Dilofenac Sodium is a potent non-steroidal
anti-inflammatory drug (NSAID) with pronounced anti-rheumatic,
anti-inflammatory, analgesic and antipyretic properties. It has also some
uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin
biosynthesis which plays a major role in causing inflammation, pain and fever.
Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract
when taken with or after meal. Peak plasma concentrations are reached within an
average of 2 hours after ingestion of it. At therapeutic concentrations, it is
99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and
undergoes first pass metabolism.
Diclofenac FC Tablet: Adults: 75-150 mg
daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in
long term use.
Diclofenac SR Tablet:
Diclofenac Dispersible Tablet:
Diclofenac TR Capsule: One capsule daily.
Diclofenac TR should be taken preferably after mealtimes.
Diclofenac Suppository:
For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.
Diclofenac injection:
For adults the usual dose is 1 ampoule daily. In serious cases this dose may be
increased up to 2 ampoules daily.
Diclofenac Gel: For
external use only. Depending on the size of area to be treated, 2-4 g of
Diclofenac gel should be applied to the skin 3-4 times daily. To the affected
area gel should be rubbed in lightly. This gel may also be given in addition to
further treatment with other dosage forms of Diclofenac.
Contraindicated to the patients hypersensitive
to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac
like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated
in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis
are precipitated by acetylsalicylic acid or by other drugs with prostaglandin
synthetase inhibitor. This Gel should not be used under occlusive airtight
dressings.
Diclofenac Sodium is generally well tolerated.
Adverse effects are mild, rare and transient. At the starting of the treatment,
however, patients may be sometimes complaining of epigastric pain, eructation,
nausea and diarrhea or dizziness or headache. These effects are usually mild in
nature. Peripheral edema and skin reactions, such as rash and eczema have also
been encountered. Diclofenac Sodium Gel may cause local irritation and
reddening of the skin and skin rash.
During pregnancy, Diclofenac should be employed
only for compelling reasons. The lowest effective dose should be used. These
types of drugs are not recommended during the first trimester of pregnancy. In
view of insufficient clinical data, Diclofenac Sodium Gel is not recommended
during pregnancy. A very insignificant quantity of Diclofenac may be detected
in breast milk but no undesirable effects on the infant to be expected.
In rare instances where peptic ulceration or
gastrointestinal bleeding occurs in patients under treatment with Diclofenac.
In patients with advanced age should be kept under close observation.
Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or
mucus membranes, after application the hands should be washed properly and not
to be taken by mouth.
Drugs for Osteoarthritis, Drugs used for
Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Store in a cool and dry place, protected from
light. Store below 30°C. Keep out of the reach of children.