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

Logo COMPU NAPROXEN 250

SCHEDULING STATUS:
S3
S2 - See indications below

PROPRIETARY NAME
(and dosage form):

COMPU NAPROXEN 250

COMPOSITION:
250 mg
Naproxen per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
COMPU NAPROXEN 250 has anti-inflammatory, antipyretic and analgesic properties. It inhibits prostaglandin synthetase.

INDICATIONS:
Schedule 3
COMPU NAPROXEN 250 is indicated for the treatment of rheumatoid arthritis, (including juvenile rheumatoid arthritis), osteoarthrosis (degenerative arthritis), ankylosing spondylitis, gout, acute musculoskeletal disorders (such as sprains and strains, direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis) and dysmenorrhoea.

Schedule 2
Emergency treatment of acute gout attacks. Treatment of post traumatic conditions such as pain, swelling and inflammation, for a maximum period of 5 days.

CONTRA-INDICATIONS:
Pregnancy. Active peptic ulceration.
Sensitivity to naproxen or naproxen sodium formulations. Since the potential exist for cross-sensitivity reactions.

COMPU NAPROXEN 250 should not be given to patients in whom aspirin or other nonsteroidal anti-inflammatory / analgesic medicines induce urticaria, rhinitis or asthma.

WARNINGS:
Serious interaction have been reported after the use of high-dose methotrexate with COMPU NAPROXEN 250.

DOSAGE AND DIRECTIONS FOR USE:
Adults: For rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis, the starting dose and sole maintenance dose is in the range of 500 mg to 1000 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 COMPU NAPROXEN 250 from a high dose of another antirheumatic compound and,

c) in osteoarthrosis where pain is the predominant symptoms.

For the patients 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 patients 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.

COMPU NAPROXEN 250 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 COMPU NAPROXEN 250 therapy. COMPU NAPROXEN 250 should be given under close supervision to patients with a history of gastro-intestinal disease.

Due to the high plasma protein binding of COMPU NAPROXEN 250 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 COMPU NAPROXEN 250 plasma levels and extent its half life considerably.

Skin rashes, urticaria and angio-oedema have been reported. Patients who have exhibited aspirin sensitivity in the past (usually as the angio-oedema / asthma syndrome) may exhibit the same phenomenon on COMPU NAPROXEN 250. Bronchospasm may be prescipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease.

The following additional occurences have been reported with COMPU NAPROXEN 250 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 oesinophilic pneumonitis may occur.

Sporadic abnormalties in laboratory test (eg. liver function tests) have occurred in patients on COMPU NAPROXEN 250 therapy. This effect should be kept in mind when bleeding times are determined.

It is suggested that COMPU NAPROXEN 250 therapy be temporarily discontinued 48 hours before adrenal function tests are performed, because COMPU NAPROXEN 250 may interfere with some assays of urinary 5-hydroxy-indo-leacetic acid.

Mild peripheral oedema has been observed in a few patients receiving COMPU NAPROXEN 250. Although sodium retention has not been reported in metabolic studies, it is possible that patients with questionable or comprised cardiac function may be at greater risk when taking COMPU NAPROXEN 250.

Use in patients with renal impairment:
As naproxen is eliminated to a large extent (95%) by urinary excretion 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. COMPU NAPROXEN 250 is not recommended in patients having baseline clearance less than 20 mL / minute.

Certain patients, specifically those whose renal blood flow is compromised, 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 COMPU NAPROXEN 250 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 COMPU NAPROXEN 250 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. COMPU NAPROXEN 250 can reduce the anti-hypertensive effect of propranolol and possibly other beta-blockers.
The natriuretic effect of furosemide has been reported to be inhibited by COMPU NAPROXEN 250.
Inhibition of renal lithium clearance leading to increases in plasma lithium concentration has been reported.
The use of COMPU NAPROXEN 250 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 accidentally or purposefully, the stomach may be emptied and the usual supportive measures employed.

IDENTIFICATION:
250 mg Tablets: Yellow, biconvex, scored tablets.

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

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

REGISTRATION NUMBER:
27/3.1/0573

NAME AND BUSINESS ADDRESS OF APPLICANT:
Compu Pharmaceutical Products Limited
476 Kings Highway
Lynwood
Pretoria

DATE AND PUBLICATION OF THIS PACKAGE INSERT:
4 April 1997

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