Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as
a mydriatic. It may be indicated to dilate the pupil in diagnostic or therapeutic
procedures.

Posology
Adults
Apply one drop to each eye. If necessary, this dose may be repeated once only, at
least one hour after the first drop.
Paediatric population
Phenylephrine 10% is contraindicated in children aged below 12 years (see section
4.3).
There is no data in children aged 12 to 18 years. Phenylephrine is not recommended in
these patients.

Elderly population
The use of phenylephrine 10% solution is contraindicated in this group because of the
increased risks of systemic toxicity(see section 4.3).
Method of administration
The use of a drop of topical anaesthetic a few minutes before instillation of
phenylephrine is recommended to prevent stinging.

Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long-standing insulin dependent diabetes mellitus and tachycardia. Children aged below 12 years (see section 4.4). The elderly, because of the increased risk of systemic toxicity. Patients on monoamine oxidase inhibitors, tricyclic anti-depressants and antihypertensive agents (including beta-blockers). Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucoma precipitated by mydriatics. Hypersensitivity to phenylephrine or to any of the excipients listed in section 6.1.

Use with caution in the presence of diabetes, cerebral arteriosclerosis or long standing
bronchial asthma.
To reduce the risk of precipitating an attack of narrow angle glaucoma evaluate the
anterior chamber angle before use.
Ocular hyperaemia can increase the absorption of phenylephrine given topically.
Corneal clouding may occur if phenylephrine 10% is instilled when the corneal
epithelium has been denuded or damaged.
Systemic absorption may be minimised by compressing the lacrimal sac at the medial
canthus for one minute during and after 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.

Paediatric population
Use in children aged below 12 years is contraindicated, since serious systemic
adverse reactions have been reported with ophthalmic products containing
phenylephrine.
Use in children aged 12 to 18 years is not recommended as adequate clinical
experience is missing.

Anti-hypertensive Agents
Topical phenylephrine should not be used as it may reverse the action of many antihypertensive
agents with possibly fatal consequences.
Monoamine Oxidase Inhibitors
There is an increased risk of adrenergic reactions when used simultaneously
with, or up to three weeks after, the administration of MAOIs.

Tricyclic Anti-depressants
The pressor response to adrenergic agents and the risk of cardiac arrhythmia may be
potentiated in patients receiving tricyclic anti-depressants (or within several days of
their discontinuation).
Halothane
Because of the increased risk of ventricular fibrillation, phenylephrine should be used
with caution during general anaesthesia with anaesthetic agents which sensitise the
myocardium to sympathomimetics.
Cardiac Glycosides or Quinidine
There is an increased risk of arrhythmias.

Safety for use in pregnancy and lactation has not been established. This product
should only be used during pregnancy if it is considered by the physician to be
essential.

May cause stinging and temporarily blurred vision. Warn patients not to drive or
operate hazardous machinery until vision is clear.

The frequency of the undesirable effects are not known (cannot be estimated from the
available data).
Immune System Disorders
Hypersensitivity
Eye Disorders
Eye pain, eye irritation, vision blurred, photophobia, allergic conjunctivitis.
Cardiac disorders
Palpitations, tachycardia, extrasystoles, arrhythmias.
Arteriospasm coronary, ventricular arrhythmia and myocardial infarction. These
sometimes fatal reactions have usually occurred in patients with pre-existing
cardiovascular disease.

Vascular disorders
Hypertension
Paediatric population
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema

To report any side effect(s)
Saudi Arabia
National Pharmacovigilance center
SFDA Call Center: 19999
E-mail : npc.drug@sfda.gov.sa
Website : https://ade.sfda.gov.sa/

Other GCC states :
Please contact the relevant competent authority.

Because a severe toxic reaction to phenylephrine is of rapid onset and short duration,
treatment is primarily supportive. Prompt injection of a rapidly acting alphaadrenergic
blocking agent such as phentolamine (dose 2 to 5mg iv) has been
recommended.

Pharmacotherapeutic group: Sympathomimetics excl. antiglaucoma preparations,
ATC code: S01FB01
Mechanism of action
Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the
stimulation of alpha receptors. There is almost no cycloplegic effect.
Pharmacodynamic effects
Maximal mydriasis occurs in 60- 90 minutes with recovery after 5 - 7 hours.
The mydriatic effects of phenylephrine can be reversed with thymoxamine.

Absorption
Phenylephrine is a weak base at physiological pH. The extent of ocular penetration is
determined by the condition of the cornea. A healthy cornea presents a physical
barrier, in addition to which, some metabolic activity may occur. Where the corneal
epithelium is damaged, the effect of the barrier and the extent of metabolism are
reduced, leading to greater absorption

The use of phenylephrine in ophthalmology has been well-established for many years.
No unexpected adverse safety issues were identified during the development of the
Minims format.

Purified water
Sodium metabisulphite
Disodium edetate

Not applicable

15 months

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

A sealed conical shaped polypropylene container fitted with a twist and pull off cap.
Each Minims unit is overwrapped in an individual polypropylene/paper pouch.

Each Minims unit should be discarded after a single use.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.