Phenylephrine/ Polyvinyl Alcohol

Registered South African indications:

• Minor eye irritation

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Narrow angle glaucoma
• Not intended for use with soft contact lenses

Cautions

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Patients with arteriosclerosis, hypertension, hyperthyroidism, prostatic enlargement or diabetes
• Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 14 days of stopping such treatment as patients may experience hypertensive crisis

Potential systemic effects

• To minimise risk of potential systemic effects, the puncta should be depressed after instillation of drops to reduce drainage through the nasolacrimal duct to the oral and nasal mucosa

Eye inflammation

• Use phenylephrine/polyvinyl alcohol with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva

Use with contact lenses

• Phenylephrine/polyvinyl alcohol contains the preservative benzalkonium chloride, which may be absorbed by and cause discolouration of soft contact lenses
• Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of phenylephrine/polyvinyl alcohol and wait at least 15 minutes following administration before reinserting soft contact lenses

Potential for eye injury or contamination

• To prevent eye injury or contamination, care should be taken to avoid touching the dispensing container to the eye or to any other surface

Examination of patient

• If patient experiences eye pain, changes in vision, ocular irritation or if eye irritation and redness persist over 72 hours, discontinue use and consult a doctor

Preservative

• As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required
• Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease

Paediatric use

• Safety and effectiveness have not been demonstrated with phenylephrine/polyvinyl alcohol in paediatric patients
• Phenylephrine/polyvinyl alcohol is not recommended to be used in paediatric patients

Effects on the ability to drive and use machines

• Phenylephrine/polyvinyl alcohol may cause pupillary dilation and transient blurring of vision, which may impair the ability to drive or operate machines
• The patient should wait until their vision has cleared before driving or using machinery

Forms avail. in SA and covered in this monograph: opd

Relief of minor eye irritation

Phenylephrine/ Polyvinyl alcohol
1.2/14 (mg/ml)

• Ophthalmic (opd): 1-2 drops into affected eye(s), 3-4hrly

Not established for use in children

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution
• Safety and efficacy in pregnancy have not been established

Breastfeeding

• Caution
• Safety and efficacy in lactation have not been established

Renal Impairment

• No dose adjustment recommended (Phenylephrine, Polyvinyl alcohol)

Hepatic Impairment

• No dose adjustment recommended (Phenylephrine, Polyvinyl alcohol)

Elderly

• No dose adjustment recommended (Phenylephrine, Polyvinyl alcohol)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Phenylephrine
Cardiovascular Disorders

• Tachycardia
• Palpitations
• Extrasystoles
• Arrhythmias
• Myocardial infarction
• Hypertension

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Eye pain
• Eye irritation
• Blurred vision
• Photophobia
• Allergic conjunctivitis

Polyvinyl alcohol
Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

Sensory Disorders

• Eye irritation
• Eye pain
• Ocular hyperaemia
• Increased lacrimation
• Foreign body sensation
• Eye pruritus

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Phenylephrine

• Antihypertensives
• Tricyclic antidepressants
• Monoamine oxidase inhibitors
• Reversible inhibitors of monoamine oxidase
• Inhalational anaesthetics
• Cardiac glycosides
• Quinidine

Polyvinyl alcohol

• No information available

None routine

Phenylephrine
Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha receptors. There is almost no cycloplegic effect.

Polyvinyl alcohol
Polyvinyl alcohol is a water-soluble polymer, applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation.

Phenylephrine/ Polyvinyl alcohol is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

COMBINATION PREPARATIONS

Phenylephrine/ Polyvinyl alcohol

Eye drops (per ml) 1.2mg/14mg

• Prefrin (Allergan)