Opcet 0.24%

Description

Indications:
Opcet 0.24% ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Pharmacology:
Cetirizine is an antihistamine that acts as a histamine-1 (H1) receptor antagonist. It works by selectively inhibiting H1 histamine receptors. Cetirizine has shown negligible anticholinergic and antiserotonergic activity in animal models. In vitro receptor binding studies reveal no measurable affinity for receptors other than H1.

After topical ocular dosing, Cetirizine achieves a mean plasma Cmax of 1.7 ng/mL following a single dose and 3.1 ng/mL after twice-daily dosing for one week. Its mean terminal half-life is 8.6 hours after a single dose and 8.2 hours after twice-daily dosing.

Dosage & Administration:

• Adults and Children (age 2 years and above):
  The recommended dosage is 1 drop in the affected eye(s) twice daily, approximately 8 hours apart.

Side Effects:
The most common side effects include ocular hyperemia, instillation site pain, and reduction in visual acuity.

Pregnancy & Lactation:

• Pregnancy:
  There are no well-controlled studies in pregnant women. Cetirizine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Lactation:
  It is not known whether Cetirizine is excreted in breast milk. The potential effects on breastfed infants or milk production are unknown. The benefits of breastfeeding and the mother’s clinical need for the drug should be considered.

Precautions & Warnings:

• Avoid touching the dropper tip with eyelids or surrounding areas to prevent contamination.
• Keep the bottle tightly closed when not in use.
• Do not wear contact lenses if the eye is red. Remove contact lenses before instillation and wait for 10 minutes before reinsertion.

Use in Special Populations:

• Pediatric Use:
  Safety and effectiveness have been established in children aged 2 years and older.
• Geriatric Use:
  No significant differences in safety or effectiveness between elderly and younger patients.

Therapeutic Class:
Ophthalmic Anti-allergic preparations

Storage Conditions:
Store below 30°C, protect from light. Do not freeze. Use within 4 weeks after opening. Keep out of reach of children.