Drugs List

Therapeutic Indications

Uses

Treatment of acute herpetic keratitis

Contraindications

Children under 18 years
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Soft contact lenses

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Administer other ophthalmic products at least 15 minutes apart
To reduce systemic absorption compress lacrimal sac during administration
May affect spermatogenesis
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Ganciclovir eye gel is contraindicated in pregnancy.

The manufacturer notes that administration during pregnancy is not recommended except for compelling reasons.

At the time of writing, there is no experience of ganciclovir eye gels in human pregnancy. There are a few reports of normal pregnancy outcome after first-trimester treatment (route unspecified) but these are inadequate to evaluate safety and the majority of reports involve treatment of cytomegalovirus.

Teratogenicity and embryotoxicity have been observed in animal studies. Foetal resorption occurred in at least 85% of mice and rabbits exposed to two times the human dose. In pregnant rabbits given two times the human dose, foetal effects included growth retardation and teratogenicity including cleft palate, anophthalmia/microphthalmia, aplastic kidneys and pancreas, hydrocephaly and brachygnathia. Ganciclovir is carcinogenic and mutagenic in mice and aspermatogenesis has been observed in mice and dogs.

Reports indicate that ganciclovir crosses the placenta passively without metabolism to the foetus. Schaefer concludes that inadvertent use of ganciclovir during pregnancy does not require termination of pregnancy or invasive diagnostic procedures. Due to the foetal toxicity and known toxic effects in animals, some investigators have recommended that ganciclovir should only be used during pregnancy for life-threatening disease or in immunocompromised patients with major cytomegalovirus infections such as retinitis.

Plasma levels reported after ocular administration were on average 0.013 microgram/ml (range 0-0.037). this is 640 times lower than observed one hour after intravenous administration of ganciclovir 5mg/kg (Cmax 8 micrograms/ml).

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

Ganciclovir eye gel is contraindicated in breastfeeding.

The manufacturer notes that administration during breastfeeding is not recommended except for compelling reasons.

At the time of writing, there is no experience in the use of ganciclovir eye gel in human lactation. There is potential for serious toxicity in a nursing infant, hence mothers taking ganciclovir are recommended not to breastfeed.

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

Blurred vision (transient)
Local burning
Superficial punctate keratopathy
Tingling sensation

Presentation

Eye gel containing ganciclovir (preservative containing)

Drugs List

Therapeutic Indications

Uses

Treatment of acute herpetic keratitis

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Soft contact lenses

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Administer other ophthalmic products at least 15 minutes apart
To reduce systemic absorption compress lacrimal sac during administration
May affect spermatogenesis
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Pregnancy and Lactation

Pregnancy

Ganciclovir eye gel is contraindicated in pregnancy.

The manufacturer notes that administration during pregnancy is not recommended except for compelling reasons.

At the time of writing, there is no experience of ganciclovir eye gels in human pregnancy. There are a few reports of normal pregnancy outcome after first-trimester treatment (route unspecified) but these are inadequate to evaluate safety and the majority of reports involve treatment of cytomegalovirus.

Teratogenicity and embryotoxicity have been observed in animal studies. Foetal resorption occurred in at least 85% of mice and rabbits exposed to two times the human dose. In pregnant rabbits given two times the human dose, foetal effects included growth retardation and teratogenicity including cleft palate, anophthalmia/microphthalmia, aplastic kidneys and pancreas, hydrocephaly and brachygnathia. Ganciclovir is carcinogenic and mutagenic in mice and aspermatogenesis has been observed in mice and dogs.

Reports indicate that ganciclovir crosses the placenta passively without metabolism to the foetus. Schaefer concludes that inadvertent use of ganciclovir during pregnancy does not require termination of pregnancy or invasive diagnostic procedures. Due to the foetal toxicity and known toxic effects in animals, some investigators have recommended that ganciclovir should only be used during pregnancy for life-threatening disease or in immunocompromised patients with major cytomegalovirus infections such as retinitis.

Plasma levels reported after ocular administration were on average 0.013 microgram/ml (range 0-0.037). this is 640 times lower than observed one hour after intravenous administration of ganciclovir 5mg/kg (Cmax 8 micrograms/ml).

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

Ganciclovir eye gel is contraindicated in breastfeeding.

The manufacturer notes that administration during breastfeeding is not recommended except for compelling reasons.

At the time of writing, there is no experience in the use of ganciclovir eye gel in human lactation. There is potential for serious toxicity in a nursing infant, hence mothers taking ganciclovir are recommended not to breastfeed.

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

Blurred vision (transient)
Local burning
Superficial punctate keratopathy
Tingling sensation

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: April 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 23 April 2015.

Summary of Product Characteristics: Virgan eye gel. Laboratoires Thea. Revised January 2016.