Acculol 0.5% Betaxolol Hydrochloride Eye Drops

ACCULOL
0.5% Eye Drops

 

FORMULATION

Each mL contains:

Betaxolol (as Betaxolol Hydrochloride) 5 mg with 0.0002 mL of 50% Benzalkonium Chloride solution as preservative

 

INDICATIONS

Acculol 0.5% Eye Drops is used in lowering intraocular pressure and may be used in patients with open-angle glaucoma and ocular hypertension. It may be used alone or in combination with other intra ocular pressure lowering medications.

 

DOSAGE and ADMINISTRATION

Instill into the affected eye(s) 1 to 2 drops twice daily.

 

CONTRAINDICATIONS

Hypersensitivity to any component of this preparation. Acculol 0.5% Eye Drops is contraindicated in patients with sinus bradycardia, greater than first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.

 

PRECAUTIONS

Diabetes, thyrotoxicosis, patients with excessive restrictions of pulmonary function, pregnancy. Do not touch dropper tip to any surface, as this may contaminate the contents. Do not use with contact lenses in eyes. Patients who are concurrently receiving a beta-adrenergic blocking agent orally should be observed for a potential additive effect either on intraocular pressure or on the known systemic effects of beta-blockade. Safety and efficacy has not been established in usual pediatric dose.

 

ADVERSE REACTIONS

Rare instances of decreased corneal sensitivity, erythema, itching, corneal punctate staining, keratitis, anisocoria, photophobia, dryness, tearing, discomfort.

Use in Pregnancy and Lactation

There are no adequate and well-controlled studies in pregnant women. Acculol 0.5% Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In breast-feeding, it is not known whether ophthalmic betaxolol is distributed into breast milk and problem in humans have not been documented.

 

DRUG INTERACTIONS

Concomitant therapy with betaxolol eye drops and epinephrine might cause mydriasis. Concomitant therapy with betaxolol eye drops and catecholamine-depleting drugs/oral beta-blockers might cause hypertension and/or bradycardia because of the possible additive effect. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

 

AVAILABILITY

Available in dropper tip bottle of 5 mL.

 

STORAGE CONDITIONS

Store in a cool dry place. Protect from light. Discard four weeks from opening. Store at temperature 20°C – 25°C.

 

Manufactured by

Ashford Laboratories Ltd.

Macau

 

Registration Numbers

MAC-00039 HK-51 670 R1410A7359

3E 243 NAFDAC Reg. No. 04-7442

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