Drugs List

Therapeutic Indications

Uses

Topical treatment for minor eye infections including conjunctivitis and blepharitis

Dibrompropamidine isetionate is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties.

Administration

For ocular administration.

Contraindications

The wearing of contact lenses during treatment

Precautions and Warnings

Pregnancy (see Pregnancy section)

Breastfeeding (see Lactation section)

If the vision or symptoms worsen, or if there is no significant improvement in 2 days, discontinue treatment and consult a doctor.

Not suitable for use with hard or soft contact lenses.

Some formulations contain lanolin.

Pregnancy and Lactation

Pregnancy

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 14-17 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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Lactation

The safety of this drug for use during breastfeeding has not been established. It should only be used during breastfeeding under the advice of a physician. Other alternatives may be deemed safer than dibrompropamidine to use whilst breastfeeding and should this be the case, these drugs should be used instead.

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

Considered suitable or recommended by manufacturer? - Should only be used if considered essential by a physician

UK Drugs in Lactation Advisory Service Classification - Unclassified

Drug substance licensed in infants? - Yes

Drugs List

Therapeutic Indications

Uses

Topical treatment for minor eye infections including conjunctivitis and blepharitis

Dibrompropamidine isetionate is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties.

Dosage

Wash hands prior to use.

Avoid contact of the container with the eye or other surfaces as contamination leading to ophthalmic infection may occur.

Contact lenses should not be worn during treatment.

Discard 4 weeks after first opening.

Adults

Elderly

Children

Administration

For ocular administration.

Contraindications

The wearing of contact lenses during treatment

Precautions and Warnings

Pregnancy (see Pregnancy section)

Breastfeeding (see Lactation section)

If the vision or symptoms worsen, or if there is no significant improvement in 2 days, discontinue treatment and consult a doctor.

Not suitable for use with hard or soft contact lenses.

Some formulations contain lanolin.

Pregnancy and Lactation

Pregnancy

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 14-17 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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Lactation

The safety of this drug for use during breastfeeding has not been established. It should only be used during breastfeeding under the advice of a physician. Other alternatives may be deemed safer than dibrompropamidine to use whilst breastfeeding and should this be the case, these drugs should be used instead.

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

Considered suitable or recommended by manufacturer? - Should only be used if considered essential by a physician

UK Drugs in Lactation Advisory Service Classification - Unclassified

Drug substance licensed in infants? - Yes

Counselling

Wash hands prior to use.

Avoid contact of the container with the eye or other surfaces as contamination leading to ophthalmic infection may occur.

Contact lenses should not be worn during treatment.

Discard 4 weeks after first opening.

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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Shelf Life and Storage

Store below 25 degrees C

Further Information

Last Full Review Date: February 2011.

Reference Sources

Summary of Product Characteristics: Brolene Eye Ointment. Sanofi-aventis. Revised November 2006.

Summary of Product Characteristics: Golden Eye 0.15%w/w Eye Ointment. Typharm Ltd. Revised November 2008.