Indomethacin Contraindications, Pregnancy Category

Indomethacin is used to treat moderate to severe pain? and stiffness?. সহজ বাংলা: বয়স/ক্ষয়ের কারণে জয়েন্টের ব্যথা।" data-rx-term="osteoarthritis" data-rx-definition="Osteoarthritis is wear-and-tear joint disease causing pain and stiffness. সহজ বাংলা: বয়স/ক্ষয়ের কারণে জয়েন্টের ব্যথা।">osteoarthritis?, swelling?, stiffness, or reduced movement. সহজ বাংলা: জয়েন্টের প্রদাহ।" data-rx-term="arthritis" data-rx-definition="Arthritis means joint inflammation causing pain, swelling, stiffness, or reduced movement. সহজ বাংলা: জয়েন্টের প্রদাহ।">arthritis?: Rheumatoid arthritis is an autoimmune? joint disease causing infection?, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation?, pain, and swelling. সহজ বাংলা: রোগপ্রতিরোধ ব্যবস্থার ভুল আক্রমণে জয়েন্টের প্রদাহ।" data-rx-term="rheumatoid arthritis" data-rx-definition="Rheumatoid arthritis is an autoimmune joint disease causing inflammation, pain, and swelling. সহজ বাংলা: রোগপ্রতিরোধ ব্যবস্থার ভুল আক্রমণে জয়েন্টের প্রদাহ।">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 infection?, or irritation, often causing pain?, swelling?, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">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 pain? in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">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

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.