Product Details
Tropicamide 0.8% , Phenylephrine HCL5% & Chlorbutol 0.05% Eye Drops 5 ML
5 ML
Product Description :
TROPICAMIDE 0.8%, PHENYLEPHRINE HCL 5% & CHLORBUTOL 0.05% EYE DROPS – 5 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Tropicamide 8 mg (0.8% w/v).
• Phenylephrine Hydrochloride 50 mg (5% w/v).
• Chlorbutol 0.5 mg (0.05% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile, clear ophthalmic solution for topical ocular administration.
3. THERAPEUTIC CLASS
Mydriatic and Cycloplegic Agent – Anticholinergic + Sympathomimetic.
4. INDICATIONS
Tropicamide + Phenylephrine Eye Drops are indicated for:
• Pupil dilation (mydriasis) for ophthalmic examination.
• Facilitation of fundus examination and diagnostic procedures.
• Pre-operative pupil dilation where clinically appropriate.
5. CONTRAINDICATIONS
• Hypersensitivity to tropicamide, phenylephrine, chlorbutol, or any component of the formulation.
• Narrow-angle glaucoma or patients at risk of angle-closure glaucoma.
• Use with caution in patients with significant cardiovascular disease or uncontrolled hypertension.
6. DRUG INTERACTIONS
• Monoamine oxidase inhibitors may enhance the pressor effects of phenylephrine.
• Tricyclic antidepressants may potentiate the cardiovascular effects of phenylephrine.
• Other sympathomimetic agents may produce additive cardiovascular effects.
• Other anticholinergic medicines may enhance anticholinergic effects.
The treating physician should review all concomitant medications before use.
7. ADMINISTRATION
For topical ophthalmic use only. Instill the prescribed number of drops into the affected eye(s) according to the approved product information and ophthalmic examination protocol. Avoid contact between the dropper tip and the eye or surrounding surfaces.
8. STORAGE
Store according to the storage conditions stated on the approved product label. Protect from excessive heat, moisture and light. Keep the container tightly closed when not in use. Do not use if the solution shows visible particles, precipitation or unexpected discoloration.