Zerodol

Aceclofenac

Aceclofenac

Description:

Zerodol is the preparation of aceclofenac. Aceclofenac, a phenylacetic acid derivative is peripherally acting, non-steroidal anti-inflammatory, analgesic, antiarthritic and antipyretic activities. It is converted to active metabolites intracellularly that inhibit the production of prostaglandins. Aceclofenac demonstrates better gastric tolerance and consequently offers greater potential security than other NSAIDs such as indomethacin and diclofenac. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.

Composition:

Zerodol® : Each film coated tablet contains Aceclofenac BP 100 mg.


Indications:

Zerodol is indicated for the relief of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, musculoskeletal trauma, primary dysmenorrhoea, post-operative pain, dental pain, knee pain and acute lumbago.


Dosage and Administration:

 

Adults: The recommended dose is 200 mg daily in two divided doses, one tablet in the morning and one in the evening. The initial dose should be reduced to 100 mg daily in patients with hepatic impairment.

 

Children: It is not recommended.



Pharmacokinetics:Aceclofenac is rapidly absorbed from gastrointestinal tract. Peak plasma concentrations are reached approximately 1.25 to 3 hours after oral administration. It is highly protein bound ( more than 99.7%). The mean plasma elemination half-life is 4-4.3 hours.


Contraindications: Aceclofenac should not be administered to patients previously sensitive to aceclofenac or in whom aspirin or NSAIDs precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs. It should not be administered to patient with active or suspected peptic ulcer or gastro-intestinal bleeding, moderate or severe renal impairment.


Precautions:Aceclofenac should be administered with caution to patients with symptoms indicative of gastrointestinal disorder, with a history of peptic ulceration, ulcerative colitis, Crohn’s disease, hepatic porphyria and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored. The dose should be kept as low as possible and renal function should be monitored.



Use in pregnancy and lactation: There is no information in the use of aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy unless there are compelling reasons for doing so. The lowest dose should be administered.

 

Lactation: There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.

 


Interactions: Aceclofenac is highly protein-bound. Concomitant use of other protein-binding drugs, e.g. anticoagulants, sulphonamides, hydantoins might necessitate modification of dosage in order to avoid increased levels of such drugs resulting from competition for plasma protein-binding sites. Similar acting drugs such as aspirin, or other non-steroidal anti-inflammatory agents should not be administered concomitantly with aceclofenac as the potential for adverse reactions is increased. Serious interactions have been recorded after the use of high dose methotrexate with non-steroidal anti-inflammatory agents including aceclofenac. Concomitant use with quinolones may occur convulsion.

Side effects:The side effects of aceclofenac usually mild and transient. Side effects include gastrointestinal discomfort, nausea, diarrhea, tinnitus, depression, drowsiness, anaphylactic shock and rash.


Overdose: Symptoms after acute aceclofenac overdose are largely limited to drowsiness, abdominal pain and vomiting, but adverse effects seen after over dosage such as hypotension, bronchospasm and gastrointestinal haemorrhage should be anticipated. Treatment should be supportive and symptomatic. It may include gastric washout and the use of activated charcoal.

 


Pharmaceutical precaution:

 

 

Protect from light, store in a cool & dry place. Keep all medicines out of reach of children.

 


Packaging:

 

Zerodol® : Each box contains 5x10's tablets in blister pack.