Voren, the brand of Diclofenac Sodium, is an anti-inflammatory, analgesic
and antipyretic agent. Chemically it is Sodium a - [0-(2,6 dichloroanilino)phenyl] acetate.
Each capsule contains:
Diclofenac Sodium Pellets ..........165mg
(eq. to Diclofenac Sodium ..........50mg)
Pharmacology (Summary of Pharmacodynamic and Pharmacokinetics)
1. Diclofenac Sodium is a nonsteroidal, anti-inflammatory agent. It has a
potent anti-inflammatory, analgesic and antipyretics activities. Its mode of
action includes potent cyclo-oxygenase inhibition and enhances uptake of
arachidonic acid into cellular triglyceride pools, resulting in a dual
effect on the cyclo-oxygenase and lipoxygenase pathways.
Sodium exhibits very marked anti-rheumatic, anti-inflammatory, analgesic and
antipyretics properties and is thus suitable for use in inflammatory and
degenerative rheumatism disease, as well as for the treatment of rheumatoid
arthritis and other rheumatic disorders.
3. Diclofenac Sodium interacts with the arachidonic acid cascade at the
level of cyclo-oxygenase so that Diclofenac Sodium prevents the formation of
thromboxanes, prostaglandin and prostacycline.
4. Diclofenac Sodium is a non-steroid-type of anti-inflammatory agent and
is widely used clinically because of its strong analgesics, antipyretics and
5. Like many other NSAIDs, diclofenac is highly bound to plasma protein,
mainly albumin and the degree of binding has been shown to be > 99.5%.
6. Diclofenac entered the synovial fluid quickly, since the mean 2 hours
synovial concentration was approximately 2/3 that in plasma (197 and 293 µg.L-1
respectively) and diclofenac persisted in the synovial fluid much longer
(mean 7 hours concentration 205µg.L-1) compared with plasma (52µg.L-1).
7. Diclofenac Sodium undergoes extensive biotransformation in the liver
during the first passage through which about 50% is metabolized.
Approximately 1/3 of the dose is excreted in the bile and approximately 2/3
via the kidney in the form of glucuronides. The mean terminal elimination
half-life of Diclofenac Sodium is 1.2 to 1.8 hours and metabolite possesses
about 1/30 of the antiinflammatory activity of parent drug (Diclofenac
8. In order to eliminate the gastrointestinal adverse effects of
Diclofenac Sodium, effective enteric-coated products were developed by Yung
Shin Pharmaceutical. Advantages of Diclofenac Sodium in Enteric
Microencapsulated capsules includes ready distribution over a large surface
area, thus minimizing the risk of local damage caused by the dumping effects
of the enteric-coated tablets.
Furthermore diclofenac enteric-microencapsulated capsules are also less
dependent on gastric transit time. They may attain more constant plasma
level, achieve slow release effect, give higher accuracy in reproducibility
between doses, and provide less decrease in bioavailability.
Inflammatory and degenerative forms of rheumatism; rheumatoid arthritis,
ankylosing spondylitis, osteoarthritis and spondyl arthritis. Non-articular
rheumatism, post traumatic inflammation and swelling.
Dosage and Administration
The usual adult dose is 1 capsule, twice daily.
To be dispensed on physician's prescription.
After assessing the risk/ benefit ratio in each individual patient, the
lowest effective dose for the shortest possible duration should be used.
1. Diclofenac Sodium should not be used in aspirin-sensitive patients,
because of the likelihood of the production of asthma rhinitis and dyspnoea
in patients who exhibits these symptoms when receiving aspirin.
2. It is contraindicated in patient with active peptic ulcer as
gastrointestinal bleeding has been reported.
Side Effect(s) / Adverse Reaction(s)
Gastrointestinal side effects are the most frequent adverse effects of
Nervous system side effects are headache, insomnia, somnolence and
Renal toxicity, edema, skin rashes, palpitation, minor hearing disorders
Thrombocytopenia and eosinophilia may occur rarely.
Occasional: rashes or skin eruptions
Cases of hair loss, bullous eruption, erythema multiforme, Stevens
Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and
photosensitivity reactions have been reported.