BETIMOL 2.56 mg/mL
timolol · SOLUTION/ DROPS · Thea Pharma Inc.
BETIMOL is a solution/ drops containing timolol at 2.56 mg/mL, taken ophthalmic. Manufactured by Thea Pharma Inc..
Key Facts
- Brand Name
- BETIMOL
- Generic Name
- timolol
- NDC Code (Product)
82584-001- Manufacturer
- Thea Pharma Inc.
- Strength
- 2.56 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA020439
- Marketing Start
- 12/01/2022
Recall History
Thea Pharma, Inc.
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Betimol ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage & Administration
DOSAGE AND ADMINISTRATION Betimol® Ophthalmic Solution is available in concentrations of 0.25% and 0.5%. The usual starting dose is one drop of 0.25% Betimol® in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) twice a day. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. Since in some patients the pressure-lowering response to Betimol® may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Betimol®. Dosages above one drop of 0.5% Betimol® twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine, an…
Warnings
WARNINGS As with other topically applied ophthalmic drugs, Betimol ® 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 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 topical administration of beta-adrenergic blocking agents. 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 cardiac 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. Betimol ® should be discontinued at the first sign or symptom of cardiac failure. Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g. chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of …
Contraindications
CONTRAINDICATIONS Betimol ® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.
Drug Interactions
Drug Interactions Beta-adrenergic blocking agents Patients who are receiving a beta-adrenergic blocking agent orally and Betimol ® should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade. Patients should not usually receive two topical ophthalmic beta-adrenergic blocking agents concurrently. Catecholamine-depleting drugs Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. Calcium antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided. Digitalis and calcium antagonists The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive eff…
Adverse Reactions
ADVERSE REACTIONS The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol ® and timolol maleate (approximately one in eight patients). The following adverse events were associated with use of Betimol ® in frequencies of more than 5% in two controlled, double-masked clinical studies in which 184 patients received 0.25% or 0.5% Betimol ® : OCULAR: Dry eyes, itching, foreign body sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache. BODY AS A WHOLE: Headache. The following side effects were reported in frequencies of 1 to 5%: OCULAR: Eye pain, epiphora, photophobia, blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract. BODY AS A WHOLE: Allergic reaction, asthenia, common cold and pain in extremities. CARDIOVASCULAR: Hypertension. DIGESTIVE: Nausea. METABOLIC/NUTRITIONAL: Peripheral edema. NERVOUS SYSTEM/PSYCHIATRY: Dizziness and dry mouth. RESPIRATORY: Respiratory infection and sinusitis. In addition, the following adverse reactions have been reported with ophthalmic use of beta blockers: OCULAR: Conjunctivitis, blepharoptosis, decrea…
Frequently Asked Questions
What is BETIMOL used for?
BETIMOL contains timolol. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is BETIMOL a controlled substance?
BETIMOL is not classified as a controlled substance by the DEA.
What is the generic name for BETIMOL?
The generic name for BETIMOL is timolol. There are 11 other brand versions of timolol.
What is the NDC code for BETIMOL 2.56 mg/mL?
The NDC (National Drug Code) for BETIMOL 2.56 mg/mL is 82584-001, listed by Thea Pharma Inc..
Product NDC
82584-001
Other Timolol Brands
See all →- Timolol Maleate2.5 mg/mL82260-818
- Timoptic2.5 mg/mL24208-812
- Timolol Maleate5 mg/mL42571-404
- 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 Maleate5 mg/mL65145-154
- Timolol Maleate10 mg/10378-0221
- Timolol Maleate6.8 mg/mL82260-496
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)