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ROFENAC
®
Antirheumatic, Anti-inflammatory, Analgesic
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COMPOSITION
Sodium-{0-[(2,6-dichlorophenyl)-amino]-phenyl}-acetate(Diclofenac
Sodium).
ROFENAC is available as an enteric coated tablets of 50mg, sustained
release 100mg tablets for oral administration, and as an ampoules
of 75 mg for intramuscular administration.
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PROPERTIES
ROFENAC
(Diclofenac) is a nonsteroidal compound with pronounced antirheumatic,
anti-inflammatory, analgesic and antipyretic properties. It inhibits
prostaglandin biosynthesis, which plays a major role in causing
inflammation, pain and fever.
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INDICATIONS
ROFENAC
is indicated in the treatment of :
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
- Non-articular rheumatism.
- Acute musculoskeletal disorders and back pain.
- Painful syndromes of the vertebral column.
- Relief of pain in acute trauma and fractures.
- Control of pain and inflammation in orthopedic, dental and other
surgeries.
- Painful inflammatory conditions in gynaecology and primary dysmenorrhea.
- Renal colic and biliary colic (ROFENAC ampoules are recommended).
- Acute attacks of gout. .
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DOSAGE
AND ADMINISTRATION
TABLETS: The dose
of ROFENAC should be adjusted to the patient's response and tolerance.
The usual recommended dose is 100-150 mg daily in divided doses
up to maximum of 200 mg daily. The tablets should be swallowed whole
with water or juice preferably before meals.
The dose of ROFENAC SR tablets 100 mg is usually 1 tablet daily.
If necessary the dosage can be increased to 150 mg daily by giving
a tablet of 50 mg in the morning.
AMPOULES: The dose is generally one ampoule daily administered by
deep intramuscular injection. In sever cases (e.g renal or biliary
colic) two injections can be given daily.
Alternatively, it is possible to combine one ampoule with the tablet
form of ROFENAC up to a maximum daily dose of 150 mg.
ROFENAC ampoules should not be given for more than 2 days, if necessary
the treatment can be continued with ROFENAC tablets.
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CONTRAINDICATIONS
Hypersensitivity to Diclofenac and to sulfite
excipient in case of ampoules, ROFENAC, Like other nonsteroidal
anti-inflammatory drugs, should not be given to patients with peptic
ulcer and to patients in whom aspirin induces asthma, acute rhinitis
and urticaria.
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PRECAUTIONS
ROFENAC (Diclofenac) should be used with caution
in patients with a history of cardiovascular disease as well as
in patients suffering from severe impairment of hepatic function.
Owing to the importance of prostaglandins for maintaining renal
blood flow, particular caution is called for when using ROFENAC
in cases of impaired cardiac or renal function, in patients being
treated with diuretics, and in those recovering from major surgical
operations. Like other non-steroidal anti-inflammatory drugs, ROFENAC
(Diclofenac) may trigger allergic reactions including anaphylaxis
even with patients receiving the product for the first time. ROFENAC
(Diclofenac) should be used during pregnancy only if the benefits
to the mother justify the potential risks to the fetus. Like other
prostaglandin inhibiting drugs, use of ROFENAC during late pregnancy
should be avoided. Diclofenac passes into the breast milk, but in
quantities so small that no undesirable effects on the infants are
to be expected. ROFENAC SR100 mg tablets should not be broken or
chewed. It should be swallowed with liquid and taken at meal times
if possible . Owing to high active substance content, ROFENAC SR
100 mg tablet is not suitable for children
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SIDE
EFFECTS
ROFENAC is generally well tolerated. The most
common side effects include gastrointestinal disturbances, headache
and dizziness, fluid retention, liver function disorder. Rashes
and pruritus have been reported.
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INTERACTIONS
Various nonsteroidal anti-inflammatory agents
are prone to inhibit to inhibit the activity of diuretics. Concomitant
treatment with potassium-sparing diuretics may be associated with
increased serum potassium levels, making it necessary to monitor
these levels. Patients taking Diclofenac and are also receiving
digoxin, methotrexate, cyclosporine or lithium should be observed
for potential development of the specific toxicities of these drugs.
Concomitant administration of other systemic nonsteroidal anti-inflammatory
agents or glucocorticoids may increases the occurrence of side effects.
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PRESENTATIONS
ROFENAC is available
as 50 mg tablets in packs of 20's and hospital packs of 500's and
1000 tablets and as 100 mg tablets SR in packs of 10 tablets.
ROFENAC is available as 75 mg /3ml ampoules in packs of 5 ampoules.
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