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Indomethacin

Capsule 25 mg

Pharmacological class

Anti-inflammatory drugs, nonsteroidal (Systemic)

Analgesic, Antipyretic, Anti-inflammatory actions



Indication

Indicated for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, psoriatic arthritis, Reiter's disease, rheumatic complications associated with Pagets disease of bone, acute gouty arthritis and calcium pyrophosphate deposition disease (pseudogout),inflammation,nonrheumatic such as: bursitis and tendinitis, fever associated with malignancy, dysmenorrhea,Hypermenorrhea, prevention and treatment of vascular headaches, Bartter's syndrome, and pericarditis.

Drug of first choice in ankylosing spondylitis, for other indications (except Bartter's syndrome), recommended only for patients unresponsive to less toxic NSAIDs or, in the case of fever, to other antipyretic agents.

Pregnancy Category

Second and third trimesters-

Use of NSAIDs during the second half of pregnancy is not recommended.

First trimester: Crosses the placenta; fetotoxic, teratogenic, and other adverse effects demonstrated in animal studies.

Third trimester: Has caused closure of the ductus arteriosus, inhibition of platelet function resulting in bleeding, renal function impairment or failure with oligohydramnios, gastrointestinal bleeding or perforation, and myocardial degenerative changes in fetuses when given to pregnant women during the third trimester.


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Contraindication & Drug interaction

Contraindication

Except under special circumstances, this medication should not be used when the following medical problems exist:

Allergic reaction, severe, such as anaphylaxis or angioedema, induced by aspirin or other NSAIDs, history of or Nasal polyps associated with bronchospasm, aspirin-induced (high risk of severe allergic reactions because of cross-sensitivity)

Risk-benefit should be considered when the following medical problems exist:

Allergic reaction, mild, such as allergic rhinitis, urticaria, or skin rash, induced by aspirin or other NSAIDs, history of (possibility of cross-sensitivity), Anemia or Asthma (may be exacerbated)

Conditions predisposing to and/or exacerbated by fluid retention, such as: Compromised cardiac function, Congestive heart disease, Edema, pre-existing, Hypertension, Renal function impairment or failure (NSAIDs may cause fluid retention and edema),Conditions predisposing to gastrointestinal toxicity, such as: Alcoholism, active,Gastrointestinal bleeding (GI), history of or Inflammatory or ulcerative disease of the upper or lower gastrointestinal tract, including Crohn's,disease, diverticulitis, peptic ulcer disease, or ulcerative colitis, active or history of or,Tobacco use,or recent history of, Congestive heart failure or, Diabetes mellitus or,Edema, pre-existing or, Extracellular volume depletion or, Sepsis(increased risk of renal failure),Hemophilia or other bleeding problems including coagulation or platelet function disorders, Hepatic cirrhosis or, Hepatic function impairment, Renal function impairment (the risk of toxicity associated with accumulation of the NSAID and/or the risk of adverse renal effects may be higher with diflunisal, Stomatitis, Systemic lupus erythematosus (SLE),Epilepsy or, Mental depression or other psychiatric disturbances or Parkinsonism

Drug interactions

ACE inhibitors, Acetaminophen, Alcohol,   Corticosteroids, oral glucocorticoid, Corticotropin, Potassium supplements ,Anticoagulants, coumarin- or indanedione-derivative,Heparin,Thrombolytic agents, such as: Alteplase, Anistreplase, Streptokinase, Urokinase, Warfarin, Antidiabetic agents, oral, Insulin , Antihypertensives, Diuretics, especially, Triamterene, Aspirin, NSAIDs, two or more concurrently, especially,

Diflunisal and indomethacin concurrently, 

Salicylates other than aspirin and diflunisal,

Bone marrow depressants , Cefamandole, Cefoperazone , Cefotetan, Plicamycin, Valproic acid ,Colchicine, Cyclosporine, Gold compounds, Nephrotoxic medications, Digitalis glycosides, Lithium, Methotrexate, Photosensitizing medications, Platelet aggregation inhibitors, Probenecid, Aminoglycosides, Zidovudine


Usual Adult Dose

Antirheumatic (nonsteroidal anti-inflammatory)-

Oral, initially 25 or 50 mg two to four times a day; if well tolerated, the dosage per day may be increased by 25 or 50 mg at weekly intervals until a satisfactory response is obtained or up to a maximum dose of 200 mg per day. After a satisfactory response has been achieved, dosage should be reduced to the lowest dose that provides continuing control symptoms.

Note: In acute flare-ups of rheumatoid arthritis, dosage may be increased by 25 or 50 mg daily, as needed and tolerated.

For those arthritic patients who have persistent night pain and/or morning stiffness, up to 100 mg of the total daily dose may be given at bedtime. Lower bedtime doses may not provide adequate symptomatic relief.

A daily dose of less than 75 mg may not be effective in active inflammatory disease.

A daily dose of more than 150 to 200 mg may increase the risk of adverse effects without providing additional clinical benefit.

Antigout agent-

Oral, 100 mg initially, then 50 mg three times a day until pain is relieved, with the dosage then being reduced until medication is discontinued.

Anti-inflammatory (nonsteroidal)-

75to 150 mg per day in three or four divided doses.

Note: When used to treat conditions not requiring chronic therapy, such as acute bursitis or tendinitis of the shoulder, indomethacin should be discontinued when symptoms of inflammation have been controlled for several days. The usual length of treatment is 7 to 14 days.

Usual adult prescribing limits

Oral, 200 mg a day.

Usual Pediatric Dose

Antirheumatic (nonsteroidal anti-inflammatory)-Oral, 1.5 to 2.5 mg per kg of body weight per day, administered in three or four divided doses, up to a maximum of 4 mg per kg of body weight per day or 150 to 200 mg per day, whichever is less. After a satisfactory response has been obtained, dosage should be reduced to the lowest dose that provides continuing control of symptoms.

Side Effects

Incidence more frequent:

Renal effects, Fluid retention/edema, Dizziness, Gastrointestinal effects, Abdominal cramps, pain, or discomfort, mild to moderate, Indigestion, Nausea, headache mild to moderate, headache, severe, especially in the morning

Incidence less frequent:

Mood or mental changes,including: Mental depression

Ringing or buzzing in ears,Increased sweating, Drowsiness, Lightheadedness/vertigo, Constipation, Diarrhea, Vomiting, General feeling of discomfort or illness


Storage

Store below 30°C (86°F).

Protect from light and keep the medicine in the box.

 


Packaging

Box of 100 Indomethacin Capsules 25mg

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Products

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