Plot 1 Junaid Dosunmu Street,Central Business District, Alausa, P.0. Box 3560 Ikeja, Lagos, Nigeria.
Tel: + 234-1-774-1205
Osaka Pharmaceuticals Pvt. Ltd. Old National Highway No. 8, Sankarda-391 350, Vadodara, Gujarat, INDIA.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN:A4-4595): Each film coated tablet contains: Aceclofenac BP 100 mg Excipients q.s. Colour: Erythrosine
Pack size: Available as blister of 10 tablets in a monocarton & such 10 monocartons in an outer carton.
Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins.
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 volume of distribution is approximately 25 L. The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein-bound (>99%).
Aceclofenac circulates mainly as unchanged drug. 4-Hydrolfyaceclofenac is the main metabolite detected in plasma. Approximately two-thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Aceclofenac is contraindicated in patients with peptic ulceration and in pregnancy & lactation. It is also contraindicated in patients with a history of hypersensitivity to any ingredient of the product, gastro-intestinal bleeding, moderate to severe renal impairment, aspirin anti-inflammatory induced allergy.
Cautiously administer to patients with GI diease, ulcerative colitis, Crohn's disease, haematological abnormalities, hepatic porphyria; history of bronchial asthama, history of heart failure or hypertension; mild renal hepatic or cardiac impairment. May impair ability to drive or operate machinery. Elderly patients.
Use in pregnancy: Use of Aceclofenac should be avoided during the first trimester of pregnancy, unless there is an absolute necessity.
Use in children: Not recommended.
Anticoagulants, lithium, methotrexate, antacids, probenecid, frusemide, digoxin, corticosteroids, antidiabetics & quinolone antibiotics.
Aceclofenac is generally well tolerated.
In the initial stage of therapy, gastrointestinal disorders, headache, or nausea may appear. These effects are usually mild and disappear with the continuation of the treatment.
In the very rare cases in which treatment with Aceclofenac is associated with peptic ulceration or gastrointestinal bleeding, patients usually had history of such disorders or they were taking other medications responsible for the appearance of such disorders.
Dosage & Administration
Aceclofenac tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.
There is no human data available on the consequences of Aceclofenac overdosage. After overdosage, following therapeutic measures are 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.
Store in an airtight container, protected from light.
KEEP MEDICINES OUT OF REACH OF CHILDREN