Levocabastine

Registered South African indications:

• Symptoms of seasonal allergic conjunctivitis

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Concomitant use of soft contact lenses
• May impair ability to drive and operate machinery

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

South African registered indications and dosages

Seasonal allergic conjunctivitis

• Ophthalmic (opd): Instil 1 drop into affected eye(s), twice daily; May be increased to 1 drop per eye 3-4 times daily; Max. treatment duration: 8 weeks

Levocabastine eye drops are available as a micro suspension and the bottle should be shaken before each application

Levocabastine eye drops should be used within one month of the first opening of the bottle. Patients should be instructed to take appropriate measures to avoid contamination

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

South African registered indications and dosages

Seasonal allergic conjunctivitis

Younger than 5 years

• Not established for use 

Older than 5 years

• See adult dosage

Pregnancy

South African recommendations

• Caution
• The safety in pregnancy has not been established. In mice and rats, levocabastine at high systemic doses did reveal embryotoxic and teratogenic effects

Breastfeeding

South African recommendations

• Caution
• The safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended
  After a single oral dose of 0.5mg levocabastine in solution, the terminal half-life of levocabastine in moderate to severe renal impairment (Creatinine Clearance 10-50ml/min) increased from 36 hours to 95 hours. Overall exposure to levocabastine based on AUC was increased by 56%

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
• In the elderly, after multiple nasal administrations of 0.4mg levocabastine, the terminal half-life of levocabastine was increased by 15%, and the peak plasma level was increased by 26%

Central Nervous System Disorders 

• Headache
• Somnolence
• Dizziness
• Fatigue

Cardiovascular Disorders

• Tachycardia

Respiratory Disorders

• Pharyngolaryngeal pain
• Epistaxis  
• Cough
• Nasal discomfort
• Nasal congestion
• Bronchospasm
• Dyspnoea
• Nasal oedema
• Sinusitis

Gastrointestinal Disorders

• Nausea

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Eyelid oedema

Others

• Pain
• Application site reactions

No information available

None routine

Levocabastine is a potent, selective histamine H1-receptor antagonist. Binding to the receptor prevents responses mediated by histamine. Levocabastine also serves as a neurotensin agonist, thereby inducing some degree of analgesia. 

Eye drops (per ml) 0.5mg

• Livostin ED (Janssen) originator

Also available in the following form: Nasal spray.