Brand names: Indocin, Tivorbex
Drug class: Other Nonsteroidal Anti-inflammatory Agents
CAS number: 53-86-1

Medically reviewed by Drugs.com on Nov 29, 2021. Written by ASHP.

Introduction

Prototypical NSAIA; indoleacetic acetic acid derivative.

Uses for Indomethacin

When used for inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Symptomatic relief of acute gout and acute painful shoulder (i.e., bursitis and/or tendinitis).

Management of juvenile rheumatoid arthritis^{† [off-label]} in children ≥2 years of age.

Pain

Indomethacin (Tivorbex): Relief of mild to moderate acute pain.

Patent Ductus Arteriosus (PDA)

Treatment of PDA in premature neonates. Used to promote closure of a hemodynamically significant PDA (i.e., left-to-right shunt large enough to compromise cardiorespiratory status) in premature neonates weighing 500–1750 g when 36–48 hours of usual medical management (e.g., fluid restriction, diuretics, cardiac glycosides, respiratory support) is ineffective.

Pericarditis

Reduction of pain, fever, and inflammation of pericarditis^{† [off-label]}; however, in the treatment of post-MI pericarditis, NSAIAs are potentially harmful and aspirin is the treatment of choice. (See Cardiovascular Thrombotic Effects under Cautions.)

Indomethacin Dosage and Administration

General

• For inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Administer orally or rectally (for inflammatory diseases or pericarditis) or by IV infusion (for PDA).

Oral Administration

In patients who have persistent night pain and/or morning stiffness, a large portion (maximum 100 mg) of the total daily dose may be given at bedtime.

Conventional Capsules and Oral Suspension

Administer conventional capsules and oral suspension in 2–4 divided doses daily.

Extended-release Capsules

Administer extended-release capsules once or twice daily.

Extended-release capsules can be used as an alternative to conventional capsules: 75 mg once daily (extended-release) as an alternative to 25 mg 3 times daily (conventional); 75 mg twice daily (extended-release) as an alternative to 50 mg 3 times daily (conventional).

Swallow extended-release capsules intact.

Extended-release capsules are not recommended for treatment of acute gouty arthritis.

Rectal Administration

Administer in 2–4 divided doses daily.

Retain suppositories in rectum for ≥1 hour to ensure complete absorption.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Avoid extravasation (irritating to extravascular tissues).

Reconstitution

Reconstitute vial containing 1 mg of indomethacin with 1 or 2 mL of preservative-free 0.9% sodium chloride injection or sterile water for injection to provide a solution containing 1 mg/mL or 0.5 mg/mL, respectively. Further dilution is not recommended.

Use of bacteriostatic water for injection containing benzyl alcohol is not recommended because of potential risk of benzyl alcohol exposure if administered to a neonate.

Prepare solutions immediately before use; discard any unused solution.

Rate of Administration

Optimum rate not established; may administer dose over 20–30 minutes.

Dosage

Available as indomethacin and indomethacin sodium; dosage expressed in terms of indomethacin.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Inflammatory Diseases

Juvenile Rheumatoid Arthritis† [off-label]

Oral

Children ≥2 years of age: Initially, 1–2 mg/kg daily in divided doses. Increase dosage until a satisfactory response is achieved, up to maximum dosage of 3 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses; limited data support the use of a maximum dosage of 4 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses. As symptoms subside, reduce dosage to the lowest effective level or discontinue the drug.

PDA

IV

Each course of therapy consists of up to 3 doses administered at 12- to 24-hour intervals.

Base dosage on neonate’s age at the time therapy is initiated.

If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.

If ductus arteriosus closes or is substantially constricted 48 hours or longer after completion of the first course, no further doses are necessary.

If ductus reopens, a second course of 1–3 doses may be administered. Surgical ligation may be necessary if ductus is unresponsive to 2 courses of therapy.

Pericarditis† [off-label]

Oral

50–100 mg daily in 2–4 divided doses.

Adults

Inflammatory Diseases

Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis

Oral

Conventional capsules or oral suspension: Initially, 25 mg 2 or 3 times daily. If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.

Extended-release capsules: Initially, 75 mg once daily. May increase dosage to 75 mg twice daily.

Rectal

25 mg 2 or 3 times daily. If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.

Gout

Oral

Conventional capsules: 50 mg 3 times daily until pain is tolerable; then reduce dosage rapidly and discontinue.

Painful Shoulder

Oral

Conventional capsules or oral suspension: 75–150 mg daily in 3 or 4 divided doses. Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.

Extended-release capsules: 75 mg once or twice daily. Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.

Rectal

75–150 mg daily in 3 or 4 divided doses. Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.

Pain

Acute Pain

Oral

Indomethacin (Tivorbex) capsules: 20 mg 3 times daily or 40 mg 2 or 3 times daily. This formulation is not interchangeable with other oral formulations. (See Bioavailability under Pharmacokinetics.)

Prescribing Limits

Pediatric Patients

Juvenile Rheumatoid Arthritis

Oral

Maximum 4 mg/kg or 150–200 mg daily, whichever is less.

Adults

Inflammatory Diseases

Rheumatoid Arthritis, Osteoarthritis, or Ankylosing Spondylitis

Oral

Maximum 200 mg daily.

Rectal

Maximum 200 mg daily.

Special Populations

Geriatric Patients

Careful dosage selection recommended due to possible age-related decreases in renal function.

Cautions for Indomethacin

Contraindications

• Known hypersensitivity to indomethacin or any ingredient in the formulation.

• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.

• In the setting of CABG surgery.

• When administered rectally, history of proctitis or recent rectal bleeding.

• When used for PDA, known or suspected untreated infection; bleeding, especially active intracranial hemorrhage or GI bleeding; thrombocytopenia; coagulation defects; known or suspected necrotizing enterocolitis; substantial renal impairment; congenital heart disease if patency of the ductus arteriosus is necessary for pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).

Warnings/Precautions

Warnings

Cardiovascular Thrombotic Effects

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.

Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.

Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.

Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.

In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.

In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.

Increased 1-year mortality rate observed in patients receiving NSAIAs following MI; absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.

Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs. FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events throughout therapy, even in those without prior cardiovascular symptoms) and at the lowest effective dosage for the shortest duration necessary.

Some clinicians suggest that it may be prudent to avoid NSAIA use, whenever possible, in patients with cardiovascular disease. Avoid use in patients with recent MI unless benefits of therapy are expected to outweigh risk of recurrent cardiovascular thrombotic events; if used, monitor for cardiac ischemia. Contraindicated in the setting of CABG surgery.

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

Incidence of major GI bleeding reported in neonates receiving IV indomethacin in clinical studies similar to that in neonates receiving placebo; minor GI bleeding occurred more frequently in indomethacin-treated neonates.

When used for inflammatory diseases in patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Hypertension

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP.

Impaired response to ACE inhibitors, angiotensin II receptor antagonists, β-blockers, and certain diuretics may occur. (See Specific Drugs under Interactions.)

Heart Failure and Edema

Fluid retention and edema reported.

NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) may increase morbidity and mortality in patients with heart failure.

NSAIAs may diminish cardiovascular effects of diuretics, ACE inhibitors, or angiotensin II receptor antagonists used to treat heart failure or edema. (See Specific Drugs under Interactions.)

Manufacturer recommends avoiding use in patients with severe heart failure unless benefits of therapy are expected to outweigh risk of worsening heart failure; if used, monitor for worsening heart failure.

Some experts recommend avoiding use, whenever possible, in patients with reduced left ventricular ejection fraction and current or prior symptoms of heart failure.

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in adults with renal or hepatic impairment or heart failure, in patients with volume depletion, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

May precipitate renal insufficiency in neonates; increased risk in those with extracellular volume depletion, CHF, sepsis, or hepatic dysfunction or those receiving concomitant therapy with a nephrotoxic drug. If a substantial reduction in urine output occurs, withhold additional doses until output returns to normal. (See PDA under Dosage and Administration.)

Hyponatremia reported in neonates. Monitor renal function and serum electrolytes.

Hyperkalemia reported in adults.

Hematologic Effects

Potential for spontaneous intraventricular hemorrhage in neonates. Observe premature infants for signs of bleeding.

Contraindicated in neonates who are bleeding and in those with thrombocytopenia or coagulation defects.

Ocular Effects

Corneal deposits and retinal disturbances reported in patients receiving long-term therapy. Ophthalmic examination recommended in patients with blurred vision; periodic ophthalmic examinations recommended in patients receiving long-term therapy.

CNS Effects

May aggravate depression or other psychiatric disturbances, epilepsy, or parkinsonism; use with caution in patients with these conditions.

May cause drowsiness; may impair ability to perform activities requiring mental alertness.

May cause headache. Discontinue the drug in patients in whom indomethacin-induced headache persists despite a reduction in dosage.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions (e.g., anaphylaxis, angioedema) reported. Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Potentially fatal or life-threatening syndrome of multi-organ hypersensitivity (i.e., drug reaction with eosinophilia and systemic symptoms [DRESS]) reported in patients receiving NSAIAs. Clinical presentation is variable, but typically includes eosinophilia, fever, rash, lymphadenopathy, and/or facial swelling, possibly associated with other organ system involvement (e.g., hepatitis, nephritis, hematologic abnormalities, myocarditis, myositis). Symptoms may resemble those of acute viral infection. Early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present in the absence of rash. If signs or symptoms of DRESS develop, discontinue indomethacin and immediately evaluate the patient.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.

Hematologic Precautions

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time. When used for inflammatory diseases, use with caution in patients with coagulation defects.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Use of NSAIAs during pregnancy at about ≥30 weeks’ gestation can cause premature closure of the fetal ductus arteriosus; use at about ≥20 weeks’ gestation associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment.

Effects of NSAIAs on the human fetus during third trimester of pregnancy include prenatal constriction of the ductus arteriosus, tricuspid incompetence, and pulmonary hypertension; nonclosure of the ductus arteriosus during the postnatal period (which may be resistant to medical management); and myocardial degenerative changes, platelet dysfunction with resultant bleeding, intracranial bleeding, renal dysfunction or renal failure, renal injury or dysgenesis potentially resulting in prolonged or permanent renal failure, oligohydramnios, GI bleeding or perforation, and increased risk of necrotizing enterocolitis.

Avoid use of NSAIAs in pregnant women at about ≥30 weeks’ gestation; if use required between about 20 and 30 weeks’ gestation, use lowest effective dosage and shortest possible duration of treatment, and consider monitoring amniotic fluid volume via ultrasound examination if treatment duration >48 hours; if oligohydramnios occurs, discontinue drug and follow up according to clinical practice. (See Advice to Patients.)

Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment observed, on average, following days to weeks of maternal NSAIA use; infrequently, oligohydramnios observed as early as 48 hours after initiation of NSAIAs. Oligohydramnios is often, but not always, reversible (generally within 3–6 days) following NSAIA discontinuance. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation. In limited number of cases, neonatal renal dysfunction (sometimes irreversible) occurred without oligohydramnios. Some neonatas have required invasive procedures (e.g., exchange transfusion, dialysis). Deaths associated with neonatal renal failure also reported. Limitations of available data (lack of control group; limited information regarding dosage, duration, and timing of drug exposure; concomitant use of other drugs) preclude a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use. Available data on neonatal outcomes generally involved preterm infants; extent to which risks can be generalized to full-term infants is uncertain.

Animal data indicate important roles for prostaglandins in kidney development and endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, inhibitors of prostaglandin synthesis increased pre- and post-implantation losses; also impaired kidney development at clinically relevant doses.

Adverse effects reported in animal reproduction studies with indomethacin (e.g., increased fetal resorptions, retarded fetal ossification, fetal malformations, increased incidence of neuronal necrosis).

Effects of indomethacin on labor and delivery not known. In animal studies, NSAIAs increased incidence of dystocia, delayed parturition, and decreased pup survival.

Lactation

Distributed into milk; use not recommended.

Fertility

NSAIAs may be associated with reversible infertility in some women. Reversible delays in ovulation observed in limited studies in women receiving NSAIAs; animal studies indicate that inhibitors of prostaglandin synthesis can disrupt prostaglandin-mediated follicular rupture required for ovulation.

Consider withdrawal of NSAIAs in women experiencing difficulty conceiving or undergoing evaluation of infertility.

Pediatric Use

Safety and efficacy established in neonates receiving the drug for PDA.

Safety and efficacy of oral or rectal indomethacin not established in children ≤14 years of age. Indomethacin should not be used in children 2–14 years of age unless toxicity or lack of efficacy with other drugs justifies the risk.

Safety and efficacy of indomethacin (Tivorbex) for relief of mild to moderate acute pain not established in pediatric patients <18 years of age.

Adverse effects reported in children receiving indomethacin capsules generally comparable to those reported in adults. Hepatotoxicity, sometimes fatal, has been reported in pediatric patients with juvenile rheumatoid arthritis. Periodic assessment of liver function recommended.

Geriatric Use

Caution advised. Geriatric patients appear to tolerate NSAIA-induced adverse effects less well than younger individuals. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.

Possible confusion or, rarely, psychosis in geriatric patients.

Substantially eliminated by the kidney; select dosage carefully and assess renal function periodically since geriatric patients more likely to have decreased renal function.

Renal Impairment

Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.

Common Adverse Effects

With oral therapy, nausea, dyspepsia, headache, dizziness.

With rectal administration, rectal irritation, tenesmus; adverse effects associated with oral administration possible.

With IV therapy, bleeding, transient oliguria, increases in serum creatinine concentrations, hyponatremia, elevated serum potassium concentrations.

Interactions for Indomethacin

Protein-bound Drugs

Possible pharmacokinetic interaction; observe for adverse effects if used with other protein-bound drugs.

Drugs Excreted by the Kidney

Possible pharmacokinetic interaction with drugs that rely on adequate renal function for excretion. In neonates receiving IV indomethacin, consider dosage adjustment for drugs that rely on adequate renal function for excretion.

Specific Drugs

Indomethacin Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract. Almost completely absorbed following oral administration as conventional or extended-release capsules; bioavailability following rectal administration is 80–90% of that of the conventional capsule.

Indomethacin extended-release capsules release 25 mg of drug initially and the remaining 50 mg over 12 hours.

When administered with food, the commercially available conventional capsules and oral suspension are bioequivalent.

Tivorbex 40-mg capsule under fasted conditions: AUC is 21% lower than that achieved with a 50-mg conventional capsule, but peak plasma concentrations are equivalent.

Food

Food may slightly decrease or delay peak plasma concentration; however, clinical importance not established.

Effect of food on pharmacokinetics appears to be comparable for Tivorbex capsules and other conventional indomethacin capsules.

Distribution

Extent

Crosses the placenta and blood-brain barrier.

Concentrations in synovial fluid 20% of those in serum.

Distributed into milk.

Plasma Protein Binding

99% (in adults).

Elimination

Metabolism

Metabolized in the liver.

Elimination Route

Undergoes appreciable enterohepatic circulation. Following oral administration, excreted in the urine (60%) and feces (33%) as unchanged drug and metabolites.

Half-life

Adults: 4.5 hours.

Neonates <7 days of age: 20 hours.

Neonates >7 days of age: 12 hours.

Neonates weighing <1 kg: 21 hours.

Neonates weighing >1 kg: 15 hours.

Stability

Storage

Oral

Conventional or Extended-release Capsules

15–30°C.

Suspension

<30°C; avoid temperatures >50°C. Protect from freezing.

Rectal

Suppositories

<30°C; avoid temperatures >40°C (even transiently).

Parenteral

Powder for Injection

<30°C; protect from light.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Reconstitute with preservative-free sterile water for injection or preservative-free 0.9% sodium chloride injection. Further dilution with IV solutions is not recommended.

Drug Compatibility

Actions

• Inhibits cyclooxygenase-1 (COX-1) and COX-2.

• Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.

• Permits closure of the ductus arteriosus in premature neonates by inhibiting prostaglandin synthesis.

Advice to Patients

• Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.

• Risk of serious cardiovascular events (e.g., MI, stroke).

• Risk of GI bleeding and ulceration.

• Risk of serious skin reactions, DRESS, and anaphylactoid and other sensitivity reactions.

• Risk of hepatotoxicity.

• Risk of ocular toxicity.

• Potential for drug to impair mental alertness; use caution when driving or operating machinery until effects on individual are known.

• Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.

• Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.

• Advise patients to stop taking indomethacin immediately if they develop any type of rash or fever and to promptly contact their clinician. Importance of seeking immediate medical attention if an anaphylactic reaction occurs.

• Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.

• Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of avoiding NSAIA use beginning at 20 weeks’ gestation unless otherwise advised by a clinician; importance of avoiding NSAIAs beginning at 30 weeks’ gestation because of risk of premature closure of the fetal ductus arteriosus; monitoring for oligohydramnios may be necessary if NSAIA therapy required for >48 hours’ duration between about 20 and 30 weeks’ gestation.

• Advise women who are trying to conceive that NSAIAs may be associated with a reversible delay in ovulation.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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