Drugs List

Therapeutic Indications

Uses

Conjunctivitis - infective

Contraindications

Neonates

Precautions and Warnings

Children under 2 years

Advise patient blurred vision may affect ability to drive/operate machinery
Chlamydia or gonococcal eye infections should be treated systemically
Consult national/regional policy on the use of anti-infectives
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Advise patient to report signs of tendinitis
Advise patient to report symptoms of allergic type hypersensitivity
Discontinue at the first sign of tendon inflammation
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue treatment if skin rash or other allergic reaction occurs
Contact lenses should not be worn during treatment

Moxifloxacin eye drops should not be used to treat Chlamydia trachomatis eye infections. Patients over 2 years of age should be treated systemically.

Not recommended for the empiric treatment or prophylaxis of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, due to the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.

Pregnancy and Lactation

Pregnancy

The manufacturer advises that moxifloxacin eye drops can be used during pregnancy.

No adequate data is available, however, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. Pharmacokinetic studies suggest exposures 1200 to 1600 times lower than 400 mg oral use. Lacrimal sac compression may be employed to minimize systemic absorption.
It is not known if moxifloxacin crosses the placenta, though based on its molecular weight and other fluoroquinolones, this should be anticipated. Animal reproduction studies using oral and parenteral administration did not reveal evidence of teratogenicity or impairment of fertility. A 2013 review stated that fluoroquinolones are usually avoided in pregnancy due to concerns for foetal cartilage damage, but there were no human studies to validate this concern (Briggs 2015).

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

The manufacturer advises that moxifloxacin eye drops can be used in breastfeeding.

It is unknown whether moxifloxacin eye drops or its metabolites are excreted in human breast milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin, although with no anticipated effects on the infant. The presence of calcium in milk may prevent absorption of fluoroquinolones, though this remains unproven. It is recommended to monitor infants for possible effects on gastrointestinal flora, such as diarrhoea or candidiasis.

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

Abnormal sensation in eye
Alanine aminotransferase increased
Blepharitis
Blurred vision
Conjunctival haemorrhage
Conjunctival oedema
Conjunctivitis
Corneal abrasion
Corneal deposits
Corneal disorders
Corneal epithelium disorder
Corneal erosion
Corneal infiltrates
Corneal oedema
Corneal opacity (reversible)
Corneal staining
Dizziness
Dry eyes
Dysgeusia
Dyspnoea
Endophthalmitis
Erythema
Eye pain
Eyelid erythema
Eyelid oedema
Eyelid reaction
Gamma glutamyl transferase (GGT) increased
Haemoglobin decrease
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Keratitis
Nasal irritation
Nausea
Ocular allergy
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular irritation
Ocular oedema
Ocular pruritus
Palpitations
Paraesthesia
Pharyngolaryngeal pain
Photophobia
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Sensation of foreign body in eye
Sensation of foreign body in throat
Ulcerative keratitis
Urticaria
Vomiting

Presentation

Eye drops containing moxifloxacin.

Drugs List

Therapeutic Indications

Uses

Conjunctivitis - infective

Dosage

Treatment should be continued for two to three days after infection improves (normally within five days).
Review of diagnosis and treatment should be considered if no improvement is observed after five days of treatment.

Adults

Children

Contraindications

Neonates

Precautions and Warnings

Children under 2 years

Advise patient blurred vision may affect ability to drive/operate machinery
Chlamydia or gonococcal eye infections should be treated systemically
Consult national/regional policy on the use of anti-infectives
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Advise patient to report signs of tendinitis
Advise patient to report symptoms of allergic type hypersensitivity
Discontinue at the first sign of tendon inflammation
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue treatment if skin rash or other allergic reaction occurs
Contact lenses should not be worn during treatment

Moxifloxacin eye drops should not be used to treat Chlamydia trachomatis eye infections. Patients over 2 years of age should be treated systemically.

Not recommended for the empiric treatment or prophylaxis of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, due to the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.

Pregnancy and Lactation

Pregnancy

The manufacturer advises that moxifloxacin eye drops can be used during pregnancy.

No adequate data is available, however, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. Pharmacokinetic studies suggest exposures 1200 to 1600 times lower than 400 mg oral use. Lacrimal sac compression may be employed to minimize systemic absorption.
It is not known if moxifloxacin crosses the placenta, though based on its molecular weight and other fluoroquinolones, this should be anticipated. Animal reproduction studies using oral and parenteral administration did not reveal evidence of teratogenicity or impairment of fertility. A 2013 review stated that fluoroquinolones are usually avoided in pregnancy due to concerns for foetal cartilage damage, but there were no human studies to validate this concern (Briggs 2015).

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

The manufacturer advises that moxifloxacin eye drops can be used in breastfeeding.

It is unknown whether moxifloxacin eye drops or its metabolites are excreted in human breast milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin, although with no anticipated effects on the infant. The presence of calcium in milk may prevent absorption of fluoroquinolones, though this remains unproven. It is recommended to monitor infants for possible effects on gastrointestinal flora, such as diarrhoea or candidiasis.

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

Abnormal sensation in eye
Alanine aminotransferase increased
Blepharitis
Blurred vision
Conjunctival haemorrhage
Conjunctival oedema
Conjunctivitis
Corneal abrasion
Corneal deposits
Corneal disorders
Corneal epithelium disorder
Corneal erosion
Corneal infiltrates
Corneal oedema
Corneal opacity (reversible)
Corneal staining
Dizziness
Dry eyes
Dysgeusia
Dyspnoea
Endophthalmitis
Erythema
Eye pain
Eyelid erythema
Eyelid oedema
Eyelid reaction
Gamma glutamyl transferase (GGT) increased
Haemoglobin decrease
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Keratitis
Nasal irritation
Nausea
Ocular allergy
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular irritation
Ocular oedema
Ocular pruritus
Palpitations
Paraesthesia
Pharyngolaryngeal pain
Photophobia
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Sensation of foreign body in eye
Sensation of foreign body in throat
Ulcerative keratitis
Urticaria
Vomiting

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: March 2017

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Moxivig 0.5% eye drops, solution. Novartis Pharmaceuticals UK Limited. Revised May 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017

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
Moxifloxacin. Last revised: 04 February 2016
Last accessed: 28 February 2017