Paroticin Paroticin

Fludrocortizone Acetate
Polymyxin B Sulfate
Paroticin
Fludrocortizone Acetate Lidocaine hydrochloride Fludrocortizone Acetate
Polymyxin B Sulfate Is indicated for the treatment of inflam- Polymyxin B Sulfate
mations and microbial infections of
Lidocaine hydrochloride the ear, such as otitis externa, eczema, Lidocaine hydrochloride
mycoses, furuncle of auditory canal.

The complete
Combination of
Name of the
medicinal product:
Paroticin
treatment for
3 active ingredients: Active ingredients: Fludrocortizone Acetate
Polymyxin B Sulfate
microbial
Lidocaine hydrochloride infections
• Polymyxin B sulfate: It develops anti-microbial
Pharmaceutical form:
Packaging:
Ear drops, solution
Dropper bottle of 10 ml
of the ear
action against most of the Gram bacteria and
Therapeutic For the treatment of inflammations and
particularly effective against Pseudomonas indications: microbial infections of the ear

aeruginosa. Method of Before the instillation of the drops, is recom-

administration: mended cleaning of the ear canal with sterile
• Fludrocortizone acetate: With glucocorticoid cotton. Keep the head with the ear to be treat-
ed turned upwards and this position should be
action 10 times more potent than that of kept for 5 minutes after the instillation of the
drops. Alternatively, with the introduction of a
hydrocortisone and mineralocorticoid action plug into the ear canal and its impregnation.
more than 100 times more potent. Posology: Adults: 2 - 4 drops, 3 - 4 times daily
Children: 3 drops, 3 - 4 times daily
• Lidocaine hydrochloride: Topical anesthetic Marketing ADELCO S.A.
authorization holder
with a fast onset and medium duration of & manufacturer:
action.

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37, Pireos Str., 183 46 Moschato
Tel: +30 210 4819311-13,
Fax: +30 210 4816790
E-mail: info@adelco.gr
Web site: www.adelco.gr
 SUMMARY OF PRODUCT CHARACTERISTICS

Paroticin
1. NAME OF THE MEDICINAL PRODUCT: PAROTICIN 5. PHARMACOLOGICAL PROPERTIES: ATC code: S02CA07
2. QUALITATIVE AND QUANTITATIVE COMPOSITION in active ingredients 5.1. Pharmacodynamic properties:
Each ml of the solution contains: • Polymyxin: It acts mainly by binding with the phospholipids of membranes and by interrupting the
• Fludrocortisone acetate 1 mg cytoplasmic membrane of bacteria. It develops anti-microbial action against most of the Gram– bacteria
• Polymyxin B sulfate 1.30 mg = 10,000 IU Polymyxin B with the exception of Proteus spp. It is particularly effective against Pseudomonas aeruginosa. The same
• Lidocaine HCl 50 mg stands for other Gram- bacteria, such as Escherichia coli, Enterobacter, Klebsiella spp., Haemophilus

Fludrocortizone Acetate 3. PHARMACEUTICAL FORM

Ear drops, solution
Influenza, Bordetella pertussis, Salmonella, Shigella spp.
• Lidocaine: It is a topical anaesthetic (amide), with a fast onset and medium duration of action.

Polymyxin B Sulfate 4. CLINICAL PARTICULARS:

4.1. Therapeutic indications:
• Fludrocortisone acetate: It has glucocorticoid action, 10 times more potent than that of hydrocortisone
and mineralocorticoid action more than 100 times more potent (to which undesirable effects are owed).

Lidocaine hydrochloride PAROTICIN is indicated for the treatment of inflammations and microbial infections of the ear.
4.2. Dosage and method of administration:
• PAROTICIN contains acetic acid as an excipient which has been used as antibacterial and antifungal
in mild infections of the ear canal.
The dosage and the method of administration of PAROTICIN for all ages is 2-4 drops inside the ear canal, 3-4 times a 5.2. Pharmacokinetic properties:
day. In children, the instillation of only 3 drops is recommended given the small capacity of the ear canal. • Fludrocortisone: It is easily absorbed from the gastrointestinal tract. Like all corticosteroids, it is also
Method of administration: Before the instillation of the drops, cleaning of the ear canal with sterile cotton is absorbed through topical application, mostly through damaged skin. It is rapidly distributed to all tissues.
recommended in order for the canal to be dry. It is also necessary to keep the head of the patient steady with the It crosses the placenta and can be traced in small quantities in breast milk. Most of corticosteroids are
ear to be treated turned upwards, and this position should be kept for 5 minutes after the instillation of the drops. An bound with plasma proteins, mainly with globulins and at a smaller extent with albumin.
alternative method of administration of PAROTICIN is the introduction of a plug into the ear canal and its impregnation • Polymyxin: Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which is produced
with the drops 3-4 times daily. The plug should be changed at least every 24 hours. by bacillus polymyxa. Polymyxin B is not absorbed by the gastrointestinal tract (except for that of the
4.3. Contraindications: newborns) and by healthy skin. It is easily absorbed by skin which has been damaged and there is a risk
• Ear drops for topical use of Paroticin have There are very few contraindications. PAROTICIN is contraindicated for patients with known history of hypersensitivity
to any of its ingredients and for cases in which herpes simplex, chicken-pox and cowpox coexist.
of systemic absorption. After intra- muscular administration, maximum plasma concentration is usually
achieved within 2 hours. It is widely distributed throughout the tissues and the cell membranes of the
4.4. Special warnings and precautions for use: tissues. The elimination half- life is 6 hours. It is excreted mainly by the kidneys (up to 60%). It is detected
a potent anti-microbial and glucocorticoid Chronic use of PAROTICIN could result in the development of micro-organisms and fungi resistant to Polymyxin. If in the urine after 12-24 hours.
the inflammation does not subside within one week, it is recommended to repeat the culture and to determine the • Lidocaine: It is easily absorbed by the gastrointestinal tract, the mucous membranes and the
action, but also anesthetic action for pain sensitivity of the microorganisms in order to modify or not the treatment. damaged skin. The absorption by healthy skin is poor. After intravenous administration, plasma
The treatment should not continue for a period longer than ten days, particularly in the case of no medical surveillance. concentrations are rapidly decreased with an initial elimination half-life less than 30 min. The elimination
relief. To avoid the risk of an infection, it is recommended to avoid contact of the dropper with the hands, the skin or the ear. time is 1-2 hours. It goes through a metabolism of first passage in the liver and bio - availability is
Should a topical irritation or allergic reaction occurs, the treatment must stop and medical advice must be asked. 35% after oral administration. The liver metabolism is rapid and nearly 90% of the dose administered is
4.5. Interaction with other medicinal products and other forms of interaction: dealcylated. It crosses the placenta and the blood- brain barrier. It is detected in breast milk.
Concurrent use and topical treatment together with another antibiotic preparation, such as neomycin, could cause a 5.3. Preclinical safety data:
cross reaction against a series of other antibiotics such as kanamycin, streptomycin, gentamicin, paromomycin the Toxicological side effects of topically acting medicinal products are associated with the topical reaction to
PAROTICIN contains as excipients: use of which is likely to become complicated in the long – run.
Polymyxin has been reported to act in synergy with a variety of other agents such as chloramphenicol, tetracycline,
the product’ s ingredients (polymixin, lidocaine, fludrocortisone) and the side effects that may be observed
due to the absorption in the cases of long-term use of the product or overdose.
sulfonamides and trimethoprim. Its action is reduced by cations such as Ca++ and Mg ++ and so its in vivo action is • Acute Toxicity: topically it is owed to idiocrasis or topical reaction.
• Acetic acid, which has antibacterial - smaller than the in vitro one. • Chronic toxicity: it is owed to topical reactions to the product’ s ingredients.
4.6. Pregnancy and lactation: • Mutagenic action-Oncogenesis: it refers to the undesirable effects caused to the mother or the foetus
antifungal properties, well tolerated that Pregnancy: Corticosteroids should not be administered during pregnancy except in the case of absolute indication
and when the benefits from the treatment outweigh the corticosteroids effects on the foetus. Do not use PAROTICIN
due to the steroids skin absorption.
• Reproduction toxicity: steroids effect on the pregnant mother and the foetus during long-term use.
does not cause sensitization and does not without consulting your doctor first.
Lactation: Hydrocortisone is excreted in breast milk. Given that the topical use of corticosteroids is accompanied by
6. PHARMACEUTICAL DATA:
6.1. List of excipients:
create resistant strains. absorption and detection of the drug in breast milk, the topical use of corticosteroids should be performed with special
caution and surveillance of the nursing mother.
PAROTICIN Ear Solution contains:
1. Acetic acid
4.7. Effects on the ability to drive and use machines: 2. Propylene glycol
• Propylene glycol which facilitates diffusion PAROTICIN does not affect the ability to drive and use machines.
4.8. Undesirable effects:
3. Distilled water
6.2. Incompatibilities:
and penetration of the drug. General undesirable effects after long-term use of corticosteroids are the following:
• Hypothalamo-pituitary-adrenal axis suppression, decrease of plasma cortisol level, Cushing’s syndrome.
None known.
6.3. Shelf life:
• Topical after long-term use: development of microbial and fungal topical infections, inhibition of injuries healing, 2 years. After the opening of the container it should be consumed within 30 days.
atrophy and linear striations in the skin, topical hypersensitivity, topical hirsutism, acme or vesication, couperose, 6.4. Special storage precautions:
hypopigmentation, perioral dermatitis. Keep at temperature below 25oC in a dry place, protected from light, out of reach and sight of children.
The use of corticosteroids is contraindicated in cases of infectious diseases, without management and treatment with 6.5. Nature and contents of the container:
antibiotics, during vaccinations and in the case of severe renal disease. FL x 10ML. Dropper bottle of 10 ml made by polyethylene.
• After the instillation of lidocaine and adrenaline in the middle ear, severe dizziness has been reported. 6.6. Instructions for use/handling:
• Polymixin, due to its pure absorption, does not cause systemic reactions when applied on intact skin, apart See section 4.2 “Dosage and method of administration”.
from rare cases of allergy. During systemic parenteral use, neurological symptoms have been reported (paresthesia, 6.7. Marketing Authorization Holder-Manufacturer:
peripheral neuropathy, confusion, psychosis, neuromuscular block, toxicity). ADELCO – CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.,
Reporting of suspected adverse reactions: 37 PIREOS STR., 183 46 MOSCHATO, ATHENS-GREECE
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued TEL.: (0030) 210 4819 311- 4, FAX: (0030) 210 4816790
monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any 6.8. Exceptional Marketing Authorization Holder in Cyprus:
suspected adverse reactions via the Greek National Organization for Medicines: 284 Mesogeion Av., GR-15562 ADELCO – CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.,
Xolargos, Athens, Greece. Tel: + 30 21 32040380/337, Fax: + 30 21 06549585, Website: http://www.eof.gr 37 PIREOS STR., 183 46 MOSCHATO, ATHENS-GREECE
4.9. Overdose: TEL.: (0030) 210 4819 311- 4, FAX: (0030) 210 4816790
The topical use of PAROTICIN is not accompanied by undesirable effects in case of overdose. 7. MARKETING AUTHORIZATION NUMBER: 66078/14/12-05-2015
If PAROTICIN is ingested and depending on the quantity, it may cause gastric discomfort (vomiting) and possible Exceptional Marketing Authorization Number in Cyprus: S00778
undesirable effects owed to the absorption of its ingredients. For this reason, medical care is recommended for the 8. DATE OF FIRST AUTHORIZATION: 10-12-1968
management of overdose. 9. DATE OF (PARTIAL) REVISION OF THE TEXT: 06-2015