T H E R A P E U T I C I N D E X

Xynofen ®100 SR
Capsule

Description
Xynofen 100 SR contains Ketoprofen is a derivative of propionic acid
which is widely used in the treatment of patients with rheumatic diseases.
It is a potent non-steroidal anti-inflammatory analgesic agent and a strong
inhibitor of prostaglandin synthetase.

Indications
♦ Rheumatic diseases : for anti-inflammatory and analgesic use in
rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.
♦ Periarticular and musculoskeletal indications : for analgesia in bursitis,
tendinitis, synovitis, tenosynovitis, lumbago.
♦ Prophylaxis and treatment of migraine headache.
♦ Surgical and traumatic uses : for analgesic action after sports injuries,
orthopaedic manipulations, dental extraction, surgery.
♦ Infectious diseases : for analgesic, anti-inflammatory and antipyretic
purposes.
♦ Gynaecological uses : in dysmenorrhoea, following IUCD insertion and
for uterine relaxation and analgesia in the post-partum, non-nursing
mother.

Dosage and Administration

Xynofen-100 SR is administered orally, in the dose of 100-200 mg once
daily, usually with food, depending on patient’s weight and severity of
symptoms.

Contraindications
♦ Hypersensitivity to Ketoprofen

♦ Patients with rhinitis, nasal polyps and asthma associated with Aspirin
may show cross sensitivity with other NSAIDs including Ketoprofen
♦ Patients with active ulceration or chronic dyspepsia
♦ Severe renal insufficiency

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Precautions
Inhibition of renal prostaglandin synthesis by NSAIDs may interfere with
renal function especially in the presence of existing renal disease.
Ketoprofen should therefore be used with caution in patients with renal
impairment. To minimise gastric intolerance, Xynofen 100 SR capsule
should always be taken with food.

Drug Interactions
Warfarin, Sulphonamide, Hydantoin : Ketoprofen is highly protein
bound. Theoretically, interaction is possible following concomitant use of
other protein bound drugs, for example anticoagulants, sulphonamides,
and Hydantoin.

Digoxin, Methotrexate, Cyclosporin : Like other NSAIDs, Ketoprofen,

through effects on renal prostaglandin, may cause increased toxicity of
certain drugs. Serum levels of Digoxin and Methotrexate may be elevated;
also there may be increased nephrotoxicity with Cyclosporin when used
concomitantly with Ketoprofen.

Aspirin : Concomitant administration of Aspirin and Ketoprofen is not

recommended as it decreases the plasma concentration of Ketoprofen.

Lithium : Ketoprofen decreases the renal clearance of Lithium and

increases the plasma level of Lithium. So, Lithium toxicity may develop.

Diuretics : Ketoprofen may reduce the activity of the diuretics.

β blockers : Ketoprofen may reduce the antihypertensive effect of β

blockers.

Oral hypoglycaemics : Ketoprofen may alter the response to insulin or

oral hypoglycaemic agents.

Side Effects
Minor side effects are variable in severity and frequency, consisting mostly
of gastrointestinal problems such as gastrointestinal discomfort, nausea,
diarrhoea and occasionally bleeding and ulceration. Dyspepsia may be
minimized by taking this drug with food or milk.

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Other minor side effects such as headache, dizziness, mild confusion,

vertigo, drowsiness, oedema, mood change and insomnia may occur less
commonly.

Major side effects involving other organ systems such as haematological

reactions, hepatic or renal damage, dermatological reactions,
bronchospasm and anaphylaxis are exceedingly rare.

In all cases of major side effects Xynofen 100 SR should be withdrawn at

once.

Use in Special Population

Pregnancy and lactation : The drug should not be used in pregnancy unless
clearly needed. It is not recommended for nursing mother as it is excreted
through breast milk.

Commercial Pack
Xynofen® 100 SR Capsule : Box containing 50 capsules in 5 x 10’s blister
strips, each capsule contains Ketoprofen BP 100 mg as sustained release
pellets.

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