Chemical formula: C₂₁H₂₃NO₃ Molecular mass: 337.412 g/mol PubChem compound: 5281071
There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration.
Olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Available data in animals have shown excretion of olopatadine in milk following oral administration.
A risk to the newborn/infants cannot be excluded.
Olopatadine should not be used during breast-feeding.
Studies have not been performed to evaluate the effect of topical ocular administration of olopatadine on human fertility.
Olopatadine has no or negligible influence on the ability to drive and use machines.
As with any eye drop, 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.
In clinical studies involving 1680 patients, olopatadine was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of olopatadine; however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions. No serious ophthalmic or systemic adverse reactions related to olopatadine were reported in clinical studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000)very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Classification | Frequency | Adverse Reactions |
|---|---|---|
| Infections and infestations | Uncommon | rhinitis |
| Immune system disorders | Not known | hypersensitivity, swelling face |
| Nervous system disorders | Common | headache, dysgeusia |
| Uncommon | dizziness, hypoaesthesia | |
| Not known | somnolence | |
| Eye disorders | Common | eye pain, eye irritation, dry eye, abnormal sensation in eyes |
| Uncommon | corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia | |
| Not known | corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting | |
| Respiratory, thoracic, and mediastinal disorders | Common | nasal dryness |
| Not known | dyspnoea, sinusitis | |
| Gastrointestinal disorders | Not known | nausea, vomiting |
| Skin and subcutaneous tissue disorders | Uncommon | dermatitis contact, skin burning sensation, dry skin |
| Not known | dermatitis, erythema | |
| General disorders and administration site conditions | Common | fatigue |
| Not known | asthenia, malaise |
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
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