Zinc Sulphate/ Naphazoline

Registered South African indications:

• Acute and chronic non-infectious conjunctivitis
• Conjunctival irritations
• Therapy post bacterial and viral infections
• Irrigation of the tear duct

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
• Dry eye
• Keratoconjunctivitis sicca
• Not to be used in infants
• Not to be administered during monoamine oxidase inhibitors or within 14 days of termination of such treatment

Cautions

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Rebound effect

• Uncontrolled use of zinc sulphate/ naphazoline over extended periods of time should be avoided, due to the rebound effect

Use in specific conditions

• Use with caution in patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes mellitus or hyperglycaemia and eye disease, infection or injury

Contact lenses

• Contact lenses should be removed before instillation and are not to be worn for at least 15 minutes after application of zinc sulphate/ naphazoline

Ocular tonometry

• Results of ocular tonometry may be affected by previous application of zinc sulphate/ naphazoline

Rebound redness

• Long term use may result in reactive redness of the eye (rebound effect)

Eye pain or vision change

• If eye pain or change in vision occurs or if redness or irritation of the eye continues, worsens or lasts for more than 72 hours, discontinue treatment and the patient should consult with the physician

Corneal permeability

• 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

Benzalkonium chloride

• Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease

Storage

• Do not use more than 30 days after opening

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

Acute and chronic non-infectious conjunctivitis
Unspecific conjunctival irritations, including allergies
Therapy post successful treatment of bacterial and viral infections
Irrigation of the tear duct

Zinc sulphate/ Naphazoline
0.2/0.05 (mg/ml)

• Ophthalmic (opd): Apply 1 drop into the lower eyelid(s), 6hrly

Not established for use in infants (See contraindications)

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

Pregnancy

• Caution
• Safety and/or efficacy has not been established

Breastfeeding

• Caution
• Safety and/or efficacy has not been established

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended
  Systemic absorption, especially in the elderly has been reported following ocular application of naphazoline containing solutions

Porphyria Information

• Not yet classified (NC) (Zinc sulphate)

Drugs in Sport

• Permitted - No warnings

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

Zinc sulphate
Gastrointestinal Disorders

• Dry mouth
• Dry throat 

Sensory Disorders

• Local irritant effect

Naphazoline
Sensory Disorders

• Mydriasis (mild)
• Blurred vision
• Eye discomfort
• Eye irritation
• Eye redness
• Increased intraocular pressure
• Increased lacrimation
• Punctate keratitis

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

Zinc sulphate

• No information available 

Naphazoline

• Other ocular agents
• Halothane

None routine. Specific cases may require

• Ophthalmic examination

Zinc sulphate
Zinc sulphate displays marked astringent properties. Astringents produce a very fine scurf on the surface of the conjunctiva. Secretion is reduced, slight contraction of the tissue occurs and the capillaries are sealed off, with the result that growth of any bacteria that may be present, is inhibited.

Naphazoline
Naphazoline is an alpha-adrenoreceptor agonist which causes vasoconstriction in the arterioles of the conjunctiva.

COMBINATION PREPARATIONS

Zinc Sulphate/ Naphazoline

Eye drops (per ml) 0.2mg/0.05mg

• Oculosan (Adcock)