Istotosal

Uses

Istotosal is used for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, and extra-articular inflammations such as tendinitis, bursitis and periarthritis of the shoulders or hips. It is also used for musculoskeletal & postoperative pain and in primary dysmenorrhea.

Istotosal is also used to associated treatment for these conditions: Backache, Osteoarthritis (OA), Pain, Rheumatoid Arthritis

How Istotosal works

The antiinflammatory effects of tenoxicam may result from the inhibition of the enzyme cycooxygenase and the subsequent peripheral inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, their inhibition accounts for the peripheral analgesic effects of tenoxicam. Antipyresis may occur by central action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat loss.

Dosage

Istotosal dosage

For all indications (except primary dysmenorrhea, post-operative pain and acute gout) the usual recommended dose is 20 mg once daily. Istotosal should be taken at the same time of day; in case of rheumatoid arthritis Istotosal should be taken at night to relieve the morning stiffness. The recommended dose for primary dysmenorrhea is 20 to 40 mg once daily. For post-operative pain the recommended dose is 40 mg once daily up to five days and for acute attacks of gout the recommended dose is 40 mg once daily for two days followed by 20 mg once daily for a further five days.

Istotosal is not recommended for use in patients under 16 years of age.

Side Effects

Istotosal is well tolerated in the recommended doses. The usual side effects are mild and transient gastric, abdominal discomfort, dyspepsia, heartburn, nausea, dizziness, headache, itching, erythema, rash, urticaria, increase in BUN or creatinine, edema and palpitations. In isolated cases GI-perforation, asthma, angioedema and elevated blood pressure may occur.

Precaution

Caution should be exercised in patients have symptoms of gastrointestinal diseases. If peptic ulceration or gastrointestinal bleeding occurs, Istotosal should be immediately withdrawn. It is necessary to adequately monitor the patient with increased risk of developing renal failure, impaired renal function in diabetics, hepatic cirrhosis and congestive heart failure. Patients having coagulation disorders or receiving therapy that interferes with haemostasis should, however, be carefully observed when treated with Istotosal. In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of Istotosal should be considered.

Interaction

Salicylates increase the clearance and volume of distribution of Istotosal by displacing it from protein binding sites. Concurrent treatment with salicylate or other NSAIDs is not recommended because of increased risk of undesirable reactions. Co-administration of Istotosal and methotrexate has been associated with reduced renal tubular secretion of methotrexate. As with NSAIDs in general, Istotosal should not be administered concurrently with potassium sparing diuretics. Istotosal might attenuate the antihypertensive effects of adrenergic blockers and ACE-inhibitors. It may also enhance the effect of antidiabetic drug (sulphonylurea group).

Food Interaction

• Take with food. Food may minimize stomach upset caused by tenoxicam.

Elimination Route

Oral absorption of tenoxicam is rapid and complete (absolute bioavailability 100%).

Half Life

72 hours (range 59 to 74 hours)

Pregnancy & Breastfeeding use

The safety of Istotosal during pregancy has not been established therefore it should be used with caution during pregnancy and only if the benefit to the mother is greater than the risk of the fetus. There is no information available about the safety of Istotosal during breastfeeding therefore it should not be used during lactation.

Contraindication

Istotosal should not be administered to patients with active peptic ulcer or active inflammatory diseases of the gastrointestinal tract. Istotosal is contraindicated in patients who have shown hypersensitivity to the drug. It should not be used in patients in whom acute asthmatic attacks, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents. Fatal anaphylactoid reactions have occurred in such individuals. Before anesthesia or surgery, Istotosal should not be given to elderly patients, to patients at risk of renal failure, or to patients with increased risk of bleeding, because of an increased risk of acute renal failure and possibility of impaired hemostasis. Istotosal is relatively contraindicated in patients with liver dysfunction.

Acute Overdose

Although there is no experience of acute overdosage with Istotosal. Overdose should be countered by reducing absorption (eg. gastrolavage and charcoal) and speed up elimination (eg. cholestyramine).

Storage Condition

Store in cool and dry place, away from children.

Innovators Monograph

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