Active ingredients: Tobramycin
MITOBRIN "0.3% eye drops, solution"
Mitobrin package inserts are available for pack sizes:- MITOBRIN "0.3% eye drops, solution"
- MITOBRIN "0.3% ear drops, solution"
Why is Mitobrin used? What is it for?
Pharmacotherapeutic group
Antibiotic from the aminoglycoside family
Therapeutic indications
MITOBRIN is indicated in the treatment of eye and adnexal infections caused by bacteria sensitive to tobramycin: acute, sub-acute and chronic catarrhal conjunctivitis; blepharitis; bacterial keratitis; dacryocystitis; pre- and post-operative prophylaxis in segment operations front.
Contraindications When Mitobrin should not be used
lpersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Mitobrin
As with all antibiotics, prolonged use can promote the growth of resistant microorganisms, including fungi.
Due to the presence in the formulation of the non-ionic surfactant tyloxapol, the simultaneous use of products containing tetracyclines is not recommended.
In the event that the use of Mitobrin is accompanied by systemic treatment with aminoglycoside antibiotics, the total serum concentration must be carefully monitored. Do not exceed the doses or the therapy period recommended by the doctor.
Interactions Which drugs or foods can modify the effect of Mitobrin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The tyloxapol component is incompatible with tetracycline.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnant women and in infancy the product should be administered in cases of real need, under the direct supervision of the doctor. The product should not be used during breastfeeding.
If the doctor deems the treatment necessary, breastfeeding should be stopped.
Effects on ability to drive and use machines
Based on its pharmacodynamic properties, the product is not expected to affect, if not negligibly, the ability to drive or use machines.
Like all ophthalmic medicines, if momentary blurring of vision occurs at the time of application of Mitobrin, it is necessary to wait for the vision to return to normal before driving or operating machinery.
MITOBRIN "0.3% eye drops, solution" multidose:
MITOBRIN contains benzalkonium chloride which may cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before reapplying.
The bleaching action against soft contact lenses is known.
Dose, Method and Time of Administration How to use Mitobrin: Posology
Instill in the conjunctival sac two drops four times a day in the acute forms and three times a day in the chronic forms, according to medical prescription.
Before use, make sure that the single-dose container is intact.
Hold the single-dose container upright and open by rotating the flap until the container opens.
The eye drops in single-dose containers should be used immediately after opening. Any residue should not be reused.
Avoid letting the tip of the container come into contact with the eye or any other surface.
Overdose What to do if you have taken too much Mitobrin
There are no known cases of overdosing.
In case of accidental intake of an overdose of Mitobrin, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of Mitobrin, ask your doctor or pharmacist.
Side Effects What are the side effects of Mitobrin
Like all medicines, Mitobrin can cause side effects, although not everybody gets them.
As with all topical ocular aminoglycoside antibiotics, local intolerance or hypersensitivity reactions such as itching, eyelid swelling or conjunctival erythema may occur. These phenomena were detected in less than 3% of patients treated with tobramycin 0.3% eye drops, solution.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored. The expiry date refers to the last day of the month.
Warning: do not use the medicine after the expiry date shown on the package.
No special storage precautions.
Validity after opening:
MITOBRIN "0.3% eye drops, single-dose solution":
The product does not contain preservatives: after administration the vial must be disposed of even if only partially used.
After opening the sachet, the remaining vials must be used within 28 days.
MITOBRIN "0.3% eye drops, solution" multidose:
After first opening the bottle must be used within 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment. Keep Mitobrin out of the reach and sight of children.
Other information
Composition
MITOBRIN "0.3% eye drops, single-dose solution"
A single-dose container contains:
- Active ingredient: Tobramycin: 0.750 mg
- Excipients: Tyloxapol, Boric acid, Sodium sulphate anhydrous, Sodium chloride, Water for injections.
MITOBRIN "0.3% eye drops, multidose solution"
One bottle contains:
- Active ingredient: Tobramycin: 15.0 mg
- Excipients: Tyloxapol, Benzalkonium chloride, Boric acid, Sodium sulphate anhydrous, Sodium chloride, Water for injections.
Pharmaceutical form and content
Eye drops, solution
MITOBRIN "0.3% eye drops, single-dose solution":
- 20 single-dose containers of 0.250 ml
MITOBRIN "0.3% eye drops, solution" multidose:
- 1 dropper bottle of 5ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MITOBRIN 0.3% EYE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
MITOBRIN "0.3% eye drops, single-dose solution"
A single-dose container contains:
Active principle:
Tobramycin: 0.750 mg
MITOBRIN "0.3% eye drops, multidose solution"
One bottle contains:
Active principle:
Tobramycin: 15.0 mg
For excipients see section "List of excipients".
03.0 PHARMACEUTICAL FORM
Eye drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
MITOBRIN 0.3% eye drops, solution is indicated in the treatment of eye and adnexal infections caused by bacteria sensitive to tobramycin: acute, sub-acute and chronic catarrhal conjunctivitis; blepharitis; bacterial keratitis; dacryocystitis; pre- and prophylaxis postoperative in operations on the anterior segment.
04.2 Posology and method of administration
Instill in the conjunctival sac two drops four times a day in the acute forms and three times a day in the chronic forms, according to medical prescription.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
As with all antibiotics, prolonged use can promote the growth of resistant microorganisms, including fungi.
In case the topical administration of tobramycin is accompanied by systemic treatment with aminoglycoside antibiotics, the total serum concentration should be carefully monitored. Do not exceed the doses or therapy period recommended by your doctor.
Keep this medicine out of the reach of children.
MITOBRIN "0.3% eye drops, multidose solution"
MITOBRIN 0.3% eye drops, solution contains benzalkonium chloride which may cause eye irritation. Soft contact lenses should not be worn before application and at least 15 minutes after administration.
04.5 Interactions with other medicinal products and other forms of interaction
The tyloxapol component is incompatible with tetracycline.
04.6 Pregnancy and breastfeeding
Clinical studies have shown that tobramycin is safe and effective in pediatric use.
In pregnant women and in infancy the product should be administered in cases of real need, under the direct supervision of the doctor. The product should not be used during breastfeeding. If the doctor deems the treatment necessary, breastfeeding should be stopped.
04.7 Effects on ability to drive and use machines
Based on its pharmacodynamic properties, the product is not expected to affect, if not negligibly, the ability to drive or use machines.
Like all ophthalmic medicines, if momentary blurring of vision occurs at the time of application of Mitobrin, it is necessary to wait for the vision to return to normal before driving or operating machinery.
04.8 Undesirable effects
As with all topical ocular aminoglycoside antibiotics, local intolerance or hypersensitivity reactions such as itching, eyelid swelling or conjunctival erythema may occur. These phenomena were detected in less than 3% of treated patients.
04.9 Overdose
No cases of overdose have ever been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibiotic from the aminoglycoside family. ATC code: S01AA12.
Tobramycin is an aminoglycoside antibiotic isolated from a complex produced by Streptomices tenebrarius, active on a wide range of gram-positive and gram-negative ocular pathogens, in particular on Staphylococcus aureus and Pseudomonas aeruginosa. The antimicrobial spectrum of tobramycin is comparable to that of gentamicin; however, it revealed a better activity in vitro and in vivo, in particular against Pseudomonas, and also has a lower nephro and ototoxic effect than other aminoglycoside antibiotics.
Clinical studies have shown that tobramycin is safe and effective in pediatric use.
05.2 Pharmacokinetic properties
Studies on the penetration of tobramycin at the ocular level, after topical administration in rabbits, have shown that the maximum concentration of tobramycin in the cornea is detected 0.5 hours after administration and 1.5 - 2.5 hours in the aqueous humor.
05.3 Preclinical safety data
The LD50 of tobramycin administered intravenously in mice is 118 mg / kg. Acute toxicity studies, by topical ocular administration in rabbits, have shown that tobramycin does not exert local irritative effects. The administration of tobramycin, repeated topical ocular route in rabbits for three weeks, did not show irritative effects at the local level as well as pharmaco-toxic effects at the systemic level.
Embryo-fetal toxicity, carcinogenesis and mutagenesis
Studies conducted in rats and rabbits with doses 33 times higher than the normal systemic human dose have shown that this antibiotic is not mutagenic or carcinogenic and does not exert toxic effects at the embryo-fetal level.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
MITOBRIN "0.3% eye drops, single-dose solution"
Tyloxapol; boric acid; anhydrous sodium sulfate; sodium chloride; water for injections.
MITOBRIN "0.3% eye drops, multidose solution"
Tyloxapol; benzalkonium chloride; boric acid; anhydrous sodium sulfate; sodium chloride; water for injections.
06.2 Incompatibility
The tyloxapol component is incompatible with tetracycline.
06.3 Period of validity
MITOBRIN "0.3% eye drops, single-dose solution":
In intact packaging: 2 years
The product does not contain preservatives: after administration the vial must be disposed of even if only partially used.
After opening the sachet, the remaining vials must be used within 28 days.
MITOBRIN "0.3% eye drops, solution" multidose:
In intact packaging: 2 years
After first opening: 28 days
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
MITOBRIN "0.3% eye drops, single-dose solution"
20 low density polyethylene containers of 0.250 ml of eye drops
MITOBRIN "0.3% eye drops, multidose solution"
One 5ml dropper bottle made of low density polyethylene.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Sooft Italia S.p.A. - Contrada Molino, 17 - 63833 Montegiorgio (FM)
08.0 MARKETING AUTHORIZATION NUMBER
"0.3% eye drops, solution" 20 single-dose containers of 0.250 ml - AIC: 039812019
"0.3% eye drops, solution" bottle of 5 ml - AIC: 039812021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 24/01/2013
