Travoprost

Registered South African indications: 

• Reduction of elevated intraocular pressure in patients with open-angle glaucoma or other ocular hypertension
  - As monotherapy or as adjunctive therapy

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnant women or women attempting to become pregnant
• Breastfeeding 
• Children below 18 years

South African recommendations

Women of childbearing potential

• Travoprost must not be used in women who may become pregnant unless adequate contraceptive measures are in place

Contamination and inflammation

• To avoid bacterial keratitis, patients must not touch the dropper tip to the eye, surrounding structures, or any surfaces to prevent contamination of the solution

Dosing frequency

• The recommended dose of one drop daily must not be exceeded

Pigmentation changes

• Travoprost may cause permanent, gradual increases in brown iris pigmentation, particularly in mixed-colored eyes, as well as darkening of the eyelid (periorbital tissue) and eyelashes

Eyelash changes

• Treatment may gradually change eyelashes in the treated eye, including increased length, thickness, number, and pigmentation, which may result in a disparity between eyes if only one eye is treated

Intraocular inflammation

• Caution is advised in patients with active intraocular inflammation or known predisposing risk factors for iritis or uveitis

Macular oedema

• Travoprost should be used with caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or those with known risk factors for macular oedema

Eye condition precautions

• Travoprost has not been evaluated for the treatment of angle closure, inflammatory or neovascular glaucoma

Respiratory conditions

• Treatment with travoprost may lead to the exacerbation of asthma

Contact lense use

• Travoprost should not be administered while wearing contact lenses; lenses should be removed prior to application and may be reinserted 15 minutes later

Excipient cautions

• Contains hydrogenated castor oil and propylene glycol which may cause skin reactions and irritation

Effects on the ability to drive or operate machinery

• Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery

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

South African registered indications and dosages

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or other ocular hypertension
- As monotherapy or as adjunctive therapy

• Topical (opd): 1 drop in the conjunctival sac of the affected eye(s), once dly in the evening; Treatment duration: Safety and efficacy beyond 3 months has not been established; Max: 1 drop/24hrs

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Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions

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If a dose is missed, treatment should be continued with the next dose as planned

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When substituting another ophthalmic antiglaucoma medicinal product with this one, the other medicinal product should be discontinued and travoprost should be started the following day

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If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart

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For method of instructions and instructions for use and handling, see Additional Prescribing Points

Not established for use in children below 18 years

Pregnancy

South African recommendations

• Contraindicated
• Travoprost is contraindicated in pregnant women or women attempting to become pregnant, as teratogenicity has been demonstrated in experimental animals
• Since travoprost is a biologically active material and since it may be absorbed through the skin, women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle
• Women of childbearing potential: Travoprost must not be used in women who may become pregnant unless adequate contraceptive measures are in place

Breastfeeding

South African recommendations

• Contraindicated
• Animal studies indicate that travoprost and its metabolites may pass into breast milk and travoprost must therefore not be used in breastfeeding women

Fertility

South African recommendations

• No information available

South African recommendations

• No dose adjustment recommended
  Travoprost has been studied in patients with mild to severe renal impairment (creatinine clearance as low as 14ml/min). No dosage adjustment is necessary in these patients

South African recommendations

• No dose adjustment recommended
  Travoprost has been studied in patients with mild to severe hepatic impairment. No dosage adjustment is necessary in these patients

South African recommendations

• No dose adjustment recommended

Central Nervous System Disorders

• Depression
• Anxiety
• Headache
• Dizziness
• Visual field defect
• Dysgeusia
• Asthenia

Cardiovascular Disorders

• Palpitations
• Irregular heart rate 
• Decreased heart rate 
• Chest pain
• Bradycardia
• Tachycardia
• Decreased diastolic blood pressure
• Increased systolic blood pressure
• Hypotension
• Hypertension

Respiratory Disorders

• Dyspnoea
• Asthma
• Nasal congestion
• Throat irritation
• Respiratory disorder
• Oropharyngeal pain
• Cough
• Dysphonia
• Aggravated asthma 

Gastrointestinal Disorders

• Reactivated peptic ulcer 
• Constipation
• Dry mouth
• Diarrhoea
• Abdominal pain
• Nausea

Genitourinary Disorders

• Dysuria
• Urinary incontinence

Musculoskeletal Disorders

• Musculoskeletal pain
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Skin hyperpigmentation 
• Skin discolouration
• Abnormal hair texture 
• Hypertrichosis
• Allergic dermatitis 
• Contact dermatitis 
• Erythema
• Rash
• Hair colour changes
• Madarosis
• Pruritus
• Abnormal hair growth 

Immune, Blood and Lymphatic System Disorders

• Herpes simplex
• Herpetic keratitis 
• Seasonal allergy

Sensory Disorders

• Ocular hyperaemia
• Iris hyperpigmentation
• Ocular discomfort
• Dry eye
• Eye pruritus
• Eye irritation
• Corneal erosion
• Uveitis
• Iritis
• Anterior chamber inflammation
• Keratitis
• Punctate keratitis
• Photophobia
• Eye discharge 
• Blepharitis
• Erythema of eyelid
• Periorbital oedema
• Eyelid pruritus
• Reduced visual acuity 
• Blurred vision 
• Increased lacrimation 
• Conjunctivitis
• Ectropion
• Cataract
• Eyelid margin crusting
• Growth of eyelashes
• Eyelash discolouration
• Asthenopia
• Iridocyclitis
• Eye inflammation
• Photopsia
• Eyelid eczema
• Conjunctival oedema
• Halo vision
• Conjunctival follicles
• Hypoaesthesia eye
• Meibomianitis
• Anterior chamber pigmentation
• Mydriasis
• Eyelash thickening
• Macular oedema
• Sunken eyes
• Vertigo
• Tinnitus

No information available

None routine

Method of administration

• To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle

Instructions for use and handling

• The patient should remove the protective over-wrap immediately prior to initial use
• Since travoprost is a biologically active material and since it may be absorbed through the skin, women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle
• In case of accidental contact with the contents of the bottle, thoroughly cleanse the exposed area immediately

Travoprost is a prostaglandin F2-alpha analogue. It reduces intraocular pressure by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.

Eye drops (per ml) 40μg

• Travatan (Novartis South Africa) originator

COMBINATION PREPARATIONS

Travoprost/ Timolol

Eye drops (per ml) 40mg/5mg

• DuoTrav (Alcon)