Acepar

Composition:

Active Ingredient:

Aceclofenac 100 mg and Paracetamol 500 mg.

Pharmacotherapeutic group:

Anti inflammatory and antirheumatıc products, non-steroids, other analgesics and antipyretics.

Pharmacological action:

Aceclofenac:

Aceclofenac is a nonsteroidal 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.

Paracetamol:

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

Pharmacokinetic:

Aceclofenac:

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'-Hydroxyaceclofenac 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.

Paracetamol:

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 – 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

Therapeutic indication:

ACEPAR is generally used to reduce pain and inflammation. The presence of the two most popular and effective medicines makes this drug effective in lowering body temperature as well.

Contraindications:

Hypersensitivity to any component of the tablet. Active, or history of recurrent peptic ulcer/haemorrhage. NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, Angioedema or urticaria) in response to ibuprofen, aspirin, or other nonsteroidal anti-inflammatory drugs. Severe heart failure, hepatic failure and renal failure. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active bleedings or bleeding disorders. Pregnancy.

Posology & method of administration:

The maximum recommended dose of ACEPAR is two tablets daily, taken as one tablet in the morning and one in the evening.

Adverse effects:

Aceclofenac:

Gastrointestinal.

Paracetamol:

Adverse effects of paracetamol are rare.

Presentation:

10 Tablets in Alu-PVC blister, such 10 blisters are packed in printed carton along with pack insert respectively.

Manufactured for:

OPES HEALTHCARE UK LIMITED,

71-75 Shelton Street, London, England, United Kingdom, WC2H 9JQ at OPES HEALTHCARE PRIVATE LIMITED Ahmedabad, Gujarat, India.