RIYADH PHARMA-Rialol - p.1/2

developing thyrotoxicosis, patients with bronchial asthma.Betaxolol Hydrochloride has produced only mini-mal effects in patients with reactive airway disease. However, caution should be exercised in the treat-ment of patients with excessive restriction of pulmo-nary function.Clinical studies to establish the safety and efficacy in children have not been performed.

WARNING:The product should not be used while wearing con-tact lens, contact lens wearers should remove the contact lenses before the instillation and replace them 15 minutes after the instillation.

DRUG INTERACTIONS:Although Betaxolol Hydrochloride when used alone has little or no effect on pupil size, mydriasis result-ing from concomitant therapy with epinephrine has been reported occasionally.Close observation of the patient is recommen-ded when a β-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effect and the production of hypotension and/or brady-cardia. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs.Betaxolol has no effect on the pupil. Therefore, it should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma.As with the use of other anti-glaucoma drugs, dimin-ished responsiveness to Betaxolol Hydrochloride after prolonged therapy has been reported in some patients.

ADVERSE REACTIONS:Discomfort of short duration may be experienced in some patients upon instillation and occasional tear-ing has been reported. Rare instances of decreased corneal sensitivity, erythema, itching sensation, cor-

COMPOSITION:Sterile Eye Drops: Each ml contains Betaxolol Hydrochloride (USP) equivalent to Betaxolol 5 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (pre-servative) and excipients.

CLINICAL PHARMACOLOGY:Betaxolol Hydrochloride is a selective β1 adrener-gic receptor blocking agent for use in glaucoma. It reduces elevated as well as normal intraocular pres-sure whether or not accompanied glaucoma. It does not have significant membrane stabilizing (local anaesthetic) activity and is devoid of intristic sympa-thomimetic action. Betaxolol is found to have mini-mal effect on pulmonary and cardiovascular para-metrics.

INDICATIONS:RIALOL has been shown to be effective in lowering intraocular pressure and is indicated in the treat-ment of:• Patients with chronic open-angle glaucoma.• Patients with elevated intraocular pressure (ocular hypersensitive patients).

• Patients with glaucoma or ocular hypertension who are currently on multiple anti-glaucoma therapy.

CONTRAINDICATIONS:Hypersensitivity to any component of this drug. Also in patients with sinus bradycardia greater than a first degree atrioventricular block, cardiogenic shock or patients with a history of overt cardiac failure.

PRECAUTIONS:Patients who are receiving orally β-adrenergic block-ing agent and Betaxolol Hydrochloride should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of β-blockade.While Betaxolol Hydrochloride has demonstrated a low potential for systemic effects, it should be used with caution in patients with diabetes (espe-cially labile diabetes) or in patients suspected of

RIALOL® RIYADH PHARMA

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RIYADH PHARMA-Rialol - p.2/2

neal punctate staining, keratitis, anisocoria and pho-tophobia have been reported.Systemic reaction following topical administration of Betaxolol Hydrochloride have been reported rarely (e.g. insomnia and depressive neurosis).

USE DURING PREGNANCY AND LACTATION:As with any other drug, if you are pregnant or nurs-ing a baby, consult your doctor before using the drug.

DOSAGE:The usual dose is one drop in the affected eye(s) twice daily. In some patients, the intraocular pres-sure lowering response to RIALOL may require a few weeks to stabilize.When a patient is transferred from a single anti-glaucoma agent, continue the agent already used and add one drop of RIALOL in the affected eye(s) twice a day. On the following day, discontinue the previous anti-glaucoma agent completely and con-tinue with RIALOL.If the intraocular pressure of the patient is not ade-quately controlled on this regimen, concomitant ther-apy with pilocarpine, other miotics, epinephrine or systemically administered carbonic anhydrase inhib-itors can be instituted.

STORAGE:Store at room temperature (15–25)°C.Once the pack has been opened, the contents should be used within 1 month.Do not use the drug after the expiry date printed on the package.

PRESENTATION:Sterile Eye Drops: 5 ml dropper bottle.For External Use Only