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| Product NDC Code | 60219-2054 | ||||
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| Drug Name | Timolol maleate |
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| Type | Generic | ||||
| Pharm Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION, GEL FORMING / DROPS | ||||
| RxCUI drug identifier | 313407, 313408 |
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| Application Number | ANDA216343 | ||||
| Labeler Name | Amneal Pharmaceuticals NY LLC | ||||
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Overdosage of Timolol maleate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE No data are available with regard to human overdose with, or accidental oral ingestion of timolol maleate ophthalmic gel forming solution. There have been reports of inadvertent overdose with timolol maleate ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic receptor inhibitors such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest [see also Adverse Reactions (6) ] . 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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS Most common adverse reactions (1% to 5%) occur upon instillation and include transient blurred vision, burning, and stinging. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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. In clinical trials with timolol maleate ophthalmic gel forming solution, transient blurred vision upon instillation of the drop was reported in approximately one in three patients. The frequency of patients reporting burning and stinging upon instillation was approximately one in eight patients which was comparable to that observed for TIMOPTIC* (timolol maleate ophthalmic solution). Adverse reactions reported in 1% to 5% of patients were: Ocular : Blepharitis, conjunctivitis, crusting, discomfort, foreign body sensation, hyperemia, pruritus and tearing; Systemic : Headache, hypertension, and upper respiratory infections. In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reactions profile of timolol maleate ophthalmic gel forming solution was comparable to that seen in adult patients. 6.2 Additional Potential Adverse Reactions Associated with Timolol Maleate 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, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, dizziness, 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 confusion, hallucinations, anxiety, depression, 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 and localized and generalized rash. Respiratory : Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, and cough. Endocrine : Masked symptoms of hypoglycemia in diabetic patients [see Warnings and Precautions (5.5) ] . 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 Warnings and Precautions (5.9) ] ; and tinnitus. Urogenital : Retroperitoneal fibrosis, decreased libido, impotence and Peyronie’s disease.
Timolol maleate Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS Oral beta-adrenergic receptor inhibitors may have additive effects. (7.1) Digitalis and calcium antagonists may have additive effects. (7.2) Catecholamine-depleting drugs may have additive effects. (7.3) Quinidine may have additive effects. (7.4) 7.1 Oral Beta-Adrenergic Receptor Inhibitors Patients who are receiving a beta-adrenergic receptor inhibiting 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. Patients should not usually receive two topical ophthalmic beta-adrenergic receptor inhibiting agents concurrently. 7.2 Digitalis and Calcium Antagonists The concomitant use of beta-adrenergic receptor inhibiting agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. Caution should be used in the co-administration of beta-adrenergic receptor inhibitors, 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, co-administration should be avoided. 7.3 Catecholamine-Depleting Drugs Close observation of the patient is recommended when a beta receptor inhibitor 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. 7.4 Quinidine Potentiated systemic beta-blockade (e.g., decreased heart rate) has been reported during combined treatment with quinidine and timolol, possibly because quinidine inhibits the metabolism of timolol via the P-450 enzyme, CYP2D6. 7.5 Clonidine Oral beta-adrenergic receptor inhibiting 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. 7.6 Injectable Epinephrine Patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions [see Warnings and Precautions (5.11) ].
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Timolol maleate is a beta 1 and beta 2 (non-selective) adrenergic receptor inhibitor 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 to 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 gel forming 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 inhibitors 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 activities. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous. 12.2 Pharmacodynamics Because in some patients the intraocular 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. If the patient’s intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered. 12.3 Pharmacokinetics Following topical ocular administration of timolol to humans, low concentrations of drug are found in plasma. After bilateral administration of a 0.5% timolol maleate solution to healthy volunteers, maximum plasma concentrations were generally below 5 ng/mL. Dosages higher than one drop of 0.5% timolol maleate ophthalmic gel forming solution once daily have not been studied. Pharmacokinetic studies in humans using this gel forming solution formulation were not performed. However, systemic uptake from a gel matrix is expected to be slower than from a non-gel forming solution based on studies using other gel forming solutions. The maximum plasma timolol concentration from the gel forming drop is not expected to exceed those of the 0.5% timolol maleate solution.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Timolol maleate is a beta 1 and beta 2 (non-selective) adrenergic receptor inhibitor 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 to 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 gel forming 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 inhibitors 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 activities. Such an effect in patients with asthma or other bronchospastic conditions is potentially dangerous.
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Because in some patients the intraocular 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. If the patient’s intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy can be considered.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Following topical ocular administration of timolol to humans, low concentrations of drug are found in plasma. After bilateral administration of a 0.5% timolol maleate solution to healthy volunteers, maximum plasma concentrations were generally below 5 ng/mL. Dosages higher than one drop of 0.5% timolol maleate ophthalmic gel forming solution once daily have not been studied. Pharmacokinetic studies in humans using this gel forming solution formulation were not performed. However, systemic uptake from a gel matrix is expected to be slower than from a non-gel forming solution based on studies using other gel forming solutions. The maximum plasma timolol concentration from the gel forming drop is not expected to exceed those of the 0.5% timolol maleate solution.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS Timolol maleate ophthalmic gel forming solution is contraindicated in patients with: bronchial asthma history of bronchial asthma severe chronic obstructive pulmonary disease sinus bradycardia second or third degree atrioventricular block overt cardiac failure cardiogenic shock hypersensitivity to any component of this product. Bronchial asthma (or history of) (4) Severe chronic obstructive pulmonary disease (4) Sinus bradycardia (4) Second or third degree atrioventricular block (4) Overt cardiac failure (4) Cardiogenic shock (4) Hypersensitivity to any component of this product (4)
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. 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 at the levo-isomer. The nominal optical rotation of timolol maleate is: 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, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active: 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). Preservative: Benzododecinium bromide, 0.12 mg (0.012%). Inactives: Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris . An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a 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. image of equation structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION Instill one drop of timolol maleate ophthalmic gel forming solution in the affected eye(s) once daily. Shake once before each use. Timolol maleate ophthalmic gel forming solution may be used alone or in combination with other intraocular pressure lowering medications. Concomitant topical ophthalmic medications should be administered at least 10 minutes before instilling timolol maleate ophthalmic gel forming solution. Instill one drop in the affected eye(s) once daily. (2)
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Ophthalmic gel forming solution: colorless to nearly colorless, slightly opalescent and slightly viscous solution containing 0.25% or 0.5% of timolol. Available in 5 mL size bottle filled with 2.5 mL or 5 mL solution. Ophthalmic gel forming solution containing: 0.25% or 0.5% of timolol. (3)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol maleate is a beta adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1)
Spl product data elements
Usually a list of ingredients in a drug product.Timolol maleate Timolol maleate TIMOLOL MALEATE TIMOLOL ANHYDROUS BENZODODECINIUM BROMIDE BORIC ACID MANNITOL POLYSORBATE 80 TROMETHAMINE XANTHAN GUM WATER Timolol maleate Timolol maleate TIMOLOL MALEATE TIMOLOL ANHYDROUS BENZODODECINIUM BROMIDE BORIC ACID MANNITOL POLYSORBATE 80 TROMETHAMINE XANTHAN GUM WATER Timolol maleate Timolol maleate TIMOLOL MALEATE TIMOLOL ANHYDROUS BENZODODECINIUM BROMIDE BORIC ACID MANNITOL POLYSORBATE 80 TROMETHAMINE XANTHAN GUM WATER Timolol maleate Timolol maleate TIMOLOL MALEATE TIMOLOL ANHYDROUS BENZODODECINIUM BROMIDE BORIC ACID MANNITOL POLYSORBATE 80 TROMETHAMINE XANTHAN GUM WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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 mg/kg/day 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 postmortem 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 oral doses of 5 mg/kg/day 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. Mutagenesis Timolol maleate was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg) 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 TA 100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA 100, 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. Impairment of Fertility 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.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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 mg/kg/day 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 postmortem 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 oral doses of 5 mg/kg/day 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. Mutagenesis Timolol maleate was devoid of mutagenic potential when tested in vivo (mouse) in the micronucleus test and cytogenetic assay (doses up to 800 mg) 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 TA 100 (in seven replicate assays), but not in the remaining three strains. In the assays with tester strain TA 100, 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. Impairment of Fertility 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
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 60219-1377-3 Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% Rx only 5 mL Amneal Pharmaceuticals LLC NDC 60219-1376-3 Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% Rx only 5 mL Amneal Pharmaceuticals LLC 1 2 3 4
Timolol maleate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION How to use the Timolol Maleate Ophthalmic Gel Forming Solution? The timolol maleate ophthalmic gel forming solution bottle is designed to assure the delivery of a precise dose of medication. Before using your timolol maleate ophthalmic gel forming solution, read the complete instructions carefully. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before timolol maleate ophthalmic gel forming solution. 2. Wash hands before each use. 3. Before using the medication for the first time, be sure the tamper evident ring on the bottle is unbroken (see Figure 1). Figure 1 4. Uncap the screwed cap to break the tamper evident seal (see Figure 2). Figure 2 5. Before each use, shake once and remove the screw cap. 6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you (see Figure 3). Figure 3 7. Tilt your head back and position the bottle above the affected eye. DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER (see Figure 4). Figure 4 8. With the opposite hand, place a finger under the eye. Gently pull down until a “V” pocket is made between your eye and lower lid (see Figure 5). Figure 5 9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication. DO NOT SQUEEZE THE SIDES OF THE BOTTLE (see Figure 6). 10. Repeat 6, 7, 8, and 9 with other eye if instructed to do so. 11. Replace screw cap by turning until firmly touching the bottle. Figure 6 Avoiding Contamination of the Product Instruct patients to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Advise patients that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.8) ] . When to Seek Physician Advice Advise patients 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 multi-dose container. Administration Instructions Instruct patients to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Instruct patients requiring concomitant topical ophthalmic medications to administer these at least 10 minutes before instilling timolol maleate ophthalmic gel forming solution. Asthma, COPD, Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock Advise 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 to not use timolol maleate ophthalmic gel forming solution [see Contraindications (4) ] . Temporary Blurred Vision Advise patients that transient blurred vision or visual disturbance, generally lasting from 30 seconds to 5 minutes, following instillation may impair the ability to perform hazardous tasks such as operating machinery or driving a motor vehicle. This product’s labeling may have been updated. For the most recent Prescribing Information, please visit www.amneal.com. *TIMOPTIC is a Registered trademark of Merck & Co., Inc. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 06-2024-01 1 2 3 4 5 6
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES In controlled, double-masked, multicenter clinical studies, timolol maleate ophthalmic gel forming solution administered once daily was compared to equivalent concentrations of TIMOPTIC* (timolol maleate ophthalmic solution) administered twice daily. Timolol maleate gel forming solution once daily was shown to be equally effective in lowering intraocular pressure as the equivalent concentration of TIMOPTIC* (timolol maleate ophthalmic solution) administered twice daily. 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 three-month study period indicate that the intraocular pressure-lowering effect of timolol maleate ophthalmic gel forming solution was consistent. The results from the clinical trials are shown in the following figures: Timolol maleate ophthalmic gel forming solution administered once daily had a safety profile similar to that of an equivalent concentration of TIMOPTIC* (timolol maleate ophthalmic solution) administered twice daily. Due to the physical characteristics of the formulation, transient blurred vision was reported more frequently in patients administered timolol maleate ophthalmic gel forming solution [see Adverse Reactions (6) ] . Timolol maleate has not been studied in patients wearing contact lenses. 1
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and IOP-lowering effect of timolol maleate ophthalmic gel forming solution has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with timolol maleate to inform a drug-associated risk. Administration of oral timolol maleate to pregnant mice, rats and rabbits did not produce teratogenicity at clinically relevant systemic exposures (see Data ) . Because animal reproductive studies are not always predictive of human response, Timolol maleate ophthalmic gel forming solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data 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 post-natal 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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with timolol maleate to inform a drug-associated risk. Administration of oral timolol maleate to pregnant mice, rats and rabbits did not produce teratogenicity at clinically relevant systemic exposures (see Data ) . Because animal reproductive studies are not always predictive of human response, Timolol maleate ophthalmic gel forming solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data 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 post-natal 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. 8.2 Lactation Risk Summary Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for timolol maleate ophthalmic gel forming solution and any potential adverse effects on the breastfed child from Timolol maleate ophthalmic gel forming solution. 8.4 Pediatric Use The safety and IOP-lowering effect of timolol maleate ophthalmic gel forming solution has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% is supplied as either a 2.5 mL or 5 mL colorless to nearly colorless, slightly opalescent and slightly viscous solution in a 5 mL low density polyethylene white opaque bottle with low density polyethylene natural nozzle and high density polyethylene yellow screw-on cap with tamper evident ring for tamper evidence feature. It is available as follows: 0.25% 2.5 mL in 5 mL Containers (Filled to 1/2 Capacity): NDC 60219-2054-3 5 mL in 5 mL Containers: NDC 60219-1377-3 Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% is supplied as either a 2.5 mL or 5 mL colorless to nearly colorless, slightly opalescent and slightly viscous solution in a 5 mL low density polyethylene white opaque bottle with low density polyethylene natural nozzle and high density polyethylene yellow screw-on cap with tamper evident ring for tamper evidence feature. It is available as follows: 0.5% 2.5 mL in 5 mL Containers (Filled to 1/2 Capacity): NDC 60219-2055-3 5 mL in 5 mL Containers: NDC 60219-1376-3 Storage and Handling: Store at 2° to 25°C (36° to 77°F). After opening, Timolol maleate ophthalmic gel forming solution can be used until the expiration date on the bottle. Protect from light.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API