GELOFEN 200 

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Ibuprofen

Soft Gelatin Cap.200 mg

Gelofen^®

(Ibuprofen)

Soft gelatin capsules

Description

Gelofen^® is a non-steroidal anti-inflammatory drug (NSAID) which is used to treat a variety of painful and inflammatory conditions.

Clinical pharmacology

Gelofen^® inhibits the activity of the enzyme cyclo-oxygenase, resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid.

Analgesic activity

Gelofen^® may block pain impulse generation via a peripheral action that involves reduction of the prostaglandins activity, and possibly inhibition of synthesis or action of other substances which sensitize pain receptors to mechanical or chemical stimulation.

Anti-inflammatory activity

Exact mechanisms have not been determined.

Gelofen^® may act peripherally in inflamed tissue, probably by reducing prostaglandin activity in these tissues and possibly by inhibiting the synthesis and actions of other local mediators of the inflammatory response inhibition of leukocyte migration, inhibition of the release and actions of lysosomal enzymes and actions on other cellular and immunological processes in mesenchymal and connective tissue maybe involved.

Antipyretic activity

It acts centrally on the hypotalmic heat-regulation center to produce peripheral vasodilatation resulting in increased blood flow through the skin, sweating and heatloss. The central action probably involves reduction of prosloglandin in the hypothalamus.

Antidysmenorrheal activity

By inhibiting the synthesis and activity of intrauterine prostaglandins, Gelofen® decrease uterine contractivity and pressure, increase uterine perfusion and relieve ischemic as well as spasmodic pain.

Vascular headache prophylactic and suppressant

Gelofen^® may directly prevent or relieve certain types of headache thought to be caused by prostaglandin- induced dilation or constriction of cerebral blood vessels.

Most of the NSAID_S inhibit platelet aggregation. However, their antiplatelet effect, unlike that of aspirin, is reversible.

Pharmacokinetics

Oral absorption > 90%

Presystemic metabolism 50%

Plasma half – life 1.8-2 h

Volume of distribution 0.15 L.kg^-1

Plasma protein binding 99.%

Indication

1- Arthritis , rheumatoid

2- Osteoarthritis

3- Menstrual cramps

4- Fever

5- Pain( toothache, muscular aches, backache)

6- Vascular headache (Prophylaxis and treatment)

Contraindication

Gelofen^® is contraindicated in patients who have shown hypersensivity to Ibuprofen or other NSAID_S, in nasal polyps associated with aspirin-induced bronchospasm,

Precaution

· Before Gelofen^® administration, previous hypersensivity reactions to NSAID_S must be determined because of cross hypersensivity among them.

· Gelofen^® should be used with caution in geriatrics specially who are at increased risk of serious gastrointestinal toxicity during NSAID therapy and who have renal function impairment.

· Risk-benefit should be considered when history of anemia, asthma, congestive heart disease, edema, hypertension, diabetes mellitus, sepsis, stomatitis, hemophilia or other bleeding problems, hepatic and/or renal function impairment exit.

Gelofen^® may induce or exacerbate active or history of blood dyscrasias and also bone, marrow depression.

Pregnancy

Pregnancy category B

There are no adequate and well controlled studies in pregnant women. Safety for use during pregnancy has not been established; use is not recommended.

Breast feeding

Gelofen^® is excreted in human milk in low concentrations. Caution should be exercised when it is administered to a nursing woman.

Dosage

Usual adult and adolescent dose

Antirhumatic