DOSAGE AND ADMINISTRATION

Gently rub a small amount of gel onto the skin around the painful and swollen area three or four times daily. The amount of gel needed will vary depending upon the size of the inflamed area. Diclofenac Gel should be rubbed-in, leaving no residual material on the skin.After application, the hands should be washed unless they are the site being treated. The usual adult dosage may be used in elderly.Diclofenac Gel may also be given to further treatment with other dosage forms of Diclofenac or as prescribed by the physician.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Diclofenac Gel is indicated for a variety of conditions characterized by pain and inflammation such as osteoarthritis, post-traumatic or acute musculoskeletal disorders including bursitis, tendinitis, fibrositis, tenosynovitis, periarthritis, sprains, strains and low back pain

(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. Diclofenac gel is used to relieve pain and reduce swelling in a number of conditions affecting the joints and muscles. Diclofenac gel works particularly well on inflammation of tendons, ligaments, muscles and joints due to trauma (e.g. sports injuries, sprains, strains and bruises), soft tissue rheumatism and localized rheumatic conditions, e.g. bursitis. For aches and pains, back, neck and shoulder pain.

(iv) CONTRAINDICATIONS

The drug is contraindicated in patients in whom aspirin and other NSAIDs induce symptoms of asthma, rhinitis, angioedema or urticaria. Diclofenac Gel is also contra-indicated to those who are hypersensitive to the gel base. Diclofenac is contra-indicated for those patients who are hypersensitive to diclofenac .

WARNING AND PRECAUTIONS

DO NOT apply Diclofenac Gel to cuts or open wounds or any other area where the skin is abnormal. After applying the gel do NOT cover with bandages or sticking plaster. Never swallow Diclofenac gel, be careful NOT to get the gel into your eyes or mucous membrane. If this happens wash your eyes out with clean water and seek immediate medical advice. If you symptoms do NOT improve within 2 weeks or they get worse seek immediate medical advice.

USE IN PREGNANCY & LACTATION
Since no experience has been acquired with diclofenac gel in pregnancy or lactation, it is not recommended for use in these circumstances
Labor and Delivery :
The effects of diclofenac on labor and delivery in pregnant women are unknown. Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), use of diclofenac during late pregnancy should be avoided and, as with other nonsteroidal anti-inflammatory drugs, it is possible that diclofenac may inhibit uterine contractions and delay parturition.

NURSING MOTHER
Because of the potential for serious adverse reactions in nursing infants from diclofenac sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

PEDIATRIC USE
Actinic keratosis is not a condition seen within the pediatric population. Diclofenac gel should not be used by children.

GERIATRIC USE
Greater sensitivity is shown by some older individual.

INTERACTION:
No drug interaction during treatment with diclofenac gel have been reported.

(v) SIDE EFFECTS

Diclofenac Gel is usually well tolerated. Local irritation, erythema, pruritus or dermatitis may occasionally occur. Although the gel has low systemic absorption, yet the possibility of the systemic side-effects cannot be completely excluded because of use to a relatively large area of skin.

(vi) TOXIC EFFECTS

CARCINOGENICITY
A photococarcinogenicity study with up to 0.035% diclofenac in the DICLOFENAC GEL vehicle gel was conducted in hairless mice at topical doses up to 2.8 mg/kg/day. Median tumor onset was earlier in the 0.035% group (DICLOFENAC GEL contains 3% diclofenac sodium).

MUTAGENICITY
Diclofenac was not genotoxic in in vitro point mutation assays in mammalian mouse lymphoma cells and Ames microbial test systems, or when tested in mammalian in vivo assays including dominant lethal and male germinal epithelial chromosomal studies in mice, and nucleus anomaly and chromosomal aberration studies in Chinese hamsters. It was also negative in the transformation assay utilizing BALB/3T3 mouse embryo cells.

TERATOGENICITY
The safety of DICLOFENAC GEL (diclofenac sodium) Gel has not been established during pregnancy. However, reproductive studies performed with diclofenac sodium alone at oral doses up to 20 mg/kg/day (15 times the estimated systemic human exposure*) in mice, 10 mg/kg/day (15 times the estimated systemic human exposure) in rats, and 10 mg/kg/day (30 times the estimated systemic human exposure) in rabbits have revealed no evidence of teratogenicity despite the induction of maternal toxicity. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.Diclofenac has been shown to cross the placental barrier in mice and rats. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy unless the benefits to the mother justify the potential risk to the fetus. Because of the risk to the fetus resulting in premature closure of the ductus arteriosus, diclofenac should be avoided in late pregnancy.