DEFLAM® 600 mg tablets

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

DEFLAM® 600 mg tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DEFLAM^® 600 mg tablets

COMPOSITION:
Each DEFLAM 600 mg tablet contains 600 mg oxaprozin. Chemically, oxaprozin is known as 4,5-diphenyl-2-oxazolepropionic acid.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 3.1 Anti-rheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Animal pharmacology:
DEFLAM (oxaprozin) has anti-inflammatory effects in animal models. Its mode of action is not fully established. However, DEFLAM (oxaprozin) does inhibit prostaglandin synthesis.

Clinical Pharmacology:
After oral administration, peak plasma levels of DEFLAM (oxaprozin) are attained in 2 to 4 hours. Plasma half-life in man, after multiple doses, is approximately 50 hours. At therapeutic levels, DEFLAM (oxaprozin) is more than 99% bound to the plasma proteins, mostly albumin.
Botransformation is the major determinant of the rate of clearance of DEFLAM (oxaprozin) from the Plasma. Approximately 60% to 70% of a single dose of DEFLAM (oxaprozin) is excreted in the urine and 30% to 35% is excreted in the faeces, mostly in the form of metabolites. Biliary excretion, measured in patients with cholecystectomy end T-tube drainage, accounts for 1% of daily DEFLAM (oxaprozin) clearance from the plasma. No further accumulation occurs with daily doses of 1200 mg. DEFLAM (oxaprozin) does not induce its own metabolism.

INDICATIONS:
DEFLAM (oxaprozin) is indicated for short- and long-term use in the relief of the signs and symptoms of:

1.	Rheumatoid arthritis.
2.	Osteoarthritis.
3.	Ankylosing spondylitis.
4.	Musculoskeletel disorders, such as acute painful shoulder (acute subacromial bursitis/suprespinatus tendinitis) and other painful acute peri-articular disorders.

Rheumatoid arthritis, Functional Class IV: The safety and effectiveness of DEFLAM (oxaprozin) have not been established in patients with rheumatoid arthritis designated as functional Class IV (incapacitated, largely or wholly bedridden, confined to wheelchair, little or no self-care).

CONTRA-INDICATIONS:
Hypersensitivity to DEFLAM (oxaprozin). DEFLAM (oxaprozin) should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory medicines induce the syndrome of asthma, rhinitis, nasal polyps, urticaria, angioedema, or bronchospasm.
Oxeprozin should not be given to patients with a history of or with active gastro-intestinal bleeding or peptic ulceration.

WARNINGS:
Peptic ulceration and overt gastro-intestinal bleeding, sometimes severe, have been reported in patients receiving DEFLAM (oxeprozin).
Both events are not always preceded by premonitory gastro-intestinal symptoms.
Patients with initial haemoglobin values of 10 g/100 mL or less, who are to receive long-term treatment, should be tested periodically for haemoglobin values.
Acute allergic reactions have been reported with non-steroidal anti-inflammatory agents. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
DEFLAM (oxaprozin) should be used with caution in patients with intrinsic coagulation effects, with severe trauma and in patients undergoing surgery as oxaprozin can inhibit platelet aggregation.
DEFLAM (oxaprozin) is predominantly excreted by the kidney. Its use in patients with renal impairment is not recommended. In the elderly, a lower dosage should be used and caution should be observed during treatment with oxaprozin.

DOSAGE AND DIRECTIONS FOR USE:
DEFLAM (oxeprozin) should be administered once or twice daily. Since food does not effect the bioavailability of DEFLAM (oxaprozin), the drug may be administered with meals. Dosage should be adjusted for optimal response as follows:

RHEUMATOID ARTHRITIS, ANKYLOSING SPONDYLITIS AND MUSCULOSKELETAL DISORDERS: 1200 mg in the morning, or as 600 mg in the morning and 600 mg in the evening.

OSTEO ARTHRITIS: 600 mg once daily. This may be increased to 1200 mg depending on the severity of symptoms.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse reactions that occur include:
Gastro-inlestinal: Abdominal pain/distress, nausea, vomiting, dyspepsia, diarrhoea, constipation, anorexia, flatulence, change in bowel habits, alteration in taste, salivation, dysphagia, eructation, alteration in liver function, gastro-intestinal bleeding, malaena, rectal pain.
Central nervous system: Tinnitus, dizziness, vertigo, nervousness, disturbance of sleep.
Genito-urinary tract: Dysuria.
Miscellaneous: Muscular cramps/aching, oedema, pruritis, rash, malaise, mass gain or loss, photosensitivity reactions, interstitial nephritis.
Other adverse reactions include oral ulcers, fatigue, angioedema, purpura, Stevens-Johnson syndrome.

Pregnancy and lactation:
The safety of DEFLAM (oxaprozin) in pregnant women has not been established.
DEFLAM (oxeprozin) is not recommended for use in nursing mothers, since many non-steroidal anti-inflammatory drugs have been shown to be partially excreted in breast milk.

Paediatric Use:
Oxeprozin is not recommended for use in children.

Drug Interactions:
Aspirin:
Concomitant administration of DEFLAM (oxaprozin) and aspirin, in clinically effective doses of each, is not recommended. Such combined administration produces decreased protein binding of DEFLAM (oxeprozin) with a reduced biological half-life, and increased clearance of DEFLAM (oxeprozin).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given symptomatic and supportive treatment, as long as necessary.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
The DEFLAM 600 mg tablet is white, film-coated, capsule-shaped, smooth on one side, “AKROMED”embossed on the other.

PRESENTATION:
DEFLAM 600 mg tablets are supplied in high density polyethylene containers, containing 20 or 60 tablets.

STORAGE DIRECTIONS:
Store in a cool (below 25°C), dry place; protect from sunlight.
Keep out of reach of children.

REGISTRATION NUMBER:
R/3.1/129

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
(Co. Reg. no. 05/13586/07)
Electron Avenue, ISANDO 1600
Trademark and product under licence from
WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

16 March 1987		NDC 8-6179
	Davbar Dbn.	349-502