Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma

NAME OF THE MEDICINAL PRODUCT

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of ophthalmic suspension contains:
Tobramycin USP………………………3mg
Dexamethasone USP…………………..1mg

For full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Eye Drops, Suspension.

White to off-white suspension.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults and children aged 2 years and older.

4.2 Posology and method of administration

Adults:

One drop instilled into the conjunctival sac(s) every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake. Dosing should continue for 14 days not to exceed a maximum of 24 days. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Use in the Elderly:

Clinical studies have indicated dosage modifications are not required for use in the elderly.

Paediatric population:

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma may be used in children 2 years of age and older at the same dose as in adults. Currently available data is described in section 5.1.

The safety and efficacy in children younger than 2 years of age have not been established, and no data is available.

Use in hepatic and renal impairment:

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma has not been studied in these patient populations

Shake the bottle well before use. To prevent contamination of the dropper tip and suspension, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. After cap is removed, if tamper evident snap collar is loose, remove before using product.

Gently closing the eyelid (s) and nasolacrimal occlusion for at least 1 minute after instillation is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.

In case of concomitant therapy with other topical ophthalmic medicinal products, an interval of 5 minutes should be allowed between successive applications.

Eye ointments should be administered last.

4.3 Contraindications

Hypersensitivity to tobramycin or dexamethasone or to any of the excipients listed in section 6.1.
Herpes simplex keratitis.
Vaccinia, varicella and other viral disease of the cornea and conjunctiva .
Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium.
Fungal diseases of ocular structures or untreated parasitic eye infections.
Untreated purulent infection of the eye.

4.4 Special warnings and precautions for use

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma is for topical use only and not for injection or oral use.

Prolonged use of topical ophthalmic corticosteroids (i.e. longer than the maximum duration used in clinical trials [24 days]) may result in ocular hypertension/glaucoma with resultant damage to the optic nerve and reduced visual acuity and visual fields defects and may also result in posterior subcapsular cataract formation.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

It is advisable that the intraocular pressure be checked frequently. This is especially important in paediatric patients receiving dexamethasone-containing products, as the risk of steroid-induced ocular hypertension may be greater in children below 6 years of age and may occur earlier than a steroid response in adults. The frequency and duration of treatment should be carefully considered, and the intraocular pressure should be monitored from the outset of treatment, recognizing the risk for earlier and greater steroid-induced intraocular pressure increases in the paediatric patients.

Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, treatment should be progressively discontinued.

The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).

Prolonged use may also result in secondary ocular infections due to suppression of host response. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, fungal or parasitic infections and mask the clinical signs of infection.

Sensitivity to topically administered aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticarial, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of this medicine, treatment should be discontinued.

Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Caution is advised when Tobradex eye drops are used concomitantly with systemic aminoglycosides.

Caution should be exercised when prescribing Tobradex Eye Drops to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson’s disease. Aminoglycosides may aggravate muscle weakness because of their potential effect on neuromuscular function

Fungal infection should be suspected in patients with persistent corneal ulceration. If fungal infection occurs, corticosteroids therapy should be discontinued.

Prolonged use of antibiotics such as tobramycin may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems (see section 4.5).

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.

Benzalkonium chloride, used as a preservative in this product, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Benzalkonium chloride may cause eye irritation and discolour soft contact lenses.

Avoid contact with soft contact lenses. Contact lens wear is not recommended during treatment of an ocular infection or inflammation. If patients are allowed to wear contact lenses, they must be instructed to remove lenses prior to application of Tobradex and wait at least 15 minutes before reinsertion.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions have been described with topical ocular dosing.

Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems.

Dexamethasone is metabolized via cytochrome P450 3A4 (CYP3A4). CYP3A4 inhibitors (including ritonavir and cobicistat); may decrease dexamethasone clearance resulting in increased effects and adrenal suppression/Cushing’s syndrome. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid effects.

4.6 Fertility pregnancy and lactation

Pregnancy:

There are no or limited amount of data from the topical ocular use of tobramycin and dexamethasone in pregnant women. Tobramycin does cross the placenta into the fetus after intravenous dosing in pregnant women. Tobramycin is not expected to cause ototoxicity from in utero exposure. Prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Studies in animals have shown reproductive toxicity after systemic administration of tobramycin and dexamethasone. These effects were observed at exposures considered sufficiently in excess of the maximum human ocular dosage delivered from the maternal use of the product (See section 5.3).

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma is not recommended during pregnancy.

Breast-feeding

Tobramycin is excreted in human milk after systemic administration. No data is available on the passage of dexamethasone into human breast milk. It is unknown whether tobramycin and dexamethasone are excreted in human milk following topical ocular administration. It is not likely that the amount of Tobramycin and Dexamethasone would be detectable in human milk or be capable of producing clinical effects in the infant following topical use of the product.

A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Studies have not been performed to evaluate the effect of tobramycin on human or animal fertility. There is limited clinical data to evaluate the effect of dexamethasone on male or female fertility.

4.7 Effects on ability to drive and use machines

Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma has no or negligible influence on the ability to drive and use machines.

No studies on the effects on the ability to drive and use machines have been performed. As with any eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.

4.8 Undesirable effects

Summary of the safety profile

In clinical studies involving over 1600 patients, Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma was administered up to six times daily. No serious ophthalmic or systemic adverse reactions related to Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma or components of the combination were reported in clinical studies. The most frequently reported adverse reactions with Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma were eye pain, intraocular pressure increased, eye irritation (burning upon instillation) and eye pruritus occurring in less than 1% of patients.

Tabulated list of adverse reactions.

The following adverse reactions have been reported with Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma during clinical trials or during post marketing experience and are classified according to the subsequent convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), and not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

System organ classification	Frequency	Adverse reaction
Immune system disorders	Not known	anaphylactic reaction, hypersensitivity
Endocrine disorders	Not known	Cushing’s syndrome, adrenal suppression (see section 4.4)
Nervous system disorders	Uncommon Not known	headache dizziness
Eye disorders	Uncommon Rare Not known	eye pain, eye pruritus, ocular discomfort, ocular hypertension, conjunctival oedema, increased intraocular pressure, eye irritation keratitis, eye allergy, vision blurred (see also section 4.4), dry eye, ocular hyperaemia eyelid oedema, erythema of the eyelid, mydriasis, lacrimation increased
Respiratory, thoracic, and mediastinal disorders	Uncommon	rhinorrhoea, laryngospasm
Gastrointestinal disorders	Rare Not known	dysgeusia nausea, abdominal discomfort
Skin and subcutaneous tissue disorders	Not known	erythema multiforme, rash, swelling face, pruritus

Description of selected adverse reactions

The following adverse reactions have been observed following use with Dexamethasone ophthalmic suspension:

System organ classification	Frequency	Adverse reaction
Nervous system disorders	Common	headache
Eye disorders	Common	eye irritation,* ocular hyperaemia,* erythema of eyelid, abnormal sensation in eye*
Respiratory, thoracic, and mediastinal disorders	Common	post nasal drip

The following adverse reactions have been observed following use with Tobramycin ophthalmic solution:

System organ classification

Frequency

Adverse reaction

Eye disorders

Common

Uncommon

ocular hyperaemia,* eye pain*

eye pruritus,* ocular discomfort,* eye allergy, eyelid oedema,* conjunctivitis,* glare, increased lacrimation,* keratitis*

∗ These adverse reactions were also observed with Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma during post marketing.

Prolonged use of topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects, posterior subcapsular cataract formation and delayed wound healing.

Due to the corticosteroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section 4.4).

The development of secondary infection has occurred after the use of combinations containing corticosteroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic tobramycin therapy (See Section 4.4).

Sensitivity to topically administered aminoglycosides may occur in some patients (See Section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one bottle or tube.

A topical overdose of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma may be flushed from the eye(s) with lukewarm tap water.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory agents and anti-infectives in combination, corticosteroids and anti-infectives in combination.

Dexamethasone:

The efficacy of corticosteroids for the treatment of inflammatory conditions of the eye is well established. Corticosteroids achieve their anti-inflammatory effects through suppression of vascular endothelial cell adhesion molecules, cyclooxygenase I or II, and cytokine expression. This action culminates in a reduced expression of pro-inflammatory mediators and the suppression of adhesion of circulating leukocytes to the vascular endothelium, thereby preventing their migration into inflamed ocular tissue. Dexamethasone has marked anti-inflammatory activity with reduced mineralocorticoid activity compared with some other steroids, and is one of the most potent anti-inflammatory agents.

Tobramycin:

Tobramycin is a potent, broad-spectrum, rapidly bactericidal aminoglycoside antibiotic. It exerts its primary effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosome. Tobramycin in this combination provides antibacterial protection against susceptible bacteria.

The following MIC breakpoints, separating susceptible from intermediate susceptible organisms, and intermediate susceptible from resistant organisms, are suggested: S (≤ 4 μg/ml, R (≥ 8 μg/ml). The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. The following information gives only an approximate guidance on probabilities whether bacteria will be susceptible to tobramycin in Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma.

The breakpoint definitions classifying isolates as susceptible or resistant are useful in predicting clinical efficacy of antibiotics that are administered systemically. However, when the antibiotic is administered in very high concentrations topically directly on the site of infection, these breakpoint definitions may not be applicable. Most isolates that would be classified as resistant by systemic breakpoints are indeed successfully treated topically.

In vitro studies have shown tobramycin to be active against most strains of common ocular pathogens and common skin flora bacteria as listed in the Table below:

Categories

Frequency of Acquired Resistance in Europe

SENSITIVE SPECIES

Aerobic Gram-Positive Microorganisms

Corynebacterium species

Staphylococcus aureus Methicillin -S ^a

Staphylococcus epidermidis Methicillin -S ^a

Other Coagulase-negative Staphylococci

0-3%

0-28%

0-40%

Aerobic Gram-Negative Microorganisms

Acinetobacter species

Citrobacter species

Escherichia coli

Enterobacter species

Haemophilus influenzae

Klebsiella species

Moraxella species

Proteus species

Pseudomonas aeruginosa

MODERATELY SUSCEPTIBLE SPECIES

(in vitro, intermediate susceptibility)

Aerobic Gram-Negative Microorganisms

Serratia marcescens

INHERENTLY RESISTANT SPECIES

Aerobic Gram-Positive Microorganisms

Enterococcus species

Staphylococcus aureus Methicillin –R ^a

Staphylococcus epidermidis Methicillin –R ^a

Streptococcus pneumoniae

Streptococcus species

50 – 70%

30 – 40%

Aerobic Gram-Negative Microorganisms

Burkholderia cepacia

Stenotrophomonas maltophilia

Anaerobic microorganisms

Strict anaerobic bacteria

Others

Chlamydia species

Mycoplasma species

Rickettsia species

^aMethicillin-susceptible (S), Methicillin-resistant (R). The beta-lactam (i.e., methicillin; penicillin) resistance phenotype is unrelated to the aminoglycoside resistance phenotype and both are unrelated to the virulence phenotypes. Some methicillin-resistant (R) S. aureus strains (MRSA) are susceptible to tobramycin (MIC: S ≤4); conversely some strains of methicillin–susceptible (S) S. aureus (MSSA) are resistant to tobramycin (MIC: S ≥8)

The frequency of methicillin resistance (R) may be up to 50 % of all staphylococci in some European countries.

Paediatric Population

The safety and efficacy of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma in children have been established by broad clinical experience, but only limited data are available. In a clinical study of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma suspension for the treatment of bacterial conjunctivitis, 29 paediatric patients, ranging in age from 1 to 17 years, were treated with 1 or 2 drops of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma every 4 or 6 hours for 5 or 7 days. In this study, differences in the safety profile between adult and paediatric patients were not observed.

Other information

Cross-resistance between aminoglycosides (e.g., gentamicin and tobramycin) is due to the specificity of the enzyme modifications, Adenyltransferase (ANT) and Acetyltransferase (ACC). However, cross-resistance varies between the aminoglycoside antibiotics due to the differing specificity of the various modifying enzymes. The most common mechanism of acquired resistance to aminoglycosides is antibiotic inactivation by plasmid and transposon-encoded modifying enzymes.

5.2 Pharmacokinetic properties

Tobramycin:

Animal studies have shown that tobramycin is absorbed into the cornea following ocular administration. Following systemic administration to patients with normal renal function, a plasma half-life of approximately 2 hours has been observed. Tobramycin is eliminated almost exclusively by glomerular filtration with little if any biotransformation. Plasma concentrations of tobramycin following the 2-day topical ocular regimen of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma were below the limit of quantification in most subjects or low (≤0.25 microgram/ml).

Dexamethasone:

Following ocular administration, dexamethasone is absorbed into the eye with maximum concentrations in the cornea and aqueous humour attained within 1-2 hours. The plasma half-life of dexamethasone is approximately 3 hours. Dexamethasone is eliminated extensively as metabolites. Systemic exposure to dexamethasone is low following topical ocular administration of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma. Peak dexamethasone plasma levels after the last topical dose ranged from 220 to 888pg/ml (mean 555 ± 217pg/ml) after administration of one drop of Tobramycin and Dexamethasone Ophthalmic Suspension USP 0.3% / 0.1% Taj Pharma to each eye four times per day for two consecutive days.

5.3 Preclinical safety data

Non-clinical data revealed no special hazard for humans from topical ocular exposure to tobramycin or dexamethasone based on conventional repeated-dose topical ocular toxicity studies, genotoxicity or carcinogenicity studies. Effects in non-clinical reproductive and developmental studies with tobramycin and dexamethasone were observed only at exposures considered sufficiently in excess of the maximum human ocular dosage indicating little relevance to clinical use for low-dose short-term courses of therapy.

Tobramycin has not been shown to induce teratogenicity in rats or rabbits. The ocular administration of 0.1% dexamethasone resulted in fetal anomalies in rabbits. Dexamethasone had no adverse effects on female fertility in a chorionic gonadotropin primed rat model.

Pharmaceutical particulars

6.1 List of excipients

Disodium edetate, Hydroxyethylcellulose, Benzalkonium chloride, Purified water, Sodium chloride, Sodium sulphate anhydrous, Sulphuric acid for pH adjustment and / or Sodium hydroxide for pH adjustment, Tyloxapol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

After the first opening of the container, the sterile ophthalmic suspension should not be used longer than four weeks.

6.4 Special precautions for storage

No special precautions for storage

6.5 Nature and contents of container

5ml dropper container (LDPE) and screw cap (polypropylene).

Pack size: 1x5ml.

6.6 Special precautions for disposal and other handling

No special requirements

MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION USP
0.3% / 0.1%
TAJ PHARMA

PACKAGE LEAFLET – INFORMATION FOR THE USER

Tobramycin and Dexamethasone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

KEEP THIS LEAFLET.

You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS PATIENT INFORMATION LEAFLET YOU WILL FIND INFORMATION ABOUT

What Tobramycin And Dexamethasone is and what it is used for
What you need to know before you use Tobramycin And Dexamethasone
How to use Tobramycin And Dexamethasone
Possible side effects
How to store Tobramycin And Dexamethasone
Content of the pack and other information
1. WHAT TOBRAMYCIN AND DEXAMETHASONE IS AND WHAT IT IS USED FOR

Tobramycin And Dexamethasone contains dexamethasone a corticosteroid and tobramycin, an antibiotic which is active against a wide range of bacteria that may infect the eye.

It is used to prevent and treat inflammation and prevent possible infection of the eye after cataract surgery in adults and children aged 2 years and older.

WHAT YOU NEED TO KNOW BEFORE YOU USE TOBRAMYCIN AND DEXAMETHASONE

Do not use Tobramycin and Dexamethasone

If you have or think that you have any type of infection of the eye. Use of corticosteroids may make infections worse.
If you have a sticky discharge from your eye.
If you have a red eye that has not been seen by a doctor.
If you are allergic to tobramycin or dexamethasone or to any of the other ingredients listed in section 6.

If any of these apply ask your doctor for advice.

Warnings and precautions

If you have a disorder causing a thinning of the eye tissues, such as rheumatoid arthritis, Fuch’s dystrophy or following a corneal transplant. Corticosteroids may cause further thinning and possible perforation, and may delay the healing of your eye wound. Topical non- steroidal anti-inflammatory drugs (NSAIDs) are also known to slow or delay healing. If you use topical NSAIDS and corticosteroids together, it may increase the potential for healing problems.

If you experience allergic reactions with Tobramycin And Dexamethasone, discontinue use and consult your doctor. Allergic reactions may vary from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same family (aminoglycoside type).
If your symptoms get worse or suddenly return, please consult your doctor. You may become more susceptible to eye infections with the use of this product.
If you are diabetic please consult your doctor. The risk of corticosteroid-induced increase intraocular pressure and / or cataract formation is increased in diabetic patients.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are using other antibiotic treatment, including oral, with Tobramycin And Dexamethasone, ask your doctor for advice.
If you have or if you have ever had conditions such as myasthenia gravis or Parkinson’s disease, ask your doctor for advice. Antibiotics of this kind may worsen muscle weakness
If you use Tobramycin And Dexamethasone for a long period of time, you may become more susceptible to eye infections, have increased pressure in your eye(s) or develop cataracts.
Talk to your doctor if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing’s syndrome. Suppression of the adrenal gland function may develop after stopping a long-term or intensive treatment with Tobramycin And Dexamethasone. Talk to your doctor before stopping the treatment by yourself. These risks are especially important in children and patients treated with a drug called ritonavir or cobicistat.
Signs and symptoms of adrenal suppression include fatigue; light-headedness upon standing or difficulty standing, muscle weakness, fever, weight loss, anxiety, nausea, vomiting, diarrhoea, headache, sweating, changes in mood or personality, and joint and muscle pains.

You may still be able to use Tobramycin And Dexamethasone, but discuss it with your doctor first.

Intraocular pressure should be checked frequently, this is especially important in children below 6 years of age receiving dexamethasone-containing products.
Do not give Tobramycin And Dexamethasone to children below 2 years old because the safety and efficacy in this population has not been established.

Other medicines and Tobramycin And Dexamethasone

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Especially tell your doctor if you are using topical NSAIDs. If you use topical steroids and topical NSAIDs together, it may increase corneal healing problems. Tell your doctor if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.

If you are using other eye drops or eye ointments, wait at least 5 minutes between using each one. Eye ointments should be administered last.

Pregnancy and breast-feeding

If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor

before you use Tobramycin And Dexamethasone. Tobramycin And Dexamethasone is not recommended during pregnancy or breastfeeding.

Driving and using machines

If you experience temporary blurred vision after using Tobramycin And Dexamethasone you should not drive or operate machinery until your vision is clear.

Important information if you wear Contact Lenses

Contact lens wear is not recommended during treatment of an ocular infection or inflammation. Benzalkonium chloride, used as a preservative in Tobramycin And Dexamethasone, may cause eye irritation and discolour soft contact lenses.

If you wear soft contact lenses remove them before using Tobramycin And Dexamethasone and wait at least 15 minutes

before putting them back in.

HOW TO USE TOBRAMYCIN AND DEXAMETHASONE

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Only use Tobramycin And Dexamethasone for dropping in your eye(s).

The usual dose

The usual dose is 1 drop in the affected eye(s) every 4 to 6 hours while you are awake. During the initial 48 hours, your doctor may increase the dose to 1 drop every 2 hours.

Do not use for more than 24 days.

Tobramycin And Dexamethasone may be used in children 2 years of age and older at the same dose as in adults.

Remove the loose collar from the cap when the bottle is first opened.

Always use Tobramycin And Dexamethasone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to use

Wash your hands before you start.
Shake the bottle well.
Twist off the bottle cap.
Hold the bottle pointing down, between your thumb and fingers.
Tilt your head back.
Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
Gently press on the base of the bottle to release one drop at a time (picture 2).
Do not squeeze the bottle, only a gentle press on the bottom is needed.
After using Tobramycin And Dexamethasone, keep the eyelid closed, while simultaneously applying gentle pressure with a finger to the corner of your eye, by the nose for at least 1 minute (picture 3). This helps to limit the amount of medicine that will get into the rest of the body.
If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use.

If a drop misses your eye, try again.

If you forget to take Tobramycin And Dexamethasone, do not worry, just take it as soon as possible. Do not take a double dose to make up.
If you use more Tobramycin And Dexamethasone than you should it can be washed out with warm water.

If you have any further questions on the use of Tobramycin And Dexamethasone, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Tobramycin And Dexamethasone can cause side effects, although not everybody gets them. The following side effects have been seen with Tobramycin And Dexamethasone

If you notice any of the following possible side effects, stop using this medicine and seek urgent medical advice immediately:

itchy rash or hives
swelling of the face, lips, tongue or other parts of the body
shortness of breath/wheezing
severe skin reactions such as blistering which may be accompanied by sore throat, fever or headache

The following side effects have also occurred with Tobramycin And Dexamethasone:

Uncommon side effects

(may affect up to 1 in 100 people)

Effects in the eye: increased pressure in your eye (s), eye irritation, eye pain, eye itching, watery eyes, eye discomfort.

General side effects: headache, runny nose, tightness of the throat.

Rare side effects

(may affect up to 1 in 1000 people)

Effects in the eye: redness, blurred vision, dry eye, eye allergy, eye surface inflammation.

General side effects: bad taste.

Not known (frequency cannot be estimated from available data)

Effects in the eye: increase in pupil size, eyelid redness, eyelid swelling, increased tear production,.

General side effects: dizziness, nausea, abdominal discomfort, rash, swelling of the face, itching.

Hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face (called ‘Cushing’s syndrome’) (see section 2, “Warnings and precautions”).

If Tobramycin And Dexamethasone is used for more than 24 days, it may cause you to get an infection and the healing of your wound may also be delayed.

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.

HOW TO STORE TOBRAMYCIN AND DEXAMETHASONE

Keep out of the reach and sight of children.
This medicinal product does not require any special temperature storage conditions.
Keep the bottle tightly closed.
Do not use the drops after the expiry date which is stated on the bottle and the carton after ‘Exp:’. The expiry date refers to the last day of that month.
Stop using the bottle 4 weeks after first opening, to prevent infections.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Do not pass this medicine on to others. It may harm them even if their symptoms are the same as yours.

FURTHER INFORMATION WHAT TOBRAMYCIN AND DEXAMETHASONE CONTAINS

The active substances are tobramycin 3 mg/ml and dexamethasone 1 mg/ml.
The other ingredients are disodium edetate, tyloxapol, sodium chloride, sodium sulphate, hydroxyethylcellulose, benzalkonium chloride, sulphuric acid and/or sodium hydroxide (to adjust pH) and purified water.

What Tobramycin And Dexamethasone looks like and contents of the pack

Tobramycin And Dexamethasone is a white to off-white suspension supplied in a pack containing a 5 ml plastic bottle with a screw cap.