Minims Cyclopentolate Hydrochloride 0.5%, Eye drops solution

1. Name of the medicinal product

Minims Cyclopentolate Hydrochloride 0.5%.

 

2. Qualitative and quantitative composition

Clear, colourless, sterile eye drops containing cyclopentolate hydrochloride BP 0.5% w/v.

 

3. Pharmaceutical form

Single-use, sterile eye drops.

 

4. Clinical particulars

4.1 Therapeutic indications

As a topical mydriatic and cycloplegic.

 

4.2 Posology and method of administration

Adults (including the elderly):

Instil dropwise into eye according to the recommended dosage.

One or two drops as required. Maximum effect is induced in 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 - 2 drops are 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, the strength of cyclopentolate used should be adjusted accordingly.

Children

< 3 months: Not recommended

3 months - 12 years: 1 drop of a 1% solution to each eye.

12 years - adult: 1 drop of 0.5% solution to each eye repeated after 10 minutes if necessary.

Children should be observed for 45 minutes after instillation.

 

4.3 Contraindications

Do not use in patients with a known hypersensitivity to any component of the preparation.

Should not be used in neonates except where, on expert evaluation, the need is considered to be compelling.

Do not use in patients with confirmed or suspected narrow-angle glaucoma as an acute attack may be precipitated.

 

4.4 Special warnings and precautions for use

Recovery of accommodation occurs within 24 hours.

Use with caution in very young children and other patients at special risk, such as debilitated or aged patients.

Caution is also advised in hyperaemia as increased systemic absorption may occur.

Systemic absorption 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 naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

 

4.5 Interaction with other medicinal products and other forms of interaction

None known.

 

4.6 Pregnancy and lactation

The safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.

 

4.7 Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery until vision is clear.

 

4.8 Undesirable effects

Local Effects

Local irritation may result following the use of this product. The frequency of this effect occurring is dependant on the concentration instilled.

Increased intraocular pressure may occur in predisposed patients.

Allergic reactions may rarely occur, manifesting as diffusely red eyes with lacrimation and stringy white mucus discharge.

Systemic Effects

Systemic cyclopentolate toxicity is dose-related and is uncommon following administration of 1% solution and would not be expected to occur following instillation of 0.5% solution. Children are, however, more susceptible to such reactions than adults. Toxicity is usually transient and is manifest mainly by CNS disturbances. Any CNS disturbances are characterised by signs and symptoms of cerebellar dysfunction and visual and tactile hallucinations.

Peripheral effects typical of anti-cholinergics, such as flushing or dryness of the skin and mucous membranes, have not been observed with topical cyclopentolate in children or adults. Temperature, pulse and blood pressure are not normally affected.

 

4.9 Overdose

Overdose is rare but symptoms can include those mentioned in Section 4.8 above. Treatment is supportive.

 

5. Pharmacological properties

5.1 Pharmacodynamic properties

Cyclopentolate hydrochloride is a synthetic tertiary amine, antimuscarinic compound with actions similar to atropine.

 

5.2 Pharmacokinetic properties

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 naso lacrimal system.

 

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

 

6. Pharmaceutical particulars

6.1 List of excipients

Hydrochloric acid

Purified water

 

6.2 Incompatibilities

None known.

 

6.3 Shelf life

15 months.

 

6.4 Special precautions for storage

Store below 25°C. Do not freeze. Protect from light.

 

6.5 Nature and contents of container

A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.

 

6.6 Special precautions for disposal and other handling

Each Minims unit should be discarded after a single use.

 

Administrative data

7. Marketing authorisation holder

Bausch & Lomb UK Limited

Bausch & Lomb House

106 London Road

Kingston-Upon-Thames

Surrey, UK

KT2 6TN

 

8. Marketing authorisation number

PL 03468/0070

 

9. Date of first authorisation/renewal of the authorisation

Date of first Authorisation: 17 June 1987

Renewal of Authorisation: 17 June 1992

 

10. Date of revision of the text

January 2015