Product Details
Timolol Maleate 5mg, Hydroxypropylmethylcellulose 3mg & Stabilized Oxychloro Complex 0.05mg Eye Drops 10 ML
10 ML
Product Description :
TIMOLOL MALEATE 5 mg + HYDROXYPROPYLMETHYLCELLULOSE 3 mg & STABILIZED OXYCHLORO COMPLEX 0.05 mg EYE DROPS – 10 mL
Sterile Ophthalmic Solution
1. COMPOSITION
Each mL contains:
• Timolol Maleate equivalent to Timolol 5 mg.
• Hydroxypropylmethylcellulose 3 mg.
• Stabilized Oxychloro Complex 0.05 mg.
• Excipients: As applicable.
• Sterile aqueous vehicle q.s.
2. PHARMACEUTICAL FORM
Sterile, clear ophthalmic solution for topical ocular administration.
3. THERAPEUTIC CLASS
Ophthalmic Beta-Adrenergic Blocking Agent.
4. INDICATIONS
Timolol Maleate Eye Drops are indicated for the reduction of elevated intraocular pressure in patients with:
• Ocular hypertension.
• Chronic open-angle glaucoma.
• Other conditions associated with elevated intraocular pressure where topical beta-blocker therapy is clinically appropriate.
Hydroxypropylmethylcellulose acts as a viscosity-enhancing and lubricating component, while Stabilized Oxychloro Complex functions as a preservative system.
5. CONTRAINDICATIONS
• Hypersensitivity to timolol, beta-adrenergic blocking agents, stabilized oxychloro complex, or any component of the formulation.
• Bronchial asthma or a history of bronchial asthma.
• Severe chronic obstructive pulmonary disease.
• Sinus bradycardia.
• Second- or third-degree atrioventricular block.
• Overt cardiac failure or cardiogenic shock.
6. DRUG INTERACTIONS
• Concomitant use with systemic beta-blockers may result in additive beta-blockade.
• Concomitant use with calcium-channel blockers, catecholamine-depleting medicines, or other medicines affecting cardiac conduction may increase the risk of cardiovascular 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 affected 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 : Avilable
Registration Support : Avilable
Regulatory documents : Avilable on request