Generic

Indications

Tenoxicam is indicated for the symptomatic treatment of the following painful inflammatory and degenerative disorders of the musculoskeletal system:

• Rheumatoid arthritis.
• Osteoarthritis.
• Arthrosis.
• Ankylosing spondylitis.
• Extra-articular disorders, e.g. tendinitis, bursitis, periarthritis of the shoulders (shoulder-hand syndrome) or hips, strains, and sprains.
• Acute gout.

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Pharmacology

Tenoxicam may be a non-steroidal anti-inflammatory medicate (NSAID) with anti-inflammatory, pain relieving and antipyretic properties and it too restrains platelet conglomeration. Tenoxicam hinders prostaglandin biosynthesis. In-vitro tests of leukocyte peroxidase propose that tenoxicam may act as a forager for dynamic oxygen at the location of aggravation. Tenoxicam may be a strong in-vitro inhibitor of human metalloproteinases (stromelysin and collagenase), which induce cartilage breakdown. These pharmacological impacts clarify, at slightest in portion, the helpful advantage of Tenoxicam within the treatment of difficult incendiary and degenerative disarranges of the musculoskeletal framework. Tenoxicam appeared no mutagenic, carcinogenic or teratogenic impacts in creatures. As with other prostaglandin inhibitors, renal and gastrointestinal impacts, expanded rate of dystocia and postponed parturition were watched in creature security thinks about.

Administration & Dosage

Standard dosage: For all indications except acute gout, a daily dosage of 20 mg should be given at the same time of day.

In acute attacks of gout: The recommended dose for acute attacks of gout is 40 mg once daily for two days followed by 20 mg once daily for a further five days.

In the treatment of chronic disorders: The therapeutic effect of tenoxicam is evident early in treatment but there is a progressive increase in response over time. In chronic disorders, daily doses higher than 20 mg should be avoided since this would increase the frequency and intensity of unwanted reactions without significantly increasing efficacy. For patients needing long-term treatment, a reduction to a daily oral dose of 10 mg may be tried for maintenance.

Interaction

As within the case of other NSAIDs, salicylate uproots tenoxicam from protein-binding locales and increments clearance and volume of dissemination of tenoxicam. Concurrent treatment with salicylate or other NSAIDs ought to be dodged since of expanded chance of gastrointestinal undesirable responses. The co-administration of a few NSAIDs and methotrexate has been related with diminished renal tubular emission of methotrexate, higher plasma concentrations of methotrexate, and serious methotrexate harmfulness. In this manner, caution ought to be worked out when Tenoxicam is managed concurrently with methotrexate. No clinically relevant interaction was found within the little number of patients accepting concomitant treatment with gold, penicillamine or probenecid. As Tenoxicam may diminish the renal clearance of lithium, their concomitant organization may lead to expanded plasma levels and harmfulness of lithium. The plasma levels of lithium ought to be closely observed.

Contraindications

Tenoxicam must not be administered to patients:

• known to be hypersensitive to the drug;
• in whom salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs) induce symptoms of asthma, rhinitis, or urticaria;
• suffering or having suffered from the disease of the upper gastrointestinal tract, such as gastritis, gastric and duodenal ulcer.

Side Effects

Based on clinical trials including large numbers of patients, Tenoxicam proved to be well tolerated in the recommended dose. Usually, the undesirable effects reported were mild and transient. In a small proportion of patients, the interruption of treatment due to undesirable effects was necessary. Local tolerance of Tenoxicam given parenterally was good. The following undesirable effects have been reported:

Frequency is greater than 1%-

• Gastrointestinal tract: gastric, epigastric and abdominal discomfort, dyspepsia, heartburn, nausea.
• Central nervous system: dizziness, headache.Frequency less than 1%-
  • Gastrointestinal tract: constipation, diarrhea, stomatitis, gastritis, vomiting, ulcers, Gl-bleeding including hematemesis and melena.
  • Central nervous system: fatigue, sleep disturbances, appetite loss, dry mouth, vertigo.
  • Skin: itching (also in the anal region after rectal administration), erythema, exanthema, rash, urticaria.
  • Urinary tract and kidneys: increase in BUN or creatinine, edema.
  • Liver and biliary tract: increased liver enzyme activity.
  • Cardiovascular system: palpitations.Isolated cases (frequency less than 0.01%)-
    • Gastrointestinal tract: Gl-perforation.
    • Central nervous system: visual disturbances.
    • Skin: Stevens-Johnson and Lyell’s syndrome, photosensitivity reaction, vasculitis.
    • Blood: anemia, agranulocytosis, leukopenia, thrombocytopenia.
    • Hypersensitivity reactions: dyspnea, asthma, anaphylaxis, angioedema.
    • Cardiovascular system: elevated blood pressure, mainly in patients treated with cardiovascular drugs.
    • Liver/Biliary tract: hepatitis.

Pregnancy & Lactation

NSAIDs have an inhibitory effect on prostaglandin synthesis and, when given during late pregnancy, may cause the closure of the fetal ductus arteriosus, prolong labor and delay parturition. Treatment during the third trimester of pregnancy should be avoided. Based on findings from single-dose administration, a very small amount (approximately 0.2%) of tenoxicam passes into breast milk. There is no evidence of adverse reactions in breast-fed infants of mothers taking Tenoxicam. Nevertheless, infants should be weaned or the drug discontinued.

Precautions & Warnings

NSAIDs repress renal prostaglandin union and thus may have an undesirable impact on renal hemodynamics and on salt and water adjust. It is essential to enough screen the persistent with a uncommon accentuation on cardiac and renal work (BUN, creatinine, advancement of edema, weight pick up, etc.) when giving Tenoxicam to patients with conditions that may increment their hazard of creating renal disappointment, such as pre-existing renal infection, disabled renal work in diabetics, hepatic cirrhosis, congestive heart disappointment, volume exhaustion or concomitant treatment with possibly nephrotoxic drugs, diuretics and corticosteroids. Tenoxicam represses platelet accumulation and may influence hemostasis. Tenoxicam has no critical impact on blood coagulation variables, coagulation time, prothrombin time or actuated thromboplastin time.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

Protect from light and moisture by storing below 30°C. Keep the medicine out of children’s reach.

Pharmaceutical Name