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Pamycon for Drops Prep., plv.


SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF THE MEDICINAL PRODUCT

                                                        PAMYCON for Drops Prep., plv.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
                                                        Neomycini sulfas 33 000 IU, 
                                                        Bacitracinum 2 500 IU in 1 vial.
(Weight amount of antibiotics is calculated always on the base of efficacy.)
Complete list of excipients, see the Part 6.1.


3. PHARMACEUTICAL FORM 
Powder for drops of yellowy color.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

In surgery – for treatment of infected wounds and injuries.
In obstetrics and gynecology – for treatment of breast nipple rhagades, mastitis and abscesses during lactation, bacterial fluorine in indicated cases.
In ophthalmology – for treatment of acute conjunctivitis (including pyogenic conjunctivitis of neonates), acute inflamed cornea, infected corneal erosions, dacryocystitis, blepharoconjunctivitis, hordeolosis and for preoperative preparation for intra-ophthalmic surgery. 
In otorhinolaryngology for the treatment of otitis externa, otitis media suppurativa chronica, sinusitis maxillaries, infections of mucosa of upper and lower airways and in bronchiectasis, for postoperative care after ear surgery.

4.2 Posology and method of administration
Solution is dropped directly into infected place so often as indicated by doctor. Solution is applied only locally; it is dropped or instilled directly onto the infected site or the gauze strips soaked with Pamycon solution are applied to infected sites and they are dropped to be kept wet continually. 
Into year there are usually dropped 2 – 5 drops 2 times daily, into nose 2 – 5 drops 3 and more times daily, into eye 1 – 2 drops 4 to 6 times daily. Treatment duration is determined by a doctor.

4.3 Contraindications

Hypersensitivity to neomycin and bacitracin.
Pamycon cannot be applied parenterally, neither to extensive areas, especially if they are eroded and madescent, ulcus cruris and varicous field below the knees. Instillation into body cavities (peritoneal, intrapleural) because of possible incidence of serious toxic effects is not recommended.

4.4 Special warnings and precautions for use
Pamycon cannot be applied in infectious processes induced by insensitive microflora, e.g. yeasts and moulds or nosocomial strains resistant to neomycin. Rational therapy with Pamycon should be based on the results of microbiological examination and antibiograms which should be performed not only at the beginning, but also during treatment. If after the application of the medicament skin irritation occurs, it is probably the case of hypersensitivity which can be proven by skin patch test with ointment or solution of Pamycon (eventually neomycin). In case of positive result the treatment has to be discontinued and the patient should be warned of that he must not be treated with Pamycon even in the future.

4.5. Interaction with other medicinal products and other forms of interaction 
At external application the drug substances contained in Pamycon do not get into blood circulation, and therefore there is no risk of mutual influence of interaction with other drug substance.

4.6 Fertility, pregnancy and lactation
In recommended method of application the unfavorable effect on fetus during pregnancy is not expected. Use during application is not connected with incidence of undesirable effects in infants, because in local use the active substances do not get into breast-milk. Application of Pamycon for treatment of nipple rhagades in mother is not connected with occurrence of undesirable effects (ototoxicity, affection of intestinal microflora) in infants, because concentration of active substances in duly prepared solution is low.

4.7 Effects on ability to drive and use machines 
Pamycon has no effect on ability to drive and use machines.

4.8 Undesirable effects
In about 5 to 15 % of treated patients occurred allergic reactions (contact dermatitis, allergic conjunctivitis, also risk of anaphylactic shock), sensibilization (especially to neomycin) particularly in long-time treatment or in repeated local application. After absorption of higher amount of Pamycon the symptoms of nephrotoxicity are possible (by effect of neomycin and bacitracin), irreversible damage of auditory branch of 8th cranial nerve with partial to total deafness (after neomycin).

4.9 Overdose
At recommended application method the intoxication is not expected.


5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group:        antibiotic for external use
ATC code:                                 D06AX

Action of neomycin is based on incorrect reading of genetic bacterial code, what disturbs the process of protein synthesis. Bacitracin inhibits biosynthesis of cell wall. So the double sided effect on bacterial cell is developed. Besides this additive effect there was observed in both bactericidal components of the drug the so called synergism for example against the growth of streptococci, enterococci, pneumococci and some staphylococci. Neomycin is effective against gram-positive and especially against gram-negative pathogens. 
Spectrum of activity of bacitracin contains particularly gram-positive bacteria and cocci, but also gram-negative cocci and some gram-negative bacteria.

5.2 Pharmacokinetic properties
Pamycon is a mixture of antibiotics for local use, which are not applied systemically. Absorption of the drug substances neomycin and bacitracin through undisturbed skin is only minimal and so the high concentration of active substances on application site is reached. 

5.3 Preclinical safety data
In acute toxicity tests the LD50 value in rats after per oral application of neomycin was determined to 2.75 g/kg and 510 000 IU/kg in mice after per oral application of bacitracin.


6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Natrii chloridum, Carbethopendecinii bromidum, Polysorbatum 80

6.2 Incompatibilities
Unknown

6.3 Shelf life
Substance: 2 years
Prepared solution: 7 days

6.4 Special precautions for storage 
Store below 15 ºC in original package, in order to protect from light and moisture.
Do not freeze.
Store the prepared solution in a refrigerator at a temperature 2 – 8 ºC.

6.5 Nature and contents of container
Glass brown bottle closed with rubber stopper and aluminium cap and dropper applicator with closure packed separately. 
Package size:    1 x 1 vial
                        10 x 1 vial
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Pamycon for external drops is not intended for immediate use and must be dissolved before it is handed over to a patient in pharmacy. Pharmacist prepares the solution in compliance with the requirements of Good Pharmacy Practice by the following procedure:

Using tweezer remove aluminium cap and rubber stopper from vial and to content in bottle add 10 mL of aqua pro injectione. After careful closing of vial with rubber stopper shake the content about 1 minute. Than remove original closure and set dropper applicator on bottle. Mark the date of preparation on box. Indicate the preparation date on box. 


7. MARKETING AUTHORISATION HOLDER

BB Pharma a.s., Pod Višňovkou 1662/21, Prague, Czech Republic


8. MARKETING AUTHORISATION NUMBER
15/0056/84-S, 15/056/84-S/C

9. DATE OF FIRST REGISTRATION / RENEWAL OF THE AUTHORISATION
18.10.1984/ without time limitation

10. DATE OF REVISION OF THE TEXT
September 2013