Brands of Indomethacin in Kenya:
Caredomet® , Careplus ltd
Cindomet® , Dawa Limited
Dinlacin® , Dinlas Pharma EPZ Limited
Indocid® , Aspen Global Incorporated
Indopac® , Shandong Xier Kangtai Pharmaceutical Co. Ltd
Indowin® , Medisel Kenya Ltd
Mode of Action:
The mechanism of action of Indomethacin, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Indomethacin capsules are indicated for:
- 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).
- Acute gouty arthritis.
- Hypersensitivity to the active substance(s) or to any of the excipients
- History of peptic ulcer or active peptic ulcer
- Recurrent history of gastro-intestinal lesions
- In patients who have nasal polyps associated with angioneurotic oedema, who show sensitivity to indometacin or any of the ingredients in this product, or who have experienced acute asthmatic attacks, urticaria or rhinitis as a result of therapy with aspirin or other non-steroidal anti-inflammatory drugs
- During the third trimester of pregnancy or lactation
Aspirin: the use of indometacin with aspirin or other salicylates is not recommended. Controlled clinical studies have shown no enhanced therapeutic effect, and one study showed a significant increase in the incidence of gastro-intestinal side effects. A study in normal volunteers showed that chronic administration of 3.6 g aspirin with indometacin lowered the indometacin blood levels by approximately 20%.
Diflunisal: co-administration of diflunisal with indometacin increases the plasma level of indometacin by about a third, with a concomitant decrease in renal clearance. Fatal gastro-intestinal haemorrhage has occurred. The combination should not be used.
Other NSAIDS: the concomitant use of indometacin with other NSAIDs is not recommended due to the increased possibility of gastro-intestinal toxicity, with little or no increase in efficacy.
Anticoagulants: although clinical studies suggest that indometacin does not influence the hypoprothrombinaemia induced by anticoagulants, patients also receiving anticoagulants should be closely observed for alterations of the prothrombin time.
Probenecid: co-administration of probenecid may increase plasma levels of indometacin.
Methotrexate: caution should be exercised with simultaneous use of indometacin with methotrexate. Indometacin has been reported to decrease the tubular secretion of methotrexate and to potentiate toxicity.
Cyclosporin: administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporin has been associated with an increase in cyclosporin-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporin, and renal function should be monitored carefully.
Lithium: indometacin 50 mg three times a day produced a clinically relevant elevation of plasma lithium and reduction in renal lithium clearance in psychiatric patients and normal subjects with steady-state plasma lithium concentrations. This effect has been attributed to inhibition of prostaglandin synthesis. As a consequence, when indometacin and lithium are given concomitantly, the patient should be observed carefully for signs of lithium toxicity. In addition, the frequency of monitoring serum lithium concentrations should be increased at the outset of such combination drug treatment.
Diuretics: in some patients, the administration of indometacin can reduce the diuretic and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when indometacin and diuretics are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Indometacin reduces basal plasma renin activity (PRA), as well as those elevations of PRA induced by frusemide administration, or salt or volume depletion. These facts should be considered when evaluating plasma renin activity in hypertensive patients.
It has been reported that the addition of triamterene to a maintenance schedule of indometacin resulted in reversible acute renal failure in two of four healthy volunteers. Indometacin and triamterene should not be administered together.
Indometacin and potassium-sparing diuretics each may be associated with increased plasma potassium levels. The potential effects of indometacin and potassium-sparing diuretics on potassium kinetics and renal function should be considered when these agents are administered concurrently.
Most of the above effects concerning diuretics have been attributed, at least in part, to mechanisms involving inhibition of prostaglandin synthesis by indometacin.
Cardiac glycosides/Digoxin: indometacin given concomitantly with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Therefore, when indometacin and digoxin are used concomitantly, serum digoxin levels should be closely monitored.
Antihypertensive medications: co-administration of indometacin and some antihypertensive agents may attenuate acutely the hypotensive effect of the latter, due partly to indometacin’s inhibition of prostaglandin synthesis. Therefore, caution should be exercised when considering the addition of indometacin to the regimen of a patient taking any of the following antihypertensive agents: alpha-adrenergic blocking agents, ACE inhibitors, beta-adrenergic blocking agents, diuretics, hydralazine, or losartan (an angiotensin II receptor antagonist).
Phenylpropanolamine: hypertensive crises have been reported due to oral phenylpropanolamine alone and, rarely, to phenylpropanolamine given with indometacin. This additive effect is probably due partly to indometacin’s inhibition of prostaglandin synthesis. Caution should be exercised when indometacin and phenylpropanolamine are administered concomitantly.
Corticosteroids: the risk of gastro-intestinal bleeding and ulceration associated with NSAIDs is increased when used with corticosteroids.
Mifepristone: NSAIDs and aspirin should be avoided until at least 8 to 12 days after administration of mifepristone.
Quinolone antibiotics: there have been reports that 4-quinolones may induce convulsions in patients with or without a history of convulsions; taking NSAIDs at the same time may also induce them.
ADVERSE DRUG REACTIONS:
CNS reactions – headaches, dizziness, light-headedness, depression, vertigo, and fatigue (including malaise and listlessness). Reactions reported infrequently include mental confusion, anxiety, syncope, drowsiness, convulsions, coma, peripheral neuropathy, muscle weakness, involuntary muscle movements, insomnia, psychiatric disturbances such as hallucinations, depersonalisation; and, rarely, paraesthesia, dysarthria, aggravation of epilepsy and Parkinsonism. These are often transient and disappear frequently with continued treatment or with reduced dosage. However, occasionally, severe reactions require stopping therapy.
Gastro-intestinal – the more frequent reactions are nausea, anorexia, vomiting, epigastric distress, abdominal pain, constipation, and diarrhoea. Others which may develop are ulceration – single or multiple – of oesophagus, stomach, duodenum or small or large intestine, including perforation and haemorrhage with a few fatalities having been reported; gastro-intestinal tract bleeding without obvious ulcer formation; and increased abdominal pain when used in patients with pre-existing ulcerative colitis. Reactions occurring infrequently are stomatitis; gastritis; flatulence; bleeding from the sigmoid colon – occult or from a diverticulum – and perforation of pre-existing sigmoid lesions (diverticula, carcinoma). Rarely, intestinal strictures (diaphragms) and intestinal ulceration followed by stenosis and obstruction has been reported. With suppositories, tenesmus and irritation of the rectal mucosa have occasionally been reported. Pancreatitis has been reported with an unknown frequency. Other gastro-intestinal side effects which may or may not be caused by indometacin include: ulcerative colitis and regional ileitis.
Hepatic – rarely, hepatitis and jaundice. (Some fatalities reported.)
Cardiovascular/Renal – oedema, increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, hypotension, congestive heart failure, blood urea elevation, and haematuria (all infrequent).
Dermatological/Hypersensitivity – pruritus, urticaria, angioneurotic oedema, angiitis, erythema nodosum, skin rash and photosensitivity, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, loss of hair, rapid fall in blood pressure resembling a shock-like state, acute anaphylaxis, acute respiratory distress including sudden dyspnoea, asthma and pulmonary oedema (all infrequent). Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
Haematological – infrequently, blood dyscrasias may occur, including leucopenia, petechiae or ecchymosis, purpura, aplastic and haemolytic anaemia, agranulocytosis, bone-marrow depression, disseminated intravascular coagulation, and particularly thrombocytopenia. Because some patients may develop anaemia secondary to obvious or occult gastro-intestinal bleeding, appropriate blood determinations are recommended.
Ocular – infrequently, blurred vision, diplopia, and orbital and peri-orbital pain. Corneal deposits and retinal disturbances, including those of the macula, have been reported in patients with rheumatoid arthritis on prolonged therapy, but similar changes may also be expected in patients with rheumatoid arthritis who have not received indometacin.
Aural – tinnitus, hearing disturbances (rarely deafness).
Genito-urinary – proteinuria, nephrotic syndrome, interstitial nephritis, and renal insufficiency including renal failure (all rare).
Miscellaneous – vaginal bleeding, hyperglycaemia, glycosuria, hyperkalaemia, flushing and sweating, epistaxis, breast changes including enlargement and tenderness, gynaecomastia, and ulcerative stomatitis (all rare).
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, email@example.com or clicking below button:
Indomethacin in Kenya
indomethacin 25 mg dosage
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Indomethacin in Kenya
Indomethacin in Kenya
Indomethacin in Kenya
Indomethacin in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: Oral, rectal, IV, topical
Bioavailability: ~100% (oral), 80–90% (rectal)
Protein Binding: 99%
Onset of Action: Not Available
Elimination Half life: 2.6-11.2 hours (adults), 12-28 hours (infants)
Excretion: Renal (60%), fecal (33%)
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This Drug is not Subject to DDA drugs Act
Dosage Forms | Strengths:
Capsules | Suppositories | Injectable | Topical
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