INDOMETHACIN - indomethacin capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin Capsule, USP has been found effective in active stages of the following: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - Moderate to severe ankylosing spondylitis. - Moderate to severe osteoarthritis. - Acute painful shoulder (bursitis and/or tendinitis). - Acute gouty arthritis. Indomethacin Capsule, USP is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin Capsule, USP 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 (see WARNINGS:Anaphy
Product summary:
Product: 63629-8066 NDC: 63629-8066-1 30 CAPSULE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8066-1

Bryant Ranch Prepack

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INDOMETHACIN CAPSULES USP

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-

Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance

increases:

with longer use of NSAID medicines

in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass

graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding:

can happen without warning symptoms

may cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called "corticosteroids" and "anticoagulants"

longer use

smoking

drinking alcohol

older age

having poor health

NSAID medicines should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical

conditions such as:

different types of arthritis

menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID

medicine

for pain right before or after heart bypass surgery

Tell your healthcare provider:

about all of your medical conditions.

about all of the medicines you take. NSAIDs and some other medicines can interact with each other

and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and

pharmacist.

if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.

if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

serious side effects include:

Other side effects include:

heart attack

stroke

high blood pressure

heart failure from body swelling (fluid

Retension)

kidney problems including kidney failure

bleeding and ulcers in the stomach and intestine

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma

stomach pain

constipation

diarrhea

heartburn

nausea

vomiting

dizziness

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following

symptoms:

nausea

more tired or weaker than usual

itching

your skin or eyes look yellow

stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for

more information about NSAID medicines. Call your doctor for medical advice about side effects. You may

report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Aspirin is an NSAID medicine but it does not increase the chance of a heart attack.Aspirin can cause

bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to

your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Celecoxib

Celebrex

Diclofenac

Cataflam, Voltaren, Arthrotec (combined with misoprostol)

Diflunisal

Dolobid

Etodolac

Lodine, Lodine XL

Fenoprofen

Nalfon, Nalfon 200

Flurbiprofen

Ansaid

Ibuprofen

Motrin, Tab-Profen, Vicoprofen( (combined with

hydrocodone), Combunox (combined with oxycodone)

Indomethacin

Indocin, Indocin SR, Indo-Lemmon, Indomethagan

Ketoprofen

Oruvail

Ketorolac

Toradol

MefenamicAcid Ponstel

Meloxicam

Mobic

Nabumetone

Relafen

Naproxen

Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn,

Naprelan, Naprapac (copackaged with lansoprazole)

Oxaprozin

Daypro

Piroxicam

Feldene

Sulindac

Clinoril

Tolmetin

Tolectin, Tolectin DS, Tolectin 600

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for

less than 10 days to treat pain. The OTC NSAIDS label warns that long term continuous use may increase the

risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Camber Pharmaceuticals, Inc

Piscataway, NJ 08854

By: Hetero Labs Limited

Jeedimetla, Hyderabad-500 055, India.

Revised: 8/2019

Document Id: af404bca-7f29-441b-9506-4ef907094ff0

34391-3

Set id: d969dcc7-f8b2-49b5-8c8a-966b5a57a81d

Version: 1

Effective Time: 20190807

Bryant Ranch Prepack

INDOMETHACIN - indomethacin capsule

Bryant Ranch Prepack

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Indomethacin Capsule, USP

Rx only

Cardiovascular Risk

NSAIDS may cause an increased risk of serious cardiovascular thrombotic events, myocardial

infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients

with Cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

(see WARNINGS).

Indomethacin is contraindicated for the treatment of perioperative pain in the setting of

coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding,

ulceration, and perforation of the stomach or intestines, which can be fatal. These events can

occur at any time during use and without warning symptoms. Elderly patients are at greater risk

for serious gastrointestinal events (see WARNINGS).

DESCRIPTION

Indomethacin Capsules, USP for oral administration are provided in two dosage strengths which contain

either 25 mg or 50 mg of indomethacin. Indomethacin is a non-steroidal anti-inflammatory indole

derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid.

The structural formula is:

C H ClNO M.W. 357.79

Indomethacin, USP 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.

Each capsule for oral administration contains 25 mg or 50 mg of indomethacin and the following

inactive ingredients: lactose monohydrate, sodium lauryl sulphate, sodium starch glycolate, colloidal

silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide USP,

FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide

E172 dye.

CLINICAL PHARMACOLOGY

19

16

4

Indomethacin 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.

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. 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 prostaglandins in peripheral

tissues.

Indomethacin has been shown to be an effective anti-inflammatory agent, appropriate for long-term use

in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.

Indomethacin affords relief of symptoms; it does not alter the progressive course of the underlying

disease.

Indomethacin suppresses inflammation in rheumatoid arthritis as demonstrated by relief of pain, and

reduction of fever, swelling and tenderness. Improvement in patients treated with indomethacin 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. Indomethacin 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 CO stimulated 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.

Indomethacin capsules have been found effective in relieving the pain, reducing the fever, swelling,

redness, and tenderness of acute gouty arthritis (see INDICATIONS AND USAGE).

Following single oral doses of indomethacin capsules 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 indomethacin capsules are virtually 100% bioavailable, with 90% of the dose

absorbed within 4 hours. A single 50 mg dose of indomethacin oral suspension was found to be

bioequivalent to a 50 mg indomethacin 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 mg 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 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 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.

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options

before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent

with individual patient treatment goals (see WARNINGS).

Indomethacin Capsule, USP has been found effective in active stages of the following:

1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease.

2. Moderate to severe ankylosing spondylitis.

3. Moderate to severe osteoarthritis.

4. Acute painful shoulder (bursitis and/or tendinitis).

5. Acute gouty arthritis.

CONTRAINDICATIONS

Indomethacin Capsule, USP is contraindicated in patients with known hypersensitivity to indomethacin or

the excipients (see DESCRIPTION).

Indomethacin Capsule, USP 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 (see

WARNINGS:Anaphylactic/Anaphylactoid Reactions, and PRECAUTIONS:General:Preexisting

Asthma).

Indomethacin Capsule, USP is contraindicated for the treatment of perioperative pain in the setting of

coronary artery bypass graft (CABG) surgery (see WARNINGS).

WARNINGS

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 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 (see WARNINGS:Gastrointestinal Effects).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first

10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and

stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, including indomethacin, can lead to onset of new hypertension or worsening of preexisting

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 indomethacin, 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.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Indomethacin should be

used with caution in patients with fluid retention or heart failure.

In a study of patients with severe heart failure and hyponatremia, indomethacin was associated with

significant deterioration of circulatory hemodynamics, presumably due to inhibition of prostaglandin

dependent compensatory mechanisms.

Gastrointestinal Effects

Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including indomethacin, 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 to 6 months, and in

about 2 to 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 indomethacin, intestinal ulceration has been associated with stenosis and

obstruction. Gastrointestinal bleeding without obvious ulcer formation and perforation of preexisting

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 a 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.

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 non-steroidal 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

indomethacin, even in some patients without renal impairment. In patients with normal renal function,

these effects have been attributed to a hyporeninemic-hypoaldosteronism state (see

PRECAUTIONS:Drug Interactions).

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of indomethacin in

patients with advanced renal disease. Therefore, treatment with indomethacin is not recommended in

these patients with advanced renal disease. If indomethacin therapy must be initiated, close monitoring

of the patient's renal function is advisable.

Anaphylactic/Anaphylactoid Reactions

As with other NSAIDs, anaphylactic/anaphylactoid reactions may occur in patients without known prior

exposure to indomethacin. Indomethacin 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 (see

CONTRAINDICATIONS and PRECAUTIONS:General:Preexisting Asthma). Emergency help should

be sought in cases where an anaphylactic/anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including indomethacin, 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.

Pregnancy

In late pregnancy, as with other NSAIDs, indomethacin should be avoided because it may cause

premature closure of the ductus arteriosus.

Ocular Effects

Corneal deposits and retinal disturbances, including those of the macula, have been observed in some

patients who had received prolonged therapy with indomethacin. The prescribing physician should be

alert to the possible association between the changes noted and indomethacin. 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 in patients where therapy is prolonged.

Central Nervous System Effects

Indomethacin 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, indomethacin should be discontinued.

Indomethacin may cause drowsiness; therefore, patients should be cautioned about engaging in activities

requiring mental alertness and motor coordination, such as driving a car. Indomethacin may also cause

headache. Headache which persists despite dosage reduction requires cessation of therapy with

indomethacin.

PRECAUTIONS

General

Indomethacin 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 indomethacin in reducing fever and inflammation may diminish the

utility of these diagnostic signs in detecting complications of presumed noninfectious, painful

conditions.

Hepatic Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs,

including indomethacin. 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

values has occurred, should be evaluated for evidence of the development of a more severe hepatic

reaction while on therapy with indomethacin. If clinical signs and symptoms consistent with liver

disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), indomethacin should

be discontinued.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs, including indomethacin. 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 indomethacin, 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 indomethacin who may be adversely affected by alterations in platelet function, such

as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

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 non-steroidal anti-inflammatory drugs has

been reported in such aspirin-sensitive patients, indomethacin should not be administered to patients with

this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

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.

1. Indomethacin, like other NSAIDs, may cause serious CV side effects, such as MI or

stroke, which may result in hospitalization and even death. Although serious CV events can occur

without warning symptoms, patients should be alert for the signs and symptoms of chest pain,

shortness of breath, weakness, slurring of speech, and should ask for medical advice when

observing any indicative sign or symptoms. Patients should be apprised of the importance of this

follow-up (see WARNINGS:Cardiovascular Effects).

2. Indomethacin, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such

as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract

ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs

and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any

indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients

should be apprised of the importance of this follow-up (see WARNINGS:Gastrointestinal

Effects:Risk of Ulceration, Bleeding, and Perforation).

3. Indomethacin, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis,

SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions

may occur without warning, patients should be alert for the signs and symptoms of skin rash and

blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice

when observing any indicative signs or symptoms. Patients should be advised to stop the drug

immediately if they develop any type of rash and contact their physicians as soon as possible.

4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their

physicians.

5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea,

fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and "flu-like" symptoms). If

these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

6. Patients should be informed of the signs of an anaphylactic/anaphylactoid reaction (e.g. difficulty

breathing, swelling of the face or throat). If these occur, patients should be instructed to seek

immediate emergency help (see WARNINGS).

7. In late pregnancy, as with other NSAIDs, indomethacin should be avoided because it may cause

premature closure of the ductus arteriosus.

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, indomethacin should be discontinued.

Drug Interactions

ACE Inhibitors and Angiotensin II Antagonists

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors and

angiotensin II antagonists. Indomethacin 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

coadministration 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.

Aspirin

When indomethacin is administered with aspirin, its protein binding is reduced, although the clearance

of free indomethacin is not altered. The clinical significance of this interaction is not known.

The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled

clinical studies have shown that the combined use of indomethacin and aspirin does not produce any

greater therapeutic effect than the use of indomethacin alone. In a clinical study of the combined use of

indomethacin and aspirin, 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 aspirin per day decreases indomethacin blood levels approximately 20%.

Beta-Adrenoceptor Blocking Agents

Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by non-steroidal anti-

inflammatory drugs including indomethacin 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.

Cyclosporin

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.

function should be carefully monitored.

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 indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage. Therefore,

diflunisal and indomethacin 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.

Diuretics

In some patients, the administration of indomethacin 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.

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.

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.

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 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.

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.

NSAIDs

The concomitant use of indomethacin with other NSAIDs is not recommended due to the increased

possibility of gastrointestinal toxicity, with little or no increase in efficacy.

Oral anticoagulants

Clinical studies have shown that indomethacin does not influence the hypoprothrombinemia produced by

anticoagulants. However, when any additional drug, including indomethacin, 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 indomethacin. Caution should be exercised when indomethacin 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.

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

satisfactory therapeutic effect. When increases in the dose of indomethacin are made, they should be

made carefully and in small increments.

Drug/Laboratory Test Interactions

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.

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 to 110 weeks) and the mouse (dosing period 62 to 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.

Pregnancy

Teratogenic Effects. Pregnancy Category C

Teratogenic studies were conducted in mice and rats at dosages of 0.5, 1, 2, and 4 mg/kg/day. Except

for retarded fetal ossification at 4 mg/kg/day considered secondary to the decreased average fetal

weights, no increase in fetal malformations was observed as compared with control groups. Other

studies in mice reported in the literature using higher doses (5 to 15 mg/kg/day) have described maternal

toxicity and death, increased fetal resorptions, and fetal malformations. Comparable studies in rodents

using high doses of aspirin have shown similar maternal and fetal effects. However, animal

reproduction studies are not always predictive of human response. There are no adequate and well

controlled studies in pregnant women.

Indomethacin should be used during pregnancy only if the potential benefit justifies the potential risk to

the fetus

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; nonclosure of the ductus arteriosus postnatally which may be resistant to

medical management; myocardial degenerative changes, platelet dysfunction with resultant bleeding,

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 mg/kg/day given during the last 3 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 mg/kg/day, no increase in neuronal necrosis

was observed as compared to the control groups. Administration of 0.5 or 4 mg/kg/day during the first 3

days of life did not cause an increase in neuronal necrosis at either dose level.

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

indomethacin on labor and delivery in pregnant women are unknown.

Nursing Mothers

Indomethacin is excreted in the milk of lactating mothers. Indomethacin is not recommended for use in

nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients 14 years of age and younger have not been established.

Indomethacin 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 indomethacin capsules, side effects in pediatric patients were comparable to those

reported in adults. Experience in pediatric patients has been confined to the use of indomethacin

capsules.

If a decision is made to use indomethacin for pediatric patients 2 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 to 2 mg/kg/day given in

divided doses. Maximum daily dosage should not exceed 3 mg/kg/day or 150 to 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

to 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.

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 are in this population (see

WARNINGS:Gastrointestinal Effects:Risk of Ulceration, Bleeding, and Perforation).

Indomethacin may cause confusion or, rarely, psychosis (see ADVERSE REACTIONS); 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).

ADVERSE REACTIONS

The adverse reactions for indomethacin capsules 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 a causal relationship exists between indomethacin and these

adverse reactions, some of which have been reported only rarely.

Incidence greater than 1%

GASTROINTESTINAL

nausea with or without vomiting

dyspepsia (including indigestion, heartburn and epigastric pain)

Diarrhea

abdominal distress or pain

constipation

CENTRAL NERVOUS SYSTEM

headache (11.7%)

dizziness

vertigo

somnolence

depression and fatigue (including malaise and listlessness)

SPECIAL SENSES

tinnitus

CARDIOVASCULAR

none

METABOLIC

none

INTEGUMENTARY

none

HEMATOLOGIC

none

HYPERSENSITIVITY

none

GENITOURINARY

none

MISCELLANEOUS

none

________________________________________

1 Reactions occurring in 3% to 9% of patients treated with indomethacin. (Those reactions occurring in

less than 3% of the patients are unmarked.)

Incidence less than 1%

GASTROINTESTINAL

anorexia

anorexia

bloating (includes distention)

flatulence

peptic ulcer

gastroenteritis

rectal bleeding

proctitis

single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach,

duodenum or small and large intestines

intestinal ulceration associated with stenosis and obstruction gastrointestinal bleeding without obvious

ulcer formation and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.)

development of ulcerative colitis and regional ileitis

ulcerative stomatitis

toxic hepatitis and jaundice (some fatal cases have been reported)

intestinal strictures (diaphragms)

CENTRAL NERVOUS SYSTEM

anxiety (includes nervousness)

muscle weakness

involuntary muscle movements

insomnia

muzziness

psychic disturbances including psychotic episodes

mental confusion

drowsiness

light-headedness

syncope

paresthesia

aggravation of epilepsy and parkinsonism

depersonalization

coma

peripheral neuropathy

convulsions

dysarthria

SPECIAL SENSES

ocular-corneal deposits and retinal disturbances, including those of the macula, have been reported in

some patients on prolonged therapy with indomethacin

blurred vision

diplopia

hearing disturbances, deafness

CARDIOVASCULAR

congestive heart failure

hypertension

hypotension

tachycardia

chest pain

arrhythmia; palpitations

METABOLIC

edema

weight gain

fluid retention

flushing or sweating

hyperglycemia

glycosuria

hyperkalemia

INTEGUMENTARY

pruritus

rash; urticaria

petechiae or ecchymosis

exfoliative dermatitis

erythema nodosum

loss of hair

Stevens-Johnson Syndrome

erythema multiforme

toxic epidermal necrolysis

HEMATOLOGIC

leucopenia

bone marrow depression

anemia secondary to obvious or occult gastrointestinal bleeding

aplastic anemia

hemolytic anemia

agranulocytosis

thrombocytopenic purpura

disseminated intravascular coagulation

HYPERSENSITIVITY

acute anaphylaxis

acute respiratory distress

rapid fall in blood pressure resembling a shock-like state

angioedema

dyspnea

asthma

purpura

angiitis

pulmonary edema

fever

GENITOURINARY

hematuria

vaginal bleeding

proteinuria, nephrotic syndrome, interstitial nephritis

BUN elevation

renal insufficiency, including renal failure

MISCELLANEOUS

epistaxis

breast changes, including enlargement and tenderness, or gynecomastia

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 β-

hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory

agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS:General).

OVERDOSAGE

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 g 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 LD50 of indomethacin in mice and rats (based on 14 day mortality response) was 50 and 12

mg/kg, respectively.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of indomethacin and other treatment options before

deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with

individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with indomethacin, the dose and frequency should be

adjusted to suit an individual patient's needs.

Indomethacin is available as 25 mg and 50 mg capsules.

Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not

all. Therefore, every effort should be made to determine the smallest effective dosage for the

individual patient.

Pediatric Use

Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see

WARNINGS).

Adult Use

Dosage Recommendations for Active Stages of the Following:

1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to

severe ankylosing spondylitis; and moderate to severe osteoarthritis.

Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the

daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a

satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES

ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE

DRUG.

In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up

to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The

total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be

necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.

If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a

tolerated dose and OBSERVE THE PATIENT CLOSELY.

If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under

control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving

the smallest effective dose or the drug is discontinued.

Careful instructions to, and observations of, the individual patient are essential to the prevention of

serious, irreversible, including fatal, adverse reactions.

As advancing years appear to increase the possibility of adverse reactions, indomethacin should be

used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).

2. Acute painful shoulder (bursitis and/or tendinitis).

Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after

the signs and symptoms of inflammation have been controlled for several days. The usual course of

therapy is 7 to 14 days

3. Acute gouty arthritis.

Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then

be rapidly reduced to complete cessation of the drug. 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.

HOW SUPPLIED

Product: 63629-8066

NDC: 63629-8066-1 30 CAPSULE in a BOTTLE

INDOMETHACIN CAPSULES USP

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal

Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This

chance increases:

with longer use of NSAID medicines

in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary

artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during

treatment. Ulcers and bleeding:

can happen without warning symptoms

may cause death

The chance of a person getting an ulcer or bleeding increases with:

taking medicines called "corticosteroids" and "anticoagulants"

longer use

smoking

drinking alcohol

older age

having poor health

NSAID medicines should only be used:

exactly as prescribed

at the lowest dose possible for your treatment

for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical

conditions such as:

different types of arthritis

menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID

medicine

for pain right before or after heart bypass surgery

Tell your healthcare provider:

about all of your medical conditions.

about all of the medicines you take. NSAIDs and some other medicines can interact with each other

and cause serious side effects. Keep a list of your medicines to show to your healthcare

provider and pharmacist.

if you are pregnant. NSAID medicines should not be used by pregnant women late in their

pregnancy.

if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

serious side effects include:

Other side effects include:

heart attack

stroke

high blood pressure

heart failure from body swelling (fluid

Retension)

kidney problems including kidney failure

bleeding and ulcers in the stomach and intestine

low red blood cells (anemia)

life-threatening skin reactions

life-threatening allergic reactions

liver problems including liver failure

asthma attacks in people who have asthma

stomach pain

constipation

diarrhea

heartburn

nausea

vomiting

dizziness

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the

following symptoms:

nausea

more tired or weaker than usual

itching

your skin or eyes look yellow

stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or

pharmacist for more information about NSAID medicines. Call your doctor for medical advice about

side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Aspirin is an NSAID medicine but it does not increase the chance of a heart attack.Aspirin can cause

bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter).

Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Celecoxib

Celebrex

Diclofenac

Cataflam, Voltaren, Arthrotec (combined with

misoprostol)

Diflunisal

Dolobid

Etodolac

Lodine, Lodine XL

Fenoprofen

Nalfon, Nalfon 200

Flurbiprofen

Ansaid

Ibuprofen

Motrin, Tab-Profen, Vicoprofen( (combined

with hydrocodone), Combunox (combined with

oxycodone)

Indomethacin

Indocin, Indocin SR, Indo-Lemmon, Indomethagan

Ketoprofen

Oruvail

Ketorolac

Toradol

MefenamicAcid Ponstel

Meloxicam

Mobic

Nabumetone

Relafen

Naproxen

Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn,

Naprelan, Naprapac (copackaged with lansoprazole)

Oxaprozin

Daypro

Piroxicam

Feldene

Sulindac

Clinoril

Tolmetin

Tolectin, Tolectin DS, Tolectin 600

Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually

used for less than 10 days to treat pain. The OTC NSAIDS label warns that long term continuous use

may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Camber Pharmaceuticals, Inc

Piscataway, NJ 08854

By: Hetero Labs Limited

Jeedimetla, Hyderabad-500 055, India.

INDOMETHACIN 50MG CAPSULE

INDOMETHACIN

indomethacin capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -8 0 6 6 (NDC:31722-543)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

INDO METHACIN (UNII: XXE1CET9 56 ) (INDOMETHACIN - UNII:XXE1CET9 56 )

INDOMETHACIN

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

Bryant Ranch Prepack

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

Product Characteristics

Color

GREEN (light green)

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

H;10 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 0 6 6 -1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 1240

11/0 1/20 11

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 0 6 6 ) , RELABEL(6 36 29 -8 0 6 6 )

Revised: 8/2019

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