Consumer medicine information

Minims Cyclopentolate

Cyclopentolate hydrochloride

BRAND INFORMATION

Brand name

Minims Cyclopentolate Eye Drops

Active ingredient

Cyclopentolate hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Cyclopentolate.

SUMMARY CMI

Minims® Cyclopentolate

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Minims Cyclopentolate?

Minims Cyclopentolate contains the active ingredient cyclopentolate hydrochloride. Minims Cyclopentolate is used to temporarily dilate (enlarge) the pupil of the eye and to stop the movement of the muscles that change the shape of the lens. It is usually used at the beginning of an eye examination so that your doctor can examine your eye(s).

For more information, see Section 1. Why am I using Minims Cyclopentolate? in the full CMI.

2. What should I know before I use Minims Cyclopentolate?

Do not use if you have ever had an allergic reaction to cyclopentolate or any of the ingredients listed at the end of the CMI. Do not use if you have narrow angle glaucoma, shallow anterior chamber, Down's syndrome, heart or blood vessel conditions, are aged over 65 years, are at risk of having high pressure in your eye, your child is a premature baby, small infant less than 3 months old, has brain damage or brain syndromes. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Minims Cyclopentolate? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minims Cyclopentolate and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Minims Cyclopentolate?

Your doctor will normally instil the drops into your eyes for you. The usual dose is one or two drops instilled into the eye.

If your doctor instructs you to instil the drops, more instructions can be found in Section 4. How do I use Minims Cyclopentolate? in the full CMI.

5. What should I know while using Minims Cyclopentolate?

Things you should do
  • If you have any irritation, pain, swelling, excessive tear production or light-sensitivity while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes. Stop using the eye drops and contact your doctor.
  • Your eyes may be sensitive to light while using this medicine. It is recommended that you protect your eyes from light e.g. by wearing sunglasses.
Things you should not do
  • Do not use this medicine to treat any other complaints unless your doctor tells you to.
  • Do not give this medicine to anyone else, even if you think they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Minims Cyclopentolate affects you. It may cause blurred vision for a short time when it is instilled into the eye. Allow enough time to regain clear vision before driving or using machines.
Looking after your medicine
  • Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

For more information, see Section 5. What should I know while using Minims Cyclopentolate? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them. Less serious side effects include: blurred vision and/or problems seeing clearly, local irritation, stinging or the feeling of having something in the eye, burning or painful sensation, red, watery and itchy eyes and sensitivity to light. Serious side effects include: allergic reaction, angle closure glaucoma and effects to the body as a whole.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Minims® Cyclopentolate

Active ingredient: Cyclopentolate hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Minims Cyclopentolate. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Minims Cyclopentolate.

Where to find information in this leaflet:

1. Why am I using Minims Cyclopentolate?
2. What should I know before I use Minims Cyclopentolate?
3. What if I am taking other medicines?
4. How do I use Minims Cyclopentolate?
5. What should I know while using Minims Cyclopentolate?
6. Are there any side effects?
7. Product details

1. Why am I using Minims Cyclopentolate?

Minims Cyclopentolate contains the active ingredient cyclopentolate hydrochloride. Minims Cyclopentolate belongs to a class of medicines called antimuscarinic agents.

Minims Cyclopentolate is used to temporarily dilate (enlarge) the pupil of the eye and to stop the movement of the muscles that change the shape of the lens. It is usually used at the beginning of an eye examination so that your doctor can examine your eye(s).

2. What should I know before I use Minims Cyclopentolate?

Warnings

Do not use Minims Cyclopentolate if:

  • You are allergic to cyclopentolate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • You have or suspect you have narrow angle glaucoma (high pressure in the eye). Cyclopentolate can increase the pressure in the eye.
  • You have a shallow anterior chamber (when the part of the eye between the cornea and the iris is narrow)
  • You are aged over 65 years.
  • You are at risk of having high pressure in your eye.
  • Your child is a premature baby, small infant less than 3 months old, has brain damage or brain syndromes.
  • You have Down's syndrome.
  • You have cardiovascular disorders (heart or blood vessel conditions).

Check with your doctor if:

  • You have had an allergy to any other medicines, foods, preservatives or dyes.
  • You have any other medical conditions, especially:
    - glaucoma (high pressure in the eye)
    - epilepsy (condition where you have repeated fits or convulsions)
    - prostate disorders
    - ataxia (poor balance or coordination)
    - dementia (condition where you have memory loss)
    - rhinitis sicca (dry nose)
    - gut disorders where the gut is partly blocked or narrow, or where the large intestine is inflamed
    - myasthenia gravis (a condition in which the muscles become weak and tire easily)
    - obstructive urinary tract disorders
  • You have hyperaemia (high blood flow e.g., red eyes)
  • You are easily affected by belladonna alkaloids (some medicines used to treat lung disease, nausea and vomiting)
  • You take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

This medicine has been developed for use in the eye only. It should not be swallowed or injected.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Use in children

Minims Cyclopentolate should be used with caution in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Cyclopentolate may interfere with each other. These medicines may be affected by Minims Cyclopentolate or may affect how well it works. These include:

  • Medicines to treat glaucoma
  • Antihistamines
  • Some medicines used to treat depression
  • Some medicines used to treat mental illness
  • Some medicines used to treat Parkinson's disease
  • Some medicines used to treat irregular heartbeats
  • Some medicines used to treat nausea and vomiting.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Minims Cyclopentolate.

4. How do I use Minims Cyclopentolate?

Your doctor will normally instil the drops into your eyes for you. If your doctor instructs you to instil the drops, please follow the directions below.

How much to use

  • Use Minims Cyclopentolate only when prescribed by your doctor. Your doctor will tell you how often to use the eye drops and how many drops to use each time.
  • The usual dose is one or two drops instilled into the eye(s).

How to use Minims Cyclopentolate

If you are wearing contact lenses, remove them before putting the drops in your eye.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are instilling your own drops, then follow these steps to use the eye drops:

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release the required number of drops into the pouch or pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.
  11. Repeat steps 4-10 for the other eye if needed.
  12. Throw away any eye drops left in the container.
  13. Wait at least 15 minutes before replacing your contact lenses.

If you use too much Minims Cyclopentolate

Overdose or accidental swallowing of Minims Cyclopentolate may possibly cause side effects due to absorption, particularly in infants or young children.

If you think that you or anyone else may have swallowed Minims Cyclopentolate or used too much Minims Cyclopentolate, you should immediately:

  • phone the Poisons Information Centre
    (in Australia phone 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Minims Cyclopentolate?

Things you should do

  • If you experience any irritation, pain, swelling, excessive tear production or light-sensitivity while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes. Stop using the eye drops and contact your doctor if these symptoms persist.
  • Your eyes may be sensitive to light while using this medicine. It is recommended that you protect your eyes from light e.g. by wearing sunglasses.

Things you should not do

  • Do not use this medicine to treat any other complaints unless your doctor tells you to.
  • Do not give this medicine to anyone else, even if you think they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Minims Cyclopentolate affects you.

Minims Cyclopentolate may cause blurred vision for a short time when it is instilled into the eye. Allow enough time to regain clear vision before driving or using machines.

Looking after your medicine

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

When to discard your medicine

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Getting rid of any unwanted medicine

If your doctor tells you to stop using the eye drops or it is out of date or damaged, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Eyes:
  • blurred vision and/or problems seeing clearly
  • local irritation or stinging or the feeling of having something in the eye
  • burning or painful sensation
  • red, watery and itchy eyes
  • sensitivity to light
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Symptoms of an allergic reaction, such as:
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.
Symptoms of angle closure glaucoma, such as:
  • Severe headache
  • Severe eye pain
  • Nausea or vomiting
  • Blurred vision
  • Halos or coloured rings around lights
  • Eye redness.
Symptoms of toxicity or effects to the body as a whole, such as:
  • mental or behaviour changes, such as restlessness, hallucinations, hyperactivity, confusion or agitation
  • nervous system effects, such as poor balance or muscle control, fits or seizures, drowsiness, speech difficulty, dizziness or involuntary shaking
  • dry mouth
  • skin effects, such as dry skin, skin rash, flushing or skin redness
  • temperature changes or fever
  • effects on the gut, such as swelling, infection, feeding problems in infants, constipation, slow gut movement, nausea or vomiting
  • difficulty in passing urine
  • heart rate changes
  • sudden loss of breathing or heart function
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Some side effects (for example, an increase in the pressure of the eye) can only be found when your doctor or optometrist does tests from time to time.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects online (in Australia, go to www.tga.gov.au/reporting-problems). By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Minims Cyclopentolate contains

Active ingredient
(main ingredient)		cyclopentolate hydrochloride (0.5% w/v or 1% w/v)
Other ingredients
(inactive ingredients)
  • Purified water
  • Hydrochloric acid

Do not take this medicine if you are allergic to any of these ingredients.

The eye drops do not contain any preservatives.

What Minims Cyclopentolate looks like

Minims Cyclopentolate is available in two strengths:

  • Minims Cyclopentolate Hydrochloride 0.5% eye drops (AUST R 32265)
  • Minims Cyclopentolate Hydrochloride 1% eye drops (AUST R 32267).

Minims Cyclopentolate comes in single dose units (tubes) containing 0.5mL of a clear, colourless solution. Each tube is wrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units.

Who distributes Minims Cyclopentolate

In Australia, Minims Cyclopentolate is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150

This leaflet was prepared in April 2025.

Published by MIMS June 2025

BRAND INFORMATION

Brand name

Minims Cyclopentolate Eye Drops

Active ingredient

Cyclopentolate hydrochloride

Schedule

S4

 

1 Name of Medicine

Cyclopentolate hydrochloride.

2 Qualitative and Quantitative Composition

Minims Cyclopentolate Eye Drops are sterile preservative-free solutions containing cyclopentolate hydrochloride 0.5% (5 mg/mL) or 1% w/v (10 mg/mL) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.
Minims Cyclopentolate Eye Drops are clear colourless solutions, reasonably free from visible particulate matter.

4 Clinical Particulars

4.1 Therapeutic Indications

Minims Cyclopentolate Eye Drops are indicated to produce mydriasis and cycloplegia.

4.2 Dose and Method of Administration

Adults (including the elderly).

Minims Cyclopentolate Eye Drops should be instilled drop wise into the eye according to the recommended dosage below.
One drop as required. Maximum effect is induced 30-60 minutes after instillation.
For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 drop is instilled every 6-8 hours.
Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides. Therefore, if the 0.5% solution does not induce cycloplegia, the dosage regimen (children) and/or the strength of cyclopentolate used should be increased accordingly.

Children.

< 3 months.

Not recommended.

3 months-12 years.

1 drop of a 0.5% solution to each eye.

12 years-adult.

1 drop of 0.5% or 1% solution to each eye repeated after 10 minutes if necessary.
Children should be observed for 45 minutes after instillation.
Parents are advised to avoid contact of the solution with the child's mouth and to wash their hands and the child's hands after administering the drops.
Systemic absorption of cyclopentolate may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Each Minims Cyclopentolate Eye Drops unit should be discarded after a single use.

4.3 Contraindications

Minims Cyclopentolate Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation.
Do not use in patients with narrow-angle glaucoma or in those with a shallow anterior chamber (see Section 4.4 Special Warnings and Precautions for Use).
Do not use in elderly (> 65 years) patients and other patients who may be predisposed to an increased intraocular pressure.
Do not use in at risk patients, especially premature babies, small infants, adults over 65 years old and patients with Down's syndrome, as well as in children with brain damage (see Section 4.4 Special Warnings and Precautions for Use).
Do not use in children with organic brain syndromes, including congenital or neurodevelopmental abnormalities, particularly those predisposing to epileptic seizures.
Do not use in patients with cardiovascular disorders.

4.4 Special Warnings and Precautions for Use

Minims Cyclopentolate Eye Drops are for topical ophthalmic use only. The solution should not be injected.
Complete recovery of accommodation usually occurs within 24 hours, however in some individuals complete recovery may require several days.
Eyes may become sensitive to light while using Minims Cyclopentolate Eye Drops. Patients should be advised to protect their eyes, e.g. by wearing sunglasses.
Cyclopentolate may cause CNS disturbances when administered topically to the eye. This is especially true in younger age groups and other patients at special risk, such as debilitated or aged patients, but may occur at any age.
Caution is advised in case of open-angle glaucoma, epilepsy, in patients with prostate disorders, ataxia, and in case of senile dementia.
Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted (see Section 4.3 Contraindications).
Tachycardia and cardiac symptoms are sometimes observed, therefore the product should not be used in patients with cardiovascular disease (see Section 4.3 Contraindications).
Caution is also advised in hyperaemia as increased systemic absorption may occur.
Cyclopentolate should only be used with special care for in patients with rhinitis sicca, mechanical stenosis of the gastrointestinal tract, toxic megacolon, myasthenia gravis, and obstructive urinary tract disorders.
Resistance to cycloplegia can occur in young children, in patients with dark irides, see Section 4.2 Dose and Method of Administration.
Extreme caution is advised for use in individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Atropine-like effects have been reported as side effects.

Use in the elderly.

Minims Cyclopentolate Eye Drops should be used with caution in elderly patients where increased intraocular pressure may be encountered and/or where they may be more susceptible to the CNS effects of cyclopentolate, see Section 4.3 Contraindications.

Paediatric use.

Minims Cyclopentolate Eye Drops should be used with caution in very young children. Increased susceptibility to cyclopentolate has been reported in infants, young children and in children with spastic paralysis or brain damage. Cyclopentolate should not, therefore, be used in premature and small infants (see Section 4.3 Contraindications), and should be used with great caution in young children.
Use of cyclopentolate has been associated with psychotic reactions, and behavioural disturbances in paediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children and in children with brain damage (see Section 4.8 Adverse Effects (Undesirable Effects)).
Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 45 minutes after administration of this medicine.
Cyclopentolate should be used with caution in children as convulsions including grand mal have been reported.

Necrotic colitis in premature children.

Particular caution should be used when used in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies (see Section 4.8 Adverse Effects (Undesirable Effects)). In such a case, immediate medical evaluation is needed.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although negligible cyclopentolate passes into the bloodstream after ocular instillation, drug interactions are nevertheless possible. The anticholinergic effects of other pharmaceuticals (e.g. antihistamines, phenothiazines, tricyclic and tetracyclic antidepressants, amantadine, quinidine, disopyramide, metoclopramide) could be increased.
The interactions observed with cyclopentolate administered by any route should therefore be taken into account.
Cyclopentolate may interfere with the antiglaucoma action of carbachol or pilocarpine; also, concurrent use of this medication may antagonise the antiglaucoma and miotic action of ophthalmic cholinesterase inhibitors.
The mydriatic effect of cyclopentolate hydrochloride is ended by the use of parasympathomimetic drugs such as physostigmine or pilocarpine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been performed to evaluate the potential fertility impairing effects of cyclopentolate.
(Category B2)
Safety for use in pregnancy has not been established, therefore, Minims Cyclopentolate Eye Drops should be used only when considered essential.
 It is not known whether cyclopentolate and/or its metabolites are excreted in milk. Safety for use in lactation has not been established, therefore, Minims Cyclopentolate Eye Drops should be used only when considered essential.

4.7 Effects on Ability to Drive and Use Machines

Cyclopentolate has a marked effect on the ability to drive and use machines.
Minims Cyclopentolate Eye Drops may cause transient blurring of vision on instillation (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients should be advised not to drive or operate hazardous machinery until vision is clear.

4.8 Adverse Effects (Undesirable Effects)

Local effects.

Local irritation may result following the use of this product. The frequency of this effect occurring is dependent on the concentration instilled.
Allergic conjunctivitis or blepharoconjunctivitis may rarely occur, manifesting as diffusely red eyes with lacrimation and itching.
Increased intraocular pressure may occur in predisposed patients.
Other local effects include: burning, photophobia, blurred vision, irritation, hyperaemia and punctate keratitis.

Systemic effects.

Systemic cyclopentolate toxicity may be dose related. Systemic adverse effects from cyclopentolate are not uncommon, especially in children, although this information is based on postmarketing reports for which frequencies are not accurately known.
Toxicity is usually transient and is manifested mainly by CNS disturbances. These reactions may include ataxia, convulsion, somnolence, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation with regard to time and place, and failure to recognise people.
Peripheral effects typical of anticholinergics, such as flushing or dryness of the skin and mucous membranes, as well as temperature changes have been also observed rarely with topical cyclopentolate in children and adults.
Other systemic effects include anaphylactic reaction and anaphylactic shock, gastrointestinal effects such as necrotising colitis, gastroenteritis and feeding intolerance in infants; skin rash; dry mouth; urinary retention; vertigo; incoordination; poor balance and tremor.
Tachycardia has also been observed.

Post marketing experience.

Adverse reactions are listed by system organ class and frequency. The following convention has been used for the classification of frequencies: 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); not known (cannot be estimated from the available data). See Table 1.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Overdose is rare but symptoms can include those mentioned (see Section 4.8 Adverse Effects (Undesirable Effects)).
In isolated cases, ocular topical application of eye drops containing cyclopentolate can lead to central nervous system disorders and general systemic manifestations, especially in children with central nervous system disorders.

a) Central nervous manifestations.

Restlessness, incoherent speech, optical hallucinations, memory loss, disorientation, ataxia, very rarely epileptiform seizures, exhaustion, sleep.

b) General systemic manifestations.

Dry mouth, flushing of the face, tachycardia, increase in temperature, urinary blockage, pupil dilation, loss of accommodation.
Treatment is supportive, and as required to control symptoms of anticholinergic overdose. Physostigmine or pilocarpine can be administered as an antidote. Specific therapies may be required, e.g. benzodiazepines for seizures.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Cyclopentolate hydrochloride is a synthetic tertiary amine, antimuscarinic compound with actions similar to atropine.
It blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilatation (mydriasis) and paralysis of accommodation (cycloplegia). It acts more quickly than atropine and has a shorter duration of action; the maximum effect is produced 30 to 60 minutes after instillation; accommodation recovers within 24 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

As a group, the synthetic tertiary amine antimuscarinic compounds are well absorbed following oral administration. Cyclopentolate may be absorbed systemically either by transcorneal absorption, direct topical absorption through the skin or by absorption from the nasal or nasolacrimal system.

5.3 Preclinical Safety Data

Genotoxicity.

No studies have been performed to evaluate the potential mutagenic and clastogenic effects of cyclopentolate.

Carcinogenicity.

No studies have been performed to evaluate the potential carcinogenic effects of cyclopentolate.

6 Pharmaceutical Particulars

6.1 List of Excipients

Purified water, hydrochloric acid.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze. Protect from light.

6.5 Nature and Contents of Container

Minims Cyclopentolate Eye Drops are available in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. Pack size: cartons of 20 x 0.5 mL units.

6.6 Special Precautions for Disposal

Each Minims Cyclopentolate Eye Drops unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 2-(dimethylamino) ethyl (RS)-2-(1-hydroxycyclopentyl)- 2-phenylacetate hydrochloride.
Molecular formula: C17H25NO3.HCl.
Molecular weight: 327.9.
Cyclopentolate is present as a racemic mixture.

CAS number.

5870-29-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes