INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TOBITIL Tablets

SCHEDULING STATUS:
S3 As per indications listed below
S2 As per indications listed below

PROPRIETARY NAME
(and dosage form):

TOBITIL Tablets

COMPOSITION:
Each film coated tablet contains:
Tenoxicam 20 mg

PHARMACOLOGICAL CLASSIFICATION:
A3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Mechanism of Action

Tenoxicam is a non steroidal anti-inflammatory agent. Non steroidal anti-inflammatory agents inhibit the activity of enzyme cyclo-oxygenase, resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid.
The antirheumatic effect of tenoxicam is via analgesic and anti-inflammatory mechanisms, the analgesic action of tenoxicam may be due to blockade of pain impulse generation via a peripheral action, that may involve prostaglandin inhibition.
Pharmacokinetics
Tenoxicam is well absorbed after oral administration. Presence of food delays the absorption of tenoxicam. With 20 mg tenoxicam dose, peak plasma concentration of 1,46 to 3,31 mcg/mL are obtained in about 1,25 hours. Tenoxicam is over 98,5% bound to plasma proteins and penetrates synovial fluid. The elimination half-life is about 60 to 75 hours. Tenoxicam is completely metabolised to inactive metabolites. About 66% of the dose is excreted through the renal route and about 17% of the dose through the biliary/faecal route.

INDICATIONS:
S3 TOBITIL is indicated for symptomatic treatment of
Rheumatoid arthritis
Osteoarthritis
Ankylosing spondylitis
Tendinitis, bursitis, periarthritis and acute gouty arthritis
Primary dsysmenorrhoea
S2 Emergency treatment of acute gout attacks, treatment ofpost-traumatic conditions such as swelling and inflammation for a maximum period of 5 days.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
History of severe allergic reactions( or anaphylaxis or angioedema induced by aspirin or other NSAIDs
Aspirin induced nasal polyps associated with bronchospasm.
The safety in pregnancy and lactation has not been established.
No information is available on the relationship of age to the effects of tenoxicam in paediatric patients. Safety, efficacy and appropriate dosages have not been established.

WARNINGS:
Patients sensitive to one of the non-steroidal anti-inflammatory agents (NSAIDs) may be sensitive to any of the other NSAIDs also.
Tonoxicam may cause bronchoconstriction or anaphylaxis in aspirin-sensitive asthmatics especially those with aspirin induced nasal polyps.

DOSAGE AND DIRECTIONS FOR USE:
Usual Adult dose:
20 mg once a day orally at the same time each day.
Usual Adult Prescribing Limits:
20 mg per day. Higher doses may increase the risk of adverse effects without providing a significantly greater therapeutic response.
Usual Paediatric Dose:
Children up to 16 years of age. Dosage has not been established.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Hypersensitivity reactions:
Angioedema, bronchospastic allergic reactions. Less frequently hepatotoxicity and aseptic meningitis Fever and rashes.
Dermatologic Effects:
Allergic dermatitis (itching, skin rash, hives etc.), photosensitive orphotoallergic dermatologic reactions, Stevens-Johnson Syndrome.
Gastrointestinal Effects:
Glossitis, aphthous stomatitis, decreased appetite, abdominal distension, dysphagia, oesophagitis, gastritis, gastrointestinal bleeding, hepatitis, jaundice, nausea, vomiting.
Hematologic Effects:
Anaemia, leucopenia, thrombocytopenia with or without purpura, agranulocytosis, neutropenia.
Cardiovascular Effects
Fast heart beat, flushing or hot flushes, increased sweating, pounding heart beat, unexplained nose bleeding, pulmonary edema, increased blood pressure.
Central Nervous System Effects:
Headache, dizziness, light headedness or vertigo, nervousness or irritability, mental confusion, depression, tinnitus, insomnia, fatigue.
Genitourinary Effects:
Cystitis, hematuria, dysuria, incontinence, proteinuria, polyuria, renal impairmentP or failure.
Ophthalmic Effects:
Conjunctivitis, blurred or double vision, changes in visual colour perception and toxic amblyopia.
Otic Effects:
Ringing or buzzing in ears, decreased hearing or any change in hearing.
Other side-effects:
Abnormalities in liver function tests.
Precautions
General
TOBITIL should not be given to patients with active peptic ulcer disease or gastrointestinal bleeding. However, if treatment with this medication is unavoidable, an antiulcer regimen should be administered concurrently.
TOBITIL may mask the usual signs of infection. It should be given with care to the elderly, patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease and in liver or renal failure. Care is also necessary in patients receiving coumarin anticoagulants. TOBITIL should be discontinued in patients who experience blurred or diminished vision or changes in colour vision.
Geriatrics
The risk of hyperkalemia may be increased in elderly patients.
Dental
Tenoxicam may cause soreness, irritation or ulceration of the oral mucosa.
Interactions
Paracetamol:
Prolonged concurrent use with tenoxicam may increase the risk of adverse renal effects.
Anticoagulants or Thrombolytic Agents:
Inhibition of platelet aggregation by tenoxicam and possibility of NSAID induced gastrointestinal ulceration or bleeding may be hazardous to patients receiving antico-agulant thrombolytic therapy.
Oral antidiabetic agents and Insulin:
Tenoxicam may increase the hypoglycaemic effects of these agents.
NSAIDs:
Concurrent use of tenoxicam and another NSAIDs may increase the risk of gastrointestinal toxicity including ulceration or hemorrhage without providing additional symptomatic relief.
Cefamandole, Cefoperazone, Cefotetan, Plicamycin, Valproic acid.
These medicines are likely to cause hypoprothombinemia. Thus concurrent use with tenoxicam may increase risk of bleeding because of interferences with platelet function and/or the potential occurence of NSAID-induced gastro-intestinal ulceration or hemorrhage.
TOBITIL should not be administered concurrently with potassium-sparing diuretics, lithium or methotrexate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment is symptomatic and supportive.

IDENTIFICATION:
Mustard-yellow, round, biconvex, film coated tablets with 'TLT’embossed on one side and having a bisecting line on the other side.

PRESENTATION:
Carton containing 10 tablets in blister strips.
Carton containing 3 x 10 tablets in blister strips.
Carton containing 10 x 10 tablets in blister strips.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/3.1/0608

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
BRYANSTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1997

                PLTT032

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