Xolamol eye drops 5 ml

Xolamol 20 mg/ml + 5 mg/ml, Ophthalmic Solution

Composition

Each ml contains:

Dorzolamide hydrochloride 22.25 mg (equivalent to 20 mg dorzolamide)

Timolol maleate 6.83 mg (equivalent to 5 mg timolol)

Therapeutic Indications

Xolamol is indicated to reduce elevated intraocular pressure (IOP) in patients with:

Open-angle glaucoma

Pseudo-exfoliative glaucoma

when monotherapy with topical beta-blockers is insufficient.

It is a fixed combination of:

Dorzolamide (carbonic anhydrase inhibitor)

Timolol (beta-blocker)

Posology and Method of Administration

Posology

One drop in the affected eye(s) twice daily.

If used with another topical ophthalmic agent, allow at least 10 minutes between applications.

Instruct patients to wash hands before use and avoid contamination.

Administration Instructions:

Ensure tamper-proof seal is intact before first use.

Remove cap.

Tilt head back and pull down lower eyelid to create a pocket.

Invert bottle and dispense one drop into the eye.

Do not touch the eye or eyelid with the dropper tip.

Press a finger at the corner of the eye by the nose for 2 minutes.

Repeat for the other eye if needed.

Replace cap tightly.

Contraindications

-Bronchial asthma or history of it

-Severe COPD

-Sinus bradycardia, sick sinus syndrome, AV block (2nd or 3rd degree) without pacemaker

-Cardiac failure or cardiogenic shock

-Severe renal impairment (CrCl < 30 ml/min)

-Hyperchloraemic acidosis

-Hypersensitivity to any component

Special Warnings and Precautions for Use

-Systemic absorption of timolol can occur; caution in cardiac, respiratory, hepatic disease.

-Avoid in combination with other beta-blockers or oral carbonic anhydrase inhibitors.

-Use with caution in:

Diabetes: may mask hypoglycemia

Hyperthyroidism: may mask symptoms

Myasthenia gravis

Corneal diseases

-Inform anesthesiologist before surgery if patient is using timolol.

-Contact lens wearers: remove lenses before instillation; wait 15 minutes before reinsertion.

Benzalkonium chloride can discolor soft lenses and cause irritation.

Pregnancy: not recommended.

Breastfeeding: use with caution; unknown if dorzolamide is excreted in human milk.

Side Effects:

Ocular (Common or Rare):

Burning/stinging, conjunctivitis, eyelid inflammation

Dry eyes, blurred vision, keratitis, blepharitis

Choroidal detachment (post-surgery), corneal erosion

Systemic (Due to Timolol absorption):

Allergic reactions: angioedema, rash, anaphylaxis

CNS: headache, dizziness, depression, insomnia, memory loss

Respiratory: bronchospasm, dyspnea

Cardiac: bradycardia, AV block, hypotension

GI: nausea

Metabolism: hypoglycemia

Storage Conditions

Store below 25°C.

Keep the bottle tightly closed.

Use within 28 days after opening.

Packaging:

A plastic bottle with a dropper tip and screw cap, in a carton box containing one 5 ml bottle and package insert.