Trade Name: ACELON

Generic Name: Aceclofenac BP

Composition:

Acelon: Each film-coated tablet contains Aceclofenac BP 100 mg.

Description:

Aceclofenac is a new phenyl acetic acid derivative non-steroidal substance with marked anti-arthritic, anti-inflammatory, analgesic and anti-pyretic effects. Its mechanism of action is thought to be due to inhibition of prostaglandin synthesis.

After oral administration, Aceclofenac is rapidly absorbed and the bioavailability is almost 100%. Peak plasma concentrations are reached approximately 1 ¹/₄ -3 hours following

ingestion. Approximately two-third of the administered dose is excreted via the urine; only 1% of an oral single dose is excreted unchanged.

Indication:

Acelon is the drug of choice for both acute and chronic inflammatory and degenerative disease-

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Post-traumatic pain
• Low back pain
• Gynaecological pain
• Dental pain.

Dosage & Administration:

Acelon should be swallowed with at least half a glass of water. Also can be taken with food.

Children & adolescents : Safety and efficacy

have not been established yet.

Adults : Acelon 100 mg 12 hourly daily.

Elderly : Generally no dose adjustment is necessary.

In renal insufficiency : There is no evidence that the dose needs to be modified in patients with mild renal impairment, but caution is advised.

In hepatic impairment : Dose should be reduced in patients with mild to moderate hepatic impairment. Recommended initial dose is Acelon 100 mg once daily.

Contraindication:

• Patients hypersensitive to Aceclofenac or any of its Excipients or Aspirin or other NSAIDs.
• Patients with active or suspected gastric or duodenal ulcer or history of recurrent gastric or duodenal ulcer or who have GI bleeding or other active bleeding or bleeding disorders.
• Patients with severe heart failure or liver cirrhosis or renal insufficiency.

Use in

pregnancy and lactation:

During pregnancy: Acelon should not be given during the last 3 months of pregnancy.

During lactation: It is not known whether Aceclofenac is excreted in human milk. Therefore, Acelon should not be prescribed during location.

Side effects:

Though Aceclofenac is well tolerated, dyspepsia, abdominal pain, nausea, diarrhoea, skin reaction may occur as with other NSAIDs.

Drug interactions:

Aceclofenac, like other NSAIDs, interact with Lithium, Digoxin, Diuretics, Anticoagulants, Quinolones, Steroids, etc.

Over dosage:

There is no human data available on the consequences of Aceclofenac overdosages.

Storage:

Keep in a dry place and below 25⁰ C, protect from light & keep out of the reach of children.

Commercial Pack:

Acelon: Box containing 100 (10 x 10’s) tablets in blister strips.