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Timolol Maleate
Overview
What is Timolol Maleate?
Timolol Maleate Ophthalmic Solution, USP 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 432.5. It is a white, or practically white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol Maleate Ophthalmic Solution, USP is stable at room temperature. Timolol Maleate Ophthalmic Solution, USP 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 Timolol Maleate Ophthalmic Solution, USPcontains the active ingredient 5 mg of timolol (6.8 mg of timolol maleate) with the inactive ingredients benzalkonium chloride (0.05 mg/mL), potassium sorbate 0.47%, sodium chloride, sodium hydroxide, sodium phosphate monobasic monohydrate and water for injection.
What does Timolol Maleate look like?
What are the available doses of Timolol Maleate?
Topical ophthalmic solution containing timolol maleate, 0.5% (5 mg/mL) ()
What should I talk to my health care provider before I take Timolol Maleate?
How should I use Timolol Maleate?
Timolol Maleate Ophthalmic Solution, USP 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 timolol maleate ophthalmic solution, 0.5% should be administered in the affected eye(s) once a day in the AM.
What interacts with Timolol Maleate?
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What are the warnings of Timolol Maleate?
Sorry No Records found
What are the precautions of Timolol Maleate?
Sorry No Records found
What are the side effects of Timolol Maleate?
Sorry No records found
What should I look out for while using Timolol Maleate?
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 ()
What might happen if I take too much Timolol Maleate?
There have been reports of inadvertent overdosage with timolol maleate 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.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 Maleate?
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].Timolol Maleate Ophthalmic Solution, USP 0.5% is supplied in white LDPE bottles with 15 mm HDPE yellow caps and 10 mm LDPE white dropper tips as follows: 5 mL in 11 mL container (NDC 60505-1005-1)2.5 mL in 5 mL container (NDC 60505-1005-4)STORAGEStore at 20ºC – 25ºC (68Fº – 77ºF). [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical 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.
Timolol maleate 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 timolol maleate ophthalmic solution 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 timolol maleate ophthalmic solution is well maintained.
The precise mechanism of the ocular hypotensive action of timolol maleate ophthalmic solutionis 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
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 ()
Dual Blockade of the Renin-Angiotensin System (RAS)
Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.
Closely monitor blood pressure, renal function and electrolytes in patients on captopril tablets and other agents that block the RAS.
Do not co-administer aliskiren with captopril tablets in patients with diabetes. Avoid use of aliskiren with captopril tablets in patients with renal impairment (GFR < 60 ml/min).
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
Hypotension - Patients on Diuretic Therapy
The possibility of hypotensive effects with captopril can be minimized by either discontinuing the diuretic or increasing the salt intake approximately one week prior to initiation of treatment with captopril tablets or initiating therapy with small doses (6.25 or 12.5 mg). Alternatively, provide medical supervision for at least one hour after the initial dose. If hypotension occurs, the patient should be placed in a supine position and, if necessary, receive an intravenous infusion of normal saline. This transient hypotensive response is not a contraindication to further doses which can be given without difficulty once the blood pressure has increased after volume expansion.
Agents Having Vasodilator Activity
Agents Causing Renin Release
Agents Affecting Sympathetic Activity
Agents Increasing Serum Potassium
Lithium
Cardiac Glycosides
Loop Diuretics
Allopurinol:
Gold:
Timolol maleate ophthalmic solution 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 (see , ).
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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