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Logo TRAUMOX TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

TRAUMOX TABLETS

COMPOSITION:
Per tablet: 500 mg
naproxen

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

PHARMACOLOGICAL ACTION:
TRAUMOX has anti-inflammatory, antipyretic and analgesic properties. It inhibits prostaglandin synthetase.

INDICATIONS:
TRAUMOX is indicated for the treatment of rheumatoid arthritis, (including juvenile rheumatoid arthritis), osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute gout, acute musculosekeletal disorders (such as sprains and strains, direct trauma, limbrosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.

CONTRA-INDICATIONS:
Pregnancy. Active peptic ulceration.

Hypersensitivity to naproxen or naproxen sodium formulations. Since the potential exists for cross-sensitivity reactions, TRAUMOX should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic medicines induce urticaria, rhinitis or asthma.

WARNINGS:
Serious interaction have been reported after the use of high-dose methotrexate with TRAUMOX.

DOSAGE AND DIRECTIONS FOR USE:
Adults: For rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis, the starting dose and usual maintenance dose is in the range of 500 mg to 1 000 mg per day taken in two doses at twelve-hour intervals.

In the following cases a dose of 750 mg or 1 000 mg per day for the acute phase is recommended:

(a) in patients reporting severe night-time pain and/or morning stiffness;
(b) in patients being switched to TRAUMOX from a high dose of another anti-rheumatic compound and,
(c) in osteoarthrosis where pain is the predominant symptom.
For the patient who requires 750 mg per day whose night-time pain and/or morning stiffness are most troublesome, 500 mg should be taken upon retiring and 250 mg upon awakening. For the patient whose day-time pain and reduced mobility are most troublesome, 500 mg should be taken upon awakening and 250 mg upon retiring.

In acute gout, the recommended dosage is 750 mg at once, then 250 mg every eight hours until the attack has passed.

For the treatment of acute musculo-skeletal disorders, the recommended dosage is 250 mg twice or thrice daily; most patients will require only 7 days treatment, but some patients may require up to 14 days treatment.

In dysmenorrhoea, the recommended regime is 500 mg initially, followed by 250 mg every six to eight hours.

Children: For juvenile arthritis in children over 5 years of age the usual dosage is 10 mg per kg body-mass per day in two doses at twelve-hour intervals. TRAUMOX is not recommended for use in other indications in children under sixteen years of age.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Episodes of gastro-intestinal bleeding have been reported in patients on TRAUMOX therapy. TRAUMOX should be given under close supervision to patients with a history of gastro-intestinal disease.

Due to the high plasma protein binding of TRAUMOX patients simultaneously receiving hydantoins, anticoagulants or other highly protein-bound medicines should be observed for signs of potentiation or overdosage of these medicines. Probenecid given concurrently increases TRAUMOX plasma levels and extent its half-life considerably.

Skin rashes, urticaria and angio-oedema have been reported. Patients who have exhibited aspirin hypersensitivity in the past (usually as the angio-oedema/asthma syndrome) may exhibit the same phenomenon on TRAUMOX. Bronchospasm may be precipitated in patients suffering from, or with a previous history of brochial asthma or allergic disease. The following additional occurences have been reported with TRAUMOX nausea, vomiting, abdominal discomfort, constipation, epigastric distress, headache, cognitive dysfunction, inability to concentrate, visual disturbances, insomnia, tinnitus and vertigo. Thrombocytopenia, granulocytopenia, jaundice, aplastic anaemia, haemolytic anaemia, peptic ulceration, reversible renal failure, nephrotic syndrome and nephritis may occur.

Other side-effects include hearing impairment, fatal hepatitis and ulcerative stomatitis, anaphylactic reactions and eosinophilic pneumonitis may occur.

Sporadic abnormalities in laboratory tests (e.g. liver function tests) have occured in patients on TRAUMOX therapy. This effect should be kept in mind when bleeding times are determined. It is suggested that TRAUMOX therapy be temporarily discontinued 48 hours before adrenal function tests are preformed, because TRAUMOX may interfere with some assays of urinary 5-hydroxy-indoleacetic acid.

Mild peripheral oedema has been observed in a few patients receiving TRAUMOX. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or compromised cardiac function may be at greater risk when taking TRAUMOX.

Use in patients with renal impairment
As naproxen is eliminated to a large extent (95%) by urinary exretion via glomerular filtration it should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients. TRAUMOX is not recommended in patients having baseline clearance less than 20 mL/minute.

Certain patients, specifically those where renal blood flow is comprised, such as in extracellular volume depletion, cirrhosis of the liver, sodium restriction, congestive heart failure and pre-existing renal disease, should have renal function assessed before and during TRAUMOX therapy. Elderly patients in whom impaired renal function may be expected could also fall within this category. A reduction in daily dosage is recommended to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.

Use in patients with impaired liver function
Chronic alcoholic liver disease and probably also other forms of cirrhosis reduce the total plasma concentration of naproxen, but the plasma concentration of unbound naproxen is increased. Caution is advised when using TRAUMOX in patients with hepatic diseases.

Use in the elderly
Although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised and lower doses might be required.

TRAUMOX can reduce the anti-hypertensive effect of propranolol and possibly other beta-blockers.

The natriuretic effect of frusemide has been reported to be inhibited by TRAUMOX.

Inhibition of renal lithium clearance leading to increases in plasma lithium concentrations has been reported.

The use of TRAUMOX should be avoided in patients who are breast-feeding.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Significant overdosage of the drug may be characterised by drowsiness, heartburn, indigestion, nausea and vomiting. Should a patient ingest a large amount of naproxen accidentically or purposefully, the stomach may be emptied and the usual supportive measures employed.

IDENTIFICATION
500 mg Tablets: Yellow, biconvexed, scored tablets.

PRESENTATION:
Securitainers containing 10, 30, 100, 250 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
A27/3.1/0202

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Unit 9 & 10 Rosen Heights
Pasita Street
ROSENPARK
7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

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