POSITON CREAM

(FAES SPAİN)


Active substances: Triamcinolone acetonide, Neomycin Sulphate and Nystatin
Composition:
Active substances:Composition per 1 g: 1 mg Triamcinolone Acetonide (Eur. Ph), 2,5 mg Neomycin Sulphate (Eur. Ph), 100.000 I.U. Nystatin (Eur. Ph).

Subsidiary substances: Sorbic acid (Eur. Ph), Cetostearyl Alcohol (Eur. Ph), Dimethicone (Eur. Ph), Titanium Dioxide (CI=77891, E-171) (Eur. Ph), Glyceryl Monostearate, Ethylenediamine Dihydrochloride, Aluminium Hydroxide, Methyl parahydroxybenzoate (Methylparaben) (Eur. Ph), Polyethylene glycol 2000 monostearate (Macrogol stearate) (Eur. Ph), Propyl parahydroxybenzoate (Propylparaben) (Eur. Ph), Propylene glycol (Eur. Ph), Sorbitol (Eur. Ph), White Vaseline (Eur. Ph), Water (Eur. Ph)

Pharmacotherapeutic group
Combinations of moderately potent corticoids and antibiotics. Triamcinolone and antibiotics.
 

ATC code: D07CB01

Pharmacological features
Pharmacodynamics
Triamcinolone acetonide is a fluorine substituted corticosteroid with known cutaneous effects. It has a potent local action over the anti-inflammatory process of the skin, superior to the action demonstrated by hydrocortisone acetate; it contributes to diminish the inflammatory phenomenon and to the subjective welfare of the patient. A vasoconstriction that contributes to its local anti-inflammatory effects has also been demonstrated, through local application over the skin.
Neomycin sulfate is an antibiotic of the aminoglycoside family that possesses bactericidal actions through topic and oral administration.  Neomycin is effective against gram positive microorganism including staphylococcus and a wide variety of gram negative organisms. The strains of Pseudomona aeruginosa, fungus and viruses are resistant to neomycin. The mechanism of action consists in the irreversible union of the antibiotic to the 30S segment of the ribosome, which produces a biocide effect. Its efficacy is not decreased in the presence of pus.
Nystatin is an antimycotic agent obtained from Streptomyces noursei.  Nystatin has fungistatic and fungicidal activities in vitro against a wide variety of related yeasts and fungus. It acts by binding to the sterols of the cellular membrane of the sensible species of Candida (Candida albicans and other species) and forming ion channels, producing changes in the permeability of the membrane and the subsequent release of intracellular elements.
During subcultures repeated at increasing concentrations of nystatin, Candida albicans does not develop resistance. Generally no resistance to nystatin is developed during treatment. Nystatin does not posses activity against bacteria, protozoos and viruses.
Pharmacokinetics
Corticosteroids can be absorbed through the skin in small amounts. The extent of the percutaneous absorption depends on various factors, as vehicle, skin integrity, application zone, use of occlusive dressings. It may be absorbed through intact skin.
Once absorbed, they present pharmacokinetics similar to the orally administrated corticosteroids (they bind to plasmatic proteins, metabolize in the liver and the excretion is renal).
Neomycin is not absorbed or it is obly absorbed in minimum quantities through intact skin. Neomycin that could have been absorbed will be excreted through the renal route in its unaltered form.
Nystatin is not absorbed through intact skin or mucosa. When administered by oral route, the elimination is through the feces in its unaltered form.
Indications
Positon cream is indicated in the treatment of the following dermatological conditions sensitive to corticoid treatment where there is risk of bacterial or fungal infection caused by susceptible organisms:
Eczema in adults and children (over 2 years), atopic or discoid eczema, prurigo nodularis, neurodermatosis (including lichen simplex and lichen planus), seborrheic dermatitis, contact sensitivity reactions, reactions to insect bites and anal and genital intertrigo .
 

Contraindications
Hypersensitivity to the active ingredients or excipients.
Do not use in cases of rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus or cutaneous viral infections (i.e. herpes simplex, chicken pox).
It shall not be used in dermatitis in children younger than 2 years, includind diaper dermatitis and eruptions, since there is a higher risk for an increase in absorption due to the immature state of the skin and the renal function.
The medicinal products that contain neomycin sulfate should not be used for the treatment of otitis in patients with prforated tympanum due to the risk of ototoxicity.
Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Positon cream in large amounts or extensive areas for prolonged periods is not recommended, owing to the possible risk of systemic absorption.

Pregnancy and lactation
Very limited information exists that demonstrates the possible effect of neomycin in pregnancy and lactation. Since neomycin may cross the placental barrier if it is present in maternal blood and may produce toxicity, the use of Positon cream during pregnancy or lactation is not recommended."

Special terms of usage
As long as it is possible, the application of a sustained or prolonged topical treatment must be avoided, especially in children, since adrenal suppression may occur, with or without clinical signs of Cushing´s syndrome, even without using occlusive dressings. If this situation were to take place, the topical corticosteroid must be gradually withdrawn under medical supervision, due to the risk of adrenal failure. 
If the infection persists, a systemic therapy must be implemented. 
In the case of dissemination of the infection, the topical corticosteroids must be withdrawn. Do not use occlusive dressings or ones that do not permit transpiration, since they may favour the development of infections and the corresponding cutaneous irritation. In case of irritation in the application zone, the use of the cream shall be suspended and, if necessary, establish an adequate treatment.
Precautions must be taken to avoid Positon cream from entering in contact with the eyes or the mucous membranes. After application, a thorough hand wash is advised. When the cream is applied to the face, the treatment must be limited to 5 days.
The continuous or recurrent application may increase the risk of contact sensitivity.
The joint administration of steroid and antibiotic treatments for more than 7 days must be avoided in case a clinical improvement does not occur, since this situation may disguise the extension of the infection by means of the masking effect of the corticoid.
After a significant systemic absorption, the aminoglycoside antibiotics like neomycin sulfate may produce irreversible ototoxicity. Neomycin has a nephrotoxic potential.
In renal failure cases, the plasmatic clearance of neomycin is reduced.
The products that contain antibiotics must not be diluted.
Warning about the excipients:
This medicinal product may produce local reactions in the skin (like contact dermatitis) because it contains cetostearyl alcohol.
This medicinal product may produce skin irritation because it contains propylene glycol.
It can produce allergic reactions (possibly retarded) since it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medicinal product may produce local reactions in the skin (like contact dermatitis) because it contains sorbic acid (E-200).
All sportsmen are informed that this medicinal product contains a component that may establish an analytical result of a doping control as positive.

Reciprocal action with other medicines
After a significant systemic absorption, neomycin sulfate may intensify and prolong the respiratory depression caused by muscle relaxants.
Administration route and doses
Topical administration. The treatment should not extend to more than 7 days without medical supervision.
Adults and children 2 years and older: Apply a small amount over the affected region, in a fine layer, 2 or 3 times a day until improvement occurs. This improvement can be maintained subsequently with applications one time a day or with less frequency.
The same adult dose can be applied to children (older than 2 years), but the duration of the treatment must be limited to 5 days, if possible.
Dosage in renal failure: The dose must be reduced in patients with renal failure.
Elderly: Positon can be administered in elderly patients; precautions must be adopted in cases with a decreased renal function and a significant systemic absorption of neomycin can occur.

Side effects.
The adverse reactions that have been communicated with the use of cutaneous corticosteroids include:
Very frequent (1/10); frequent (1/100, <1/10); low frequency (1/1000, <1/100); rare (1/10.000, <1/1.000); very rare (<1/10.000). 
Disorders of the skin and subcutaneous tissue
Frequent: burning sensation, from low to moderate, in the point of application, pruritus and local cutaneous atrophy.
Low frequency: striation, secondary infection, papulose rosacea dermatitis (in facial skin), echymosis, folliculitis.
Rare: hypertrychosis, sensibilization, hyper/hypo pigmentation, telangiectasia.
Endocrine disorders
Rare: hypercorticism, corticosuprarrenal supression
Other adverse effects include: purpura, acne (especially in prolonged treatments). Rarely, perioral dermatitis and systemic activity. In rare occasions, the treatment of psoriasis with corticosteroids may have provoked the pustular form of the disease.

Extradose intake
It is very improbable that an acute overdose may be produced; however, in the case of chronic overdose or bad use, symptoms of hypercorticism may appear and in this situation, the application of topical steroids shall be interrupted gradually, under medical supervision, with a control of the auditory acuity and renal and neuromuscular functions. The blood levels of neomycin sulfate should also be determined. Hemodialysis may reduce the serum levels of neomycin sulfate.

Package
Positon cream is packaged in glazed aluminum tube printed on the exterior, with an internal coating of varnish and latex joint in the proximity of the open end of the tube containing 30 g of cream per tube.

The keeping terms
Store below 30ºC and keep out of the reach of children

Usefull time
3 years
Terms of release
With medical prescription

Company-manufacturer
LABORATÓRIOS VITORIA, S.A.
Rua Elias Garcia, 28
VENDA NOVA
2700 – 327 AMADORA
PORTUGAL