| indomethacin | Indocin SR | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Voltaren-XR | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Motrin IB | Nonsteroidal anti-inflammatory drugs |
| sulindac | Clinoril | Nonsteroidal anti-inflammatory drugs |
| naproxen | Anaprox-DS | Nonsteroidal anti-inflammatory drugs |
| ketoprofen | Orudis KT | Nonsteroidal anti-inflammatory drugs |
| diflunisal | Dolobid | Nonsteroidal anti-inflammatory drugs |
| oxaprozin | Daypro | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Children's Motrin | Nonsteroidal anti-inflammatory drugs |
| flurbiprofen | Ansaid | Nonsteroidal anti-inflammatory drugs |
| ketoprofen | Oruvail | Nonsteroidal anti-inflammatory drugs |
| ketoprofen | Orudis | Nonsteroidal anti-inflammatory drugs |
| tolmetin | Tolectin DS | Nonsteroidal anti-inflammatory drugs |
| indomethacin | Tivorbex | Nonsteroidal anti-inflammatory drugs |
| fenoprofen | Nalfon | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Ibu-Tab | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | IBU | Nonsteroidal anti-inflammatory drugs |
| naproxen | Flanax Pain Reliever | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Advil Migraine | Nonsteroidal anti-inflammatory drugs |
| meloxicam | Vivlodex | Nonsteroidal anti-inflammatory drugs |
| tolmetin | Tolectin 600 | Nonsteroidal anti-inflammatory drugs |
| nabumetone | Relafen DS | Nonsteroidal anti-inflammatory drugs |
| meloxicam | Qmiiz ODT | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Q-Profen | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Proprinal | Nonsteroidal anti-inflammatory drugs |
| fenoprofen | ProFeno | Nonsteroidal anti-inflammatory drugs |
| lansoprazole/naproxen | Prevacid NapraPAC | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Nuprin | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | NeoProfen | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Motrin Junior Strength | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Motrin Childrens | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Midol IB | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Lofena | Nonsteroidal anti-inflammatory drugs |
| etodolac | Lodine XL | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | IBU-200 | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Ibu-8 | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Ibu-6 | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Ibu-4 | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Haltran | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Genpril | Nonsteroidal anti-inflammatory drugs |
| fenoprofen | Fenortho | Nonsteroidal anti-inflammatory drugs |
| naproxen | EC-Naprosyn | Nonsteroidal anti-inflammatory drugs |
| diclofenac | Dyloject | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Caldolor | Nonsteroidal anti-inflammatory drugs |
| meloxicam | Anjeso | Nonsteroidal anti-inflammatory drugs |
| naproxen | All Day Relief | Nonsteroidal anti-inflammatory drugs |
| naproxen | All Day Pain Relief | Nonsteroidal anti-inflammatory drugs |
| naproxen | Aflaxen | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Advil Infant's Concentrated Drops | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Advil Children's | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Addaprin | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | Actiprofen | Nonsteroidal anti-inflammatory drugs |
| ibuprofen | A-G Profen | Nonsteroidal anti-inflammatory drugs |