Antazoline/ Tetryzoline

Registered South African indications: 

• Hay-fever
• Conjunctivitis
• Allergic conjunctivitis
• Sore, red or itching eyes

Registered South African contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Patients with dry eyes, especially keratoconjunctivitis sicca
• Patients at risk of narrow angle glaucoma
• Not recommended for children under two years of age, due to the greater incidence of systemic absorption and effects
• Patients receiving monoamine oxidase inhibitors or within 14 days of its treatment

South African recommendations

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

Benzalkonium chloride

• May be absorbed by soft contact lenses and change their colour
• Can cause eye irritation, especially in patients with dry eyes or corneal disorders
• If abnormal eye sensations, stinging, or pain is experienced, consult a doctor

Specific health conditions

• Use with caution in patients with
  • Increased intra-ocular pressure
  • Hypertension
  • Cardiac irregularities, including heart failure
  • Poorly controlled hypertension and diabetes mellitus
  • Hyperthyroidism
  • Pheochromocytoma
  • Eye infections

Chronic recurring allergies

• Consider alternative medications

Effects on ability to drive and use machines

• This medicine may cause drowsiness, impaired concentration or blurred vision
• Patients should be advised, especially at the start of therapy, to avoid operating vehicles or machinery or engaging in potentially hazardous tasks where loss of concentration could lead to accidents

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

South African registered indications and dosages

Hay-fever
Conjunctivitis
Allergic conjunctivitis
Sore, red or itching eyes

Antazoline/ Tetryzoline
0.5/0.4 (mg/ml)

• Ophthalmic (opd): Instil 1 drop, 3 or 4 times daily, into the lower eyelid

If redness or irritation continues, worsens, or lasts for more than 3 days, advise patients to consult a doctor

When using another ophthalmic treatment, maintain a 5-minute interval between each administration to avoid washing away the active ingredient

Contact lenses should be removed before using this medicine. The contact lenses can be placed back 15 minutes afterwards

Paed. forms avail. in SA and covered in this monograph: opd

South African registered indications and dosages

Hay-fever
Conjunctivitis
Allergic conjunctivitis
Sore, red or itching eyes

Antazoline/ Tetryzoline
0.5/0.4 (mg/ml)

Ophthalmic (opd)

• Younger than 2 years: Contraindicated
• Between 2-12 years: Instil 1 drop 1-2 times daily, into the lower eyelid
• Older than 12 years: See adult dosage

Not recommended for children under the age of 2 years

If redness or irritation continues, worsens, or lasts for more than 3 days, advise patients to consult a doctor

When using another ophthalmic treatment, maintain a 5-minute interval between each administration to avoid washing away the active ingredient

Contact lenses should be removed before using this medicine. The contact lenses can be placed back 15 minutes afterwards

Pregnancy

South African recommendations

• Caution
• Safety and/or efficacy in pregnancy has not been established. No controlled studies are available either in animals, or pregnant women

Breastfeeding

South African recommendations

• Caution
• No controlled studies are available either in animals, or nursing women. It is not known whether either active substance passes into breast milk

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

Immune System Disorders

• Hypersensitivity reactions (Unknown)

Nervous System Disorders

• Headache (Less Frequent)
• Drowsiness (Less Frequent)
• Tremor (Less Frequent)
• Agitation (Less Frequent)

Eye Disorders

• Transient irritation immediately after instillation (Less Frequent)
• Blurred vision after systemic absorption (Less Frequent)
• Mydriasis (Less Frequent)
• Elevation of intraocular pressure (Less Frequent)
• Systemic undesirable effects due to absorption (Less Frequent)
• Reactive hyperaemia after discontinuation of treatment (Less Frequent)

Cardiac Disorders

• Tachycardia particularly in small children (Less Frequent)
• Pectanginous symptoms (Less Frequent)

Vascular Disorders

• Hypertension (Less Frequent)

Skin and Subcutaneous Tissue Disorders

• Sweating (Less Frequent)

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

Tetryzoline

• Monoamine oxidase inhibitors
• Tricyclic antidepressants

None routine

Antazoline
Antazoline, an antihistamine acts by blocking the action of histamine through competitive inhibition of H1 receptors.

Tetryzoline
Tetryzoline a sympathomimetic agent with alpha-adrenergic activity, acts as a local vasoconstrictor.

COMBINATION PREPARATIONS

Antazoline/ Tetryzoline

Eye drops (per ml) 0.5mg/0.4mg

• Gemini (Adcock Ingram) originator
• Oculerge (Pharmacare)
• Spersallerg (Adcock Ingram) originator
• Spersallerg single dose unit (Adcock Ingram) originator