Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/118
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INDOCIN (Suspension)
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Carefully consider the potential benefits and risks
of INDOCIN and other treatment options before deciding to use INDOCIN.
Use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals . After
observing the response to initial therapy with INDOCIN, the dose and
frequency should be adjusted to suit an individual patient's
needs. Oral Suspension INDOCIN contains 25 mg of indomethacin per 5 mL. Adverse reactions appear to correlate with the size of the dose of INDOCIN in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.<br/>Pediatric Use: INDOCIN ordinarily should not be prescribed for pediatric
patients 14 years of age and under .<br/>Adult Use: Dosage Recommendations for Active Stages of the Following:
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| dailymed-instance:descripti... |
Suspension INDOCINfor oral use contains 25 mg of indomethacin per 5 mL, alcohol 1%, and sorbic acid 0.1% added as a preservative and the following inactive ingredients: antifoam
AF emulsion, flavors, purified water, sodium hydroxide or hydrochloric
acid to adjust pH, sorbitol solution, and tragacanth. Indomethacin is
a non-steroidal anti-inflammatory indole derivative designated chemically
as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin is practically insoluble
in water and sparingly soluble in alcohol. It has a pKa of 4.5 and
is stable in neutral or slightly acidic media and decomposes in strong
alkali. The suspension has a pH of 4.0-5.0. The structural formula
is:
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| dailymed-instance:clinicalP... |
INDOCIN is a non-steroidal anti-inflammatory drug
(NSAID) that exhibits antipyretic and analgesic properties. Its mode
of action, like that of other anti-inflammatory drugs, is not known.
However, its therapeutic action is not due to pituitary-adrenal stimulation. INDOCIN is a potent inhibitor of prostaglandin synthesis in vitro. Concentrations are reached
during therapy which have been demonstrated to have an effect in vivo as well. Prostaglandins
sensitize afferent nerves and potentiate the action of bradykinin
in inducing pain in animal models. Moreover, prostaglandins are known
to be among the mediators of inflammation. Since indomethacin is an
inhibitor of prostaglandin synthesis, its mode of action may be due
to a decrease of prostaglandinsin peripheral tissues. INDOCIN has been shown to be an effective anti-inflammatory
agent, appropriate for long-term use in rheumatoid arthritis, ankylosing
spondylitis, and osteoarthritis. INDOCIN affords
relief of symptoms; it does not alter the progressive course of the
underlying disease. INDOCIN suppresses inflammation
in rheumatoid arthritis as demonstrated by relief of pain, and reduction
of fever, swelling and tenderness. Improvement in patients treated
with INDOCIN for rheumatoid arthritis has been demonstrated by a reduction
in joint swelling, average number of joints involved, and morning
stiffness; by increased mobility as demonstrated by a decrease in
walking time; and by improved functional capability as demonstrated
by an increase in grip strength. INDOCIN may enable the reduction
of steroid dosage in patients receiving steroids for the more severe
forms of rheumatoid arthritis. In such instances the steroid dosage
should be reduced slowly and the patients followed very closely for
any possible adverse effects. Indomethacin has
been reported to diminish basal and COstimulated cerebral
blood flow in healthy volunteers following acute oral and intravenous
administration. In one study after one week of treatment with
orally administered indomethacin, this effect on basal cerebral blood
flow had disappeared. The clinical significance of this effect has
not been established. Capsules INDOCIN have
been found effective in relieving the pain, reducing the fever, swelling,
redness, and tenderness of acute gouty arthritis . Following single oral doses of Capsules INDOCIN 25 mg
or 50 mg, indomethacin is readily absorbed, attaining peak plasma
concentrations of about 1 and 2 mcg/mL, respectively, at about
2 hours. Orally administered Capsules INDOCIN are virtually 100% bioavailable,
with 90% of the dose absorbed within 4 hours. A single 50 mg
dose of Oral Suspension INDOCIN was found to be bioequivalent to a
50 mg INDOCIN capsule when each was administered with food. Indomethacin is eliminated via renal excretion, metabolism,
and biliary excretion. Indomethacin undergoes appreciable enterohepatic
circulation. The mean half-life of indomethacin is estimated to be
about 4.5 hours. With a typical therapeutic regimen of 25 or
50 mg t.i.d., the steady-state plasma concentrations of indomethacin
are an average 1.4 times those following the first dose. Indomethacin exists
in the plasma as the parent drug and its desmethyl, desbenzoyl, and
desmethyldesbenzoyl metabolites, all in the unconjugated form. About
60 percent of an oral dosage is recovered in urine as drug and
metabolites (26 percent as indomethacin and its glucuronide),
and 33 percent is recovered in feces (1.5 percent as indomethacin). About 99% of indomethacin is bound to protein in plasma
over the expected range of therapeutic plasma concentrations. Indomethacin
has been found to cross the blood-brain barrier and the placenta.
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| dailymed-instance:contraind... |
INDOCIN is contraindicated in patients with known
hypersensitivity to indomethacin or the excipients . INDOCIN should not be given to patients
who have experienced asthma, urticaria, or allergic-type reactions
after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid
reactions to NSAIDs have been reported in such patients . INDOCIN is
contraindicated for the treatment of peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery .
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| dailymed-instance:supply |
Oral Suspension INDOCIN, 25 mg per 5 mL, is an off-white suspension
with a pineapple coconut mint flavor. It is supplied as follows: NDC 42211-101-11 in bottles of 237 mL.<br/>Storage: Store Oral Suspension INDOCIN below 30��C (86��F).
Avoid temperatures above 50��C (122��F). Protect from freezing.
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Cardiovascular Risk Gastrointestinal Risk
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dailymed-ingredient:alcohol,
dailymed-ingredient:antifoam_AF_emulsion,
dailymed-ingredient:artificial_mint_flavor_compound,
dailymed-ingredient:hydrochloric_acid,
dailymed-ingredient:pineapple_coconut_flavor,
dailymed-ingredient:sodium_hydroxide,
dailymed-ingredient:sorbic_acid,
dailymed-ingredient:sorbitol_solution,
dailymed-ingredient:tragacanth,
dailymed-ingredient:water
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| dailymed-instance:precautio... |
General: INDOCIN cannot be expected to substitute for corticosteroids
or to treat corticosteroid insufficiency. Abrupt discontinuation of
corticosteroids may lead to disease exacerbation. Patients on prolonged
corticosteroid therapy should have their therapy tapered slowly if
a decision is made to discontinue corticosteroids. The pharmacological activity of INDOCIN in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications
of presumed noninfectious, painful conditions.<br/>Hepatic Effects: Borderline elevations of one or more liver tests
may occur in up to 15% of patients taking NSAIDs including INDOCIN.
These laboratory abnormalities may progress, may remain unchanged,
or may be transient with continuing therapy. Notable elevations of
ALT or AST (approximately three or more times the upper limit of normal)
have been reported in approximately 1% of patients in clinical trials
with NSAIDs. In addition, rare cases of severe hepatic reactions,
including jaundice and fatal fulminant hepatitis, liver necrosis and
hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver
dysfunction, or in whom an abnormal liver test has occurred, should
be evaluated for evidence of the development of a more severe hepatic
reaction while on therapy with INDOCIN. If clinical signs and symptoms
consistent with liver disease develop, or if systemic manifestations
occur (e.g., eosinophilia, rash, etc.), INDOCIN should be discontinued.<br/>Hematological Effects: Anemia is sometimes seen in patients receiving NSAIDs,
including INDOCIN. This may be due to fluid retention, occult or gross
GI blood loss, or an incompletely described effect upon erythropoiesis.
Patients on long-term treatment with NSAIDs, including INDOCIN, should
have their hemoglobin or hematocrit checked if they exhibit any signs
or symptoms of anemia. NSAIDs inhibit platelet
aggregation and have been shown to prolong bleeding time in some patients.
Unlike aspirin, their effect on platelet function is quantitatively
less, of shorter duration, and reversible. Patients receiving INDOCIN
who may be adversely affected by alterations in platelet function,
such as those with coagulation disorders or patients receiving anticoagulants,
should be carefully monitored.<br/>Preexisting Asthma: Patients with asthma may have aspirin-sensitive asthma.
The use of aspirin in patients with aspirin-sensitive asthma has been
associated with severe bronchospasm which can be fatal. Since cross
reactivity, including bronchospasm, between aspirin and other nonsteroidal
anti-inflammatory drugs has been reported in such aspirin-sensitive
patients, INDOCIN should not be administered to patients with this
form of aspirin sensitivity and should be used with caution in patients
with preexisting asthma.<br/>Information for Patients: Patients should be informed
of the following information before initiating therapy with an NSAID
and periodically during the course of ongoing therapy. Patients should
also be encouraged to read the NSAID Medication Guide that accompanies
each prescription dispensed.<br/>Laboratory Tests: Because serious GI tract ulcerations and bleeding
can occur without warning symptoms, physicians should monitor for
signs or symptoms of GI bleeding. Patients on long-term treatment
with NSAIDs should have their CBC and a chemistry profile checked
periodically. If clinical signs and symptoms consistent with liver
or renal disease develop, systemic manifestations occur (e.g., eosinophilia,
rash, etc.) or if abnormal liver tests persist or worsen, INDOCIN
should be discontinued.<br/>Drug Interactions:<br/>ACE-Inhibitors and Angiotensin II Antagonists: Reports suggest that NSAIDs may diminish the antihypertensive
effect of ACE-inhibitors and angiotensin II antagonists. INDOCIN
can reduce the antihypertensive effects of captopril and losartan.
These interactions should be given consideration in patients taking
NSAIDs concomitantly with ACE-inhibitors or angiotensin II antagonists.
In some patients with compromised renal function, the co-administration
of an NSAID and an ACE-inhibitor or an angiotensin II antagonist
may result in further deterioration of renal function, including possible
acute renal failure, which is usually reversible.<br/>Aspirin: When INDOCIN is administered with aspirin, its protein
binding is reduced, although the clearance of free INDOCIN is not
altered. The clinical significance of this interaction is not known. The use of INDOCIN in conjunction with aspirin or other
salicylates is not recommended. Controlled clinical studies have shown
that the combined use of INDOCIN and aspirin does not produce any
greater therapeutic effect than the use of INDOCIN alone. In a clinical
study of the combined use of INDOCIN and aspirin, the incidence of
gastrointestinal side effects was significantly increased with combined
therapy. In a study in normal volunteers, itwas found that chronic concurrent administration of 3.6 g of
aspirin per day decreases indomethacin blood levels approximately
20%.<br/>Beta-adrenoceptor blocking agents: Blunting of the antihypertensive effect of beta���adrenoceptor
blocking agents by non-steroidal anti-inflammatory drugs including
INDOCIN has been reported. Therefore, when using these blocking agents
to treat hypertension, patients should be observed carefully in order
to confirm that the desired therapeutic effect has been obtained.<br/>Cyclosporine: Administration of non-steroidal anti-inflammatory
drugs concomitantly with cyclosporine has been associated with an
increase in cyclosporine-induced toxicity, possibly due to decreased
synthesis of renal prostacyclin. NSAIDs should be used with caution
in patients taking cyclosporine, and renal function should be carefully
monitored.<br/>Diflunisal: In normal volunteers receiving indomethacin, the
administration of diflunisal decreased the renal clearance and significantly
increased the plasma levels of indomethacin. In some patients, combined
use of INDOCIN and diflunisal has been associated with fatal gastrointestinal
hemorrhage. Therefore, diflunisal and INDOCIN should not be used concomitantly.<br/>Digoxin: INDOCIN given concomitantly with digoxin has been
reported to increase the serum concentration and prolong the half���life
of digoxin. Therefore, when INDOCIN and digoxin are used concomitantly,
serum digoxin levels should be closely monitored.<br/>Diuretics: In some patients, the administration of INDOCIN can
reduce the diuretic, natriuretic, and antihypertensive effects of
loop, potassium-sparing, and thiazide diuretics. This response has
been attributed to inhibition of renal prostaglandin synthesis. INDOCIN reduces basal plasma renin activity (PRA), as
well as those elevations of PRA induced by furosemide administration,
or salt or volume depletion. These facts should be considered when
evaluating plasma renin activity in hypertensive patients. It has been reported that the addition of triamterene
to a maintenance schedule of INDOCIN resulted in reversible acute
renal failure in two of four healthy volunteers. INDOCIN and triamterene
should not be administered together. INDOCIN
and potassium-sparing diuretics each may be associated with increased
serum potassium levels. The potential effects of INDOCIN and potassium-sparing
diuretics on potassium kinetics and renal function should be considered
when these agents are administered concurrently. Most of the above effects concerning diuretics have been attributed,
at least in part, to mechanisms involving inhibition of prostaglandin
synthesis by INDOCIN. During concomitant therapy
with NSAIDs, the patient should be observed closely for signs of renal
failure (see WARNINGS,
Renal Effects), as well as to assure diuretic efficacy.<br/>Lithium: Capsules INDOCIN 50 mg t.i.d. produced a clinically
relevant elevation of plasma lithium and reduction in renal lithium
clearance in psychiatric patients and normal subjects with steady
state plasma lithium concentrations. This effect has been attributed
to inhibition of prostaglandin synthesis. As a consequence, when NSAIDs
and lithium are given concomitantly, the patient should be carefully
observed for signs of lithium toxicity. (Read circulars for lithium
preparations before use of such concomitant therapy.) In addition,
the frequency of monitoring serum lithium concentration should be
increased at the outset of such combination drug treatment.<br/>Methotrexate: NSAIDs have been reported to competitively inhibit
methotrexate accumulation in rabbit kidney slices. This may indicate
that they could enhance the toxicity of methotrexate. Caution should
be used when NSAIDs are administered concomitantly with methotrexate.<br/>NSAIDs: The concomitant use of INDOCIN with other NSAIDs
is not recommended due to the increased possibility of gastrointestinal
toxicity, with little or no increase in efficacy.<br/>Oral anticoagulants: Clinical studies have shown that INDOCIN does not
influence the hypoprothrombinemia produced by anticoagulants. However,
when any additional drug, including INDOCIN, is added to the treatment
of patients on anticoagulant therapy, the patients should be observed
for alterations of the prothrombin time. In post-marketing experience,
bleeding has been reported in patients on concomitant treatment with
anticoagulants and INDOCIN. Caution should be exercised when INDOCIN
and anticoagulants are administered concomitantly. The effects of
warfarin and NSAIDs on GI bleeding are synergistic, such that
users of both drugs together have a risk of serious GI bleeding higher
than users of either drug alone.<br/>Probenecid: When INDOCIN is given to patients receiving probenecid,
the plasma levels of indomethacin are likely to be increased. Therefore,
a lower total daily dosage of INDOCIN may produce a satisfactory therapeutic
effect. When increases in the dose of INDOCIN are made, they should
be made carefully and in small increments.<br/>Drug/Laboratory Test Interactions: False-negative results in the dexamethasone suppression
test (DST) in patients being treated with INDOCIN have been reported.
Thus, results of the DST should be interpreted with caution in these
patients.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: In an 81���week chronic oral toxicity study
in the rat at doses up to 1 mg/kg/day, indomethacin had no tumorigenic
effect. Indomethacin produced no neoplastic
or hyperplastic changes related to treatment in carcinogenic studies
in the rat (dosing period 73-110 weeks) and the mouse (dosing
period 62-88 weeks) at doses up to 1.5 mg/kg/day. Indomethacin did not have any mutagenic effect in in vitro bacterial tests (Ames
test and E. coli with
or without metabolic activation) and a series of in vivo tests including the host-mediated
assay, sex-linked recessive lethals in Drosophila, and the micronucleus test in mice. Indomethacin at dosage levels up to 0.5 mg/kg/day
had no effect on fertility in mice in a two generation reproduction
study or a two litter reproduction study in rats.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nonteratogenic Effects: Because of the known effects of non-steroidal anti-inflammatory
drugs on the fetal cardiovascular system (closure of ductus arteriosus),
use during pregnancy (particularly late pregnancy) should be avoided. The known effects of indomethacin and other drugs of this
class on the human fetus during the third trimester of pregnancy include:
constriction of the ductus arteriosus prenatally, tricuspid incompetence,
and pulmonary hypertension; non-closure of the ductus arteriosus postnatally
which may be resistant to medical management; myocardial degenerative
changes, platelet dysfunction with resultant bleeding, intracranial
bleeding, renal dysfunction or failure, renal injury/dysgenesis which
may result in prolonged or permanent renal failure, oligohydramnios,
gastrointestinal bleeding or perforation, and increased risk of necrotizing
enterocolitis. In rats and mice, 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. 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. 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.<br/>Labor and Delivery: In rat studies with NSAIDs, as with other drugs known
to inhibit prostaglandin synthesis, an increased incidence of dystocia,
delayed parturition, and decreased pup survival occurred. The effects
of INDOCIN on labor and delivery in pregnant women are unknown.<br/>Use in Nursing Mothers: Indomethacin is excreted in the milk of lactating mothers.
INDOCIN is not recommended for use in nursing mothers.<br/>Pediatric Use: Safety and effectiveness in pediatric patients 14 years
of age and younger has not been established. INDOCIN should not be prescribed for pediatric patients 14 years
of age and younger unless toxicity or lack of efficacy associated
with other drugs warrants the risk. In experience
with more than 900 pediatric patients reported in the literature or
to the manufacturer who were treated with Capsules INDOCIN, side effects
in pediatric patients were comparable to those reported in adults.
Experience in pediatric patients has been confined to the use of Capsules
INDOCIN. If a decision is made to use indomethacin
for pediatric patients two years of age or older, such patients should
be monitored closely and periodic assessment of liver function is
recommended. There have been cases of hepatotoxicity reported in pediatric
patients with juvenile rheumatoid arthritis, including fatalities.
If indomethacin treatment is instituted, a suggested starting dose
is 1-2 mg/kg/day given in divided doses. Maximum daily dosage should
not exceed 3 mg/kg/day or 150���200 mg/day, whichever is less.
Limited data are available to support the use of a maximum daily dosage
of 4 mg/kg/day or 150-200 mg/day, whichever is less. As symptoms subside,
the total daily dosage should be reduced to the lowest level required
to control symptoms, or the drug should be discontinued.<br/>Geriatric Use: As with any NSAID, caution should be exercised in
treating the elderly (65 years and older) since advancing age
appears to increase the possibility of adverse reactions (see WARNINGS,
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation and DOSAGE AND ADMINISTRATION). Elderly patients seem to tolerate ulceration or bleeding less
well than other individuals and many spontaneous reports of fatal
GI events arein this population (see WARNINGS,
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation). Indomethacin may cause confusion or, rarely,
psychosis ; physicians
should remain alert to the possibility of such adverse effects in
the elderly. This drug is known to be substantially
excreted by the kidney and the risk of toxic reactions to this drug
may be greater in patients with impaired renal function. Because elderly
patients are more likely to have decreased renal function, care should
be taken in dose selection and it may be useful to monitor renal function
(see WARNINGS,
Renal Effects).
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| dailymed-instance:overdosag... |
The following symptoms may be observed following
overdosage: nausea, vomiting, intense headache, dizziness, mental
confusion, disorientation, or lethargy. There have been reports of
paresthesias, numbness, and convulsions. Treatment
is symptomatic and supportive. The stomach should be emptied as quickly
as possible if the ingestion is recent. If vomiting has not occurred
spontaneously, the patient should be induced to vomit with syrup of
ipecac. If the patient is unable to vomit, gastric lavage should be
performed. Once the stomach has been emptied, 25 or 50 g of activated
charcoal may be given. Depending on the condition of the patient,
close medical observation and nursing care may be required. The patient
should be followed for several days because gastrointestinal ulceration
and hemorrhage have been reported as adverse reactions of indomethacin.
Use of antacids may be helpful. The oral LDof indomethacin in mice and rats (based on 14 day mortality
response) was 50 and 12 mg/kg, respectively.
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indomethacin
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INDOCIN (Suspension)
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| dailymed-instance:adverseRe... |
The adverse reactions for Capsules INDOCIN listed in the following
table have been arranged into two groups: (1) incidence greater than
1%; and (2) incidence less than 1%. The incidence for group (1) was
obtained from 33 double-blind controlled clinical trials reported
in the literature (1,092 patients). The incidence for group (2) was
based on reports in clinical trials, in the literature, and on voluntary
reports since marketing. The probability of acausal relationship
exists between INDOCIN and these adverse reactions, some of which
have been reported only rarely. The adverse reactions reported with Capsules INDOCIN may
also occur with use of the suspension. Causal relationship unknown: Other reactions have been reported but occurred under circumstances
where a causal relationship could not be established. However, in
these rarely reported events, the possibility cannot be excluded.
Therefore, these observations are being listed to serve as alerting
information to physicians: Cardiovascular: Thrombophlebitis Hematologic: Although
there have been several reports of leukemia, the supporting information
is weak Genitourinary: Urinary frequency A rare occurrence of fulminant
necrotizing fasciitis, particularly in association with Group A��hemolytic streptococcus, has been described in persons treated with
non-steroidal anti-inflammatory agents, including indomethacin, sometimes
with fatal outcome .
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| dailymed-instance:warning |
Cardiovascular Effects:<br/>Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and nonselective
NSAIDs of up to three years duration have shown an increased
risk of serious cardiovascular (CV) thrombotic events, myocardial
infarction, and stroke, which can be fatal. All NSAIDs, both COX-2
selective and nonselective, may have a similar risk. Patients with
known CV disease or risk factors for CV disease may be at greater
risk. To minimize the potential risk for an adverse CV event in patients
treated with an NSAID, the lowest effective dose should be used for
the shortest duration possible. Physicians and patients should remain
alert for the development of such events, even in the absence of previous
CV symptoms. Patients should be informed about the signs and/or symptoms
of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of
aspirin mitigates the increased risk of serious CV thrombotic events
associated with NSAID use. The concurrent use of aspirin and an NSAID
does increase the risk of serious GI events . Two large, controlled, clinical trials of
a COX-2 selective NSAID for the treatment of pain in the first 10-14
days following CABG surgery found an increased incidence of myocardial
infarction and stroke .<br/>Hypertension: NSAIDs, including INDOCIN, can lead to onset of new
hypertension or worsening of pre-existing hypertension, either of
which may contribute to the increased incidence of CV events. Patients
taking thiazides or loop diuretics may have impaired response to these
therapies when taking NSAIDs. NSAIDs, including INDOCIN, should be
used with caution in patients with hypertension. Blood pressure (BP)
should be monitored closely during the initiation of NSAID treatment
and throughout the course of therapy.<br/>Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some
patients taking NSAIDs. INDOCIN should be used with caution in patientswith fluid retention or heart failure. In a
study of patients with severe heart failure and hyponatremia, INDOCIN
was associated with significant deterioration of circulatory hemodynamics,
presumably due to inhibition of prostaglandin dependent compensatory
mechanisms.<br/>Gastrointestinal Effects:<br/>Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including INDOCIN, can cause serious gastrointestinal
(GI) adverse events including inflammation, bleeding, ulceration,
and perforation of the esophagus, stomach, small intestine, or large
intestine, which can be fatal. These serious adverse events can occur
at any time, with or without warning symptoms, in patients treated
with NSAIDs. Only one in five patients, who develop a serious upper
GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers,
gross bleeding, or perforation caused by NSAIDs occur in approximately
1% of patients treated for 3-6 months, and in about 2-4% of patients
treated for one year. These trends continue with longer duration
of use, increasing the likelihood of developing a serious GI event
at some time during the course of therapy. However, even short-term
therapy is not without risk. Rarely, in patients
taking INDOCIN, intestinal ulceration has been associated with stenosis
and obstruction. Gastrointestinal bleeding without obvious ulcer formation
and perforation of pre-existing sigmoid lesions (diverticulum, carcinoma,
etc.) have occurred. Increased abdominal pain in ulcerative colitis
patients or the development of ulcerative colitis and regional ileitis
have been reported to occur rarely. NSAIDs should
be prescribed with extreme caution in those with prior history of
ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal
bleeding who use NSAIDs have a greater than 10���fold
increased risk for developing a GI bleed compared to patients with
neither of these risk factors. Other factors that increase the risk
for GI bleeding in patients treated with NSAIDs include concomitant
use of oral corticosteroids or anticoagulants, longer duration of
NSAID therapy, smoking, use of alcohol, older age, and poor general
health status. Most spontaneous reports of fatal GI events are in
elderly or debilitated patients and therefore, special care should
be taken in treating this population. To minimize
the potential risk for an adverse GI event in patients treated with
an NSAID, the lowest effective dose should be used for the shortest
possible duration. Patients and physicians should remain alert for
signs and symptoms of GI ulceration and bleeding during NSAID therapy
and promptly initiate additional evaluation and treatment if a serious
GI adverse event is suspected. This should include discontinuation
of the NSAID until a serious GI adverse event is ruled out. For high
risk patients, alternate therapies that do not involve NSAIDs should
be considered.<br/>Renal Effects: Long-term administration of NSAIDs has resulted in
renal papillary necrosis and other renal injury. Renal toxicity has
also been seen in patients in whom renal prostaglandins have a compensatory
role in the maintenance of renal perfusion. In these patients, administration
of a nonsteroidal anti-inflammatory drug may cause a dose-dependent
reduction in prostaglandin formation and, secondarily, in renal blood
flow, which may precipitate over renal decompensation. Patients at
greatest risk of this reaction are those with impaired renal function,
heart failure, liver dysfunction, those taking diuretics and ACE inhibitors,
patients with volume depletion, and the elderly. Discontinuation of
NSAID therapy is usually followed by recovery to the pretreatment
state. Increases in serum potassium concentration,
including hyperkalemia, have been reported with use of INDOCIN, even
in some patients without renal impairment. In patients with normal
renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism
state .<br/>Advanced Renal Disease: No information is available from controlled clinical
studies regarding the use of INDOCIN in patients with advanced renal
disease. Therefore, treatment with INDOCIN is not recommended in these
patients with advanced renal disease. If INDOCIN therapy must be initiated,
close monitoring of the patient's renal function is advisable.<br/>Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic/anaphylactoid
reactions may occur in patients without known prior exposure to INDOCIN.
INDOCIN should not be given to patients with the aspirin triad. This
symptom complex typically occurs in asthmatic patients who experience
rhinitis with or without nasal polyps, or who exhibit severe, potentially
fatal bronchospasm after taking aspirin or other NSAIDs . Emergency help should be sought in cases where an anaphylactic/anaphylactoid reaction occurs.<br/>Skin Reactions: NSAIDs, including INDOCIN, can cause serious skin
adverse events such as exfoliative dermatitis, Stevens���Johnson
Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be
fatal. These serious events may occur without warning. Patients should
be informed about the signs and symptoms of serious skin manifestations
and use of the drug should be discontinued at the first appearance
of skin rash or any other sign of hypersensitivity.<br/>Pregnancy: In late pregnancy, as with other NSAIDs, INDOCIN
should be avoided because it may cause premature closure of the ductus
arteriosus.<br/>Ocular Effects: Corneal deposits and retinal disturbances, including
those of the macula, have been observed in some patients who had received
prolonged therapy with INDOCIN. The prescribing physician should be
alert to the possible association between the changes noted and INDOCIN.
It is advisable to discontinue therapy if such changes are observed.
Blurred vision may be a significant symptom and warrants a thorough
ophthalmological examination. Since these changes may be asymptomatic,
ophthalmologic examination at periodic intervals is desirable inpatients
where therapy is prolonged.<br/>Central Nervous System Effects: INDOCIN may aggravate depression or other psychiatric
disturbances, epilepsy, and parkinsonism, and should be used with
considerable caution in patients with these conditions. If severe
CNS adverse reactions develop, INDOCIN should be discontinued. INDOCIN may cause drowsiness; therefore, patients should
be cautioned about engaging in activities requiring mental alertness
and motor coordination, such as driving a car. INDOCIN may also cause
headache. Headache which persists despite dosage reduction requires
cessation of therapy with INDOCIN.
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| dailymed-instance:indicatio... |
Carefully consider the potential benefits and risks
of INDOCIN and other treatment options before deciding to use INDOCIN.
Use the lowest effective dose for the shortest duration consistent
with individual patient treatment goals . Indomethacin
has been found effective in active stages of the following:
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INDOCIN
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