| INDOCID® INDOCID® SR |
|Nonsteroidal Anti-inflammatory |
|Action And Clinical Pharmacology: Indomethacin is a nonsteroidal anti-inflammatory drug with marked analgesic, and antipyretic properties. It has a unique chemical structure, which differentiates it from the salicylates, corticosteroids, phenylbutazone-like compounds and colchicine. Unlike corticosteroids, it has no effect on pituitary or adrenal function.
Indomethacin 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.
Although indomethacin does not alter the course of the underlying disease, it has been found effective to relieve pain, reduce fever, swelling and tenderness, and increase mobility in patients with rheumatic disorders of the types listed.
Pharmacokinetics: In man, indomethacin is readily absorbed, attaining peak plasma concentrations of about 1 and 2 µg/mL at about 2 hours following single oral doses of 25 and 50 mg, respectively. Ninety percent of the orally administered indomethacin is absorbed within 4 hours. Indomethacin is eliminated via renal excretion 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 on average 1.4 times those following the first dose.
Indomethacin exists in the plasma as the parent drug and its desmethyl, desbenzoyl, and desmethyl-desbenzoyl metabolites, all in the unconjugated form. About 60% of an oral dosage is recovered in urine as drug and metabolites (26% as indomethacin and its glucuronide), and 33% is recovered in feces (1.5% as indomethacin).
About 90% of indomethacin is bound to protein in plasma over the expected range of therapeutic plasma concentration.
Indocid SR 75 mg capsules are designed to release 25 mg of the drug initially and the remaining 50 mg over 6 hours or longer. When measured over a 24-hour period, the cumulative amount and time-course of indomethacin absorption from a single capsule Indocid SR are similar to those of 3 doses of 25 mg capsules Indocid given at 4 to 6 hour intervals. Absorption into the systemic circulation continues over an extended period with 90% of the dose absorbed by 12 hours.
Indications And Clinical Uses: Indomethacin is not a simple analgesic and its use should be limited to the conditions listed below, particularly those cases not responding to conservative measures. Indocid: Indocid has been effective in symptomatic treatment of selected cases of rheumatoid arthritis; ankylosing (rheumatoid) spondylitis; gout. Selected cases of severe osteoarthritis, including degenerative disease of the hip. In these conditions indomethacin may on occasion replace other commonly used agents such as corticosteroids, salicylates, phenylbutazone-like compounds, and colchicine.
The suppositories are for those patients in whom rectal administration is preferred.
Indocid SR: May be used for all the indications listed for standard Indocid suppositories except gout. Dose titration should not be attempted with Indocid SR. No long-term experience is available on Indocid SR. Limited clinical studies of 6 weeks' duration have shown that 1 capsule Indocid SR was clinically similar to one 25 mg capsule Indocid t.i.d.; and one capsule Indocid SR taken in the morning and evening was clinically similar to one 50 mg capsule Indocid t.i.d.
Rheumatoid Arthritis: Indomethacin may be used singly or in combination with other agents. However, it should not be used as a drug of first choice because of the adverse reactions that may occur with its use.
Best results (relief of pain, tenderness, swelling and stiffness) have been obtained in the acute episodes of the disease. However, in many patients with chronic rheumatoid arthritis, indomethacin produces a significant lessening of pain and stiffness within 48 hours. In other patients, treatment must be continued longer before significant subjective relief or objective evidence of decreased joint swelling and tenderness occur. In some cases of chronic rheumatoid arthritis, it may be necessary to continue treatment for at least a month before concluding that it has not produced significant benefit. Use of indomethacin may enable reduction of steroid dosage in patients receiving corticosteroids. In such instances, the steroid dosage should be reduced slowly.
Ankylosing (Rheumatoid) Spondylitis: Indomethacin frequently produces marked relief of pain and improved motion of the spine within 3 to 10 days.
Osteoarthritis: Indomethacin should be used in those cases of severe osteoarthritis which do not respond to treatment with such other drugs as the salicylates. In many cases prompt relief of pain is obtained.
Degenerative Joint Disease (Osteoarthritis) of the Hip: Indomethacin has provided relief of pain and increased range of motion in patients with degenerative joint disease of the hip.
Gout: In acute attacks of gout the response to indomethacin is usually rapid and often dramatic. Marked reduction of pain may be obtained within 2 to 4 hours. Tenderness and heat subside within 24 to 36 hours, and swelling decreases over a 3 to 5 day period.
Contra-Indications: As with other anti-inflammatory agents, indomethacin may mask the signs and symptoms of peptic ulcer. Indomethacin itself may cause peptic ulceration or irritation of the gastrointestinal tract. For these reasons, it should not be given to patients with active peptic ulcer, gastritis, regional enteritis, ulcerative colitis, diverticulitis or with a recurrent history of gastrointestinal lesions.
Contraindicated in patients who are hypersensitive to any component of this product, and in patients in whom acute asthmatic attacks, urticaria, or rhinitis are precipitated by ASA or other nonsteroidal anti-inflammatory agents (NSAIDs). Fatal anaphylactoid reactions have occurred in such individuals.
Indomethacin suppositories are contraindicated in subjects with a recent history of rectal bleeding or proctitis.
The drug should not be prescribed for children because safe conditions for use have not been established. In a few cases of severe juvenile rheumatoid arthritis, where indomethacin was given along with other drugs, severe reactions, including fatalities, were reported.
Manufacturers' Warnings In Clinical States: Gastrointestinal: Single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small or large intestine have been reported to occur with indomethacin. Fatalities have been reported in some instances. Rarely, intestinal ulceration has been associated with stenosis and obstruction.
Gastrointestinal bleeding without obvious ulcer formation and performation 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.
Indomethacin should be given under close medical supervision to patients prone to gastrointestinal tract irritation particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract. In these cases the physician must weigh the benefits of treatment against the possible hazards.
Patients taking any NSAID including this drug should be instructed to contact a physician immediately if they experience symptoms or signs suggestive of peptic ulceration or gastrointestinal bleeding. These reactions can occur without warning symptoms or signs and at any time during the treatment.
Elderly, frail and debilitated patients appear to be at higher risk from a variety of adverse reactions from NSAIDs. For such patients, consideration should be given to a starting dose lower than usual, with individual adjustment when necessary and under close supervision (see Precautions).
CNS: Headache, sometimes accompanied by dizziness or lightheadedness, may occur usually early in treatment with indomethacin. Although the severity of these effects rarely requires discontinuing therapy, if headache persists despite dose reduction, indomethacin therapy should be discontinued.
Occupational Hazards: Patients should be warned that they may experience dizziness and in this event should not operate motor vehicles and should avoid potentially dangerous activities which require alertness.
Indomethacin should be used with caution in patients with psychiatric disturbances, epilepsy, or parkinsonism, since it may, in some instances, aggravate these conditions.
Pregnancy and Lactation: The known effects of drugs of this class on the human fetus during the third trimester of pregnancy are closure of the ductus arteriosus, platelet dysfunction with resultant bleeding, renal dysfunction or failure with oligohydramnios, gastrointestinal bleeding or perforation and myocardial degenerative changes.
Administration of indomethacin is not recommended during pregnancy or in nursing mothers.
Indomethacin is excreted in breast milk.
Precautions: Gastrointestinal: If peptic ulceration is suspected or confirmed, or if gastrointestinal bleeding or perforation occurs indomethacin should be discontinued, an appropriate treatment instituted and patient closely monitored.
There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow continuation of indomethacin therapy when and if these adverse reactions appear.
Indomethacin, both capsules and suppositories, should be used with caution because of the gastrointestinal reactions which may occur. The gastrointestinal effects may be decreased by giving the oral formulations of the drug immediately after meals, with food or with antacids. The risk of continuing therapy with indomethacin in the face of such symptoms must be weighed against the possible benefits to the individual patient. Indomethacin suppositories should be given with caution to patients with any anal or rectal pathology.
Studies in normal subjects with radioactive chromate-tagged red blood cells indicate that large doses of indomethacin (50 mg 4 times a day) produce less fecal blood loss than average doses of ASA (600 mg 4 times a day). Notwithstanding, indomethacin may cause single or multiple ulceration of the stomach, duodenum, or small and large intestine. There have been reports of severe bleeding and of perforation with a few fatalities. Patients may also develop gastrointestinal bleeding with no obvious ulcer formation. If gastrointestinal bleeding occurs, discontinue using the drug. In many patients with peptic ulceration, a history of a previous ulcer was present or they were on concomitant steroids, salicylates or phenylbutazone. A possible potentiation of the ulcerogenic effect of these drugs cannot be ruled out at present. In some patients there was no history of a previous ulcer and other drugs were not being given. As a result of obvious or occult gastrointestinal bleeding some patients may manifest anemia. For this reason appropriate blood determinations are recommended periodically.
Renal Function: As with other NSAIDs, there have been reports of acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome in patients receiving long-term administration of indomethacin.
In patients with reduced renal blood flow where renal prostaglandins play a major role in maintaining renal perfusion, administration of a nonsteroidal anti-inflammatory agent may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with renal or hepatic dysfunction, diabetes mellitus, advanced age, extracellular volume depletion, congestive heart failure, sepsis, or concomitant use of any nephrotoxic drug. A NSAID should be given with caution and renal function should be monitored in any patient who may have reduced renal reserve. Discontinuation of non-steroidal anti-inflammatory therapy is usually followed by recovery to the pretreatment state.
Increases in serum potassium concentration, including hyperkalemia, have been reported, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state (see Drug Interactions).
Since indomethacin is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored; a lower daily dosage should be used to avoid excessive drug accumulation.
Hepatic Function: As with other NSAIDs, borderline elevations of one or more liver tests may occur.
Significant (3 times the upper limit of normal) elevations of ALT or AST occurred in controlled clinical trials in less than 1% of patients receiving therapy with NSAIDs. 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 more severe hepatic reaction while on therapy with indomethacin.
If abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), therapy should be discontinued.
During long-term therapy, liver function tests should be monitored periodically. If this drug is to be used in the presence of impaired liver function, it must be done under strict observation.
Fluid and Electrolyte Balance: Fluid retention and peripheral edema have been observed in some patients taking indomethacin. Therefore, as with other NSAIDs, indomethacin should be used with caution in patients with cardiac dysfunction, hypertension, or other conditions predisposing to fluid retention.
Serum electrolytes should be monitored periodically during long-term therapy, especially in those patients at risk.
Hematology: Drugs inhibiting prostaglandin biosynthesis do interfere with platelet function to some degree; therefore patients who may be adversely affected by such an action should be carefully observed when indomethacin is administered.
Blood dycrasias associated with the use of NSAIDs are rare, but could have severe consequences.
Indomethacin, like other nonsteroidal anti-inflammatory agents, can inhibit platelet aggregation. This effect is of shorter duration than that seen with ASA and usually disappears within 24 hours after discontinuation of indomethacin. Indomethacin has been shown to prolong bleeding time (but within the normal range) in normal subjects. Because this effect may be exaggerated in patients with underlying hemostatic defects, indomethacin should be used with caution in persons with coagulation defects.
Infection: In common with other drugs which have anti-inflammatory, analgesic and antipyretic properties, indomethacin possesses the potential of masking the signs and symptoms which ordinarily accompany infectious disease. The physician must be alert to this possibility to avoid undue delay in initiating appropriate treatment of the infection. Indomethacin should be used with caution in patients with existing, but controlled, infections.
Ophthalmology: Corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients with rheumatoid arthritis on prolonged therapy with indomethacin. Similar eye changes have been observed in some patients with this disease who have not received indomethacin. Nevertheless, where therapy is prolonged, it is desirable to perform ophthalmological examinations at periodic intervals.
CNS: Headache may occur, usually early in treatment with indomethacin. If headache persists despite dosage reduction therapy with indomethacin should be discontinued (see Warnings).
Hypersensitivity Reactions: Patients should be followed carefully to detect unusual manifestations of drug sensitivity, and since advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly.
Drug Interactions: ASA: The use of indomethacin in conjunction with ASA or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and ASA does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy.
In a study in normal volunteers, it was found that chronic concurrent administration of 3.6 g of ASA/day decreases indomethacin blood levels approximately 20%.
Antihypertensive Medications: Coadministration of indomethacin and some antihypertensive agents has resulted in an attenuation of the latter's hypotensive effect acutely, due at least in part to indomethacin's inhibition of prostaglandin synthesis. Caution should be exercised when considering the addition of indomethacin to the regimen of a patient taking one of the following antihypertensive agents: an alpha-adrenergic blocking agent (such as prazosin), an angiotensin converting enzyme inhibitor (such as captopril or lisinopril), a beta-adrenergic blocking agent, a diuretic (see Diuretics), or hydralazine.
Cyclosporine: Administration of nonsteroidal 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 monitored carefully.
Diflunisal: The combined use of indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage. The coadministration of diflunisal and indomethacin results in an increase of about 30 to 35% in indomethacin plasma levels and a concomitant decrease in renal clearance of indomethacin and its conjugate. Therefore, indomethacin and diflunisal should not be used concomitantly.
Digoxin: Indomethacin given concomitantly with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Therefore, when indomethacin and digoxin are used concomitantly, serum digoxin levels should be closely monitored.
Phenylpropanolamine: Hypertensive crises have been reported due to oral phenylpropanolamine alone and rarely to phenylpropanolamine given with indomethacin. This additive effect is probably due at least in part to indomethacin's inhibition of prostaglandin synthesis. Caution should be exercised when indomethacin and phenylpropanolamine are administered concomitantly.
Anticoagulants: Clinical studies have shown that indomethacin did not influence the hypoprothrombinemia produced by the use of anticoagulants in patients and in normal subjects. However, when any additional drug, including indomethacin is added to the treatment of patients on anticoagulant therapy, the patient should be observed closely for alterations of the prothrombin time.
Hypoglycemic Agents: Indomethacin and hypoglycemic agents should not be used concomitantly.
Diuretics: In some patients, the administration of indomethacin can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics. Therefore, when indomethacin and diuretics are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Indomethacin 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 indomethacin resulted in reversible acute renal failure in two of four healthy volunteers. Indomethacin and triamterene should not be administered together.
Indomethacin and potassium-sparing diuretics each may be associated with increased serum potassium levels. The potential effects of indomethacin 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 indomethacin.
Beta-adrenergic Receptor Blocking Agents: A decrease in the antihypertensive effect of beta-adrenergic receptor blocking agents by NSAIDs including indomethacin has been reported. Therefore, when using a beta blocking agent to treat hypertension, patients should be observed carefully in order to confirm that the desired therapeutic effect has been obtained.
Methotrexate: Caution should be used if indomethacin is administered simultaneously with methotrexate. Indomethacin has been reported to decrease the tubular secretion of methotrexate and to potentiate toxicity.
Lithium: Indomethacin capsules 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 indomethacin and lithium are given concomitantly, the patient should be carefully observed for signs of lithium toxicity. (Read the product monographs for the appropriate lithium preparation 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.
Probenecid: When indomethacin is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased. Therefore, a lower total daily dosage of indomethacin may produce a therapeutic effect. When increases in the dose of indomethacin are made under these circumstances, they should be made cautiously and in small increments.
Clinical Lab Tests: False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.
Adverse Reactions: The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred on occasion, particularly in the elderly.
The following adverse reactions for capsules have been arranged into 2 groups: (1) incidence greater than 1% and (2) incidence less than 1% (see Table I). 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 a causal relationship exists between Indocid and these adverse reactions, some of which have been reported only rarely.
In controlled clinical trials, the incidence of adverse reactions to Indocid SR capsules and equal 24-hour doses of Indocid capsules were similar.
The adverse reactions reported with the capsules may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the suppositories.
The following local adverse reactions have been associated with the use of the suppositories: tenesmus, proctitis, rectal bleeding, burning, pain, discomfort and itching.
Adverse Reactions-Causal Relationship Unknown: The following additional side effects have been reported; however a causal relationship to therapy with indomethacin has not been established.
Hematologic: Although there have been several reports of leukemia, the supporting information is weak.
Genitourinary: urinary frequency.
Symptoms And Treatment Of Overdose: Symptoms: The following symptoms may be observed following overdosage: nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy might be observed. There have been reports of paresthesias, numbness and convulsions. Signs of gastrointestinal hemorrhage could appear but have not been reported following the acute ingestion of large amounts of indomethacin accidentally or intentionally. Treatment: 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. tag_DosageDosage
Dosage And Administration: In chronic disorders, treatment should be started with a dosage of 25 mg 2 or 3 times a day. By starting therapy with low dosage, increased gradually when necessary, maximum benefit will be produced with fewer adverse reactions. Always give indomethacin with food or with antacids to reduce gastric irritation.
As with all drugs, the lowest possible effective dose should be utilized for each individual patient.
The drug should not be prescribed for children because safe conditions for use have not been established.
Since advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly.
Adults: Rheumatoid arthritis and ankylosing (rheumatoid) spondylitis: Initial Dosage: 25 mg 2 or 3 times a day. If the response is not adequate, increase the daily dosage by 25 mg at about weekly intervals until a satisfactory response is obtained or a dosage of 150 to 200 mg/day is reached.
If a satisfactory response is not obtained with 200 mg a day, larger doses probably will not be effective.
If adverse reactions develop as the dosage is increased, reduce the dosage to a tolerated level and maintain this for 3 to 4 weeks. If an adequate response has not been obtained, gradually increase the daily dosage by 25 mg at about weekly intervals to 150 mg to 200 mg a day.
For patients with acute rheumatoid arthritis or with acute flares of chronic rheumatoid arthritis, increase the dosage daily by 25 mg until a satisfactory response is obtained or a total daily dosage of 150 to 200 mg is reached. If adverse effects develop as the dosage is increased, the dosage should be reduced to a tolerated level for 2 or 3 days, and then gradually increased by 25 mg every few days as tolerated. After the acute phase is under control, it is often possible to reduce the daily dosage gradually to 75 to 100 mg.
Reduction of Steroid Dosage: Use of indomethacin often will permit a gradual reduction of steroid dosage by 25 to 50%. In some patients steroids can be slowly discontinued over a period of several weeks or months. The usual precautions should be observed in withdrawing steroids.
Severe Osteoarthritis and Degenerative Joint Disease of the Hip: Initial Dosage: 25 mg 2 or 3 times a day. If the response is not adequate, increase the daily dosage by 25 mg at about weekly intervals until a satisfactory response is obtained or a dosage of 150 to 200 mg a day is reached. If a satisfactory response is not obtained with 200 mg/day, larger doses will probably not be effective.
If adverse reactions develop as the dosage is increased, reduce the dosage to a tolerated level and maintain this for 3 to 4 weeks. If an adequate response has not then been obtained, gradually increase the daily dosage by 25 mg at about weekly intervals to 150 to 200 mg a day.
Gout: To Control Acute Attacks: 50 mg 3 times a day until all signs and symptoms subside. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
Indocid SR capsules are not recommended for use in acute attacks of gout.
Use of Alternate Dosage Forms: Indocid SR: Indocid SR may be tried after the daily dose has been established using the standard capsules and found to fall within 75 to 150 mg range. Patients stabilized on 25 mg three times daily should be tried on 1 SR capsule once daily and those stabilized on 50 mg 3 times daily should be tried on one SR capsule twice daily.
Indocid Suppositories: The recommended dosage is 100 to 200 mg daily and should be individually adjusted to the patient's response and tolerance. Daily dose of 100 mg can be given as 50 mg twice daily or as 100 mg at night. Doses higher than 100 mg must be given on a twice daily schedule.
Combined Administration: One 50 mg or 100 mg suppository at bedtime, supplemented the following day by 25 mg capsules as needed up to a total of 150 to 200 mg of indomethacin. The total daily dose of Indocid (capsules and suppositories) should not exceed 200 mg.
Availability And Storage: Indocid: 50 mg: Each white, opaque suppository contains: indomethacin 50 mg. Nonmedicinal ingredients: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000 and sodium chloride. Boxes of 30. Store below 25°C.
100 mg: Each white, opaque suppository contains: indomethacin 100 mg. Nonmedicinal ingredients: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350 and polyethylene glycol 8000. Boxes of 30. Store below 25°C.
Indocid SR: Each opaque capsule with clear body and yellow cap, printed with MSD trademark in black and "693", containing a mixture of blue and white pellets, contains: indomethacin 75 mg. Nonmedicinal ingredients: allura red, black iron oxide, confectioner's sugar, cornstarch, gelatin, hydroxypropyl methylcellulose, indigotine, magnesium stearate, microcrystalline cellulose, polyvinyl acetate-crotonic acid copolymer, quinoline yellow, sunset yellow and titanium dioxide. Blister packages of 30 and bottles of 250. Store at room temperature (15 to 30°C).
(Shown in Product Recognition Section)