Artifen (Diclofenac Sodium)

            Artifen (Diclofenac sodium)

Artifen (Diclofenac Sodium) 

Artifen (Diclofenac Sodium)

DESCRIPTION:
Diclofenac sodium is a phenylacetic acid derivative which has analgesic, antipyretic and anti-
inflammatory actions. Artifen is an oral anti-arthritic supplied as an enteric coated tablets containing
25 mg and 50 mg of diclofenac sodium.
CLANICAL PHARMACOLOGY:
Diclofenac Sodium is rapidly absorbed into the plasma with peak levels occurring at around two hours. lt
is extensively bound to proteins. The elimination half life is in order of 1.2 to 1.8 hours. Diclofenac
penetrates rapidly into synovial fluid. Peak levels in the synovial fluid of patients with active rheumatoid
arthritis, and chronic joint effusions are achieved two to four hours after peak plasma levels following
single or multiple dosing. Higher synovial fluid levels are sustained for upto 12 hours after single or
multiple dose therapy.
INDICATIONS AND USAGE 
Carefully consider the potential benefits and risks of Diclofenac sodium enteric-coated tablets and
other treatment options before deciding to use diclofenac. Use the lowest effective dose for the
shortest duration consistent with individual patient treatment goals.
·Artifen is indicated:
·For relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis
·For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
·Also indicated for controlling pain and inflammation in acute gout and minor surgery.
It is also indicated for chronic juvenile arthritis and other musculoskeletal disorders including
periarthritis, bursitis, tendinitis, tenosynovitis, sprain, strains and dislocation.

Artifen (Diclofenac Sodium) 

Artifen (Diclofenac Sodium)

CONTRAINDICATIONS:
Diclofenac sodium enteric-coated tablets is contraindicated in patients with known hypersensitivity to
diclofenac.
Diclofenac should not be given to patients who have experienced asthma, urticaria, or other alle/rgic-
type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to
NSAIDs have been reported in such patients (see WARNINGS, Anaphylactic Reactions, and
PRECAUTIONS, Preexisting Asthma).
Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery
bypass graft (CABG) surgery
SIDE EFFECTS:
Gastrointestinal disturbances, headache, tinnitus, dizziness, skin rashes, fluid retention and peripheral
oedema. Very rarely peptic ulcer, haematemesis or melaena and blood dyscrasias.
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with
cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Diclofenac
sodium enteric-coated tablets are contraindicated for the treatment of perioperative pain in the
setting of coronary artery bypass graft (CABG) surgery
GASTROINTESTINAL RISK 
NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation,
bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly patients are at greater risk for
serious gastrointestinal events.
PRECAUTIONS
General
Diclofenac sodium enteric-coated tablets cannot be expected to substitute for corticosteroids or to
treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease
exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if
a decision is made to discontinue corticosteroids.
The pharmacological activity of diclofenac in reducing fever and inflammation may diminish the utility
of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Hematological Effects 
Anemia is sometimes seen in patients receiving NSAIDs, including diclofenac. This may be due to fluid
retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis.
Patients on long-term treatment with NSAIDs, including diclofenac, should have their hemoglobin or
hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.
Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible.
Patients receiving diclofenac who may be adversely affected by alterations in platelet function, such as
those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Preexisting Asthma 
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-
sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross-
reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs
has been reported in such aspirin-sensitive patients, diclofenac should not be administered to patients
with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Laboratory Tests
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians
should monitor for signs or symptoms of GI bleeding. In patients on long-term treatment with

NSAIDs, including diclofenac, the CBC and a chemistry profile (including transaminase levels) should be checked periodically.
If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations
occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, diclofenac should be
discontinued.
DRUG INTERACTIONS: 
Aspirin: When diclofenac is administered with aspirin, its protein binding is reduced. The clinical
significance of this interaction is not known; however, as with other NSAIDs, concomitant
administration of diclofenac and aspirin is not generally recommended because of the potential of
increased adverse effects.
Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in
rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution
should be used when NSAIDs are administered concomitantly with methotrexate.
Cyclosporine: Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity
of certain drugs. Therefore, concomitant therapy with diclofenac may increase cyclosporine's
nephrotoxicity. Caution should be used when diclofenac is administered concomitantly with
cyclosporine.
ACE Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE
inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly
with ACE inhibitors.
Furosemide: Clinical studies, as well as postmarketing observations, have shown that diclofenac can
reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been
attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs,
the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as
well as to assure diuretic efficacy.
Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium
clearance. The mean minimum lithium concentration increased 15% and the renal clearance was
decreased by approximately 20%. These effects have been attributed to inhibition of renal
prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered
concurrently, subjects should be observed carefully for signs of lithium toxicity.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both
drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Artifen (Diclofenac Sodium) 

CYP2C9 Inhibitors or Inducers: Diclofenac is metabolized by cytochrome P450 enzymes,
predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g.
voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with
CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac. Use caution when
dosing diclofenac with CYP2C9 inhibitors or inducers; a dosage adjustment may be warranted
USE IN PREGNANCY/ LACTATION: 
Use in pregnancy should be avoided if possible because of the risk of premature closure of ductus
arteriosus with prostaglandin inhibitors. Detected in breast milk hence not recommended in nursing
mothers.
DOSAGE AND ADMINISTRATION:
ARTIFEN 50 MG: Usual dose is one tablet 2 to 3 times daily. (100 - 150 mg)
ARTIFEN 25 MG: Usual dose is two tablets 2 to 3 times daily. (100 - 150 mg)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
OVERDOSAGE
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea,
vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal
bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but
are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may
occur following an overdose.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There
are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in
children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with
symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of
urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
STORAGE CONDITION:
Protect from heat, light & moisture.
HOW SUPPLIED:
Artifen 50 mg pack of 10 x 10's enteric coated tablets in blister strip in carton. (list no.G884)

Artifen 25 mg pack of 10 x 10's enteric coated tablets in blister strip in carton. (list no.G883)