Panderm is indicated for the relief of the inflammatory and pruritic manifestations of dermatoses likely to become or which are already infected.

Apply to the affected area 2 to 3 times daily.

General

If sensitivity or irritation develops, use of this medication should be discontinued and appropriate therapy instituted. Hypersensitivity reactions to the anti-infective components may be masked by the presence of a corticosteroid.

Because of the potential hazard of nephrotoxicity and ototoxity, this medication should not be used in patients with extensive skin damage or other conditions where absorption of neomycin is possible.

The use of occlusive dressing should be avoided because of the increased risk of sensitivity reactions and increased percutaneous absorption particularly of triamcinolone acetonide and neomycin.

As with any antibiotic preparation, prolonged use may result in overgrowth of non-susceptible organisms, including fungi other than Candida. Corticosteroids, furthermore, can enhance microbial infections. Therefore constant observation of the patient is essential. Should superinfection due to non-susceptible organisms occur, suitable concomitant antimicrobial therapy must be administered. If a favourable response does not occur promptly, application should be discontinued until the infection is adequately controlled by other anti-infective measures.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic- pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycaemia and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas and prolonged use. Therefore, patients receiving a large dose of any potent topical steroid under any condition(s) which may enhance systemic absorption should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If any of these conditions occur, an attempt should be made to withdraw the drug, to reduce the frequency of application, or substitute a less potent steroid.

Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur that requiring supplemental systemic corticosteroids.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Information for Patients

Patients using this medication should receive the following information and instructions:

1.      This medication is to be used as directed by the doctor. It is for skin use only. Avoid contact with your eyes.

2.      Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.

3.      Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt therapy until the prescribed course of treatment is completed.

4.      Patients should report any signs of adverse reactions.

5.      The treated skin should not be bandaged, covered or wrapped unless directed by the doctor. Do not use tight fitting plastic pants/incontinence garments as these may constitute occlusive dressing.

6.      When using this medication in the inguinal area, patients should be advised to apply the preparation sparingly and to wear loosely fitting clothing.

7.      Patients should be advised on preventive measures to avoid reinfection.

Use in the elderly

No data available.

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroid.

Paediatric Use

Use of this medication over large surface areas or for prolonged periods in paediatric patients could result in sufficient systemic absorption to produce systemic effects. Paediatric patients may demonstrate greater susceptibility to HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteriods (see Section 4.8, Adverse effects – Paediatric Patients).

When applied to paediatric patients, this medication should be limited to the least amount for the shortest duration compatible with an effective therapeutic regimen. These patients should be closely monitored for signs and symptoms of systemic effects.

Effects on laboratory tests

If there is a lack of therapeutic response, KOH smears, cultures or other diagnostic methods should be repeated.

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating hypothalamic-pituitary-adrenal (HPA) axis suppression due to corticosteroid.

No data available.

Effects on fertility

Long-term animal studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Use in pregnancy – Pregnancy Category D

Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of gentamicin by the foetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be noted that therapeutic blood levels in the mother do not equate with safety for the foetus.

Use in lactation

It is not known whether topical administration of this medicine could result in sufficient systemic absorption of the components to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when this medication is administered to a nursing woman.

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

The ointment is usually well tolerated. The reactions listed, while uncommon, may occur.

The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and millaria.

Nystatin is well tolerated even with prolonged therapy. Irritation and cases of contact dermatitis have been reported.

Delayed type hypersensitivity reactions have been reported during use of neomycin; sensitisation has been reported following prolonged use. Ototoxicity and nephrotoxicity have been reported when applied to large surfaces or damaged skin.

Sensitivity reactions to gramicidin have been reported.

Adverse effects - Paediatric Patients

Manifestations of adrenal suppression in paediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilloedema.

Post marketing adverse effects

Eye disorders: blurred vision.

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Topically applied corticosteroids and neomycin can be absorbed in sufficient amounts to produce systemic effects (see Section 4.4, Special Warnings and Precautions for use).

Treatment: No specific antidote is available, and treatment should be symptomatic.

Mechanism of action

Triamcinolone acetonide, a topical corticosteroid has anti-inflammatory, antipruritic and vasoconstrictive actions.

Nystatin acts by binding to steroids in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.

On repeated subculturing with increasing levels or nystatin Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy.

Nystatin exhibits no activity against bacteria, protozoa or viruses.

Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for topical bacterial infections.

Neomycin exerts its antibacterial activity against a number of gram-negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of gram-negative bacteria may develop.

Gramicidin exerts its antibacterial activity against many gram-positive organisms by altering cell membrane permeability.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognisable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

These ingredients give symptomatic relief of the pain, burning and itching of infected skin, while combating the relevant bacterial and/or monilial infection.

Clinical trials

No data available.

Mechanism of action

Triamcinolone acetonide, a topical corticosteroid has anti-inflammatory, antipruritic and vasoconstrictive actions.

Nystatin acts by binding to steroids in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components.

On repeated subculturing with increasing levels or nystatin Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy.

Nystatin exhibits no activity against bacteria, protozoa or viruses.

Neomycin and gramicidin provide antibacterial activity against microorganisms likely to be responsible for topical bacterial infections.

Neomycin exerts its antibacterial activity against a number of gram-negative organisms by inhibiting protein synthesis. It is not active against Pseudomonas aeruginosa, and resistant strains of gram-negative bacteria may develop.

Gramicidin exerts its antibacterial activity against many gram-positive organisms by altering cell membrane permeability.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognisable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

These ingredients give symptomatic relief of the pain, burning and itching of infected skin, while combating the relevant bacterial and/or monilial infection.

Clinical trials

No data available.

Genotoxicity

No data available.

Carcinogenicity

No data available.

Not applicable.

Store below 30ºC.

§ 15g Ointment in a collapsible cylindrical aluminium tube capped with a plastic cap packed in a printed carton along with a leaflet.

30g Ointment in a collapsible cylindrical aluminium tube capped with a plastic cap packed in a printed carton along with a leaflet

None