Betoptic S

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Betaxolol hydrochloride 0.28% w/v equivalent to to Betaxolol 2.5 mg/mL;  
Available from:
Novartis New Zealand Ltd
INN (International Name):
Betaxolol hydrochloride 0.28% w/v (Equiv. to Betaxolol 2.5 mg/mL)
Dosage:
0.25% w/v
Pharmaceutical form:
Eye drops, suspension
Composition:
Active: Betaxolol hydrochloride 0.28% w/v equivalent to to Betaxolol 2.5 mg/mL   Excipient: Amberlite Benzalkonium chloride as 50% soln + 5% overage. Equiv. to 0.1mg/mL Carbomer Disodium edetate dihydrate Hydrochloric acid Mannitol Purified water Sodium hydroxide
Units in package:
Bottle, dropper, 5mL, 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sanofi-Aventis Deutschland GmbH
Therapeutic indications:
The treatment of ocular hypertension or chronic open angle glaucoma. May be used alone or in combination with other IOP-lowering medication.
Product summary:
Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C. Store the bottle in the outer carton 4 weeks opened stored at or below 25°C. Store the bottle in the outer carton
Authorization number:
TT50-4063/1
Authorization date:
1991-04-11

Intermal document code

Bet131017cNZ

BETOPTIC

®

Eye Drops 0.5%

BETOPTIC

®

S Eye Drops 0.25%

Betaxolol hydrochloride

CONSUMER MEDICINE INFORMATION

What in this leaflet

Read this leaflet carefully

before you start to use

Betoptic and Betoptic S

Eye Drops.

This leaflet answers some

common questions about

Betoptic and Betoptic S Eye

Drops. It does not contain

all the available

information. It does not

take the place of talking to

your doctor or pharmacist.

The information in this

leaflet was last updated on

the date listed on the final

page. More recent

information on the medicine

may be available.

You should ensure that

you speak to your

pharmacist or doctor to

obtain the most up to date

information on the

medicine.

You can also download the

most up to date leaflet

from

www.medsafe.govt.nz.

The updates may contain

important information about

the medicine and its use of

which you should be aware.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you

using Betoptic against the

expected benefits it will

have for you.

The information in this

leaflet applies to Betoptic

and Betoptic S Eye Drops

only. This information does

not apply to similar

products, even if they

contain the same

ingredients.

If you have any concerns

about using this medicine,

ask your doctor or

pharmacist.

Keep this leaflet with your

medicine.

You may need to read it

again.

What Betoptic is

used for

Betoptic contains the active

ingredient

betaxolol

hydrochloride.

Betaxolol

hydrochloride belongs to a

class of medicines known as

“beta-adrenergic

blocking

agents”.

Your doctor has prescribed

Betoptic for you because the

pressure within your eye(s),

known

“intraocular

pressure”

higher

than

normal. This raised pressure

may damage your eyesight

lead

condition

known as glaucoma.

There

usually

symptoms of glaucoma. If

glaucoma is not treated it can

lead

serious

problems,

including

total

blindness.

Untreated glaucoma is one

of the most common causes

of blindness.

Betoptic is used, either alone

or in combination with other

medicines,

lower

raised pressure within your

eye(s).

Betoptic does this by

reducing the amount of fluid

produced within your eye(s).

Although

Betoptic

helps

control your glaucoma it

does not cure it. So you

must

keep

using

it

until

your

doctor

tells

you

to

stop.

more

information

glaucoma contact Glaucoma

Zealand

8779.

Ask

your

doctor

if

you

have any questions about

why

Betoptic

has

been

prescribed for you.

Your

doctor

have

prescribed

another

reason.

Use in Children

Betoptic

recommended

children.

safety

effectiveness of Betoptic in

children

been

established.

Before you use

Betoptic

When you must not use it

Let

your doctor

know if

any of the following applies

to

you

before

you

start

using Betoptic:

allergic

betaxolol hydrochloride

or to any of the other

ingredients in these eye

drops

that

listed

under

“Product

Description”

Some of the symptoms of an

allergic

reaction

include:

shortness of breath

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wheezing

difficulty

breathing

swelling of the face, lips,

tongue or other parts of

the body

rash, itching or hives on

the skin.

Tell your doctor if:

You have a very slow

heartbeat

irregular

heartbeat

You have cardiac failure

other

serious

heart conditions.

If you have not told

your doctor about any

of the above, tell

him/her before you

start using Betoptic.

Do not use this medicine if

the expiry date has passed,

the packaging is torn, the

safety seal around the

closure and neck area is

broken.

If it has expired or is

damaged, return it to your

pharmacist for disposal.

If you use your medicine

after the expiry date has

passed, it may not work as

well.

Before you start to use it

Tell your doctor if:

You are pregnant, or

intend to become

pregnant

Your doctor will discuss

the possible risks and

benefits of using

Betoptic during

pregnancy.

You are breast-feeding

or intend to breast-

feed

Your doctor will discuss

the possible risks and

benefits of using

Betoptic when you are

breast-feeding.

Tell your doctor if have or

have

had

any

of

the

following

medical

conditions:

Any type of respiratory

breathing

disorder

(e.g.

wheezing

asthma)

Diabetes

overactive

thyroid

gland

form

muscle

weakness

Heart

failure

heart

block

heart

condition

Severe

circulation

disorders e.g. Raynaud’s

disease or syndrome

condition

called

phaeochromocytoma

which is a tumour in the

brain

Metabolic

acidosis

where the body produces

excessive acid that is not

cleared by the kidneys.

Tell your doctor if you are

about to have either major

surgery or eye surgery.

This includes those doctors

treating you in hospital or in

clinic.

Your

dose

Betoptic

need

adjusted

gradually

stopped prior to surgery.

contact

lenses

wearer. This is particularly

important

currently

using

other

type

anti-glaucoma

medication or any other eye

drops.

Betoptic

into

your eye(s) while you are

wearing soft contact lenses.

The preservative in Betoptic,

benzalkonium chloride, may

deposited

contact

lenses.

your

soft

contact lenses back into your

eyes 15 minutes after you

have used Betoptic.

If you are not sure if you

should start using Betoptic,

talk to your doctor.

Taking

or

using

other

medicines

Tell

your

doctor

or

pharmacist

if

you

are

taking

or

using

other

medicines,

including

medicines

that

you

get

without

a

doctor’s

prescription

from

a

pharmacy, supermarket or

health food shop.

Some

medicines

Betoptic interfere with each

other. These include

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other

beta-blockers,

calcium

blockers,

including

amiodarone,

and digitalis glycosides

certain

medicines

used

treat

lower

blood

pressure e.g. reserpine

some medicines used to

treat

major

mental

illnesses.

These

medicines

affected by Betoptic or may

affect

well

works.

need

different

amounts of your medicines.

Your doctor or pharmacist

have

more

information

medicines to be careful with

avoid

while

using

this

medicine.

How to use Betoptic

Follow all directions given

to you by your doctor or

pharmacist carefully.

They

differ

from the

information contained in this

leaflet.

If you do not understand

the instructions on the box,

ask

your

doctor

or

pharmacist for help.

How much to use

The usual dose of Betoptic or

Betoptic S Eye Drops is

one

drop

in the affected eye(s)

two times each day

. Your

dosing instructions will be

printed

label

your

pharmacist put on the bottle

or carton.

Using your eye drops at the

same time each day will

have the best effect on your

eye pressure. It will also

help you remember when to

use the eye drops.

Do not use Betoptic more

often than your doctor or

pharmacist has told you.

If you have been using any

other

drops

treatment

raised

intraocular

pressure

glaucoma,

take

several days to change from

the old drops to Betoptic or

Betoptic S Eye Drops. It is

important that you carefully

follow

your

doctor’s

instructions

changeover.

After using Betoptic wait

at least 5 minutes before

putting

any

other

eye

drops in your eye(s).

How to use it

Follow

these

steps

Betoptic:

It is important that you shake

Betoptic S Eye Drops well

before using them.

Wash

your

hands

thoroughly.

Immediately

before

using a bottle for the first

time,

break

safety

seal

around

neck

area and throw the loose

plastic ring away.

Shake the bottle well.

Remove

from

the bottle.

Hold the

bottle

upside

down

hand

between your thumb and

middle

finger

(See

Diagram 1).

While tilting your head

back,

gently

pull

lower eyelid of your eye

down

using

forefinger of your other

hand.

Place the dropper tip

close to, but not

touching, your lower

eyelid and gently tap or

press the base of the

bottle with your

forefinger to release one

drop. Do not squeeze

the bottle. (See

Diagrams 2) and 3).

Close

your

gently

without

blinking

press

inside

corner of your eye with

of your index

finger for two minutes.

If necessary, repeat the

above

steps

your

other eye.

Place

bottle

close

tightly.

Wash your hands again.

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feel

slight

burning sensation in the eye

shortly after using Betoptic.

If this persists, or is very

uncomfortable, contact your

doctor or pharmacist.

Do not touch the tip of the

dropper to your eye or to

any other surface.

This

will

help

prevent

your

drops

becoming

dirty or contaminated.

If you wear contact lenses

take the lenses out before

you use Betoptic. Wait 15

minutes

before

putting

back your contact lenses.

How long to use it

Continue

using

Betoptic

every day as long as your

doctor prescribes.

Betoptic helps control your

condition but does not cure

If you forget to use it

If you forget to use Betoptic,

you should put the drops that

you missed in as soon as you

remember and then go back

to using them normally. If it

is almost time for your next

dose, skip the dose that you

have missed and take your

next dose when you are due

Never use a double dose to

make up for the one that

you missed.

If you are not sure what to

do, contact your doctor or

pharmacist.

If

you

use

too

much

(overdose)

If you accidentally put too

many drops in your eye(s),

immediately

rinse

your

eye(s) with warm water or

normal saline.

If

anyone

accidentally

swallows

Betoptic

or

Betoptic

S

Eye

Drops,

immediately

telephone

your doctor, the National

Poisons

Centre

on

0800

POISON or 0800 764 766

or

go

to

Accident

and

Emergency at the nearest

hospital. Do this even if

there

are

no

signs

of

discomfort or poisoning.

While you are using

Betoptic

Things you must do

To make sure that Betoptic

is working properly, have

your eye pressure checked

regularly by your doctor.

Have your eyes checked for

any

other

changes

you

experience.

Tell

your

doctor

become pregnant while you

are using Betoptic.

Tell

your

doctor

pharmacist

that

using

Betoptic

before

start

taking

using

other medicines.

Things that you must not

do

Do not let children handle

Betoptic or Betoptic S Eye

Drops.

child

accidentally swallows any of

drops

read

instructions

under

If

you

use too much (overdose)”.

Do not give this medicine to

anyone

else,

even

they

appear

have

same

condition as you.

Things to be careful of

Be careful driving or

operation machinery until

you know how Betoptic

affects you.

As with any eye medicines,

temporary blurred vision or

other

visual

disturbances

affect

ability

drive and use machinery in

some

people.

blurred

vision occurs when you use

your drops, wait until your

vision

before

driving.

Side effects

All medicines can have side

effects. Sometimes they are

serious,

most

time

they are not. You may need

medical treatment if you get

some of the side effects.

Tell your doctor as soon as

possible if you do not feel

well

while

using

Betoptic.

Most

side

effects

from

Betoptic

occur

in,

or

around, the eye.

These include:

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Discomfort

pain

the eye(s)

A loss of feeling to the

surface of the eye(s)

Redness,

inflammation,

irritation and/or itching

in your eye(s), eyelids or

the surrounding lining of

the eyelids

Inflammation

cornea

(clear

front

portion

your

eye)

(punctuate keratitis)

Blurred

vision

and/or

problems seeing clearly

A feeling that something

is in your eye(s)

Eyelid spasms

A dry eye(s)

Crusty

eyelash(es)

eyelids

Discomfort in the eye(s)

greater

sensitivity to light

Weakness

easily

fatigued eyes.

Occasionally,

some

people

notice unwanted effects in

the rest of their body as a

result of using Betoptic.

Tell

your

doctor

immediately if notice any

of the following effects:

Changes

breathing

(e.g.

wheezing

asthma)

Cough

Respiratory

infection,

sinusitis, runny nose

Circulation problems

Fast or slowing of heart

beat, irregular heart beat

Nausea

Trouble sleeping

Headache

Dizziness

Fainting

Tiredness

and/or

depression

Decreased libido

Hives and more severe

forms of skin rash

Flaking skin and/or hair

loss

Sore tongue

Altered taste sensation.

These may be serious side

effects.

need

urgent

medical

attention.

Serious side effects are rare.

Other side effects not listed

above

occur

some

people.

After using Betoptic

Keep

Betoptic

and

Betoptic S Eye Drops in a

cool place, below 25

C. Do

not freeze.

Store the bottle in the outer

carton.

Do not leave Betoptic or

Betoptic S Eye Drops in the

bathroom or near a sink.

Do not leave it on a

window sill or in the

car.

Heat and dampness can

destroy some medicines.

Keep

Betoptic

and

Betoptic S Eye Drops, and

all

other

medicines,

in a

safe place away from the

sight or reach of children.

A locked cupboard at least

one-and-a half metres above

the ground is a good place to

store medicines.

Discard

each

bottle

of

Betoptic or Betoptic S Eye

Drops 4 weeks after it has

been

opened.

Write

the

date the bottle was opened

on the label to remind you

when to discard the bottle.

Product description

What it looks like

Betoptic

drops

sterile

isotonic

solution

supplied in a 5 mL Drop-

Tainer® dispensing bottle.

Betoptic S Eye drops are a

sterile

ophthalmic

resin

suspension supplied in in a 5

Drop-Tainer®

dispensing bottle.

Intermal document code

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Ingredients

The active ingredient in

Betoptic Eye Drops is

betaxolol hydrochloride

equivalent to betaxolol 5mg

in 1 mL.

Betoptic Eye Drops also

contain:

Benzalkonium chloride

(as a preservative)

Disodium edetate

Sodium chloride

Purified water.

The active ingredient in

Betoptic S Eye Drops is

betaxolol hydrochloride

equivalent to betaxolol

2.5mg in 1 mL.

Betoptic S Eye drops also

contain:

Benzalkonium chloride

(as a preservative)

Polystyrene sulfonate

hydrogen

Carbomer 934P

Sodium edetate

Mannitol

Purified water.

Supplier

This product is supplied in

New Zealand by:

Novartis New Zealand

Limited

109 Carlton Gore Road

Newmarket

Auckland 1023.

PO Box 99102

Newmarket

Auckland 1149

New Zealand.

Free Phone: 0800 354 335.

Date of Preparation

This leaflet was revised in

September 2017.

® Registered Trademark.

© Novartis Pharmaceuticals

Australia Pty Limited 2017.

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NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

BETOPTIC

(betaxolol hydrochloride) Eye Drops 0.5%

BETOPTIC

S (betaxolol hydrochloride) Eye Drops 0.25%

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Betoptic Eye Drops contains betaxolol 5 mg in 1 mL.

Betoptic S Eye Drops contains betaxolol 2.5 mg in 1 mL.

Excipient with known effect

Benzalkonium chloride 0.1 mg in 1 mL (preservative).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Betoptic: eye drops, solution.

Betoptic S: eye drops, suspension.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Betoptic Eye Drops 0.5% and Betoptic S Eye Drops 0.25% have been shown to be effective

in lowering intraocular pressure and are indicated in the treatment of ocular hypertension or

chronic open angle glaucoma.

Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% may be used alone or in

combination with other IOP-lowering medication.

4.2

Dose and method of administration

NOTE: Shake Betoptic S Eye Drops 0.25% well before use.

The usual dose is one drop of Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% in the

affected eye(s) twice daily. In some patients, the intraocular pressure lowering response to

Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% may require a few weeks to

stabilise. Clinical follow up should include a determination of the intraocular pressure during

the first month of treatment with Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25%.

Thereafter, intraocular pressure should be determined on an individual basis at the judgement

of the physician.

Because of diurnal variations of intraocular pressure in individual patients, satisfactory

response to twice-a-day therapy is best determined by measuring intraocular pressure at

different times during the day. Intraocular pressure

22 mmHg may not be optimal for

control of glaucoma in each patient; therefore, therapy should be individualised.

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If the intraocular pressure of the patient is not adequately controlled on this regimen,

concomitant therapy with pilocarpine, other miotics, adrenaline or systemically administered

carbonic anhydrase inhibitors can be instituted.

When a patient is transferred from several concomitantly administered anti-glaucoma agents,

individual adjustment is required. Adjustment should involve one agent at a time made at

intervals of not less than one week. A recommended approach is to continue the agents being

used and add one drop of Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% in the

affected eye(s) twice a day. On the following day, discontinue one of the other anti-glaucoma

agents. The remaining anti-glaucoma agents may be decreased or discontinued according to

the patient's response to treatment. The physician may be able to discontinue some or all of

the other anti- glaucoma agents.

In order to minimise systemic absorption, apply pressure to the tear duct for two minutes

immediately after administration.

Contact Lenses

Neither Betoptic Eye Drops 0.5% nor Betoptic S Eye Drops 0.25% should be instilled while

the patient is wearing contact lenses.

If patients continue to wear soft (hydrophilic) contact lenses while under treatment with

Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25%, they should remove their lens(es)

prior to instilling the drops in the affected eye(s). Lens(es) should not be inserted into the

eye(s) until 15 minutes after instillation of the drops.

4.3

Contraindications

Hypersensitivity to any component of this product (refer to Section 6.1).

Betaxolol hydrochloride is contraindicated in patients with sinus bradycardia greater than a

first degree block, cardiogenic shock, or patients with a history of overt cardiac failure.

4.4

Special warnings and precautions for use

FOR OCULAR USE ONLY

General

Topically applied beta-adrenergic blocking agents may be absorbed systemically. The same

types of cardiovascular and pulmonary and other adverse reactions found with systemic

administration of these agents may occur with topical administration. For example, severe

respiratory reactions, including death due to exacerbation of bronchospasm in patients with

asthma, and rarely death in association with cardiac failure, have been reported with

ophthalmic application of beta- adrenergic blocking agents.

Cardiovascular

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While ophthalmic betaxolol hydrochloride has been shown to have a minor effect on heart

rate and blood pressure in clinical studies, caution should be used in treating patients with a

history of cardiac failure or heart block. When beginning therapy with betaxolol patients with

a history of severe cardiac disease should be monitored closely for signs of cardiac failure.

Treatment with ophthalmic betaxolol hydrochloride should be discontinued at the first sign

of cardiac failure.

Because of potential effects of beta-blockers on blood pressure and pulse (e.g. hypotension,

bradycardia), use with caution in patients with cerebrovascular insufficiency, untreated

phaeochromocytoma

metabolic

acidosis,

since

beta-adrenergic

blocking

agents

adversely affect such diseases.. If signs or symptoms suggesting reduced cerebral blood flow

develop, consider alternative therapy.

In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal’s angina and

cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and

the therapy with other active substances should be considered. Patients with cardiovascular

diseases should be watched for signs of deterioration of these diseases and of adverse

reactions.

Vascular disorders

Patients

with

severe

peripheral

circulatory

disturbance/disorders

(i.e.

severe

forms

Raynaud’s disease or Raynaud’s syndrome) should be treated with caution.

Pulmonary

Caution should be exercised in the treatment of glaucoma patients with excessive restriction

of pulmonary function. Exacerbation of asthma and bronchospasm have been reported in

patients receiving betaxolol treatment. Although rechallenge(s) of some such patients with

ophthalmic betaxolol hydrochloride has not adversely affected pulmonary function test

results, the possibility of adverse pulmonary effects in patients sensitive to beta-adrenergic

blockers cannot be ruled out.

Diabetes Mellitus

While ophthalmic betaxolol hydrochloride has demonstrated a low potential for systemic

effects, beta-adrenergic blocking agents should be used with caution in patients subject to

spontaneous hypoglycaemia, or in diabetic patients (especially those with labile diabetes)

receiving insulin oral hypoglycaemic agents. Beta-adrenergic blocking agents may mask the

signs and symptoms of acute hypoglycaemia.

Major surgery

Consideration should be given to the gradual withdrawal of beta-adrenergic receptor blocking

agents prior to general anaesthesia because of the reduced ability of the heart to respond to

beta-adrenergically mediated sympathetic reflex stimuli.

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Surgical Anaesthesia

Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of

adrenaline. The anaesthesiologist should be informed when the patient is receiving betaxolol.

Muscle weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with

certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).

Ocular

In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the

angle by constriction of the pupil with a miotic agent. Betaxolol has little or no effect on the

pupil; therefore, Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% should be used

with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma.

As with other antiglaucoma drugs, diminished responsiveness to ophthalmic betaxolol

hydrochloride after prolonged therapy has been reported in some patients. However, in one

long- term study in which 250 patients have been followed for up to three years, no significant

difference in mean intraocular pressure has been observed after initial stabilisation.

Contact lenses

Betaxolol Eye Drops contain benzalkonium chloride which may cause irritation and is known

to discolour soft contact lenses. Avoid contact with soft contact lenses.

Patients must be instructed to remove contact lenses prior to application of eye drops

containing betaxolol and wait at least 15 minutes before reinsertion.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask certain clinical signs of hyperthyroidism, e.g.

tachycardia. Patients having or suspected of developing thyrotoxicosis should be managed

carefully to avoid abrupt withdrawal of these agents which might precipitate a thyroid storm.

Paediatric population

Clinical studies to establish the safety and efficacy in children have not been performed.

4.5

Interaction with other medicines and other forms of interaction

The potential exists for additive systemic and/or intraocular beta blockade effects either on

the intraocular pressure or on the known systemic effects of beta blockade for patients

receiving a beta-adrenergic receptor blocking agent orally and ophthalmologically or with

oral

calcium

channel

blockers,

antiarrhythmics

(including

amiodarone)

digitalis

glycosides. Neither Betoptic Eye Drops 0.5% nor Betoptic S Eye Drops 0.25% should be

used in conjunction with other topical beta-blocking agents. Coadministration of ophthalmic

beta-blockers

with

digitalis

have

additive

effects

prolonging

atrioventricular

conduction time.

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Although betaxolol hydrochloride used alone has little or no effect on pupil size, mydriasis

resulting from concomitant therapy with betaxolol hydrochloride and adrenaline has been

reported occasionally.

Close observation of the patient is recommended when a beta blocker is administered to

patients receiving catecholamine-depleting drugs such as reserpine, because of possible

additive effects and the production of hypotension and/or bradycardia which may result in

vertigo, syncope, or postural hypotension. Caution should be exercised in patients using

concomitant adrenergic psychotropic drugs.

Risk from anaphylactic reaction: While taking beta blockers, patients with a history of atopy

or severe anaphylactic reaction to a variety of allergens may be more reactive to repeated

accidental diagnostic or therapeutic challenge with such allergens. Such patients may be

unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.

Caution should be used where a beta-2-agonist is administered concurrently with a beta-

blocker. When used in conjunction with topical miotics and/or systemically administered

carbonic anhydrase inhibitors, the effect of betaxolol eye drops in lowering IOP may be

additive.

Ophthalmic

beta-blockers

phenothiazone

compounds

have

potential

additive

hypotensive effects due to mutual inhibition of metabolism.

4.6

Fertility, pregnancy and lactation

Pregnancy

Category C

There have been no adequate and well controlled studies in pregnant women. Studies in

animals have shown reproductive toxicity. Because animal reproduction studies are not

always predictive of human response, this drug should be used during pregnancy only if

clearly indicated. Betaxolol is not recommended during pregnancy.

Epidemiological studies show a risk for intra uterine growth retardation when beta-blockers

are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g.

bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the

neonate when beta-blockers have been administered until delivery.

Beta-adrenergic receptor blocking agents may cause bradycardia in the fetus and newborn

infant. During the final part of pregnancy and parturition these drugs should, therefore, only

be given after weighing the needs of the mother against the risk to the fetus. If betaxolol eye

drops is administered until delivery, the neonate should be carefully monitored during the first

days of life

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Breast-feeding

It is not known whether ophthalmic betaxolol hydrochloride is excreted in human milk

following topical ocular administration. However, a risk to the suckling child cannot be

excluded.

Betaxolol concentrations in milk following oral administration may be up 3 times those in

maternal blood, having the potential to cause serious undesirable effects in the infant of the

nursing mother.

While it is unlikely that clinically important doses of the drug would be absorbed by breast-

fed infants during ophthalmic use in women, caution should be exercised when ophthalmic

betaxolol hydrochloride is prescribed for breast-feeding women.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from

betaxolol therapy taking into account the benefit of breast-feeding for the child and the benefit

of therapy for the woman.

Fertility

There is no data on the effects of Betaxolol Eye Drops on human fertility.

4.7

Effects on ability to drive and use machines

As with any eye drop, temporary blurred vision or other visual disturbances may affect the

ability to drive or use machines.

If blurred vision occurs at instillation, the patient must wait until the vision clears before

driving or using machinery.

4.8

Undesirable effects

Ocular

In clinical trials the most frequent event associated with the use of ophthalmic betaxolol

hydrochloride has been transient ocular discomfort. The incidence of discomfort was 16% in

patients treated with Betoptic S Eye Drops 0.25% and 25% in patients treated with Betoptic

Eye Drops 0.5%. Decreased corneal sensitivity, erythema, itching sensation, corneal punctate

keratitis,

anisocoria,

blurred

vision,

foreign

body

sensation,

tearing,

dryness

eyes,

inflammation, discharge, ocular pain, decreased visual acuity, crusty lashes and photophobia

have been reported in up to 4% of patients.

Systemic

Systemic reactions following topical administration of Betoptic Eye Drops 0.5% or Betoptic

S Eye Drops 0.25% have been reported rarely.

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These include:

Cardiovascular

Bradycardia,

heart

block

congestive

failure.

Pulmonary

Pulmonary

distress

characterised

dyspnoea,

bronchospasm,

thickened

bronchial secretions, asthma and respiratory

failure.

Central Nervous System

Insomnia,

dizziness,

vertigo,

headaches,

depression, lethargy and an increase in signs

and symptoms of myasthenia gravis.

Other

Hives, toxic epidermal necrolysis, hair loss,

glossitis.

Post Marketing Experience

Since topically applied beta-adrenergic blocking agents may be absorbed systemically,

adverse reactions found with systemic administration of beta1-adrenergic blocking agents

may occur with topical administration. These may include bradycardia, a slowed AV

(atrioventricular) - conduction or increase of an existing AV-block, hypotension, heart failure,

cold and cyanotic extremities, Raynauds phenomenon, paraesthesia of the extremities,

increase

existing

intermittent

claudication,

fatigue,

headaches,

impaired

vision,

hallucinations, psychoses, confusion, impotence, dizziness, sleep disturbances, depression,

nightmares,

gastro-intestinal

problems,

nausea,

vomiting,

diarrhoea,

bronchospasm

patients with bronchial asthma or a history of asthmatic complaints, disorder of the skin,

especially rash, and dry eyes. Beta blockers may mask the symptoms of thyrotoxicosis or

hypoglycaemia.

The following adverse reactions are classified according to the following convention: very

common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare

(≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the

available data). Within each frequency-grouping, adverse reactions are presented in order of

decreasing seriousness. The adverse reactions were obtained from clinical trials and post

marketing spontaneous reports.

Eye disorders

Very Common (≥ 10%): ocular discomfort.

Common (≥ 1% to < 10%): vision blurred, lacrimation increased, foreign body sensation in

eyes.

Uncommon (≥ 0.1% to < 1%): punctate keratitis, keratitis, conjunctivitis, blepharitis, visual

acuity

reduced,

visual

impairment,

photophobia,

pain,

eye,

asthenopia,

blepharospasm, abnormal sensation in eye, eye pruritus, eye discharge, eyelid margin

crusting, eye inflammation, eye irritation, conjunctival disorder, conjunctival oedema, ocular

hyperaemia.

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Rare (≥ 0.01% to < 0.1%): cataract, refraction disorder, eye disorder.

Not Known: erythema of eyelid.

Cardiac disorders

Uncommon (≥ 0.1% to < 1%): bradycardia, tachycardia.

Not Known: arrhythmia.

Vascular disorders

Rare (≥ 0.01% to < 0.1%): hypotension.

Nervous system disorders

Common (≥ 1% to < 10%): headache.

Rare (≥ 0.01% to < 0.1%): syncope.

Not Known: dizziness.

Psychiatric disorders

Rare (≥ 0.01% to < 0.1%): anxiety.

Not Known: insomnia, depression.

Immune system disorders

Not Known: hypersensitivity.

Respiratory, thoracic and mediastinal disorders

Uncommon (≥ 0.1% to < 1%): asthma, dyspnoea, respiratory disorder, rhinitis.

Rare (≥ 0.01% to < 0.1%): cough, rhinorrhea.

Gastrointestinal disorders

Uncommon (≥ 0.1% to < 1%): nausea.

Rare (≥ 0.01% to < 0.1%): dysgeusia.

Skin and subcutaneous tissue disorders

Rare (≥ 0.01% to < 0.1%): dermatitis, rash.

Not Known: periorbital oedema, alopecia.

Infections and infestations

Rare (≥ 0.01% to < 0.1%): influenza, infection, bronchitis, sinusitis.

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Reproductive system and breast disorders

Rare (≥ 0.01% to < 0.1%): libido decreased.

Surgical and medical procedures

Rare (≥ 0.01% to < 0.1%): antral lavage.

General disorders and administration site conditions

Not Known: asthenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows

continued

monitoring

benefit/risk

balance

medicine.

Healthcare

professionals

asked

report

suspected

adverse

reactions

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

4.9

Overdose

No information is available on overdosage of humans. The oral LD50 of the drug ranged from

350-920 mg/kg in mice and 860-1050 mg/kg in rats. The symptoms which might be expected

with an overdose of a systemically administered beta-1-adrenergic receptor blocking agent are

bradycardia, hypotension and acute cardiac failure.

A topical overdose of Betoptic Eye Drops 0.5% or Betoptic S Eye Drops 0.25% may be flushed

from the eye(s) with warm water or normal saline (sodium chloride solution 0.9%). If

accidentally ingested, efforts to decrease further absorption may be appropriate (gastric

lavage). The most common signs and symptoms of overdosage from systemic beta-blockers

are bradycardia, hypotension, bronchospasm, and acute cardiac failure. If these occur,

discontinue therapy and initiate appropriate supportive therapy.

For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764 766).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic Group: Ophthalmologicals - Antiglaucoma Preparations and Miotics.

ATC Code: S01E D02.

Mechanism of action

When instilled in the eye, Betoptic Eye Drops 0.5% and Betoptic S Eye Drops 0.25% have the

action of reducing elevated intraocular pressure as well as normal intraocular pressure, whether

or not accompanied by glaucoma.

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Optic nerve head damage and visual field loss are a result of a sustained elevated intraocular

pressure and poor ocular perfusion. The ocular hypotensive action of betaxolol appears to be

mediated by a reduction of aqueous production as demonstrated by tonography and aqueous

fluorophotometry. The onset of action with betaxolol can generally be noted within 30 minutes

and the maximal effect can usually be detected 2 hours after topical administration. A single

dose provides a 12-hour reduction in intraocular pressure.

Betaxolol has little or no effect on pupil size and does not produce accommodative spasm

which are frequently seen with miotic agents. The blurred vision and night blindness often

associated with standard miotic therapy are not associated with Betoptic Eye Drops 0.5% or

Betoptic S Eye Drops 0.25%. Thus, patients with central lenticular opacities avoid the visual

impairment caused by a constricted pupil.

Pharmacodynamic effects

Betaxolol hydrochloride is a cardioselective (beta-1-adrenergic) receptor blocking agent.

Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects

and patients with heart disease. In patients with severe impairment of myocardial function,

beta- adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary

to maintain adequate cardiac function.

In clinical pharmacology studies ophthalmic betaxolol has minimal effect on pulmonary and

cardiovascular parameters.

Ophthalmic betaxolol hydrochloride solution at 1% (one drop in each eye) was compared to

placebo in a three-way masked, crossover study challenging nine patients with reactive airway

disease1. Betaxolol hydrochloride has no significant effect on pulmonary function as measured

by Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and

FEV1/FVC. Additionally, the action of isoprenaline, a beta stimulant, administered at the end

of the study was not inhibited by ophthalmic betaxolol hydrochloride. In contrast, ophthalmic

timolol significantly decreased these pulmonary functions.

FEV1 - PERCENT CHANGE FROM BASELINE1

Means

Betaxolol 1%

Timolol 0.5%

Placebo

Baseline

60 minutes

-25.7*

120 minutes

-27.4*

240 minutes

-6.4

-26.9*

Isoprenaline

36.1

-12.4*

42.8

Schoene RB

et al

., Am J Ophthal, 97, 86-92, 1984.

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Twice the clinical concentration.

Inhaled at 240 minutes; measurement at 270 minutes.

* Timolol statistically different from betaxolol and placebo (p<0.05).

No evidence of cardiovascular beta adrenergic-blockade during exercise was observed with

betaxolol in a double-masked, crossover study in 24 normal subjects comparing ophthalmic

betaxolol hydrochloride solution 1.0% and placebo for effects on blood pressure and heart

rate

. Mean arterial blood pressure was not affected by any treatment; however, ophthalmic

timolol produced a significant decrease in the mean heart rate.

MEAN HEART RATES

Bruce

Stress

Exercise

Test Minutes

Treatment

Betaxolol 1%

Timolol 0.5%

Placebo

79.2

79.3

81.2

130.2

126.0

130.4

133.4

128.0*

134.3

136.4

129.2*

137.9

139.8

131.8*

139.4

140.8

131.8*

141.3

Atkins JM

et al

., Am J Ophthal, 99, 173-175, 1985.

Twice the clinical concentration.

* Mean heart rate significantly lower for timolol than betaxolol or placebo (p<0.05).

Clinical efficacy and safety

In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive

effect of Betoptic Eye Drops 0.5% and Betoptic S Eye Drops 0.25% were clinically equivalent.

Betoptic S Eye Drops 0.25% were significantly more comfortable than Betoptic Eye Drops

0.5%.

Clinical studies show that topical betaxolol reduces mean intraocular pressure 25% from

baseline. In trials using 22 mmHg as a generally accepted index of intraocular pressure control,

betaxolol hydrochloride solution was effective in more than 94% of the population studied, of

which 73% were treated with the beta blocker alone. In controlled, double-masked studies, the

magnitude and duration of the ocular hypotensive effect of Betoptic Eye Drops 0.5% and

ophthalmic timolol were clinically equivalent.

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Clinical observation of glaucoma patients treated with betaxolol hydrochloride solution for up

to three years shows that the intraocular pressure lowering effect is well maintained.

Ophthalmic betaxolol hydrochloride has also been used successfully in glaucoma patients who

have

undergone

laser

trabeculoplasty

have

needed

additional

long

term

ocular

hypotensive therapy. Ophthalmic betaxolol hydrochloride has been well-tolerated in glaucoma

patients

wearing

hard

soft

contact

lenses

(See

Section

Dose

method

administration, Contact Lenses) and in aphakic patients.

5.2

Pharmacokinetic properties

Pharmacokinetics

Not available.

5.3

Preclinical safety data

Ocular anaesthesia has been observed in rabbit studies.

Carcinogenicity

Lifetime studies with betaxolol hydrochloride have been completed in mice at oral doses of 6,

20 or 60 mg/kg/day and in rats at 3, 12 or 48 mg/kg/day; betaxolol hydrochloride demonstrated

no carcinogenic effect.

Mutagenicity

In a variety of

in vitro

in vivo

bacterial and mammalian cell assays, betaxolol hydrochloride

was non-mutagenic.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Betoptic Eye Drops 0.5%

Benzalkonium chloride (as a preservative)

Disodium edetate

Sodium chloride

Purified water.

Betoptic S Eye Drops 0.25%

Benzalkonium chloride (as a preservative)

Mannitol

Polystyrene sulfonate hydrogen

Carbomer 934P

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Disodium edetate

Purified water.

6.2

Incompatibilities

Unknown.

6.3

Shelf life

Betoptic

36 months.

Betoptic S

24 months.

6.4

Special precautions for storage

Store below 25° C.

Store the bottle in the outer carton.

Discard container 4 weeks after opening.

6.5

Nature and contents of container

Bottle dropper (Drop-Tainer

6.6

Special precautions for disposal

No special requirements for disposal.

7.

MEDICINE SCHEDULE

Prescription Only bMedicine.

8.

SPONSOR

Novartis New Zealand Limited

109 Carlton Gore Road

Newmarket

Auckland 1023.

PO Box 99102

Newmarket

Auckland 1149

New Zealand.

Free Phone: 0800 354 335.

9.

DATE OF FIRST APPROVAL

Betoptic: 19 June 1986.

Betoptic S: 11 April 1991.

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10.

DATE OF REVISION OF THE TEXT

21 September 2017.

Summary Table of Changes

All sections

Updated

Summary

Product

Characteristics format

8. Sponsor

Change

sponsor

from

Pharmaco

Novartis

REFERENCES

Schoene RB

et al

., Am J Ophthal, 97, 86-92, 1984.

Atkins JM

et al

., Am J Ophthal, 99, 173-175, 1985.

® Registered Trademark.

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