Indomethacin Contraindications is a non-steroidal anti-inflammatory agent (NSAID) that inhibits the enzyme cyclooxygenase necessary for the formation of prostaglandins and other autacoids. It also inhibits the motility of polymorphonuclear leukocytes.
Indomethacin is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of indomethacin is as a Cyclooxygenase Inhibitor. The chemical classification of indomethacin is Nonsteroidal Anti-inflammatory Compounds.
Indomethacin is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis. Indomethacin is also used to treat shoulder pain caused by bursitis or tendinitis.
Indomethacin Indications
Indomethacin Tablet is used for the treatment, control, prevention, & improvement of the following diseases, conditions, and symptoms
- For moderate to severe rheumatoid arthritis including acute flares of chronic disease, ankylosing spondylitis, osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.
- Polyarthralgia
- Muscles stiffness in nerve diseases
- Morning stiffness
- Multiple joint pain
- Steroid induce arthritis
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Gouty arthritis
- Pain due to especially musculoskeletal system
- Muscles stiffness in spinal
- Muscles stiffness in muscle diseases
- Muscles stiffness in the joint diseases
- Lumbago
- Low back pain
- PLID
- Pain caused by nonarticular rheumatism
- Periarthritis of scapulohumeral
- Ischiadynia
Therapeutic Indications Indomethacin
- Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Tocolytic Agents
- 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.
- Indomethacin 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).
- Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray.
- IV indomethacin sodium trihydrate has been used prophylactically in premature neonates with subclinical patent ductus arteriosus (PDA) and as routine prophylaxis during the first day of life in low-birthweight premature neonates.
- In the management of Reiter’s syndrome, many clinicians consider indomethacin a drug of choice.
- Indomethacin also has been used to reduce the pain, fever, and inflammation of pleurisy and pleuritic chest pain of diverse origins.
- Indomethacin has been used to inhibit uterine contractions during preterm labor (tocolysis) and thus prolong gestation. However, safety and efficacy of indomethacin for tocolysis have not been established and such use is controversial since there have been reports of serious adverse fetal effects, including constriction of the fetal ductus arteriosus, neonatal primary pulmonary hypertension, and fetal deaths.
- A 1% indomethacin suspension has been applied topically to the eye for the prevention of postoperative cystoid macular edema in patients undergoing cataract surgery or retinal surgery, but a commercially available ophthalmic preparation currently is not available in the US.
- Indomethacin has been recommended by some clinicians to treat orthostatic hypotension associated with multiple system atrophy characterized by predominantly autonomic failure (formerly known as Shy-Drager syndrome). It has been suggested, however, that at least some autonomic activity must be present for indomethacin therapy to be successful in this condition.
- Indomethacin has also been used for symptomatic treatment of postoperative pain, biliary pain, chronic erythema nodosum, and certain types of a headache (e.g., cluster headache, exertional headache).
- Although indomethacin has been used in the treatment of primary pulmonary hypertension, it appears that the drug provides little hemodynamic benefit in these patients and may adversely affect their hemodynamic status.
- Indomethacin has been used for its antipyretic effect in the management of fever associated with infection in children and with neoplasms (e.g., Hodgkin’s disease, hepatic metastases of solid tumors).
- The drug appears to be more effective in reducing fever associated with neoplasms than fever caused by infections. In adults with fever associated with various neoplasms, indomethacin has effectively controlled fever that had not responded to other antipyretics (e.g., aspirin, acetaminophen), antineoplastic agents, and/or anti-infective agents. Indomethacin has been reported to have a greater antipyretic effect than aspirin in children with infection. However, indomethacin should not be used routinely as an antipyretic because of potentially serious adverse effects.
- Indomethacin has been used occasionally to relieve severe primary dysmenorrhea.
- Indomethacin has been used for symptomatic treatment of Bartter’s syndrome. However, because of potentially serious adverse effects of indomethacin, the drug may not be suitable for the long-term therapy necessary to control the disease; use of other NSAIDs such as ibuprofen is being evaluated.
- Indomethacin also has been used successfully in the treatment of idiopathic pericarditis and postpericardiotomy pericarditis in children (11-15 years of age).
- Indomethacin has also been used for symptomatic treatment of traumatic synovitis, tennis elbow, athletic injuries, psoriatic arthritis, juvenile arthritis, Paget’s disease, mild uveitis, and acute pseudogout.
- Indomethacin is used to reduce the pain, fever, and inflammation of pericarditis, including that associated with myocardial infarction or occurring during maintenance hemodialysis.
Indomethacin Contraindications
Hypersensitivity to indomethacin tablet is a contraindication. In addition, Aceclofenac Tablet should not be used if you have the following conditions:
- Active peptic ulcer
- Acute rhinitis
- Allergic to thiocolchicoside
- Asthma
- Breastfeeding
- Pregnant
- Urticaria
- Concurrent peptic ulcer, or history of ulcer disease
- Allergy to indomethacin, aspirin, or other NSAIDs
- Patients with nasal polyps reacting with an angioedema to other NSAIDs
- Children under 2 years of age (with the exception of neonates with patent ductus arteriosus)
- Some painkillers, including opioid painkillers;
- Hypnotic drugs;
- Psychotropic drugs;
- Used monoamine oxidase inhibitors (MAOIs) such as phenelzine or tranylcypromine
- Epilepsy;
- Addiction or are recovering from addiction to another medication.
- History of peptic ulcer disease,
- Gastrointestinal bleeding,
- Severe pre-existing renal and liver damage
- Caution: pre-existing bone marrow damage (frequent blood cell counts are indicated)
- Caution: bleeding tendencies of unknown origin (indometacin inhibits platelet aggregation)
- Caution: Parkinson’s disease, epilepsy, psychotic disorders (indomethacin may worsen these conditions)
- Concurrent with potassium-sparing diuretics
- Patients who have a patent ductus arteriosus dependent heart defect (such as transposition of the great vessels)
- Significant hypertension (high blood pressure)
- Concomitant administration of lithium salts (such as lithium carbonate)
Dosage of Indomethacin
Strengths: 25 mg; 50 mg; 75 mg; 25 mg/5 mL; 1 mg; 20 mg; 40 mg
Acute Gout
- 50 mg orally or rectally 3 times a day
- Duration of therapy: Until gout attack
Bursitis
Immediate-release capsules and suspension
- 75 to 150 mg orally per day in 3 or 4 divided doses
Suppository
- 50 mg rectally up to 3 times a day
Extended Release
- 75 mg orally once or twice a day
Tendonitis
Immediate-release capsules and suspension
- 75 to 150 mg orally per day in 3 or 4 divided doses
Suppository
- 50 mg rectally up to 3 times a day
Extended Release
- 75 mg orally once or twice a day.
Pain
- 20 mg orally 3 times a day or 40 mg orally 2 to 3 times a day
Rheumatoid Arthritis
Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day.
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day.
Ankylosing Spondylitis
Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day.
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day.
Osteoarthritis
Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day
Pediatric Dose
Patent Ductus Arteriosus
- Dosing depends on the age of neonate at time of therapy; A course of therapy is defined as 3 IV doses given at 12 to 24-hour intervals.
Age at first dose: Less than 48 hours
- First dose: 0.2 mg/kg IV
- Second dose: 0.1 mg/kg IV
- Third dose: 0.1 mg/kg IV
Age at first dose: 2 to 7 days
- First dose: 0.2 mg/kg IV
- Second dose: 0.2 mg/kg IV
- Third dose: 0.2 mg/kg IV
Age at first dose: Over 7 days
- First dose: 0.2 mg/kg IV
- Second dose: 0.25 mg/kg IV
- Third dose: 0.25 mg/kg IV
Rheumatoid Arthritis
2 to 14 years
- Initial dose: 1 to 2 mg/kg/day orally in divided doses
- Maximum dose: 3 mg/kg/day or 150 to 200 mg/day, whichever is less; limited data supports a maximum of 4 mg/kg/day
Over 14 years >Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day
Ankylosing Spondylitis
Over 14 years >Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day
Osteoarthritis
Over 14 years >Immediate-release capsules and suspension
- Initial dose: 25 mg orally 2 or 3 times a day
- Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg
Suppository
- Initial dose: 50 mg rectally once a day
- Maintenance dose: 50 to 200 mg rectally per day in divided doses
- Maximum single dose: 100 mg
- Maximum daily dose: 200 mg per day
Extended-release
- Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release
- 150 mg per day
- Initial dose: 75 mg orally twice a day
Bursitis
Over 14 years >Immediate-release capsules and suspension
- 75 to 150 mg orally per day in 3 or 4 divided doses
Suppository
- 50 mg rectally up to 3 times a day
Extended Release
- 75 mg orally once or twice a day
Tendonitis
Over 14 years >Immediate-release capsules and suspension
- 75 to 150 mg orally per day in 3 or 4 divided doses
Suppository
- 50 mg rectally up to 3 times a day
Extended Release
- 75 mg orally once or twice a day
Side effect Indomethacin
The most common
- GI disorders (e.g. dyspepsia, abdominal pain, nausea, vomiting, diarrhea, flatulence, constipation,, ulcerative stomatitis, ), indigestion,
- Disturbances of the gut such as diarrhea, constipation, nausea, vomiting or abdominal pain.
- Drowsiness and lightheadedness
- Nausea and vomiting
- joint pain
- Nausea and vomiting
- Severe stomach ache
- Severe diarrhea
- Vaginal thrush
- Skin rash
- A headache
- Chest pain
- Diarrhea or loose stools
- Difficulty with breathing
- Dizziness
- Heartburn
- Muscle pain
More common
- Abdominal or stomach pain,
- Chills or fever
- A headache,
- Joint or back pain
- Muscle aching or cramping
- Muscle pains or stiffness
- Chest pressure or squeezing pain in the chest
- Excessive sweating
- feeling of heaviness, pain, warmth and/or swelling in a leg or in the pelvis
- sudden tingling or coldness in an arm or leg
- Constipation
- Diarrhea
- Loss of muscle coordination
- Sleepiness or unusual drowsiness
- Clumsiness or unsteadiness
- Drowsiness
Rare
- Anxiety
- change in vision
- seizures
- abnormal or fast heart rate
- weight loss
- chest pain or tightness
- confusion
- a cough
- Agitation
- arm, back, or jaw pain
- blurred vision
- chest pain or discomfort
- convulsions
- extra heartbeats, fainting
- blurred vision
- chest pain or discomfort
- convulsions
- extra heartbeats
- hallucinations
- headache
- irritability
- lightheadedness
- mood or mental changes
- muscle pain or cramps
- muscle spasm or jerking of all extremities
- muscle pains or stiffness
- chest pressure or squeezing pain in cthe hest
- discomfort in arms, shoulders, neck or upper back
Drug Interactions of Indomethacin
Indomethacin may interact with following drugs, suppliments & may change the efficasy of drugs
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- angiotensin-converting enzyme inhibitors (ACEIs; e.g., captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- beta-adrenergic blockers (e.g., metoprolol, atenolol)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- celecoxib
- cilostazol
- clopidogrel
- clopidogrel
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- cyclosporine
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- 5-ASA medications (e.g, sulfasalazine)
- glucosamine
- haloperidol
- heparin
- methotrexate
- multivitamins
- other non-steroidal anti-inflammatory medications (NSAIDs;e.g., diclofenac, ibuprofen, ketorolac, naproxen)
- Omega-3 fatty acids
- pentoxifylline
- quinolone antibiotics (e.g., ciprofloxacin, ofloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine,f luoxetine, paroxetine, sertraline)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g, duloxetine, )
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- warfarin
Pregnancy and Lactation of Indomethacin
FDA pregnancy category D
Pregnancy
You should not take indomethacin tablets during the last 3 months of pregnancy as it may affect the baby s circulation. If you are in the first 6 months of pregnancy talk to your doctor before taking this medicine indomethacin tablet should only be taken if the benefit is likely to outweigh the risks. Taking indomethacin tablets may make it more difficult for you to get pregnant. You should talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant.
Lactation
Tablets during the last 3 months of pregnancy as it may affect the baby s circulation. If you are in the first 6 months of pregnancy talk to your doctor before taking this medicine as indomethacin tablets should only be taken if the benefit is likely to outweigh the risks.
