Sunactic Gel

/ Perrigo

Adults: Sunactic is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The usual duration of therapy is from 60 to 90 days.
Maximum efficacy has been observed with treatment duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. A maximum of 8 grams daily should not be exceeded. Long term efficacy has not been established.
Elderly: The usual adult dose may be used.
Children: Dosage recommendations and indications for the use of
Sunactic have not been established for use in children.

For the topical treatment of actinic keratosis.

Hypersensitivity, previous allergic reaction, such as skin rash (hives/nettle-rash), breathing difficulties (wheezing) or allergic rhinitis as a result of taking aspirin or any other non-steroidal anti-inflammatory medicine.
Use in the third trimester of pregnancy.

The likelihood of systemic side effects occurring following the topical application of Sunactic is very small compared to the frequency of side effects with oral diclofenac, owing to low systemic absorption with Sunactic. However, the possibility of systemic adverse events from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. This product should be used with caution in patients with a history of and/or active gastrointestinal ulceration or bleeding, or reduced heart, liver or renal function, since isolated cases of systemic adverse reactions consisting of renal affection, has been reported with topically administered antiphlogistics.
It is known that NSAIDs can interfere with platelet function. Although the likelihood of systemic side effects is very low, caution should be used in patients with intracranial haemorrhage and bleeding diathesis.
Direct sunlight, including solarium, should be avoided during treatment. If sensitivity skin reactions occur, discontinue use.
Sunactic should not be applied to skin wounds, infections or exfoliative dermatitis. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
Discontinue the treatment if a generalised skin rash develops after applying the
product.
Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Most frequently reported reactions include skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, irritation, pain and blistering.
See prescribing information for full details.

Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely.

Pregnancy: Do not use this drug during the last three months of pregnancy. Can be taken with caution during the first six months of pregnancy.
Lactation: This drug can be used with caution when breastfeeding, but do not use this medicine on the breasts.
See prescribing information for full details.  

Due to the low systemic absorption of Sunactic, overdosage is extremely unlikely as a result of topical use. However, the skin should be rinsed with water. There have been no clinical cases of ingestion of Sunactic inducing overdosage.
In the event of accidental ingestion (100 g Sunactic gel contain the equivalent of 3000 mg diclofenac sodium) resulting in significant systemic side effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal antiinflammatories should be used.
Supporting and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation and respiratory depression.
Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
Specific therapies such as forced diuresis and dialysis will probably not be therapeutic in eliminating NSAIDs due to their high rate of protein binding.