Drugs List

Contraindications

None known.

Precautions and Warnings

If irritation, pain, redness and changes in vision occur, or worsen, treatment should be discontinued and a new assessment considered.

Application may cause transient blurring of vision; patients should avoid driving or operating machinery until vision is clear.

Pregnancy and Lactation

Pregnancy

Carmellose sodium is a high molecular weight substance widely used as an excipient in oral and topical pharmaceutical formulations, also in cosmetics, toiletries and food products.

At the time of writing there is limited published experience regarding the safety of carmellose sodium in human pregnancy, however, carmellose sodium eye drops have been used for many years with no adverse effects reported and the manufacturer states no special precautions are necessary during pregnancy. Schaefer advises that artificial tears may be used for all appropriate indications during pregnancy (Schaefer 2007).

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 on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Carmellose sodium is a high molecular weight substance widely used as an excipient in oral and topical pharmaceutical formulations, also in cosmetics, toiletries and food products.

At the time of writing there is limited published experience regarding the safety of carmellose sodium in breastfeeding, however, carmellose sodium eye drops have been used for many years with no adverse effects reported and the manufacturer states no special precautions are necessary during breastfeeding. Carmellose has a high molecular weight and would be unlikely to be present in breastmilk. Schaefer considers that most eye drops are compatible with breastfeeding and that artificial tears are not amongst those ophthalmic preparations likely to raise concern (Schaefer 2007).

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)
Eye irritation
Eye pain
Lacrimation increased

Presentation

Eye drop solution containing:

10mg/1ml carmellose sodium (1%)
5mg/1ml carmellose sodium (0.5%)

Drugs List

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.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of carmellose sodium eye drops.

Containers are for single use only, to be discarded immediately after use.

Adults

Elderly

Children

Contraindications

None known.

Precautions and Warnings

If irritation, pain, redness and changes in vision occur, or worsen, treatment should be discontinued and a new assessment considered.

Application may cause transient blurring of vision; patients should avoid driving or operating machinery until vision is clear.

Pregnancy and Lactation

Pregnancy

Carmellose sodium is a high molecular weight substance widely used as an excipient in oral and topical pharmaceutical formulations, also in cosmetics, toiletries and food products.

At the time of writing there is limited published experience regarding the safety of carmellose sodium in human pregnancy, however, carmellose sodium eye drops have been used for many years with no adverse effects reported and the manufacturer states no special precautions are necessary during pregnancy. Schaefer advises that artificial tears may be used for all appropriate indications during pregnancy (Schaefer 2007).

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 on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Carmellose sodium is a high molecular weight substance widely used as an excipient in oral and topical pharmaceutical formulations, also in cosmetics, toiletries and food products.

At the time of writing there is limited published experience regarding the safety of carmellose sodium in breastfeeding, however, carmellose sodium eye drops have been used for many years with no adverse effects reported and the manufacturer states no special precautions are necessary during breastfeeding. Carmellose has a high molecular weight and would be unlikely to be present in breastmilk. Schaefer considers that most eye drops are compatible with breastfeeding and that artificial tears are not amongst those ophthalmic preparations likely to raise concern (Schaefer 2007).

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

Effects on Ability to Drive and Operate Machinery

If patient experiences transient blurring of vision, they should be advised not to drive or operating machinery until vision is clear.

Counselling

Advise patient to wash their hands prior to use.

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

Concomitant ocular medication should be administered 15 minutes prior to the instillation of carmellose sodium eye drops.

Advise patients that instillation of eye drops may cause transient blurring of vision and to avoid driving or operating machinery until vision is clear.

Containers are for single use only, to be discarded immediately after use.

Side Effects

Blurred vision (transient)
Eye irritation
Eye pain
Lacrimation increased

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 ).

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

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

Summary of Product Characteristics: Celluvisc 0.5% w/v eye drops solution. Allergan Ltd. Revised May 2010.

Summary of Product Characteristics: Celluvisc 1.0% w/v eye drops solution. Allergan Ltd. Revised October 2008.