Oxymetazoline/ Polyvinyl Alcohol

Registered South African indications:

• Conjunctivitis
• Eye irritation

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Individuals with conditions where pupillary dilation should be avoided (e.g. angle-closure glaucoma or those with critically narrow angles)
• Use of sympathomimetic medicines in patients taking systemic MAO inhibitors due to the risk of increased blood pressure (see Cautions below)
• Use in children, especially infants, as it may result in CNS depression, coma, and marked reduction in body temperature
• Cardiovascular effects following topical application of sympathomimetics to the eye in children and susceptible adults (e.g. peripheral vasoconstriction, decreased heart rate, and increased blood pressure, particularly in those with a predisposition to sympathetic sensitivity)

Cautions

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Elderly

Corneal permeability

• Regular ophthalmological examinations are required due to the possibility of adverse effects on corneal permeability and the risk of disrupting the corneal epithelium with prolonged or repeated use of benzalkonium chloride-preserved ophthalmological preparations

Ocular surface disease

• Caution should be exercised when using benzalkonium chloride-preserved topical medication over an extended period in patients with extensive ocular surface disease

Cardiovascular and metabolic conditions

• Use with caution in patients with cardiovascular diseases, hypertension, hyperglycaemia (diabetes), hyperthyroidism, and individuals on antidepressants

MAO inhibitors

• MAO inhibitor therapy or those who have stopped such treatment within the last 14 days may experience hypertensive crisis if using oxymetazoline/ polyvinyl alcohol

Prostatic enlargement

• Should be given with care to patients with prostatic enlargement as it may increase difficulty in micturition

Inflamed eyes

• Use cautiously on inflamed eyes, as significant hyperaemia increases the rate of systemic absorption through the conjunctiva, potentially leading to systemic effects with prolonged or frequent use

Contact lenses

• Contains benzalkonium chloride, which may discolour soft contact lenses. Patients wearing soft contact lenses should remove them before administration and wait at least 15 minutes before reinserting them

Avoid contamination

• To avoid eye injury or contamination, do not touch the dispensing bottle to the eye or any surface, and ensure the bottle is not shared to prevent infection

Persistent symptoms

• If symptoms persist or worsen after 2-3 days of treatment, consult a doctor

Effects on ability to drive and use machines

• If transient blurred vision occurs after instillation, the patient should wait until their vision clears before driving or operating machinery

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

Conjunctivitis
Eye irritation

Oxymetazoline/ Polyvinyl Alcohol
0.25/14 (mg/ml)

• Ophthalmic (opd): 1-2 drops in affected eye(s), 6-12hrly

Not established for use in children (See contraindications)

 

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

Pregnancy

• Caution

Breastfeeding

• Caution

Renal Impairment

• No dose adjustment recommended (Oxymetazoline,Polyvinyl alcohol)

Hepatic Impairment

• No dose adjustment recommended (Oxymetazoline, Polyvinyl alcohol)

Elderly

• Caution

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

Oxymetazoline
Central Nervous System Disorders

• Headaches
• Dizziness
• Insomnia
• Tremor
• Anxiety

Cardiovascular Disorders

• Palpitations
• Hypertension
• Tachycardia

Gastrointestinal Disorders

• Nausea

Skin and Subcutaneous Tissue Disorders

• Contact dermatitis

Sensory Disorders

• Eye irritation
• Eye discomfort
• Eye redness
• Rebound eye congestion
• Disruption of corneal epithelium

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

• Monoamine oxidase inhibitors
• Methyldopa
• Maprotiline
• Tricyclic antidepressants

None routine. Specific cases may require

• Ophthalmic examination

Oxymetazoline
Oxymetazoline is an alpha-adrenergic agonist that acts on nasal and ophthalmic vasculature to produce vasoconstriction thus relieving symptoms of congestion.

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.

COMBINATION PREPARATIONS

Polyvinyl alcohol/ Oxymetazoline

Eye drops (per ml) 14mg/0.25mg

• Oxylin (Allergan) originator