Bimatoprost

Registered South African indications: 

• Reduction of elevated intraocular pressure
  - In chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers)

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Previous adverse reaction to benzalkonium chloride (0.01%)

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Risk factors for macular oedema 
• History of significant ocular viral infections or uveitis/iritis
• Compromised respiratory function
• Inflammatory ocular conditions
• Closed angle glaucoma
• Risk factors for bradycardia
• Risk factors for hypotension
• Dry eyes 
• Compromised cornea
• Concomitant use of soft contact lenses

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

South African registered indications and dosages

Reduction of elevated intraocular pressure
- In chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers)

• Ophthalmic (opd): 0.01% sol. or 0.03% sol: 1 drop into affected eye(s), once daily in the evening; Max: 1 drop/eye/24hrs

The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect

If other ophthalmic medications are being used, administer at least 5 minutes apart

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

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses
• Bimatoprost should not be used during pregnancy unless clearly necessary

Breastfeeding

• Caution; not recommended
• It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue from bimatoprost therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

• Caution; no dose adjustment recommended

• Caution; no dose adjustment recommended

• No dose adjustment recommended

Central Nervous System Disorders

• Headache
• Dizziness
• Asthenia

Cardiovascular Disorders

• Hypertension

Respiratory Disorders

• Asthma
• Asthma exacerbation
• Chronic obstructive pulmonary disease exacerbation 
• Dyspnoea

Gastrointestinal Disorders

• Nausea

Skin and Subcutaneous Tissue Disorders

• Skin hyperpigmentation
• Hypertrichosis
• Dry skin
• Eyelid margin crusting
• Pruritus
• Hirsutism
• Erythema of eyelid
• Growth of eyelashes
• Periorbital and lid changes including deepening of the eyelid sulcus
• Eyelash darkening

Immune, Blood and Lymphatic System Disorder

• Hypersensitivity reaction

Sensory Disorders

• Punctate keratitis
• Eye irritation
• Eye pruritus
• Eyelid pruritus
• Asthenopia
• Blurred vision
• Conjunctival disorder
• Conjunctival oedema
• Iris hyperpigmentation
• Madarosis
• Eyelid oedema
• Blepharal pigmentation
• Macular oedema
• Dry eye
• Corneal erosion
• Ocular burning
• Allergic conjunctivitis
• Blepharitis
• Worsening of visual acuity
• Foreign body sensation
• Eye pain
• Photophobia
• Tearing 
• Eye discharge
• Visual disturbance
• Blurred vision
• Retinal haemorrhage
• Uveitis
• Iritis
• Blepharospasm
• Eyelid retraction

Others

• Instillation site irritation

• Prostaglandin analogues 

• Intraocular pressure

Bimatoprost is a synthetic prostamide, structurally related to prostaglandin F2 alpha. It reduces intraocular pressure by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.

Eye drops (per ml) 0.1mg

• Lumigan 0.01% (Allergan) originator

Eye drops (per ml) 0.3mg

• Lumigan 0.03% (Allergan) originator

COMBINATION PREPARATIONS

Bimatoprost/ Timolol

Eye drop (per ml) 3mg/5mg

• Ganfort (Allergan) originator