(i) ROUTE OF ADMINISTRATION
Oral
DOSAGE AND ADMINISTRATION

Adult:The usual adult daily dose is 1.2 to 1.8 g daily in divided doses. This can be increased to 2.4 g total daily dose if necessary in acute conditions.
Children: Half measure (5 ml) thrice daily or 20 mg/kg body weight per day in three divided doses.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

•Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylosis. Sprains, bruises, accidental injuries, operative trauma. Low back pain, fibrositis, sciatica, bursitis, tendonitis . •Toothaches, oral surgical procedures and dental extractions.
•Tonsillitis, pharyngitis, laryngitis, sinusitis, rhinitis, bronchitis, cellulitis and other infective inflammatory conditions along with appropriate therapy.
•Pelvic inflammation, dysmenorrhoea. Ibuprofen has analgesic, anti-inflammatory and antipyretic properties. Ibuprofen acts by inhibiting the synthesis of prostaglandins, which are known mediators of pain and inflammation.

(iii) DESCRIPTION OF DOSAGE FORM

Anti-inflammatory analgesic often used to treat inflammation and pain arising from arthritis, gout or rheumatic disease. Normally taken orally (tablets) but also available for injection or as suppositories. Contraindicated in patients with peptic ulcers and asthma or in individuals with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin iodides or other NSAIDs.

WARNING AND PRECUATIONS:

DRUG INTERACTIONS: There are no serious drug interactions.
Aspirin: Aspirin and ibuprofen should not be co-administered because this may lead to a decrease in plasma ibuprofen levels
No clinical interaction has been noted with commonly prescribed drugs such as digitalis, thyroxine, steroids, antibiotics and benzodiazepines.

USE IN PREGNANCY AND NURSING MOTHERS
At low doses (below 600 mg per day) ibuprofen appears to be safe for management of arthritis in pregnant and lactating women.

(iv) CONTRAINDICATIONS

Hypersensitivity to non-steroidal anti-inflammatory agents.Ibuprofen is contraindicated in patients with peptic ulcers and asthma or in individuals with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin iodides or other NSAIDs

(v) SIDE EFFECTS

The major adverse reactions with Health 2000 Ibuprofen 400 mg tablets are those affecting the gastrointestinal tract. Peptic ulcer, severe gastric pain or vomiting are the common side effects. A nonspecific rash occurs occasionally. Headache, depression and somnolence are very rare.

( vi ) TOXIC EFFECT:

Mutagenicity, Carcinogenecity and Teratogenecity
No mutagenic activity was demonstrated in the Ames test or the mouse micronucleus test in vivo. However, chromosomal aberrations occurred in lymphocytes exposed in vitro to Ibuprofen 400 mg tablets or its active metabolite 6-MNA at concentrations of 80mg/ml or higher Ibuprofen 400 mg tablets produced no carcinogenic effects in rats or mice in life time studies. There are no teratogenic effects shown by Ibuprofen.

Ibuprofen 400 mg tablets