Product Details
Phenylephrine Hydrochloride 5% , Tropicamide 0.08% & Benzalkonium Chloride Solution 0.01% 10 ML
10 ML
Product Description :
PHENYLEPHRINE HYDROCHLORIDE 5% + TROPICAMIDE 0.08% & BENZALKONIUM CHLORIDE 0.01% EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Phenylephrine Hydrochloride 50 mg (5% w/v).
• Tropicamide 0.8 mg (0.08% w/v).
• Benzalkonium Chloride 0.1 mg (0.01% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile, clear ophthalmic solution for topical ocular administration.
3. THERAPEUTIC CLASS
Ophthalmic Mydriatic – Sympathomimetic and Antimuscarinic Combination.
4. INDICATIONS
Phenylephrine Hydrochloride and Tropicamide Eye Drops are indicated for:
• Production of mydriasis (pupil dilation) for ophthalmic examination.
• Facilitation of diagnostic procedures involving examination of the fundus.
• Other ophthalmic procedures requiring temporary pupil dilation, as clinically appropriate.
Phenylephrine produces mydriasis primarily through sympathomimetic activity, while tropicamide produces mydriasis and cycloplegia through muscarinic receptor blockade.
5. CONTRAINDICATIONS
• Hypersensitivity to phenylephrine hydrochloride, tropicamide, benzalkonium chloride, or any component of the formulation.
• Use in patients with narrow-angle glaucoma or an anatomically narrow anterior chamber angle, unless specifically directed by an ophthalmologist.
6. DRUG INTERACTIONS
• Concomitant use with monoamine oxidase inhibitors or other medicines that may potentiate sympathomimetic effects should be considered carefully.
• Concurrent use with other anticholinergic or mydriatic ophthalmic preparations may enhance pharmacological effects.
• Other ophthalmic preparations should generally be administered with an appropriate interval between applications.
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 eye(s) according to the approved product information. Do not touch the dropper tip to the eye or surrounding surfaces. If using other ophthalmic preparations, separate administration by an appropriate interval.
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.
Market : international export
Private Label : Available
Registration Support : Available
Regulatory documents : Available on request