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Timolol Maleate

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Overview

What is Istalol?

Istalol(timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(-butylamino) -3- [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer.

Its molecular formula is CHNOS-CHO and its structural formula is:

Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Istalol is stable at room temperature. Istalol ophthalmic solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in a single strength. It has a pH of 6.5-7.5 and an osmolality of 275-330 mOsm/kg.

Each mL of Istalolcontains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), monobasic sodium phosphate monohydrate, potassium sorbate 0.47%, sodium chloride, sodium hydroxide, and purified water. 



What does Istalol look like?



What are the available doses of Istalol?

Topical ophthalmic solution containing timolol maleate, 0.5% (5 mg/mL) ()

What should I talk to my health care provider before I take Istalol?

How should I use Istalol?

Istalol (timolol maleate ophthalmic solution) 0.5% is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.

One drop of Istalol (timolol maleate ophthalmic solution) 0.5% should be administered in the affected eye(s) once a day in the AM.


What interacts with Istalol?

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What are the warnings of Istalol?

Sorry No Records found


What are the precautions of Istalol?

Sorry No Records found


What are the side effects of Istalol?

Sorry No records found


What should I look out for while using Istalol?

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What might happen if I take too much Istalol?

There have been reports of inadvertent overdosage with Istalol 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.An hemodialysis study, using C timolol added to human plasma or whole blood, showed that timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that timolol did not dialyze readily.


How should I store and handle Istalol?

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not freeze.Protect from light.Discard unused portion. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not freeze.Protect from light.Discard unused portion. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not freeze.Protect from light.Discard unused portion. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not freeze.Protect from light.Discard unused portion. Istalol(timolol maleate ophthalmic solution) 0.5% is supplied in white LDPE bottles with 15 mm LDPE yellow caps and 15 mm LDPE white dropper tips as follows: 5 mL in 10 mL container (NDC 24208-004-03)2.5 mL in 7.5 mL container (NDC 24208-004-01)STORAGEStore at 15º – 25ºC (59º – 77ºF).Istalol(timolol maleate ophthalmic solution) 0.5% is supplied in white LDPE bottles with 15 mm LDPE yellow caps and 15 mm LDPE white dropper tips as follows: 5 mL in 10 mL container (NDC 24208-004-03)2.5 mL in 7.5 mL container (NDC 24208-004-01)STORAGEStore at 15º – 25ºC (59º – 77ºF).Istalol(timolol maleate ophthalmic solution) 0.5% is supplied in white LDPE bottles with 15 mm LDPE yellow caps and 15 mm LDPE white dropper tips as follows: 5 mL in 10 mL container (NDC 24208-004-03)2.5 mL in 7.5 mL container (NDC 24208-004-01)STORAGEStore at 15º – 25ºC (59º – 77ºF).Istalol(timolol maleate ophthalmic solution) 0.5% is supplied in white LDPE bottles with 15 mm LDPE yellow caps and 15 mm LDPE white dropper tips as follows: 5 mL in 10 mL container (NDC 24208-004-03)2.5 mL in 7.5 mL container (NDC 24208-004-01)STORAGEStore at 15º – 25ºC (59º – 77ºF).Istalol(timolol maleate ophthalmic solution) 0.5% is supplied in white LDPE bottles with 15 mm LDPE yellow caps and 15 mm LDPE white dropper tips as follows: 5 mL in 10 mL container (NDC 24208-004-03)2.5 mL in 7.5 mL container (NDC 24208-004-01)STORAGEStore at 15º – 25ºC (59º – 77ºF).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Timolol maleate is a beta and beta (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function.

Beta-adrenergic receptor blockade in the bronchi and bronchioles results in increased airway resistance from unopposed parasympathetic activity. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous. Istalol ophthalmic solution, when applied topically on the eye, has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The onset of reduction in intraocular pressure following administration of Istalol can usually be detected within one-half hour after a single dose. The maximum effect usually occurs in one to two hours and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. Repeated observations over a period of one year indicate that the intraocular pressure lowering effect of Istalol is well maintained. The precise mechanism of the ocular hypotensive action of Istalolis not clearly established at this time. Tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed.

Non-Clinical Toxicology
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4.3

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Istalol contains timolol maleate; and although administered topically, it can be absorbed systemically. Therefore, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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