NOSTRIN®
Aceclofenac

COMPOSITION:
Nostrin® tablet: Each film-coated tablet contains Aceclofenac BP 100mg.

PHARMACOLOGICAL INFORMATIONS:
Pharmacological Action
Aceclofenac a phenylacetic acid derivative, is a non-steroid substance, which belongs to anti-rheumatic, anti-inflammatory drugs with analgesic & antipyretic properties. Aceclofenac is generally well tolerated and is indicated for the treatment of rheumatic diseases of either inflammatory or degenerative origin. It is also recommended for the treatment of painful conditions not associated with rheumatic disease. The film coating of Nostrin® tablet: is resistant to gastric acid and therefore the active substance of Aceclofenac is released in the small intestine.

Mechanism of action
Its mode of action is largely based on inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cycloxygenase, which is involved in the production prostaglandins. It also stimulates cartilage matrix (glycosoaminoglycans) synthesis.

CLINICAL INFORMATION:
Therapeutic Indications
Rheumatology: Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, low back pain & other acute musculosketal disorders such as periarthritis, tendonitis.
Surgery and Traumatology: Bursitis, Sprains, strains, and dislocation, control pain and inflammation in orthopedic, dental and other minor surgery & postoperative pain.
Obstetrics and Gynaecology: Primary dysmenorrhoea, episiotomy, endometritis, parametrized and mastiffs.
Other indications: For the treatment of pain and inflammation and swelling of patients Operated in the urogenital tract, renal & billiard colic.
Feverish conditions and as an adjutant to chemotherapy of infectious diseases and painful conditions not associated with rheumatic disease.

Dosage if Administration
Adults: 1 tablet (100mg) twice daily - 1 tablet in morning & 1 tablet in the evening. Reduce the dosage to 100 mg once daily initially in patient with hepatic dysfunction.

Use in Children
Not recommended.

Contraindication
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, Aspirin anti-inflammatory induced allergy.

Use in patients with impaired renal function
Renal impairment Patients with mild renal function should be monitored regularly since the use of NSAIDS may result in deterioration of renal function.

Use in patients with impaired hepatic function
There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100mg be used.

Use in Elderly patients
Aceclofenac should be used with caution in elderly patients with hepatic impairment.

Drug Interaction
Anticoagulants, lithium, methorexate, antacids, probenecid, frusemide, digoxin, corticosteroids, antidiabetics & quinolone antibiotics.

Use in Pregnancy & Lactation
Aceclofenac should not be administered during pregnancy & breast feeding, unless the potential benefits to the mother outweigh the possible risks to the fetus & child respectively.

Undesirable effects
Aceclofenac is generally well tolerated. In the initial stage of therapy, gastrointestinal disorders, vomiting 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.

PHARMACEUTICAL INFORMATIONS
Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & packaging:
Each commercial box contains 5X10's tablet in Alu-PVC blister pack.