Timolol Maleate 5 mg/mL Solution, Gel Forming / Drops
Other active recalls for Timolol Maleate (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 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 ↗- Yes, and this is something your pharmacist and doctor take seriously. Even though you're putting the drops in your eye, a small amount is absorbed into your bloodstream. This can s...
- I was prescribed timolol eye drops for glaucoma. Can the drops affect my heart or breathing?
- Please don't stop on your own — this is one of the most important things to know about timolol tablets. Stopping suddenly, especially if you have any heart disease, can cause a dan...
- I take timolol tablets for high blood pressure. Is it safe to just stop if I feel fine?
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.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII IRY12B2TQ6
A synthetic antimicrobial chemical used as a preservative to prevent bacterial and fungal growth in liquid medicines and topical products during storage and use.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $17.78 | $88.90 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Timolol Maleate 5 mg/mL 25021-0009-05 | Sagent | 1 bottle | $10.066 | AB | Availability likely | — |
| Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 mg/mL 43598-0748-11 | Dr. | 1 bottle | $10.066 | AB | Availability likely | — |
| Timolol GFS 5 mg/mL 61314-0225-05 | Sandoz | 5 ml | $10.066 | AB | Availability likely | — |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% 5 mg/mL 62332-0546-05 | Alembic | 1 bottle | $10.066 | AB | Availability likely | — |
| Timolol Maleate Ophthalmic Gel Forming Solution 5 mg/mL 72266-0200-01 | FOSUN | 1 bottle | $10.066 | AB | Availability likely | — |
| Timolol Maleate Ophthalmic Gel Forming Solution 0.5% 5 mg/mL 72603-0163-01 | NorthStar | 1 bottle | $10.066 | AB | Availability likely | — |
| Timolol Maleate 5 mg/mL 82260-0819-05 | Bausch | 1 bottle | $10.066 | AB | Availability likely | — |
| Timoptic-XE 5 mg/mL 24208-0816-05 | Bausch | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% 5 mg/mL 46708-0546-05 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mL 59651-0313-05 | Aurobindo | 1 bottle | — | AB | FDA listed | — |
| timolol maleate ophthalmic gel forming solution 5 mg/mL 68083-0458-01 | Gland | 1 bottle | — | AB | FDA listed | — |
| Timolol Maleate 5 mg/mLthis 70069-0251-01 | Somerset | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70069-0251-01 You're viewing this | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE | 2024-10-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before timolol maleate ophthalmic gel forming solution [see PRECAUTIONS, Information for Patients and accompanying INSTRUCTIONS FOR USE ].
Timolol maleate ophthalmic gel forming solution is available in concentrations of 0.25% and 0.5%. The dose is one drop of timolol maleate ophthalmic gel forming solution (either 0.25% or 0.5%) in the affected eye(s) once a day. Because in some patients the pressure-lowering response to timolol maleate ophthalmic gel forming solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol maleate ophthalmic gel forming solution.
Dosages higher than one drop of 0.5% timolol maleate ophthalmic gel forming solution once a day have not been studied. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. The concomitant use of two topical beta-adrenergic blocking agents is not recommended [see PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents ].
When patients have been switched from therapy with timolol maleate ophthalmic solution administered twice daily to timolol maleate ophthalmic gel forming solution administered once daily, the ocular hypotensive effect has remained consistent.
⛔ Contraindications ▾
CONTRAINDICATIONS Timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS, Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure [see WARNINGS, Cardiac Failure ]; (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
⚠️ 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 ophthalmic 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, timolol maleate ophthalmic gel forming solution should be discontinued.
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 bronchospastic disease (other than bronchial asthma or a history of bronchial asthma) in which Timolol maleate ophthalmic gel forming solution is contraindicated [see CONTRAINDICATIONS ] should, in general, not receive beta-blockers, including Timolol maleate ophthalmic gel forming solution. Major Surgery The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial.
Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted, severe hypotension during anesthesia.
Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
Diabetes Mellilus 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. 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In clinical trials, transient blurred vision upon instillation of the drop was reported in approximately one in three patients (lasting from 30 seconds to 5 minutes). Less than 1% of patients discontinued from the studies due to blurred vision. The frequency of patients reporting burning and stinging upon instillation was comparable between timolol maleate ophthalmic gel forming solution and timolol maleate ophthalmic solution (approximately one in eight patients).
Adverse experiences reported in 1-5% of patients were: Ocular: Pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing; Systemic: Headache, dizziness, and upper respiratory infections. The following additional adverse experiences have been reported with the ocular administration of this or other timolol maleate formulations: BODY AS A WHOLE Asthenia/fatigue, and chest pain. CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebrovascular 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 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 anaphylaxis, angioedema, urticaria, localized and generalized rash. RESPIRATORY Bronchospasm (predominantly in patients with preexisting bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.
ENDOCRINE Masked symptoms of hypoglycemia in diabetic patients [see WARNINGS, Diabetes Mellitus ]. SPECIAL SENSES Signs and symptoms of ocular irritation including blepharitis, keratitis, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery [see PRECAUTIONS, General ]; and tinnitus. UROGENITAL Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.
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 irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory: Rales, bronchial obstruction; Urogenital: Urination difficulties.
To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800 -FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
Drug Interactions Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and timolol maleate ophthalmic gel forming solution 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. Calcium Antagonists Caution should be used in the coadministration of beta-adrenergic blocking agents, such as timolol maleate ophthalmic gel forming solution, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension.
In patients with impaired cardiac function, coadministration should be avoided. 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 result in vertigo, syncope, or postural hypotension. Digitalis 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.
CYP2D6 Inhibitors Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, SSRIs) and timolol. Clonidine 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.
Injectable Epinephrine [See PRECAUTIONS, General, Anaphylaxis ]
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects 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 1000 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 gel forming solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of timolol maleate ophthalmic solution have been established when administered in pediatric patients aged 2 years and older. Use of timolol maleate ophthalmic solution in these children is supported by evidence from adequate and well-controlled studies in children and adults. Safety and efficacy in pediatric patients below the age of 2 years have not been established.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE No data are available in regard to human overdosage with or accidental oral ingestion of timolol maleate ophthalmic gel forming solution. 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 [see ADVERSE REACTIONS ]. 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 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 ▾
CLINICAL PHARMACOLOGY Mechanism 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. timolol maleate ophthalmic gel forming 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 and optic nerve damage.
The precise mechanism of the ocular hypotensive action of timolol maleate ophthalmic gel forming solution is not clearly established at this time. Tonography and fluorophotometry studies of timolol maleate ophthalmic solution 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 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. Pharmacokinetics In a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following once daily administration of timolol maleate ophthalmic gel forming solution 0.5% in the morning. The mean peak plasma concentration following this morning dose was 0.28 ng/mL.
Clinical studies In controlled, double-masked, multicenter clinical studies, comparing timolol maleate ophthalmic gel forming solution 0.25% to timolol maleate ophthalmic solution 0.25% and timolol maleate ophthalmic gel forming solution 0.5% to timolol maleate ophthalmic solution 0.5%, timolol maleate ophthalmic gel forming solution administered once a day was shown to be equally effective in lowering intraocular pressure as the equivalent concentration of timolol maleate ophthalmic solution administered twice a day.
The effect of timolol in lowering intraocular pressure was evident for 24 hours with a single dose of timolol maleate ophthalmic gel forming solution. Repeated observations over a period of six months indicate that the intraocular pressure-lowering effect of timolol maleate ophthalmic gel forming solution was consistent. The results from the largest U.S. and international clinical trials comparing timolol maleate ophthalmic gel forming solution 0.5% to timolol maleate ophthalmic solution 0.5% are shown in Figure 1.
Timolol maleate ophthalmic gel forming solution administered once daily had a safety profile similar to that of an equivalent concentration of timolol maleate ophthalmic solution administered twice daily. Due to the physical characteristics of the formulation, there was a higher incidence of transient blurred vision in patients administered timolol maleate ophthalmic gel forming solution. A slight reduction in resting heart rate was observed in some patients receiving timolol maleate ophthalmic gel forming solution 0.5% (mean reduction 24 hours post-dose 0.8 beats/minute, mean reduction 2 hours post-dose 3.8 beats/minute) [see ADVERSE REACTIONS ].
Timolol maleate ophthalmic gel forming solution has not been studied in patients wearing contact lenses. Image Image
🧬 Mechanism of Action ▾
Mechanism 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. timolol maleate ophthalmic gel forming 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 and optic nerve damage.
The precise mechanism of the ocular hypotensive action of timolol maleate ophthalmic gel forming solution is not clearly established at this time. Tonography and fluorophotometry studies of timolol maleate ophthalmic solution 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 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent and slightly viscous solution free from visible extraneous matter. Timolol maleate ophthalmic gel forming solution, 0.25% timolol equivalent, is supplied in a natural high density polyethylene (HDPE) plugged with 60 µL Natural low density polyethylene (LDPE) Nozzle and a yellow high density polyethylene (HDPE) cap as follows: NDC 70069- 241 -01, 5 mL in a 10 mL capacity bottle. Timolol maleate ophthalmic gel forming solution, 0.5% timolol equivalent, is supplied in a natural high density polyethylene (HDPE) plugged with 60 µL Natural low density polyethylene (LDPE) Nozzle and a yellow high density polyethylene (HDPE) cap as follows: NDC 70069- 251 -01, 5 mL in a 10 mL capacity bottle.
Storage Store at 15°C to 25°C (59°F to 77°F). Avoid Freezing. Protect from light.
📋 Description ▾
DESCRIPTION Timolol maleate ophthalmic gel forming solution 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.
The optical rotation of timolol maleate is: 25 0 [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm 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 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol.
Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate).
Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%.
The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.
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💬 Information for Patients ▾
Information for Patients Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. 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 PRECAUTIONS, General ].
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. Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once.
Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling timolol maleate ophthalmic gel forming solution. 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 ]. Transient blurred vision, generally lasting from 30 seconds to 5 minutes, following instillation, and potential visual disturbances may impair the ability to perform hazardous tasks such as operating machinery or driving a motor vehicle.
INFORMATION FOR PATIENTS Instructions for Use Timolol Maleate (tim oh lol mal ee ate) Ophthalmic Gel Forming Solution 0.25% and 0.5 % Read this Instructions for Use that comes with timolol maleate ophthalmic gel forming solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
Important information about timolol maleate ophthalmic gel forming solution: Use timolol maleate ophthalmic gel forming solution exactly as your doctor tells you to use it. Your doctor will tell you how much timolol maleate ophthalmic gel forming solution to use and when to use it. If you use other medicines in your eye, wait at least 10 minutes between using timolol maleate ophthalmic gel forming solution and your other eye medicines.
Do not touch your eye or areas around your eye with the tip of the timolol maleate ophthalmic gel forming solution bottle . You may get bacteria on the tip of the bottle that can cause you to get an eye infection that can lead to serious eye damage or vision loss . How should I use timolol maleate ophthalmic gel forming solution?
Step 1. Wash your hands. Step 2.
Turn your closed bottle of timolol maleate ophthalmic gel forming solution upside down (invert) and shake once. Step 3. Remove the timolol maleate ophthalmic gel forming solution cap by turning the cap in the direction of the arrows shown ( See Figure A ).
Put the cap in a clean and dry area. Do not let the tip of the bottle touch your fingers or other surfaces. Step 4.
Hold the bottle between your thumb and index finger with 1 hand. Use the index finger of the other hand to pull down the lower eyelid to form a pocket for the eye drop ( See Figure B ). Tilt your head backwards.
Step 5. Place the tip of the bottle close to your eye. Be careful not to touch your eye with the tip of the bottle .
Gently squeeze the bottle and let 1 drop fall into the space between your lower eyelid and your eye ( See Figure C ). If a drop misses your eye, follow the instructions in steps 4 and 5 again. Step 6.
If your doctor has told you to use timolol maleate ophthalmic gel forming solution in both eyes, repeat steps 4 and 5 for your other eye. Step 7. Put the cap back on the bottle and close.
The timolol maleate ophthalmic gel forming sol…