Loteprednol Etabonate

Registered South African indications:

• Allergic conjunctivitis
• Acute anterior chamber uveitis

Contraindications

2mg/ml (opd)

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to  other corticosteroids
• Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella
• Untreated purulent ocular infections
• Eyes with suspected or confirmed infections
• Amoebic infections
• Mycobacterial infections
• Fungal diseases of ocular structures
• Glaucoma
• Children under the age of 18 years
• Pregnancy
• Lactation

5mg/ml (opd, opg)

• Known or suspected hypersensitivity to the active ingredient or any of its excipients
• Known or suspected hypersensitivity to other corticosteroids
• Viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella
• Fungal diseases of ocular structures
• Mycobacterial infection of the eye

Cautions

• Pregnancy (5mg/ml opd, opg)
• Breastfeeding  (5mg/ml opd, opg)
• Prolonged use 
• Glaucoma 
• Concomitant use of contact lens 

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

Seasonal allergic conjunctivitis
Acute anterior chamber uveitis

• Ophthalmic (opd): 1-2 drops into affected eye(s), 6hrly; Max treatment duration: 6 weeks

During the initial treatment within the first week, the dosing may be increased up to one drop every hour, if necessary

Other topical ophthalmic preparations should be administered at least 10min apart

Post-operative inflammation following ocular surgery

• Ophthalmic (opd): 1-2 drops into affected eye(s), 6hrly; Treatment duration: 2 weeks

Treatment should begin 24hrs following the surgical procedure

Not established for use in children below 18 years

Pregnancy

2mg/ml (opd)

• Contraindicated

5mg/ml (opd, opg)

• Caution; positive evidence of risk in animal studies

Breastfeeding

• Caution 

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Nervousness
• Headache
• Migraine
• Dizziness
• Paresthesia
• Twitching
• Asthenia

Cardiovascular Disorders

• Chest pain

Respiratory Disorders

• Pharyngitis
• Rhinitis
• Cough

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Genitourinary Disorders

• Urinary tract infection
• Urethritis

Endocrine and Metabolic Disorders

• Breast neoplasm
• Weight gain

Skin and Subcutaneous Tissue Disorders

• Facial oedema
• Urticaria
• Rash
• Dry skin
• Eczema

Immune, Blood and Lymphatic System Disorders

• Neoplasms
• Fever

Sensory Disorders

• Increased intraocular pressure
• Optic nerve damage
• Visual acuity defects
• Visual field defects
• Posterior subcapsular cataract formation
• Secondary ocular infection
• Perforation of the globe
• Corneal defect
• Eye discharge
• Ocular discomfort
• Dry eye
• Epiphora
• Foreign body sensation
• Conjunctival hyperaemia
• Ocular itching
• Abnormal vision
• Chemosis
• Keratoconjunctivitis
• Conjunctivitis
• Iritis 
• Eye pain
• Conjunctival papillae
• Photophobia
• Uveitis
• Blurred vision
• Taste perversion
• Tinnitus
• Instillation site burning

• Anticholinergics
• Ocular hypotensives
• Cycloplegic agents 
• CYP3A inhibitors

None routine. Specific cases may require 

• Intraocular pressure 

Loteprednol etabonate suppresses the inflammatory response to inciting agents of mechanical, chemical or immunological nature. It is highly lipid soluble and penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes.

Eye drops (per ml) 2mg

• Alrex (Soflens) originator

Eye drops (per ml) 5mg

• Lotemax (Soflens) originator