Indocin 25 mg Capsules

Brand Name

Indocin is the well-established brand name under which this medication is marketed, widely respected in clinical practice for its efficacy in managing pain and inflammation. It serves as a reliable option for healthcare providers treating a variety of inflammatory and musculoskeletal disorders.

International Nonproprietary Name (INN)

The active substance in this drug is identified by its International Nonproprietary Name (INN) as indomethacin. This indole acetic acid derivative is carefully formulated to deliver potent anti-inflammatory and analgesic effects within the body.

Forms of Release

Indocin is available in several forms to meet diverse patient needs and administration preferences. These include immediate-release capsules in 25 mg and 50 mg strengths, and sustained-release capsules at 75 mg for prolonged action. An oral suspension is offered at 25 mg/5 mL, ideal for those requiring precise dosing or unable to swallow capsules. Additionally, suppositories at 50 mg and 100 mg provide an alternative route, while an injectable solution at 1 mg/vial supports acute care settings. Each formulation ensures flexible delivery of indomethacin tailored to specific therapeutic contexts.

Composition

The core active ingredient in Indocin is indomethacin, driving its pharmacological benefits. Alongside this primary component, various inactive substances enhance stability and usability across its forms. Immediate-release capsules contain lactose, sodium lauryl sulfate, and magnesium stearate, with a gelatin shell incorporating titanium dioxide and colorants like iron oxides. Sustained-release capsules include ethylcellulose for controlled release, with similar fillers. The oral suspension features sorbitol, tragacanth, and alcohol as a preservative, while suppositories use polyethylene glycol and cocoa butter as a base. The injectable form includes sodium hydroxide and hydrochloric acid in a sterile solution. These auxiliary elements ensure the drug’s consistency and effective administration.

Pharmacologic Properties

Pharmacodynamics

This medication exerts its effects by modulating the inflammatory processes within the body. Indomethacin acts as a non-steroidal anti-inflammatory drug (NSAID) by inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, which curbs the production of prostaglandins—key mediators of pain, inflammation, and fever. This non-selective inhibition reduces swelling, stiffness, and discomfort in affected tissues, particularly joints and muscles. Beyond prostaglandin suppression, it may stabilize lysosomal membranes and reduce neutrophil activity, further dampening inflammation. Its robust action provides relief in both acute and chronic conditions, making it a versatile therapeutic agent.

Pharmacokinetics

The pharmacokinetic profile of Indocin describes how indomethacin is handled by the body. After oral administration, it is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 1 to 2 hours for immediate-release forms, or 4 to 6 hours for sustained-release, with bioavailability near 90–100%, slightly reduced by food. Rectal suppositories achieve peaks in 1–2 hours, while IV administration delivers immediate levels. It is 90% bound to plasma proteins, mainly albumin, with a volume of distribution of 0.34–1.57 L/kg, penetrating synovial fluid and the brain. Metabolism occurs in the liver via O-demethylation and N-deacylation, producing inactive metabolites, with excretion split between urine (60%) and feces (33%) via enterohepatic circulation. Its half-life ranges from 4.5 to 9 hours, prolonged in hepatic or renal impairment, requiring careful dosing adjustments.

Indications for Use

This medication is employed to address conditions involving inflammation, pain, or fever, capitalizing on its ability to alleviate these symptoms across various clinical scenarios.

Diseases and Conditions

Indocin is indicated for moderate to severe rheumatoid arthritis and osteoarthritis in adults, reducing joint inflammation and improving function. It is also approved for ankylosing spondylitis, easing spinal pain and stiffness, and for acute gouty arthritis, targeting sudden flare-ups. Acute shoulder pain from bursitis or tendinitis, and patent ductus arteriosus (PDA) in preterm infants (via IV form), are additional uses. Its comprehensive anti-inflammatory action makes it a key option for these acute and chronic states.

Contraindications

Despite its efficacy, certain conditions preclude the use of this medication due to significant risks, necessitating careful screening before initiation.

Conditions Prohibiting Use

Indocin is contraindicated in patients with known hypersensitivity to indomethacin or other NSAIDs, as reactions could range from mild skin irritation to severe anaphylaxis. It is prohibited in individuals with active gastrointestinal ulcers, bleeding, or perforation, given its COX-1 inhibition increasing these risks. Patients with severe heart failure, recent coronary artery bypass graft surgery, or uncontrolled hypertension should avoid it due to cardiovascular concerns. It is also barred in severe hepatic or renal failure, and in those with aspirin-exacerbated respiratory disease (e.g., asthma with nasal polyps), ensuring safety in high-risk groups.

Method of Administration and Dosage

How to Take

This medication is administered according to its form, with oral capsules and suspension taken with a full glass of water, preferably with food or milk to reduce gastric irritation. Sustained-release capsules should not be crushed, maintaining their prolonged action. Suppositories are inserted rectally, ideal when oral intake is impractical, while the injectable form is given IV over 20–30 minutes in a clinical setting, avoiding bolus delivery. Consistent timing—typically 2–3 times daily for immediate-release—supports steady levels, with adherence to prescribed methods ensuring optimal efficacy.

Dosages for Adults and Children

Dosing varies by indication and age, with specific pediatric use for PDA. For rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis in adults, Indocin starts at 25 mg two to three times daily, increasing to 150–200 mg/day if needed (max 200 mg/day). Acute gout uses 50 mg three times daily until resolved, while shoulder pain begins at 75–150 mg/day in divided doses for 7–14 days. For PDA in preterm infants, IV dosing is 0.2 mg/kg initially, followed by 0.1–0.25 mg/kg every 12–24 hours for 2–3 doses, based on age and response. Adult dosing adjustments ensure relief while minimizing risks.

Dose Adjustment in Specific Conditions

Adjustments are critical in organ impairment. In mild to moderate renal dysfunction (creatinine clearance 30–80 mL/min), doses may be reduced by 25–50% (e.g., 50–100 mg/day), with severe cases (below 30 mL/min) often avoiding use. Moderate hepatic impairment (Child-Pugh B) lowers doses to 25–75 mg/day, with severe cases contraindicating use. Elderly patients start at 25 mg twice daily, with cautious increases due to heightened gastrointestinal and renal risks, guided by monitoring to balance safety and efficacy.

Side Effects

This medication can elicit a variety of adverse reactions, from mild to significant, and patients should be informed to facilitate timely management.

Possible Adverse Reactions

Common effects include gastrointestinal issues—nausea, dyspepsia, or abdominal pain—often eased with food. Headache, dizziness, or drowsiness may impair daily function, while fluid retention or edema occurs in some. Gastrointestinal bleeding, ulcers, or perforation are serious risks, particularly with prolonged use. Cardiovascular effects like hypertension or rare thrombotic events warrant caution, as do renal declines (e.g., reduced filtration) or hepatic enzyme elevations. Skin rashes or rare severe reactions (e.g., Stevens-Johnson syndrome) also occur, with regular oversight essential to address these potential issues.

Overdose

Symptoms of Overdose

Excessive intake of Indocin can trigger pronounced symptoms requiring urgent attention. These include severe nausea, vomiting, or epigastric pain from gastrointestinal distress, alongside lethargy or confusion from systemic effects. Hypertension, tachycardia, or respiratory depression may signal cardiovascular or central nervous system strain, while acute renal failure or oliguria could emerge in extreme cases. Seizures or coma are rare but possible with high doses, necessitating rapid recognition and response.

First Aid Measures

In an overdose situation, swift action is crucial. If the patient is alert and ingestion was recent, contact emergency services or poison control without inducing vomiting unless directed. Maintain airway and vital signs while awaiting help. In medical settings, activated charcoal may be given within an hour of ingestion to limit absorption, followed by supportive care—IV fluids, gastric protection (e.g., PPIs), and monitoring. Dialysis is ineffective due to high protein binding, but symptom management aids recovery.

Drug Interactions

Effects on Other Medications

This medication can influence co-administered drugs through metabolic and pharmacodynamic interactions. It increases levels of warfarin or lithium by competing for protein binding or excretion, heightening their effects or toxicity, requiring adjustments. Diuretics or ACE inhibitors may lose efficacy, raising blood pressure risks, while aspirin co-use amplifies gastrointestinal hazards. Methotrexate clearance decreases, necessitating caution. Monitoring ensures safe combination therapy.

Compatibility with Alcohol and Food

Alcohol should be avoided with Indocin, as it significantly increases gastrointestinal bleeding risk and may worsen dizziness. Food or milk reduces gastric irritation, making administration with meals advisable, with no specific dietary limits beyond minimizing irritants. Consistency supports tolerability.

Special Precautions

Use During Pregnancy and Breastfeeding

This medication is Category C before 30 weeks gestation, used only if benefits outweigh fetal risks, shifting to Category D after 30 weeks due to ductus arteriosus closure risks, contraindicating late-term use (except IV for PDA). Indomethacin enters breast milk; breastfeeding is not recommended due to potential infant effects, with alternatives preferred.

Impact on Driving and Operating Machinery

Indocin may impair alertness or coordination due to dizziness or drowsiness, particularly early in therapy. Patients should avoid driving or machinery until they assess its impact, ensuring safety in daily tasks.

Considerations for Elderly and Pediatric Patients

In elderly patients, this drug requires cautious dosing (e.g., 25 mg twice daily) due to increased gastrointestinal and renal risks, with close monitoring. In preterm infants, IV use for PDA (0.1–0.25 mg/kg) is established, with oversight for renal or bleeding effects; other pediatric uses lack data, with adult adjustments ensuring tolerability.