Uniren Spray

Diclofenac diethylammonium.

Diclofenac diethylammonium eq. to Diclofenac sodium.

Pharmacotherapeutic group: Topical Anti-Inflammatory/Anti-Rheumatic.
Pharmacology: Uniren Spray 1% w/w is an anti-inflammatory and analgesic preparation designed for external application.
Pharmacokinetics: After cutaneous application of 1.5 g of Uniren Spray 1% w/w, a rapid onset of Diclofenac absorption can be observed leading to measurable plasma levels of about 1 ng/mL as early as 30 minutes and to maximum levels of about 3 ng/mL at about 24 hours after application.
The achieved systemic concentrations of Diclofenac are about 50 times lower than those achieved following oral administration of equivalent amounts of Diclofenac. Systemic plasma levels are not supposed to contribute to the efficacy of Uniren Spray 1% w/w.
Diclofenac is extensively bound to plasma proteins (about 99%).

For the local symptomatic relief of pain and inflammation in: trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises; localized forms of soft tissue rheumatism.

Topical.
Adults and children aged 14 years and over: Uniren Spray 1% w/w should be sprayed onto the skin. Depending on the size of the affected site to be treated, should be applied 3-4 times a day. After application, the hands should be washed unless they are the site being treated. A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period. If symptoms persist after 7 days or get worse at any time, medical advice should be sought.
Not to be used for more than 7 days unless recommended by a doctor.
Use in the elderly: The usual adult dosage may be used.
Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.

Signs and symptoms: The low systemic absorption of topical Diclofenac renders overdosage extremely unlikely. In the event of accidental ingestion, resulting in significant systemic side-effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be used.
Treatment: Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from Diclofenac overdosage. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

Patients with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by Aspirin or other non-steroidal anti-inflammatory agents.
Hypersensitivity to Diclofenac, Acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Hypersensitivity to any other ingredient of the spray.
Concomitant use of oral NSAIDs.
Uniren Spray 1% w/w should not be co-administered with other products containing Diclofenac.
The use in children and adolescents aged less than 14 years is contraindicated.

UNIREN Spray 1% w/w should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth.
Patients with a history of, or active, peptic ulceration. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Like other drugs that inhibit prostaglandin synthetase activity, Diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of asthma or allergic disease. Discontinue if rash develops.
*Severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported with Diclofenac sodium. Patients treated with Diclofenac sodium should be closely monitored for signs of hypersensitivity reactions. Discontinue Diclofenac sodium immediately if rash occurs.
Adverse effects: Dermatological: Occasional rashes or skin eruptions. Cases of hair loss, bullous eruptions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and photosensitivity reactions have been reported.

Since no experience has been acquired with Uniren Spray 1% w/w in pregnancy or lactation, it is not recommended for use in these circumstances. During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of ductus arteriosus, or in uterine inertia.

Local reactions: Uniren Gel is usually well tolerated. Occasional: allergic or non-allergic contact dermatitis (with symptoms and signs such as itching, reddening, edema, papules, vesicles, bullae or scaling of skin).
Systemic reactions: Systemic absorption of Uniren Spray 1% w/w is low compared with plasma levels obtained following administration of oral forms of Diclofenac and the likelihood of systemic side-effects occurring with topical Diclofenac is small compared with the frequency of side-effects associated with oral Diclofenac. However, where UNIREN Spray 1% w/w is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on Diclofenac oral dosage forms should be consulted.
Gastro-intestinal: Abdominal pain, dyspepsia. Bronchospasm may be precipitated in patients suffering from or with a previous history of asthma or allergic disease.

Systemic absorption of Uniren Spray 1% w/w is low and hence the risk of an interaction is small. There are no known interactions with Uniren Spray 1% w/w but for a list of interactions known with oral Diclofenac the Summary of Product Characteristics for oral dosage forms should be consulted. Concurrent use of Aspirin or other NSAIDs may result in an increased incidence of adverse reactions.

Store at temperature of not more than 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

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