Timolol Maleate 5 mg/mL Solution/ Drops, 1 bottle — NDC 68682-045-25 (Billing 68682-0045-25)
This is a package of 1 bottle of Timolol Maleate 5 mg/mL Solution/ Drops from Oceanside Pharmaceuticals, no longer marketed (first marketed May 2018), no longer in the FDA NDC Directory, this package's marketing ended Aug 2026; retail pharmacies pay about $26.38 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68682-045-25 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68682 labeler · 045 product · 25 package
- Package marketed since
- May 30, 2018
- Package marketing ended
- Aug 31, 2026
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 6868204525 3
- Medicaid fills, this package
- 149 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Timolol Maleate (different manufacturers) — 6 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059074
- GCN: 24615
- GPI-14 (Medi-Span): 86250030102060
- HICL (First Databank): 002105
- AHFS class code: 52:40.08.00
- RxCUI (RxNorm): 1992299
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Ophthalmic timolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Timolol is in a class of medications called beta-blockers. It works by decreasing the pressure in the eye.
Read the full MedlinePlus article ↗- It depends on the form. The eye drops lower high pressure in the eye from ocular hypertension or open-angle glaucoma. The tablets treat high blood pressure, lower the risk of death...
- Put the drop in the affected eye as directed, usually once or twice a day depending on your product. If yours is a gel-forming type, shake the closed bottle once first. Wait at lea...
- Burning or stinging right after the drops go in is the most common. Blurred vision, redness, itching and headache can also happen. Call your doctor if you notice wheezing, a very s...
- If your drops contain benzalkonium chloride, soft lenses can absorb it. Take your lenses out before using the drops and wait 15 minutes before putting them back in.
Patient education
Supplement & herbal interactions
Timolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $26.378 | $65.95 / 2.5 ml |
| Medicaid paysCMS SDUD · 12 mo | $25.40 | $63.49 / 2.5 ml |
| Medicare drug plans payPart D · Q2 2026 | $43.15 | $107.87 / 2.5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q3 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68682-0045-25 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER | $26.38 / mL | $65.95 | 2018-05-30 | Aug 31, 2026 | Discontinued by firm |
| 68682-0045-50 68682-045-50 | 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER | $23.41 / mL | $117.05 | 2018-05-30 | — | Discontinued by firm |
Per mL, this pack runs about 13% above the cheapest pack (NDC 68682-0045-50, $23.41 vs $26.38 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Timolol Maleate 5 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| timolol maleate 5 mg/mL 70756-0657-30 | Lifestar | 1 bottle | $0.720 | AT1 | Availability likely | save 97% |
| Timolol Maleate 5 mg/mL 64980-0514-01 | Rising | 1 bottle | $0.720 | AT1 | Availability likely | save 97% |
| Timolol maleate 5 mg/mL 70069-0707-01 | Somerset | 1 bottle | $0.720 | AT1 | Availability likely | save 97% |
| Timolol Maleate 5 mg/mL 65145-0153-01 | Caplin | 1 bottle | $0.720 | AT1 | Availability likely | save 97% |
| Timolol maleate 5 mg/mL 70069-0708-01 | Somerset | 1 bottle | $0.774 | AT1 | Availability likely | save 97% |
| Timolol Maleate 5 mg/mL 65145-0154-01 | Caplin | 1 bottle | $0.774 | AT1 | Availability likely | save 97% |
| timolol maleate 5 mg/mL 70756-0656-15 | Lifestar | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| Timolol Maleate 5 mg/mL 65145-0152-01 | Caplin | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| Timolol maleate 5 mg/mL 70069-0706-01 | Somerset | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| Timolol Maleate 5 mg/mL 61314-0227-05 | Sandoz | 5 ml | $1.046 | AT1 | Availability likely | save 96% |
| Timolol Maleate 5 mg/mL 69315-0325-05 | Leading | 5 ml | $1.046 | AT1 | Availability likely | save 96% |
| Timolol Maleate 5 mg/mL 60758-0801-05 | Pacific | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| Timolol Maleate 5 mg/mL 82260-0813-05 | Bausch | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| timolol maleate 5 mg/mL 72603-0540-01 | NorthStar | 1 bottle | $1.046 | AT1 | Availability likely | save 96% |
| Timoptic in Ocudose 5 mg/mL 69918-0601-60 | Nordic | 60 pouches | $1.255 | AT3 | Availability likely | save 95% |
| Timolol Maleate 5 mg/mL 82260-0819-05 | Bausch | 1 bottle | $8.302 | AB | Availability likely | save 69% |
| Timolol hemihydrate 5 mg/mL 70069-0516-01 | Somerset | 1 bottle | $21.806 | AT2 | Availability likely | save 17% |
| Timolol hemihydrate 5 mg/mL 70069-0517-01 | Somerset | 1 bottle | $22.290 | AT2 | Availability likely | save 16% |
| Timolol Maleate 5 mg/mL 82260-0045-05 | Bausch | 1 bottle | $22.290 | AT2 | Availability likely | save 16% |
| Timolol Maleate 5 mg/mLthis 68682-0045-25 | Oceanside | 1 bottle | $26.378 | AT2 | Discontinued | — |
| Istalol 5 mg/mL 24208-0004-01 | Bausch | 1 bottle | $79.763 | AT2 | Availability likely | +202% |
| Timoptic 5 mg/mL 24208-0813-05 | Bausch | 1 bottle | — | AT1 | FDA listed | — |
| Timoptic-XE 5 mg/mL 24208-0816-05 | Bausch | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-7837-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-3441-00 | A-S | 10 ml | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 59651-0313-05 | Aurobindo | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-5769-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
| timolol maleate 5 mg/mL 81469-0210-05 | First | 1 bottle | — | AT1 | FDA listed | — |
| Timolol Maleate 5 mg/mL 50090-1852-00 | A-S | 1 bottle | — | AT1 | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Oceanside Pharmaceuticals labeler code 68682
- Diltiazem Hydrochloride 120 mg Tablet NDC 68682-009-10
- Sodium sulfacetamide 100 mg/mL Lotion NDC 68682-010-04
- ethacrynic acid 25 mg Tablet NDC 68682-011-10
- Metformin hydrochloride 1000 mg Tablet, Film Coated, Extended Release NDC 68682-018-90
- Ribavirin 6 g Powder, For Solution NDC 68682-019-01
- Metformin hydrochloride 500 mg Tablet, Film Coated, Extended Release NDC 68682-021-50
- Omeprazole and Sodium Bicarbonate 20 mg; 1100 mg Capsule NDC 68682-102-30
- Diclofenac Sodium 100 mg Tablet, Film Coated, Extended Release NDC 68682-103-01
- Omeprazole and Sodium Bicarbonate 40 mg; 1100 mg Capsule NDC 68682-104-30
- Nifedipine 30 mg Tablet, Extended Release NDC 68682-105-10
- Nifedipine 60 mg Tablet, Extended Release NDC 68682-106-10
- Nifedipine 90 mg Tablet, Extended Release NDC 68682-107-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Timolol Maleate Ophthalmic Solution 0.5% is a non-selective beta-adrenergic receptor blocking agent indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol Maleate Ophthalmic Solution 0.5% is a non-selective beta-adrenergic receptor blocking agent indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION One drop of Timolol Maleate Ophthalmic Solution 0.5% should be administered in the affected eye(s) once a day in the AM. One drop in the affected eye(s) once a day in the AM. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution containing 5 mg/mL timolol (6.8 mg/mL of timolol maleate). Topical ophthalmic solution containing timolol maleate, 0.5% (5 mg/mL) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease ( 4.1 , 5.1 , 5.3 ) Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock ( 4.2 , 5.2 ) Hypersensitivity to any component of this product ( 4.3 )
4.1Asthma, COPD Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions ( 5.1 , 5.3 )].
4.2Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock [see Warnings and Precautions ( 5.2 )] .
4.3Hypersensitivity Reactions Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this product in the past.
4.1Asthma, COPD Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions ( 5.1 , 5.3 )].
4.2Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock [see Warnings and Precautions ( 5.2 )] .
4.3Hypersensitivity Reactions Timolol Maleate Ophthalmic Solution 0.5% is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this product in the past.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Potentiation of Respiratory Reactions Including Asthma ( 5.1 ) Cardiac Failure ( 5.2 ) Obstructive Pulmonary Disease ( 5.3 ) Increased Reactivity to Allergens ( 5.4 ) Potentiation of Muscle Weakness ( 5.5 ) Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus ( 5.6 ) Masking of Thyrotoxicosis ( 5.7 )
5.1Potentiation of Respiratory Reactions Including Asthma Timolol Maleate Ophthalmic Solution 0.5% 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 Contraindications ( 4.1 )].
5.2Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of 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, Timolol Maleate Ophthalmic Solution 0.5% should be discontinued [see Contraindications ( 4.2 )].
5.3Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease [other than bronchial asthma or a history of bronchial asthma in which Timolol Maleate Ophthalmic Solution 0.5% is contraindicated] should, in general, not receive beta-blocking agents, including Timolol Maleate Ophthalmic Solution 0.5% [see Contraindications ( 4.1 )].
5.4Increased Reactivity to Allergens While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
5.5Potentiation of Muscle Weakness Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
5.6Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.
5.7Masking of Thyrotoxicosis Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
5.8Contamination of Topical Ophthalmic Products After Use There have been reports of bacterial keratitis associated with the use of multidose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [ see Patient Counseling Information ( 17 )].
5.9Impairment of Beta-adrenergically Mediated Reflexes During Surgery The necessity or desirability of withdrawal of beta-adrenergic… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with Timolol Maleate Ophthalmic Solution 0.5%. Additional reactions reported with Timolol Maleate Ophthalmic Solution 0.5% at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity . ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with Timolol Maleate Ophthalmic Solution 0.5%. Additional reactions reported with Timolol Maleate Ophthalmic Solution 0.5% at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity.
The following additional adverse reactions have been reported less frequently with ocular administration of this or other timolol maleate formulations. Timolol (Ocular Administration) Body as a Whole: Asthenia/fatigue and chest pain; Cardiovascular: Bradycardia, arrhythmia, hypotension, 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 angioedema, urticaria, and localized and generalized rash; Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections; Endocrine: Masked symptoms of hypoglycemia in diabetic patients [see Warnings and Precautions ( 5.6 )]; Special Senses: Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis, decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery [see Warnings and Precautions ( 5.12 )]; Urogenital: Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie’s disease.
6.2Postmarketing Experience Oral Timolol/Oral Beta-Blockers The following additional adverse effects have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive : Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic : Nonthrombocytopenic purpura; thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irri… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. ( 7.1 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ( 7.2 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia.
( 7.3 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ( 7.4 ) Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and timolol. ( 7.5 )
7.1Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and Timolol Maleate Ophthalmic Solution 0.5% should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.
7.2Calcium Antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents, such as Timolol Maleate Ophthalmic Solution 0.5%, 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.
7.3Catecholamine-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 result in vertigo, syncope, or postural hypotension.
7.4Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
7.5CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine) and timolol.
7.6Clonidine Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation of rebound hypertension with ophthalmic timolol maleate.
7.1Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and Timolol Maleate Ophthalmic Solution 0.5% should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.
7.2Calcium Antagonists Caution should be used in the co-administration of beta-adrenergic blocking agents, such as Timolol Maleate Ophthalmic Solution 0.5%, 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.
7.3Catecholamine-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 result in vertigo, syncope, or postural hypotension.
7.4Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.
7.5CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine) and timolol.
7.6Clonidine Oral beta-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. There have been no reports of exacerbation… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects Teratogenicity studies have been performed in animals. Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring.
Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women.
Timolol Maleate Ophthalmic Solution 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.3Nursing Mothers Timolol has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Timolol Maleate Ophthalmic Solution 0.5% in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Teratogenicity studies have been performed in animals. Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring.
Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. There are no adequate and well-controlled studies in pregnant women.
Timolol Maleate Ophthalmic Solution 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE There have been reports of inadvertent overdosage with Timolol Maleate Ophthalmic Solution 0.5% 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 in vitro hemodialysis study, using 14 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Timolol maleate is a beta 1 and beta 2 (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 0.5% 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 0.5% 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 0.5% is well maintained. The precise mechanism of the ocular hypotensive action of Timolol Maleate Ophthalmic Solution 0.5% is 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.
12.3Pharmacokinetics In a study of plasma drug concentration in 12 healthy subjects, the systemic exposure to timolol was determined following twice daily administration of Timolol Maleate Ophthalmic Solution 0.5% (exaggerated regimen) for eight days. With Timolol Maleate Ophthalmic Solution 0.5%, mean plasma concentrations of timolol were 0.68 ng/mL and 0.88 ng/mL two hours after the first dose and the dose on the eighth day, respectively.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Timolol maleate is a beta 1 and beta 2 (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 0.5% 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 0.5% 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 0.5% is well maintained. The precise mechanism of the ocular hypotensive action of Timolol Maleate Ophthalmic Solution 0.5% is 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Timolol Maleate Ophthalmic Solution 0.5% is supplied in white LDPE bottles with 15 mm PP yellow caps and 15 mm LLDPE white dropper tips as follows: NDC 68682-045-50 5 mL in 10 mL container NDC 68682-045-25 2.5 mL in 7.5 mL container Storage: Store at 15° to 25°C (59° to 77°F).
📋 Description ▾
11 DESCRIPTION Timolol Maleate Ophthalmic Solution 0.5% is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -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 C 13 H 24 N 4 O 3 S-C 4 H 4 O 4 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. Timolol Maleate Ophthalmic Solution 0.5% is stable at room temperature.
Timolol Maleate Ophthalmic Solution 0.5% 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 0.5% contains 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. structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be advised not to take this product [see Contraindications ( 4.1 , 4.2 )]. Patients should also be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.8 )]. Patients should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Patients should be advised that Timolol Maleate Ophthalmic Solution 0.5% contains benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following Timolol Maleate Ophthalmic Solution 0.5% administration.
🍼 Nursing Mothers ▾
8.3Nursing Mothers Timolol has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Timolol Maleate Ophthalmic Solution 0.5% in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics In a study of plasma drug concentration in 12 healthy subjects, the systemic exposure to timolol was determined following twice daily administration of Timolol Maleate Ophthalmic Solution 0.5% (exaggerated regimen) for eight days. With Timolol Maleate Ophthalmic Solution 0.5%, mean plasma concentrations of timolol were 0.68 ng/mL and 0.88 ng/mL two hours after the first dose and the dose on the eighth day, respectively.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In a controlled, double-masked, parallel study in 332 patients with untreated intraocular pressures of 22 mm Hg or greater, Timolol Maleate Ophthalmic Solution 0.5% administered once daily (AM) was equivalent to Timolol Maleate Ophthalmic Solution 0.5% administered twice daily. In both groups, mean intraocular pressure decreased from 25 mm Hg at baseline to 18 mm Hg at peak and 19 mm Hg at trough. Timolol Maleate Ophthalmic Solution 0.5% was generally well tolerated, and 3% of patients had treatment discontinued for adverse events judged related to treatment.
There was a slight decrease in cardiovascular function consistent with known systemic absorption of a β-adrenoceptor antagonists.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a two-year study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Similar differences were not observed in rats administered oral doses equivalent to approximately 14,000 times the maximum recommended human ophthalmic dose.
In a lifetime oral study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.
The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.
Timolol maleate was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in vitro in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2.
A ratio of 2 is usually considered the criterion for a positive Ames test. Reproduction and fertility studies in rats demonstrated no adverse effect on male or female fertility at doses up to 21,000 times the systemic exposure following the maximum recommended human ophthalmic dose.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a two-year study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Similar differences were not observed in rats administered oral doses equivalent to approximately 14,000 times the maximum recommended human ophthalmic dose.
In a lifetime oral study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). In a subsequent study in female mice, in which post-mortem examinations were limited to the uterus and the lungs, a statistically significant increase in the incidence of pulmonary tumors was again observed at 500 mg/kg/day.
The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. An increased incidence of mammary adenocarcinomas in rodents has been associated with administration of several other therapeutic agents that elevate serum prolactin, but no correlation between serum prolactin levels and mammary tumors has been established in humans. Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin.
Timolol maleate was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg/kg) and in vitro in a neoplastic cell transformation assay (up to 100 mcg/mL). In Ames tests the highest concentrations of timolol employed, 5,000 or 10,000 mcg/plate, were associated with statistically significant elevations of revertants observed with tester strain TA100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2.
A ratio of 2 is usually considered the criterion for a positive Ames test. Reproduction and fertility studies in rats demonstrated no adverse effect on male or female fertility at doses up to 21,000 times the systemic exposure following the maximum recommended human ophthalmic dose.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 68682-045-50 Rx only TIMOLOL MALEATE OPHTHALMIC SOLUTION 0.5% FOR TOPICAL APPLICATION IN THE EYE Once Daily Sterile 5mL OCEANSIDE PHARMACEUTICALS carton.jpg
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