Chlorsig

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Chloramphenicol 1% w/w; Chloramphenicol 1% w/w
Available from:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
INN (International Name):
Chloramphenicol 1% w/w
Dosage:
1 %
Pharmaceutical form:
Eye ointment
Composition:
Active: Chloramphenicol 1% w/w Excipient: Lanolin Liquid paraffin White soft paraffin Active: Chloramphenicol 1% w/w Excipient: Lanolin Liquid paraffin White soft paraffin
Units in package:
Tube, aluminium, 4 g
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
Quimica Sintetica SA
Therapeutic indications:
For the treatment of bacterial conjunctivitis. For use under medical supervision only in the treatment of other superficial ocular infections caused by chloramphenicol-sensitive organisms.
Product summary:
Package - Contents - Shelf Life: Tube, aluminium, - 4 g - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-2748/1
Authorization date:
1979-11-15

NewZealand Consumer Medicine Information

CHLORSIG

(Klor - sig)

EYE DROPS and EYE OINTMENT

Chloramphenicol

What is in this leaflet

This leaflet answers some

common questions about

CHLORSIG.

Itdoes notcontain allof the

available information.

It does not take the place of

talking toyour doctor,

pharmacistor optometrist.

Allmedicines have risks and

benefits. Your doctor,

pharmacistor optometristhas

weighed the risks of you taking

CHLORSIG against the benefits

they expect it will havefor you.

If you have any concerns about

taking this medicine, ask your

doctor,pharmacist or

optometrist.

Keep this leaflet with the

medicine.

You may need to read it again.

What is CHLORSIG

The nameof your medicine is

CHLORSIG.

The active ingredientis called

Chloramphenicol.

Chloramphenicolis a synthetic

antibiotic.

CHLORSIG is available as eye

drops and eye ointment.

What CHLORSIG is used

for

CHLORSIG is used to treat an

eye infection called bacterial

Bacterial conjunctivitis is a

bacterialinfection involving the

mucous membrane of the surface

of the eye. The mostcommon

symptomisthe presence of a sticky

yellow-white discharge with mucus

and pus (or glued eyes, especiallyin

the morning on waking). Other

symptomsinclude a grittysensation

in the eye, redness, irritation and

watering of the eyes. The infection

usuallystarts in one eye and then

spreadsto the other

Your doctor mayhave prescribed

CHLORSIG for another purpose.

Ask your doctor, pharmacistor

optometrist ifyou have any

questions aboutwhyCHLORSIG

has been prescribed for you.

Donotuse Chlorsigandtalkto

your pharmacistor doctor

straight away if any of the

followingapplies toyou.

ƒ You have painwithinyour

eye (rather than just feeling

sore orgritty) andswelling

around the eye, blurred vision

orsensitivity tolight

ƒ Your pupil(the black circle

in the centre of the eye) may

be torn, notround, verybig

or does notchange size inthe

light

ƒ Your eye looks cloudy

ƒ There iscopious yellow-

green purulentdischarge that

accumulates after being

wiped away

ƒ You have injured your eye

ƒ You have been welding

withouteye protection

immediately before your eye

symptomsappeared

ƒ You have glaucoma

ƒ You have dryeye syndrome

ƒ You are using other eye

drops or eye ointments

ƒ You have had similar

symptomsinthe past few

weeks

ƒ You have had eye surgeryor

laser treatmentinthe past six

months

ƒ Recent overseas travel

ƒ You wear contact lenses

If you wear contactlenses and

your doctor has advised you to

use Chlorsig, do notwear contact

lenses during the course of

Chlorsigtreatment. If youwear

hard or disposablecontactlenses,

you can startusing contactlenses

again after successfully

completing the course of

treatment. If wearing soft

contactlenses, you should wait

24 hours after successfully

completing a course of treatment

before starting touse contact

lenses again.

Before you use

CHLORSIG

When you must not use it

Do not use CHLORSIG if you

are allergic to:

ƒ CHLORSIG orany ofthe

ingredients listedat the end

ofthis leaflet

ƒ other antibioticeye drops or

eye ointments

Someofthesymptomsofan

allergic reactiontoCHLORSIG

mayinclude irritation, painand

swellinginthe eye. Skinrashes,

blisters and fever mayalso occur.

Do not use CHLORSIG after

the expiry date (EXP.) printed

on the pack.

If you use itafter the expirydate

has passed, itmayhave no effect

at all, or worse, there may be an

entirely unexpected effect.

Do not purchase or use

CHLORSIG if the packaging is

torn or shows signs of

tampering.

Do not give CHLORSIG to

children under 2 years of age

unless your doctor or

optometrist tells you.

Before you start touse it

You must tellyour doctor, or

pharmacist if:

1. you are allergicto

any other medicines or any

foods, dyes or preservatives

2. you have surgery (including

dentalsurgery) using a general

anaesthetic

3. you have any other medical

conditions/health problems

4. you are pregnant

or plan to become

pregnant

Yourpharmacist ordoctor will

advise you of the risks and

benefitsof taking Chlorsigin

pregnancy.

5. you are

breastfeeding or

plan to breastfeed

Yourpharmacist ordoctor will

advise you of the risks and

benefits oftakingChlorsigwhile

breastfeeding

If you have not toldyour

doctor, pharmacist or

optometrist about any of the

above, tellthem before you

take any CHLORSIG.

Taking other medicines

Tell your doctor, pharmacist or

optometrist if you are using

any other medicines, including

medicines that you buy without

a prescription from a

pharmacy, supermarket or

health food shop.

Somemedicinesmayinterfere

with CHLORSIG. These include

other eye drops and eye

ointments.

These medicines may either

reduce or increase the

effectiveness of CHLORSIG,

reduce its own effectiveness

and/or react with CHLORSIG

resulting inuntoward or

sometimes dangerous side

effects.

Your doctor, pharmacistor

optometristhas more information

on medicines tobe carefulwith

or avoid whileusing

CHLORSIG.

How to use CHLORSIG

Follow all directions given to

you by your doctor or

pharmacist carefully.They may

differ fromthe information

containedinthis leaflet.

If you do not understand the

instructions on the box/bottle,

ask your doctor or pharmacist

for help.

How much to use

The dose of CHLORSIG maybe

different for each person and

their medicalcondition. Your

doctor andpharmacist will

recommend the rightdose for

you.

Donotuse Chlorsiginchildren

under 2 years of age excepton

doctor’s advice.

The recommended doses are:

ƒ CHLORSIG eye drops:For

adultsand children (2 years

andover): Instil 1or2eye

drops in the affected eye(s)

everytwo tosix hours for up

to5 daysor as directed by

your pharmacistor doctor.

ƒ CHLORSIG eye ointment:

For adultsand children

(2 years and over):Apply

1.5 cmof eye ointmentevery

three hours for up to5 days

or as directed byyour doctor

or pharmacist. If ointmentis

used together withdrops for

dayand nightcoverage eye

ointmentshould be applied

before bedtime whileusing

the drops during the day.

If the condition does notget

better after 2 days, consultyour

doctor or pharmacist

How to apply the eye drops

ƒ Wash hands thoroughly

before and after use

ƒ Openthe eye, tilt headback

and look upwards

ƒ Gently pull downthe lower

lidtoforma pouch

ƒ Approach the eye fromthe

sideandholdthe bottle

dropper near the lid, butdo

notletthe tipof the dropper

touch the eye, eyelids or

lashes

ƒ Applyone drop intothe

pouch

ƒ Close the eyes (do notrub

them) and trynottoblink for

a short time

ƒ Applygentlepressure for a

few minutes witha finger to

the bridge of the nose to

preventthe medicine being

drained fromthe eye

ƒ Blotexcess solution around

the eye with a tissue

ƒ If instillingmore thanone

drop in an eye, separate each

installationbyseveral

minutes toavoid washing

drops outof the eye

ƒ To minimise contamination,

do notallow the dropper to

contact the surface of the eye.

How to apply the eye

ointment

ƒ Wash hands thoroughly

before and after use

ƒ Tilt headbackgently

ƒ Gently pull lower eyelid

down

ƒ Squeeze 1.5 cmof eye

ointmentinside the lower

eyelid, butdonotlet the tip

of the tube touch the eye,

eyelids orlashes

ƒ Release the eyelid slowly and

close eyes gentlyfor 1-2

minutes or blink a few times

tohelpspread the ointment

over the eye

ƒ Blotexcessive ointmentfrom

around the eye witha tissue

ƒ To minimise contamination,

donotallow the tiptocontact

the surface of the eye.

ƒ Vision maybe temporarily

blurred. Avoidactivities that

require good visual ability

until visionclears.

ƒ To minimise contamination,

donotallow the tiptocontact

the surface of the eye.

How long to use it

Chlorsigshould be used for up to

5 daysor as directed byyour

doctor, pharmacistor

optometrist.

If you forget to use it

If it is almost time for your

next dose, skip the dose you

missed and use your next dose

when next due.

Otherwise, use itas soon as you

remember, and then go back to

using it as you would normally.

Do not use a double dose to

make up for the dose that you

missed.

If you are unsure about

whether to use your next dose,

speak to your doctor or

pharmacist.

Do not try to make up for

missed doses by using more

than one dose at a time.

This may increase the chance of

you getting an unwanted side

effect.

If you have trouble remembering

when touse your medicine, ask

your pharmacistfor somehints.

If you use too much

(overdose):

Accidentalingestion of the drug

inadults is unlikely tocause any

toxicitydue tolow contentof

antibiotic, butconsult your

doctor or Poison Information

Centre (see below).

If the eye drops are accidentally

ingested byinfants or young

children:

Immediately telephone your

doctor or Poisons Information

Centre (telephone: 0800 764

Accident and Emergency at the

nearest hospital. Do this even

if there are no signs of

discomfort or poisoning.

Urgentmedicalattention maybe

needed.

While you are using

CHLORSIG

Things you must do:

Use CHLORSIG exactly as

your doctor or pharmacist has

prescribed.

Tell all doctors, dentists,

optometrists and pharmacists

who are treating you that you

are using CHLORSIG.

Tell your doctor immediately if

you become pregnant while you

are using CHLORSIG.

Always discuss with your

doctor or pharmacist any

problems or difficulties during

or after taking CHLORSIG.

Tell your doctor, optometrist

or pharmacist if, for any

reason, you have not taken

your medicine exactly as

prescribed.

Otherwise your doctor,

optometristor pharmacistmay

thinkthat it was noteffective and

change your treatment

unnecessarily.

Things you must not do:

Do not drive or operate

machinery until you know how

CHLORSIG affects you.

CHLORSIG maydistortyour

vision temporarily. Make sure

you know how you react to

CHLORSIG before you drive a

car, operate machinery, or do

anything else thatcould be

dangerous.

Do not use CHLORSIG for a

longer time than your doctor,

optometrist or pharmacist has

prescribed.

Do not increase the dose,

without first checking with

your doctor or pharmacist..

Unless your doctor says to do

not use this medicine to treat

any other complaints..

Donot givethis medicine to

anyone else, even if they have

the same condition as you.

Things to be careful of:

Be careful if you are elderly,

unwell or taking other

medicines.

Somepeople mayexperience

side effects such as distorted or

blurred vision, which may

increase the risk of a fall.

Side effects

Tell your doctor or pharmacist

as soon as possible ifyou do

not feel well while youare

using CHLORSIG.

CHLORSIG helps mostpeople

witheye infections, butit may

have unwanted side effects ina

few people.

Allmedicines have side effects.

Sometimes they are serious, most

of the time they are not. You

may need medical treatment if

you getsomeof the side effects.

Ask your doctor or pharmacist

ifyou have any questions.

Tell your doctor or pharmacist

immediately if you notice any

of the following:

ƒ local eye irritationwith

itching or burning

ƒ skin rashes and urticaria

ƒ skinblisters orfever

Check with your doctor or

pharmacist as soon as possible

ifyou have any problems while

using CHLORSIG even ifyou

do not think the problems are

connected with the medicine or

are not listed in this leaflet.

After using CHLORSIG

Storage

KeepCHLORSIG eye drops

ƒ In a refrigerator where the

temperature stays between

2 - 8 °C until opened

ƒ Do not freeze

ƒ On opening the drops may

be stored at room

temperature (below 25 °C)

ƒ Discard 4 weeks after

opening

ƒ Protect from light

KeepCHLORSIG eye ointment

ƒ in a cool dry place where

the temperature stays

below 25 o C

ƒ Discard 4 weeks after

opening

Do not store Chlorsigor any

other medicine in a bathroom

or near a sink. Do not leave

CHLORSIGin the car or on

windowsills.

Heatand dampness can destroy

somemedicines.

KeepCHLORSIGout of the

reach of children .

A locked cupboard atleastone-

and-a-halfmetres above the

ground is a good place to store

medicines.

Disposal

If your doctor or pharmacist

tellsyou to stop using

CHLORSIG or the expiry date

haspassed, ask your

pharmacist what to do with

any CHLORSIG that isleft

over.

Product description

What it looks like

CHLORSIG eye dropsis ina

plastic dropper bottle with

tamper seals. It is a clear to

slightly hazy colourless, slightly

viscous liquid and odourless.

CHLORSIG eye ointmentis ina

4g tube withan ophthalmiccap.

Ingredients

CHLORSIG eye drops contain:

Active Ingredient

ƒ Chloramphenicol (5mg/mL)

Excipients

ƒ phenylmercuric acetate

ƒ boricacid

ƒ borax

ƒ hypromellose

ƒ sodiumhydroxide

ƒ purifiedwater

CHLORSIGeye dropscontain

the preservative phenylmercuric

acetate (0.002%w/v).

CHLORSIG eye ointment

contains:

Active Ingredient

ƒ Chloramphenicol(10 mg/g)

Excipients

ƒ Paraffin – liquid

ƒ Paraffin – soft white

ƒ Woolfat

CHLORSIGeye ointmentis

free from preservatives.

Manufacturer

Aspen PharmaPtyLtd

(A.C.N. 004 118 594)

96 MerrindaleDrive

Croydon Victoria3136

AUSTRALIA

Telephone:03 - 9839 2800

The Australian Registration

numbers are:

CHLORSIG eye dropsAUST R

19661 and CHLORSIG eye

ointmentAUST R19662.

New Zealand Sponsor:

Pharmacy Retailing (NZ)

Limited

Trading as Healthcare Logistics

58 Richard Pearce Drive

AirportOaks

Auckland

Ph (09) 918 5100

Fax (09) 901 5101

Thisdocumentwas lastprepared

in 01 March 2011

New Zealand Data Sheet

1.

CHLORSIG (Eye drops 0.5% and Eye ointment 1%)

2.

QUANTITATIVE AND QUALITATIVE COMPOSITION

Chlorsig eye drops contain chloramphenicol 0.5% w/v in aqueous base

thickened with hypromellose. Phenylmercuric acetate (0.002% w/v) is used

as a preservative.

Chlorsig eye ointment contains chloramphenicol 1.0% w/w in a sterile

oculentum base. Contains no preservatives.

Chloramphenicol exists as a white to greyish-white or yellowish white, fine

crystalline powder or fine crystals, needles or elongated plates.

Chloramphenicol is slightly soluble in water (1 in 400), chloroform and ether.

Freely soluble in ethanol (1 in 2.5), propylene glycol (1 in 7), acetone and

ethyl acetate

Molecular formula is C

and a molecular weight of 323.1.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Chlorsig eye drops is a clear to slightly hazy colourless, slightly viscous

liquid and odourless.

Chlorsig eye ointment is a yellowish-white unctuous ointment, free of

visible contamination. Odour faintly of paraffin and wool fat.

4.

CLINICAL PARTICULARS

4.1 Therapeutic Indications

For the treatment of bacterial conjunctivitis. For use under medical

supervision only in the treatment of other superficial ocular infections caused

by chloramphenicol-sensitive organisms.

4.2 Dose and method of administration

CHLORSIG EYE DROPS:

For adults and children (2 years and over): Instil 1 or 2 drops in the affected

eye(s) every two to six hours for up to 5 to three days. The interval between

applications may then be increased. To minimise contamination do not allow

the dropper to contact the surface of the eye. Discard solution within one

month of opening container.

The systemic absorption of CHLORSIG eye drops can be minimised by

applying gentle pressure on the tear-duct for a few minutes immediately after

application.

CHLORSIG EYE OINTMENT:

For adults and children (2 years and over): Apply 1.5cm into lower eye lid of

the affected eye every three hours for up to 5 days. If ointment is used

together with drops for day and night coverage, 1.5cm should be applied

before bedtime, while using the drops during the day. To minimise

contamination do not allow the tip to contact the surface of the eye.

Chlorsig is not recommended for children under 2 years except on medical

advice.

Treatment should be continued for at least 48 hours after the eye appears

normal.

The systemic absorption of CHLORSIG EYE DROPS can be minimised by

applying gentle pressure on the tear-duct for approximately one minute

immediately after application.

4.3 Contraindications

Chloramphenicol is contraindicated in individuals with a history of

hypersensitivity to any excipients and/or toxic reaction to the medicine.

4.4 Special warnings and precautions for use

Bone marrow hypoplasia, including aplastic anaemia and death, has been

rarely reported following local application of chloramphenicol.

Chloramphenicol should not be used when less potentially dangerous agents

would be expected to provide effective treatment. Ophthalmic agents may

retard corneal wound healing.

The use of this antibiotic, as with other antibiotics, may result in the

overgrowth of non-susceptible organisms, including fungi. If infections

caused by non-susceptible organisms appear during therapy, its use should

be discontinued and appropriate measures should be taken. In all serious

infections, the topical use of chloramphenicol should be supplemented by

appropriate systemic medication.

The mechanism for the irreversible aplastic anaemia following ophthalmic

use of chloramphenicol has not been established.

Chloramphenicol eye drops and ointment should not be recommended for

OTC use under the following circumstances:

■ Photophobia

■ Severe pain in the eye or pain and swelling around the eye

■ Loss of, reduced or blurred vision

■ Restriction of eye movement

■ Cloudy cornea

■ Copious yellow-green purulent discharge that accumulates after being

wiped away

■ Contact lens wear

■ Abnormal pupils

■ Injury to the eye or suspicion of a foreign body in the eye

■ History of welding without eye protection immediately prior to onset of

symptoms

■ Glaucoma

■ Dry eye syndrome

■ Patient is a contact lens user

■ Patient is using other eye drops or eye ointments at the time of

presentation

■ Patient has had eye surgery or laser treatment in the past six months

■ Individual or family history of bone marrow problems

■ Recent overseas travel

■ Patient has had similar symptoms in the past

■ Patient feels unwell

In these cases, referral to a doctor or optometrist is required.

Instructions to Patients

■ If symptoms worsen at any time or if the eye infection does not improve

within 48 hours, seek prompt medical advice.

■ Patients who wear contact lenses should be advised to seek advice from

their doctor or optometrist before using Chlorsig. Contact lenses should not

be worn during the course of Chlorsig treatment. If wearing hard or

disposable contact lenses, patients can start using their lenses again after

successfully completing the course of treatment. If wearing soft contact

lenses, patients should wait 24 hours after successfully completing a course

of treatment before starting to use their lenses again.

4.5 Interaction with other medicines and other forms of interaction

No data available.

4.6 Fertility, pregnancy and lactation

Fertility

No data available.

Pregnancy and lactation

Systematically absorbed/administered forms of chloramphenicol enter the

foetal circulation and are distributed into breast milk. If given systematically

to the mother shortly before parturition or whilst breastfeeding,

chloramphenicol may cause bone marrow suppression of the neonate or the

“grey baby syndrome”, characterised by cyanosis and hypothermia, owing to

the limited glucuronidating capacity of the neonate’s liver. However, limited

absorption following ophthalmic use at the recommended dosage is

generally not expected to pose a risk to the foetus or neonate.

4.7 Effects on ability to drive and use machines

No data available.

4.8 Undesirable effects

Blood dyscrasias have been reported in association with the use of

chloramphenicol (see Warnings and Precautions). Chloramphenicol is

absorbed systemically from the eye, and toxicity has been reported following

chronic exposure. Dose related toxicity following a single ocular exposure is

unlikely. Local irritation with the ophthalmic form may include subjective

symptoms of itching or burning. More serious side effects such as

angioneurotic oedema; anaphylaxis, urticaria, fever, vesicular and

maculopapular dermatitis have been reported in patients sensitive to

chloramphenicol and are causes for discontinuing the medication. Similar

sensitivity reactions to other materials in topical preparations also may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is

important. It allows continued monitoring of the benefit/risk balance of the

medicine. Healthcare professionals are asked to report any suspected

adverse reactions https://nzphvc.otago.ac.nz/reporting/

4.9 Overdose

Accidental ingestion of the medicine is unlikely to cause any toxicity due to

low content of antibiotic. CHLORSIG EYE DROPS contains 18.80mg/ml of

borax/boric acid as buffer with less than 0.13mg/ml of sodium hydroxide. If

the eye drops are accidentally ingested by infants or young children, Poisons

Information Centre (Telephone: 0800 764 766) should be contacted. The

medication should be kept out of reach of children.

Treatment

If irritation, pain, swelling, lacrimation or photophobia occur after undesired

eye contact, the exposed eye(s) should be irrigated with copious amounts of

room temperature water for at least 15 minutes. If symptoms persist after 15

minutes of irrigation, an ophthalmological examination should be considered.

{For advice on the management of overdose please contact the National

Poisons Centre on 0800 POISON (0800 764766).}

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Chloramphenicol is a broad spectrum antibiotic originally isolated from

Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition

of protein synthesis by interfering with the transfer of activated amino acids

from soluble RNA to ribosomes.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

No data available.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

CHLORSIG EYE DROPS and CHLORSIG EYE OINTMENT contain the

following excipients:

Chlorsig Eye Drops

Chlorsig Eye Ointment

Phenylmercuric acetate

liquid paraffin

Boric acid

white soft paraffin

Borax

Wool fat

Hypromellose

Sodium hydroxide

Purified Water

6.2 Incompatibilities

No data available.

6.3 Shelf-life

Chlorsig Eye Ointment: 36 months from date of manufacture.

Chlorsig Eye Drops: 24 months from date of manufacture stored at 2° to 8°C

(Refrigerate, do not freeze)

6.4 Special precautions for storage

CHLORSIG EYE DROPS: Store between 2-8°C. Refrigerate. Do not freeze.

After dispensing, store below 25°C. Discard one month after opening.

Protect from light.

CHLORSIG EYE OINTMENT: Store below 25°C.

6.5 Nature and contents of container

Packaged Quantities

CHLORSIG EYE DROPS: 10mL plastic dropper bottle with tamper seals.

CHLORSIG EYE OINTMENT: 4g tube with an ophthalmic cap.

6.6 Special precautions for disposal (and other handling)

No data available.

7.

MEDICINE SCHEDULE

Restricted Medicine.

8.

SPONSOR

Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics

58 Richard Pearce Drive

Airport Oaks

Auckland

New Zealand

9.

DATE OF FIRST APPROVAL

March 2011

10. DATE OF REVISION OF THE TEXT

May 2019

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

All sections

revised

Update to the SPC-style format

Please note: Chlorsig eye drops are not available in New Zealand.

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