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Ostoflex (Aceclofenac )

Composition:

Ostoflex tablet: Each film coated tablet contains Aceclofenac BP 100 mg.

 Pharmacology:

Ostoflex (Aceclofenac) is a non-steroidal agent with marked anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production 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. The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein-bound (>99%).

Indication :

Ostoflex is used for the treatment of Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, Dental pain, Gynaecological pain and Low back pain etc.

Dosage and Administration:

Adults: The maximum recommended dose is 200 mg daily, to be taken in two equally divided doses, one tablet in the morning and one in the evening.

Children: There is 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.

Renal insufficiency: There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment.

Hepatic insufficiency: The dose of Aceclofenac should be reduced in patients with hepatic impairment. An initial daily dose of 100 mg should be administered.

Side Effect:

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

Contraindication:

Aceclofenac is contraindicated in patients previously sensitive to Aceclofenac or Aspirin or other NSAIDs. It should not be administered to patients with active and moderate to severe renal impairment.

Precaution:

Aceclofenac should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, hepatic porphyria and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored.

Use in Pregnancy and Lactation:

Pregnancy: There is no information on the use of Aceclofenac during pregnancy. Aceclofenac should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective 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 fetus.

Drug Interaction:

Lithium and digoxin: Aceclofenac, like other NSAIDs, may increase plasma concentrations of lithium and digoxin.
Diuretics: The concurrent administration of diuretics with Aceclofenac may inhibit the activity of diuretics.
Anticoagulants: Aceclofenac may enhance the activity of anticoagulants.
Quinolones: Convulsions may occur due to an interaction between quinolones and NSAIDs.
Other NSAIDs and steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of side effects.

Overdose:

There is no human data available on the consequences of Aceclofenac overdosage. After overdosage, following thereapeutic measures to be taken, absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.

Storage:

Keep in a cool and dry place, protected from light and moisture.

Packaging:

Each box contains 10 ´ 10's tablets in blister pack.

 

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