Aristomol Eye Drops

Aristomol is a non-selective β-adrenergic receptor blocker. It does not have significant intrinsic sympathomimetic activity, direct myocardial depressant activity or local anaesth activity. Exact mechanism of ocular hypotensive effect is unclear, but it is thought to be related to reduction of aqueous humour formation. β-blockade also causes lowering of BP.

Uses

Aristomol Maleate Ophthalmic Solution is used for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Aristomol is also used to associated treatment for these conditions: Increased Intra Ocular Pressure (IOP), Migraine, Ocular Hypertension, Open Angle Glaucoma (OAG)

Trade Name Aristomol
Generic Timolol
Other Names Timolol, Timololo, Timololum
Weight 0.25%, 0.5%
Type Eye Drops
Formula C13H24N4O3S
Weight Average: 316.42
Monoisotopic: 316.156911344
Protein binding

The plasma protein binding of timolol is not extensive and is estimated to be about 10%.

Therapeutic Class Drugs for miotics and glaucoma
Manufacturer Aristopharma Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:25 am

Dosage

Aristomol dosage

Eye drops Solution: Initially, instill 1 drop of 0.25% solution bid into the affected eye(s), may increase to 1 drop of 0.5% solution bid if there is inadequate response; decrease to 1 drop once daily if controlled. Do not exceed 1 drop bid of 0.5% solution.

Gel-forming eye drops: 0.25% or 0.5%  Gel-forming eye drops: Instill 1 drop into the affected eye(s) once daily.

Side Effects

Burning and stinging sensation of the eyes, bradycardia, hypotension, arrhythmia and AV or SA nodal block, CHF, pulmonary oedema, Raynaud's phenomenon, headache, dizziness, fatigue, asthenia, abdominal discomfort, nausea, constipation, hypoglycaemia.

Precaution

Patients with inadequate cardiac function, DM, myasthenia gravis, cerebrovascular insufficiency, history of atopy. Avoid abrupt withdrawal as it may exacerbate angina symptoms or precipitate MI in patients with coronary artery disease, or precipitate thyroid crisis in patients with thyrotoxicosis. Patients undergoing major surgery. May mask signs of hyperthyroidism and hypoglycaemia. Ophth soln should not be used as monotherapy for angle-closure glaucoma. Renal and hepatic impairment. Pregnancy and lactation.

Interaction

Although Aristomol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with Aristomol Maleate and epinephrine has been reported occasionally. Drug interactions of Aristomol Maleate have been noticed with concomitant administration of beta-adrenergic blocking agents (both oral and topical), calcium antagonists, catecholamine-depleting drugs, digitalis, quinidin, clonidine, injectable epinephrine.

Food Interaction

No interactions found.

Volume of Distribution

1.3 - 1.7 L/kg

Aristomol is distributed to the following tissues: the conjunctiva, cornea, iris, sclera, aqueous humor, kidney, liver, and lung.

Half Life

Aristomol half-life was measured at 2.9 ± 0.3 h hours in a clinical study of healthy volunteers.

Clearance

One pharmacokinetic study in healthy volunteers measured the total plasma clearance of timolol to be 557 ± 61 ml/min. Another study determined the total clearance 751.5 ± 90.6 ml/min and renal clearance to be 97.2 ± 10.1 ml/min in healthy volunteers.

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Aristomol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Aristomol has been detected in breast milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Aristomol in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindication

Aristomol is contraindicated in patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, hypersensitivity to any component of this product.

Acute Overdose

There have been reports of inadvertent overdosage with Aristomol Ophthalmic Solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest.

Storage Condition

Store between 15-30° C. Avoid freezing and protect from light.

Aristomol contains Timolol see full prescribing information from innovator Monograph