Drugs List

Therapeutic Indications

Uses

Postoperative inflammation after cataract surgery
Prophylaxis of infection following cataract surgery

Contraindications

Children under 2 years
Herpes simplex keratitis
Ocular infection

Precautions and Warnings

Soft contact lenses
Breastfeeding
Corneal damage
Glaucoma
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Cross sensitivity with other aminoglycosides may occur
Exclude bacterial infection before treatment
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may result in ocular infections
Discontinue if hypersensitivity reactions occur
Avoid prolonged use
Contact lenses should not be worn during treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use tobramycin and dexamethasone with caution in pregnancy.

The manufacturer notes that this medication should only be used when the potential benefit justifies the potential risks.

Tobramycin
Tobramycin crosses the placenta into the foetal circulation and amniotic fluid, but studies with pregnant women have demonstrated no detectable risk to the foetus. High systemic doses of tobramycin have been associated with nephrotoxicity and ototoxicity, but these were encountered at doses well above those used in topical ocular use, and systemic exposure after ocular use is expected to be low.

Animal studies have shown reproductive toxicity.

Dexamethasone
Compression of the lacrimal sac to reduce absorption when used in the eye, would appear advisable if treatment is required.

The manufacturers note that there is no, or limited amount, of data from the use of this medication in pregnant woman. Studies in animals have shown reproductive toxicity. The maximum daily dose (2 x 30microlitres x 4 times per day, equivalent to about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily.

Most information available relates to use of systemically administered corticosteroids.

Toxicity in the foetus and newborn following the use of dexamethasone is rare. Dexamethasone crosses the placenta to the foetus.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use tobramycin and dexamethasone with caution in breastfeeding.

The manufacturer notes that this medication should not be used during breastfeeding unless the potential benefit outweighs the potential risks.

Tobramycin

Neonatal systemic exposure is judged to be low following topical administration to the mother, and one authority considers that maternal use of tobramycin eye drops will present little or no risk for the nursing infant (LactMed). The UK Drugs in Lactation Advisory service warns that minor adverse effects may be anticipated on theoretical grounds, but these are unlikely, given the poor excretion of tobramycin into breast milk.

Dexamethasone

No data is available on the transfer of dexamethasone into human milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal discomfort
Abnormal sensation in eye
Adrenal suppression
Anaphylactic reaction
Blurred vision
Conjunctival oedema
Conjunctivitis
Cushing's syndrome
Dizziness
Dry eyes
Dysgeusia
Erythema multiforme
Eyelid erythema
Eyelid oedema
Facial swelling
Glare
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Keratitis
Laryngospasm
Mydriasis
Nausea
Ocular allergy
Ocular discomfort
Ocular hyperaemia
Ocular hypertension
Ocular irritation
Ocular pain
Ocular pruritus
Postnasal drip
Pruritus
Rash
Rhinorrhoea

Presentation

Eye drop suspension containing tobramycin and dexamethasone.

Drugs List

Therapeutic Indications

Uses

Postoperative inflammation after cataract surgery
Prophylaxis of infection following cataract surgery

Dosage

Adults

Contraindications

Children under 2 years
Herpes simplex keratitis
Ocular infection

Precautions and Warnings

Soft contact lenses
Breastfeeding
Corneal damage
Glaucoma
Pregnancy

May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Cross sensitivity with other aminoglycosides may occur
Exclude bacterial infection before treatment
Exclude fungal infection before treatment
Exclude tubercular infection before treatment
Exclude viral infection before treatment
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may result in ocular infections
Discontinue if hypersensitivity reactions occur
Avoid prolonged use
Contact lenses should not be worn during treatment
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Use tobramycin and dexamethasone with caution in pregnancy.

The manufacturer notes that this medication should only be used when the potential benefit justifies the potential risks.

Tobramycin
Tobramycin crosses the placenta into the foetal circulation and amniotic fluid, but studies with pregnant women have demonstrated no detectable risk to the foetus. High systemic doses of tobramycin have been associated with nephrotoxicity and ototoxicity, but these were encountered at doses well above those used in topical ocular use, and systemic exposure after ocular use is expected to be low.

Animal studies have shown reproductive toxicity.

Dexamethasone
Compression of the lacrimal sac to reduce absorption when used in the eye, would appear advisable if treatment is required.

The manufacturers note that there is no, or limited amount, of data from the use of this medication in pregnant woman. Studies in animals have shown reproductive toxicity. The maximum daily dose (2 x 30microlitres x 4 times per day, equivalent to about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily.

Most information available relates to use of systemically administered corticosteroids.

Toxicity in the foetus and newborn following the use of dexamethasone is rare. Dexamethasone crosses the placenta to the foetus.

Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use tobramycin and dexamethasone with caution in breastfeeding.

The manufacturer notes that this medication should not be used during breastfeeding unless the potential benefit outweighs the potential risks.

Tobramycin

Neonatal systemic exposure is judged to be low following topical administration to the mother, and one authority considers that maternal use of tobramycin eye drops will present little or no risk for the nursing infant (LactMed). The UK Drugs in Lactation Advisory service warns that minor adverse effects may be anticipated on theoretical grounds, but these are unlikely, given the poor excretion of tobramycin into breast milk.

Dexamethasone

No data is available on the transfer of dexamethasone into human milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal discomfort
Abnormal sensation in eye
Adrenal suppression
Anaphylactic reaction
Blurred vision
Conjunctival oedema
Conjunctivitis
Cushing's syndrome
Dizziness
Dry eyes
Dysgeusia
Erythema multiforme
Eyelid erythema
Eyelid oedema
Facial swelling
Glare
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Keratitis
Laryngospasm
Mydriasis
Nausea
Ocular allergy
Ocular discomfort
Ocular hyperaemia
Ocular hypertension
Ocular irritation
Ocular pain
Ocular pruritus
Postnasal drip
Pruritus
Rash
Rhinorrhoea

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Tobradex Eye Drops. Novartis Pharmaceuticals UK Limited. Revised September 2017.

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: June 17, 2014

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Tobramycin. Last revised: September 7, 2013
Last accessed: June 17, 2014