Indometacin 100 mg, 10 rectal suppositories

Trade Name:

Indometacin 100 mg

10 rectal suppositories

Composition:

Indometacin 100 mg

Inactive ingredients:

Suppocire NAS 50, Myrj 52(polyaxial 40 stearate)

Properties:

Pharmacotherapeutic group: Antiinflammatory and Antirheumatic Products, Non-Steroids, ATC code: M01AB01

Indometacin has anti-inflammatory, antipyretic, and analgesic effects, it is an inhibitor of prostaglandin synthetase.

Indications:

Non-steroidal anti-inflammatory agent indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, degenerative joint disease of the hip, low-back pain, and acute gouty arthritis.

Also indicated in inflammation, pain and oedema following orthopedic procedures; and the treatment of pain and associated symptoms of primary dysmenorrhoea.

Indometacin Suppositories may be used where night pain and morning stiffness are prominent. 

Dosage and administration:

The dosage of indometacin should be carefully adjusted to suit the needs of the individual patient.

Adults:

One suppository to be inserted once or twice a day. One should be used at bedtime. If another is necessary, it should be used in the morning.

Elderly:

Indometacin should be used with particular care in older patients who are more prone to adverse reactions.

Pediatric population:

The safety and efficacy of Indometacin in children has not yet been established.

Side effects:

–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 diarrhea. Others which may develop are ulceration – single or multiple – of esophagus, 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 anemia secondary to obvious or occult gastro-intestinal bleeding, appropriate blood determinations are recommended.

–Ocular: infrequently, blurred vision, diplopia, and orbital and periorbital 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).

–The following adverse reactions have been associated with use of Indometacin Suppositories: tenesmus; proctitis; rectal bleeding, burning, pain, discomfort, and itching.

Contraindications:

–Hypersensitivity to the active substances or to any other ingredients

–History of peptic ulcer or active peptic ulcer

–Recurrent history of gastro-intestinal lesions

–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

–Patients with a history of proctitis or recent rectal bleeding

–During the third trimester of pregnancy or lactation

Warnings and precautions:

Indometacin may have a reversible inhibitory effect on women’s ovulation. The use of Indometacin may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Indometacin should be considered.

• Headache, sometimes accompanied by dizziness and light-headedness, may occur, usually early in treatment. Starting therapy with a low dosage and increasing it gradually will usually minimize the incidence of headache. These symptoms frequently disappear on continuing therapy or reducing the dosage, but if headache persists despite dosage reduction, indometacin should be withdrawn. Patients should be warned that they may experience dizziness and, if they do, should not drive a car or undertake potentially dangerous activities needing alertness.
• Indometacin should be used cautiously in patients with a history of bronchial asthma and in patients with psychiatric disorders, epilepsy, or parkinsonism, as Indometacin may tend to aggravate these disorders.
• Single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small or large intestine, have been reported to occur with Indometacin.  Fatalities have been reported in some instances. Rarely, intestinal ulceration has been associated with stenosis and obstruction.
• NSAIDs should only be given with caution to patients with a history of gastro-intestinal disease.
• Gastro-intestinal bleeding without obvious ulcer formation and perforation of pre-existing sigmoid lesions (diverticulum, carcinoma, etc.) have occurred. Increased abdominal pain in ulcerative colitis patients or the development of ulcerative colitis and regional ileitis have been reported to occur rarely.
• Fluid retention and peripheral oedema have been observed in some patients taking Indometacin. It should therefore be used with caution in patients with cardiac dysfunction, hypertension or other conditions predisposing to fluid retention.
• Tenesmus and irritation of the rectal mucosa have been reported occasionally with Indometacin Suppositories.
• Indometacin may mask the signs and symptoms of infection. Indometacin should be used with caution in patients with existing but controlled infection.
• In patients with rheumatoid arthritis, eye changes may occur which may be related to the underlying disease or to the therapy. Therefore, in chronic rheumatoid disease, ophthalmological examinations at periodic intervals are recommended. Discontinue therapy if eye changes are observed.
• Patients should be periodically observed to allow early detection of any unwanted effects on peripheral blood (anemia), liver function, or gastro-intestinal tract.
• Indometacin can inhibit platelet aggregation. This effect usually disappears within 24 hours of discontinuing indometacin. Bleeding time is prolonged (but within normal range) in normal adults. Because this effect may be exaggerated in patients with underlying haemostatic defects, indometacin should be used cautiously in patients with coagulation defects.
• As with other non-steroidal anti-inflammatory drugs, there have been reports of acute interstitial nephritis with haematuria, proteinuria, and occasionally nephrotic syndrome in patients receiving long-term administration of Indometacin.
• In patients with reduced renal blood flow where renal prostaglandins play a major role in maintaining renal perfusion, administration of a non-steroidal anti-inflammatory agent may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with renal or hepatic dysfunction, diabetes mellitus, advanced age, extracellular volume depletion, congestive heart failure, sepsis, or concomitant use of any nephrotoxic drug. A non-steroidal anti-inflammatory drug should be given with caution and renal function should be monitored in any patient who may have reduced renal reserve. Discontinuation of non-steroidal anti-inflammatory therapy is usually followed by recovery to the pretreatment state.
• Increases in plasma potassium concentration, including hyperkalaemia, have been reported, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.
• Since Indometacin is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored; a lower daily dosage should be used to avoid excessive drug accumulation.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds a strip of 10 suppositories and paper instructions