Noak Aceclofenac

Noak (Aceclofenac) is a phenylacetic acid derivative and related to diclofenac, developed with the aim of producing a NSAID with an improved safety profile.

Composition
Each tablet contains Aceclofenac BP 100 mg.

Mode of Action
Noak (Aceclofenac) acts primarily by inhibiting prostaglandin synthesis. Aceclofenac is a potent inhibitor of cyclooxygenase, which is involved in the production of prostaglandin.

Pharmacokinetics
Noak (Aceclofenac) is well absorbed from the gastrointestinal tract; peak plasma concentration is reached 1-3 hours after an oral dose. Plasma elimination half-life is about 4 hours.

Indications
Noak (Aceclofenac) is indicated for the symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and primary dysmenorrhoea.

Dosage and Administration
The maximum recommended dose is 200 mg daily in two divided doses. Reduction of dose is not necessary in case of elderly.

In renal failure: Dose adjustment is not necessary in mild renal insufficiency.

In hepatic failure: Dose should be decreased in patients with easy to moderately severe liver malfunction. The recommended initial daily dose is 100 mg in that case.

Side Effects
The major side effects are gastrointestinal like dyspepsia, abdominal pain, nausea, and diarrhea. Flatulence, gastritis, constipation, vomiting etc may also occur.

Contraindications
Noak (Aceclofenac) is contraindicated in the following situations:
* Patients previously sensitive to Aceclofenac or Aspirin or other NSAIDs
* Patients with active or suspected peptic or duodenal ulcer or who have GI or other bleeding disorders.
* In severe heart failure and renal or hepatic insufficiency.
* During last three months of pregnancy.

Precautions
Noak (Aceclofenac) should be used with caution in patients suffering from GI disease and history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis or coagulation disorders.

Caution should be exercised in patients with mild to moderate renal, hepatic or cardiac function. Caution is also required in patients with diuretic treatment.

Drug Interactions
Noak (Aceclofenac) is metabolized through cytochrome P4502C9 and a risk of pharmacokinetic interaction is, therefore, possible with Phenytoin, Digoxin, Cimetidine, Tolbutamide. There is also a risk of pharmacokinetic interactions with drugs eliminated by active renal secretion such as Methotrexate and Lithium.

Use in Pregnancy and Lactation
There is no information on the use of Aceclofenac during pregnancy and lactation. The use of Noak (Aceclofenac) should, therefore, be avoided during pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks.

Storage
Store in a cool and dry place, away from light.

Commercial Pack
Box containing 5 x 10 Tablets in blister pack.

Orion Laboratories Limited