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Timolol GFS

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Overview

What is Timolol GFS?

Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt).

Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is:

[α] 25° in 0.1N HCl (C=5%) = -12.2°

     405 nm

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

Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and purified water. Preservative: benzododecinium bromide 0.012%.

Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears.



What does Timolol GFS look like?



What are the available doses of Timolol GFS?

• 5 mL size bottle filled with 2.5 mL or 5 mL of 0.25% or 0.5% sterile ophthalmic gel forming solution ().

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

How should I use Timolol GFS?

Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Instill one drop of Timolol GFS (either 0.25% or 0.5%) in the affected eye(s) once daily. It may be used alone or in combination with other intraocular pressure lowering medications.


What interacts with Timolol GFS?

Sorry No Records found


What are the warnings of Timolol GFS?

Sorry No Records found


What are the precautions of Timolol GFS?

Sorry No Records found


What are the side effects of Timolol GFS?

Sorry No records found


What should I look out for while using Timolol GFS?

Timolol GFS is contraindicated in patients with:



• 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.


What might happen if I take too much Timolol GFS?

No data are available with regard to human overdose with, or accidental oral ingestion of Timolol GFS. There have been reports of inadvertent overdose with Timolol maleate ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic receptor inhibitors such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest [see also ].

Overdosage has been reported with timolol maleate tablets. A 30-year old female ingested 650 mg of timolol maleate tablets (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block. She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block.

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 Timolol GFS?

Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]For Single-use only.Discard unused portion.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.Timolol GFS, 0.25% timolol equivalent and 0.5% timolol equivalent, are both supplied as either a 2.5 mL or 5 mL solution in a 5 mL white polyethylene bottle with a natural polyethylene dropper tip and a yellow polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER®** package.• NDC               5 mL fill 61314-224-05• NDC               5 mL fill 61314-225-05Storage and HandlingStore at 2° to 25°C (36° to 77°F).Protect from light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Timolol maleate is a beta and beta (non-selective) adrenergic receptor inhibitor that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity. Timolol GFS, when applied topically to 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 and optic nerve damage. The precise mechanism of the ocular hypotensive action of Timolol GFS is not clearly established at this time. Tonography and fluorophotometry studies of Timolol GFS 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. 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 inhibitors 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 activities. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous.

Non-Clinical Toxicology
Timolol GFS is contraindicated in patients with:



• 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.

As with many topically applied ophthalmic drugs, this drug is absorbed systemically.

The same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical ophthalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate [see ].

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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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Professional

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Tips

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Interactions

Interactions

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