Timolol Maleate 5 mg/mL
Timolol Maleate · SOLUTION · Sandoz Inc
Timolol Maleate is a solution containing timolol maleate at 5 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Timolol Maleate
- Generic Name
- Timolol Maleate
- NDC Code (Product)
61314-227- Manufacturer
- Sandoz Inc
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA074262
- Marketing Start
- 01/15/1996
Recall History
Apotex Corp.
Lack of Assurance of Sterility
Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
PACK Pharmaceuticals, LLC
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Akorn, Inc
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Allergan Sales, LLC
Failed Impurities/Degradation Specifications.
FDC Limited
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Rising Pharmaceuticals, Inc.
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
FDC Limited
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may be used when a patient is sensitive to the preservative in Timolol Maleate Ophthalmic Solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
Dosage & Administration
DOSAGE AND ADMINISTRATION Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is a sterile solution that does not contain a preservative. The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be guaranteed after the individual unit is opened, the remaining contents should be discarded immediately after administration. Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is available in concentrations of 0.25 and 0.5%. The usual starting dose is one drop of 0.25% Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE in the affected eye(s) administered twice a day. Apply enough gentle pressure on the individual container to obtain a single drop of solution. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) administered twice a day. Since in some patients the pressure-lowering response to Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment …
Warnings
WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. 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 CONTRAINDICATIONS ). Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE should be discontinued. Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) o…
Contraindications
CONTRAINDICATIONS Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS ); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
Adverse Reactions
ADVERSE REACTIONS The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations: Body as a Whole Headache, asthenia/fatigue, and chest pain. Cardiovascular Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud’s phenomenon, and cold hands and feet. Digestive Nausea, diarrhea, dyspepsia, anorexia, and dry mouth. Immunologic Systemic lupus erythematosus. Nervous System/Psychiatric Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss. Skin Alopecia and psoriasiform rash or exacerbation of psoriasis. Hypersensitivity Signs and symptoms of systemic allergic reactions including…
Frequently Asked Questions
What is Timolol Maleate used for?
Timolol Maleate contains Timolol Maleate. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Timolol Maleate a controlled substance?
Timolol Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Timolol Maleate?
The generic name for Timolol Maleate is Timolol Maleate. There are 6 other brand versions of Timolol Maleate.
What is the NDC code for Timolol Maleate 5 mg/mL?
The NDC (National Drug Code) for Timolol Maleate 5 mg/mL is 61314-227, listed by Sandoz Inc.
Other Timolol Brands
See all →- Timoptic2.5 mg/mL24208-812
- TIMOLOL MALEATE5 mg/mL60758-801
- TIMOLOL MALEATE2.5 mg/mL60758-802
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%2.5 mg/mL62332-545
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%5 mg/mL62332-546
- Timolol Maleate Ophthalmic Gel Forming Solution 0.25%2.5 mg/mL43598-747
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)