Active ingredients: Gentamicin
GENTAMICINA MYLAN GENERICS 0.1% cream
Why is Gentamicin Cream - Generic Drug used? What is it for?
GENTAMICINAMYLAN GENERICS is a skin cream that contains the active ingredient gentamicin. GENTAMICIN MYLAN GENERICS belongs to a group of medicines called aminoglycoside antibiotics, used against bacterial infections.
GENTAMICINAMYLAN GENERICS is indicated for the treatment of skin inflammations caused by bacteria such as:
- skin infection with lesions and blisters (ecthyma), boils, skin irritation (eczema) caused by microbes, stasis ulcers and traumatic injuries;
- inflammation of the hair follicles (folliculitis, sycosis);
- secondary bacterial infections of skin lesions (impetigo);
- infected burns and grazes;
- inflammation with pimples (acne);
- a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
- inflammation of the skin caused by a continuous friction of two parts of the body (intertrigo);
- disease of the superficial layers of the skin and nails (perionissi) of bacterial origin.
This medicine is not active against fungal infections, however it is useful in fungal and virus infections if they are simultaneously infected with bacteria. Particular efficacy has been demonstrated by GENTAMICINA MYLAN GENERICS in the treatment of burns.
Contraindications When Gentamicin Cream - Generic Drug should not be used
Do not use GENTAMICINAMYLAN GENERICS:
- if you are allergic to gentamicin sulphate, closely related substances or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Gentamicin Cream - Generic Drug
Talk to your doctor or pharmacist before using GENTAMICIN MYLAN GENERICS.
This medicine should not be applied to the eyes.
Stop the treatment and tell your doctor if you experience an "irritation or allergic reaction (sensitization) following" use of this medicine, especially for prolonged periods.
It may occur, as a result of prolonged use of gentamicin, as well as other antibiotics, that resistant microorganisms develop, in which case the doctor will advise you to stop the treatment and prescribe a suitable therapy.
Use this medicine with caution and tell your doctor if you are allergic to other antibiotics of the aminoglycoside group, as an allergic reaction (cross-hypersensitivity) may occur.
Use in children
In very early childhood, use this medicine only in case of real need and under the direct supervision of your doctor.
Interactions Which drugs or foods can modify the effect of Gentamicin Cream - Generic Drug
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known interactions with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only when clearly needed and under the direct supervision of your doctor.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
GENTAMICINAMYLAN GENERICS contains chlorocresol and cetostearyl alcohol
This medicine contains chlorocresol which can cause allergic reactions and cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Gentamicin Cream - Generic Drug: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
GENTAMICINAMYLAN GENERICS should not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until results are achieved. After that you can reduce the applications to 1-2 times a day.
Protect the treated area with a sterile gauze after applying the cream.
Use in children
In very early childhood, use this medicine only in case of real need and under the direct supervision of your doctor.
Overdose What to do if you have taken an overdose of Gentamicin Cream - Generic Drug
No cases of overdose have been reported.
In case of accidental ingestion / intake of GENTAMICINAMYLAN GENERICS contact your doctor or go to the emergency room of the nearest hospital immediately.
and if you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Gentamicin Cream - Generic Drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with this medicine may cause temporary skin irritation such as redness or itching. These effects do not usually require discontinuation of therapy.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP".
The expiry date refers to the last day of that month.
GENTAMICINA MYLAN GENERICS should be used within 12 weeks after first opening the tube. After this time, throw away the tube, even if there is some cream left. To help you remember, write the date you first opened the tube on the box.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What GENTAMICINAMYLAN GENERICS contains
- The active ingredient is gentamicin. 100 g of cream contains 0.166 g of gentamicin sulfate (equal to 0.1 g gentamicin).
- The other ingredients are: liquid paraffin, white petroleum jelly, chlorocresol, cetomacrogol, cetostearyl alcohol, monobasic sodium phosphate, purified water.
Description of the appearance of GENTAMICINAMYLAN GENERICand contents of the package
Pack containing a 30 g tube of cream.
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
GENTAMICIN MYLAN GENERICS 0.1% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of cream contain:
Active ingredient: gentamicin sulfate 0.166 g (equal to 0.1 g of gentamicin).
Excipient (s) with known effect: chlorocresol and cetostearyl alcohol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Gentamicina Mylan Generics cream is indicated in primarily bacterial inflammatory skin forms such as pyoderma of varying severity and extent, including ecthyma, folliculitis, sycosis, furunculosis, microbial eczema, as well as in secondary infected forms such as dermatitis and impetiginized eczemas, stasis ulcers, traumatic lesions, burns and infected abrasions. Other skin diseases that benefit from the application of Gentamicin Mylan Generics are acne and pustular psoriasis, intertriginoid forms and perionyses of bacterial origin . In the fungal forms, Gentamicin Mylan Generics is ineffective, since gentamicin is not active on any strain of fungi; the drug has however useful application in bacterial superinfections of fungal and viral infections. Particular efficacy has been demonstrated by the preparation in burns of various degrees. and extension, in which the "mortification of the land", implemented d due to the exceptional intensity of the thermal insult, it favors the development of a particularly virulent bacterial flora.
04.2 Posology and method of administration
Apply the cream 3-4 times a day until the first results are achieved, after which the number of dressings can be reduced to 1-2 in 24 hours. It will be good, after the application, to protect the part with sterile gauze.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, treatment must be interrupted and suitable therapy instituted. The preparation cannot be used for ophthalmic use. As for all antibiotics, treatment with gentamicin can cause an overdevelopment of insensitive microorganisms, in which case treatment must be stopped and appropriate therapy instituted. Cross-allergenicity between aminoglycosides has been demonstrated. The product contains chlorocresol, which can cause allergic reactions.
The product also contains cetostearyl alcohol, which can cause local skin reactions, such as contact dermatitis.
04.5 Interactions with other medicinal products and other forms of interaction
None known until now.
04.6 Pregnancy and lactation
In pregnant women and in very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
No effect.
04.8 Undesirable effects
Treatment with gentamicin can sometimes cause transient irritation (erythema or pruritus) which usually does not require the interruption of therapy. In these subjects the patch test conducted subsequently did not show irritation and sensitization phenomena.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibiotics and chemotherapeutic agents for dermatological use.
ATC code: D06AX07.
Gentamicin is produced by the fermentation of Micromonospora purpurea and is obtained as a white amorphous powder, soluble in water and stable in the heat. This broad-spectrum antibiotic isolated in Schering Corporation's Research Laboratories has been shown to be highly effective in the topical treatment of primary and secondary bacterial skin infections. Bacteria sensitive to gentamicin include Staphylococcus aureus (coagulase positive, coagulase negative and penicillinase producing strains), Gram negative bacteria (Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneuomtoconiae) and also strep group A beta-haemolytics and alpha-haemolytics). The results of the skin reaction tests carried out in the clinic have shown that gentamicin is not a primary irritant; moreover, gentamicin has a low skin sensitization index.
05.2 "Pharmacokinetic properties
Transcutaneous absorption of gentamicin is usually absent.
05.3 Preclinical safety data
Acute toxicity studies in mice, using gentamicin in aqueous solution, gave the following LD50: subcutaneous 485 mg / kg, endoperitoneum 430 mg / kg, intravenous 75 mg / kg, oral> 9050 mg / kg. Experiences conducted on animals and humans with preparations at concentrations of antibiotics much higher than the therapeutic ones, have not shown any signs of primary irritation or sensitization phenomena. Epicutaneous tests performed in 100 patients gave negative results in each case. Gentamicin does not have structural analogies with compounds with an established carcinogenic action. In chronic toxicity studies and during clinical trials, it has never shown phenomena capable of suggesting carcinogenic potential.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Liquid paraffin, white petroleum jelly, chlorocresol, cetomacrogol, cetostearyl alcohol, monobasic sodium phosphate, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
Shelf life of the tube after first opening: 12 weeks.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
30 g tube.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
08.0 MARKETING AUTHORIZATION NUMBER
0.1% cream - tube 30 g AIC n. 036130019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
June 2004
10.0 DATE OF REVISION OF THE TEXT
January 2015
