Loflam-100
Aceclofenac BP 100 mg

Composition:
Loflam-100 Tablet: Each film-coated tablet contains Aceclofenac BP 100 mg.

Pharmacology:
Loflam-100 (Aceclofenac) is a non-steroidal agent with marked anti inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxigenase, which is involved in the producton of prostaglandin. After oral administration, Aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The mean plasma elimination half life is around 4 hours. Aceclofenac is highly protein-bound (>99%). Aceclofenac circulates mainly as unchanged drug, 4-Hydroxy Aceclofenac is the main metabolite detected in plasma. Approximately two-thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.

Indications and Usage:
For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Dosage and Administration:
Adults : The recommended dose is 100 mg, twice daily.
Children : There are no clinical data on the use of Aceclofenac in children.
Elderly : The pharmacokinetics of Aceclofenac is not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.


Contraindications:
Aceclofenac should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to severe renal impairment. Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function. It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. 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 hypertensive to these drugs.

Side effect:
The majority of side-effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

Drug interaction:
Lithium and Digoxin : Aceclofenac, like many NSAIDs may increase plasma concentrations of lithium and Digoxin.
Diuretics: Aceclofenac, like other NSAIDs, may interact the activity of diuretics.
Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulant. Close monitoring of patients on combined anticoagulants and Aceclofenac therapy should be undertaken.
Methotrexate:Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma levels, resulting in increased toxicity.

Use in pregnancy & Lactation:
There is no information on the use of Aceclofenac during pregnancy. The regular use of NSAIDs during the last trimester of pregnancy may increase uterine tone and contraction. There is no information on the secretion of Aceclofenac to breast milk. The use of Aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks to the fetus.

Storage:
Keep at a cool and dry place, protect from light and moisture.


How supplied:
Loflam-100 Tablet : Box containing 10 x 10 tablets in Alu blister pack.