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Timolol Maleate (Timoptic In Ocudose)

Trade Name : Timoptic in Ocudose

Bausch Health US LLC

SOLUTION

Strength 6.8 mg/mL

TIMOLOL MALEATE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Timolol Maleate (Timoptic In Ocudose) which is also known as Timoptic in Ocudose and Manufactured by Bausch Health US LLC. It is available in strength of 6.8 mg/mL per ml. Read more

Timolol Maleate (Timoptic In Ocudose) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Timolol maleate 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:
  • Its molecular formula is CHNOSu2022CHO,u00a0and 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 is stable at room temperature.
  • Timolol maleate ophthalmic solution is supplied in two formulations: Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution), which contains the preservative benzalkonium chloride; and Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution), the preservative-free formulation.
  • Preservative-free Ophthalmic Solution TIMOPTIC is supplied in OCUDOSE, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of Preservative-free TIMOPTIC in OCUDOSE 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free TIMOPTIC in OCUDOSE 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.
  • Mechanism of Action
  • Timolol maleate is a beta and beta(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.
  • TIMOPTIC (timolol maleate 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 TIMOPTIC (timolol maleate ophthalmic solution) 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 TIMOPTIC (timolol maleate ophthalmicsolution) is well maintained.
  • The precise mechanism of the ocular hypotensive action of TIMOPTIC (timolol maleate ophthalmic solution) 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.
  • Pharmacokinetics
  • In a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following twice daily administration of TIMOPTIC 0.5%. The mean peak plasma concentration following morning dosing was 0.46 ng/mL and following afternoon dosing was 0.35 ng/mL.
  • Clinical Studies
  • In controlled multiclinic studies in patients with untreated intraocular pressures of 22 mmHg or greater, TIMOPTIC (timolol maleate ophthalmic solution) 0.25 or 0.5% administered twice a day produced a greater reduction in intraocular pressure than 1, 2, 3, or 4% pilocarpine solution administered four times a day or 0.5, 1, or 2% epinephrine hydrochloride solution administered twice a day.
  • In these studies, TIMOPTIC (timolol maleate ophthalmic solution) was generally well tolerated and produced fewer and less severe side effects than either pilocarpine or epinephrine. A slight reduction of resting heart rate in some patients receiving TIMOPTIC (timolol maleate ophthalmic solution) (mean reduction 2.9 beats/minute standard deviation 10.2) was observed.
  • Preservative-free TIMOPTIC in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
  • Preservative-free TIMOPTIC in OCUDOSE may be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
  • Preservative-free TIMOPTIC in OCUDOSE is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
  • As with many topically applied ophthalmic drugs, this drug is absorbed systemically.
  • The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate (see CONTRAINDICATIONS).
  • Cardiac Failure
  • Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.
  • In Patients without a History of Cardiac Failure
  • 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 TIMOPTIC in OCUDOSE is contraindicated [see CONTRAINDICATIONS]) should, in general, not receive beta-blockers, including Preservative-free TIMOPTIC in OCUDOSE.
  • 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 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.
  • 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.
  • No data
  • The most frequently reported adverse experiences have been burning and stinging upon instillation
  • (approximately one in eight patients).
  • The following additional adverse experiences have been reported less frequently with ocular administration of this or other timolol maleate formulations:
  • BODY AS A WHOLE
  • Headache, asthenia/fatigue, and chest pain.
  • CARDIOVASCULAR
  • Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet.
  • DIGESTIVE
  • Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.
  • IMMUNOLOGIC
  • Systemic lupus erythematosus.
  • NERVOUS SYSTEM/PSYCHIATRIC
  • Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss.
  • SKIN
  • Alopecia and psoriasiform rash or exacerbation of psoriasis.
  • HYPERSENSITIVITY
  • Signs and symptoms of systemic allergic reactions including anaphylaxis, 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).
  • 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 PRECAUTIONS, ); and tinnitus. n
  • 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: : Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; : Extremity pain, decreased exercise tolerance, weight loss; : Worsening of arterial insufficiency, vasodilatation; : Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Nonthrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; : Hyperglycemia, hypoglycemia; : Pruritus, skin irritation, increased pigmentation, sweating; : Arthralgia; : 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; : Rales, bronchial obstruction; : Urination difficulties.
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • There have been reports of inadvertent overdosage with Ophthalmic Solution TIMOPTIC (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 hemodialysis study, using 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.
  • Preservative-free TIMOPTIC in OCUDOSE is a sterile solution that does not contain a preservative. The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be guaranteed after the individual unit is opened, the remaining contents should be discarded immediately after administration.
  • Preservative-free TIMOPTIC in OCUDOSE is available in concentrations of 0.25 and 0.5%. The usual starting dose is one drop of 0.25% Preservative-free TIMOPTIC in OCUDOSE in the affected eye(s) administered twice a day. Apply enough gentle pressure on the individual container to obtain a single drop of solution. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% solution in the affected eye(s) administered twice a day.
  • Since in some patients the pressure-lowering response to Preservative-free TIMOPTIC in OCUDOSE may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Preservative-free TIMOPTIC in OCUDOSE.
  • If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.
  • Dosages above one drop of 0.5% TIMOPTIC (timolol maleate ophthalmic solution) twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted taking into consideration that the preparation(s) used concomitantly may contain one or more preservatives. The concomitant use of two topical beta-adrenergic blocking agents is not recommended (see PRECAUTIONS, ).
  • Preservative-free Sterile Ophthalmic Solution TIMOPTIC in OCUDOSE is a clear, colorless to light yellow solution.
  • Preservative-free TIMOPTIC, 0.25% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows:
  • NDC
  • Preservative-free TIMOPTIC, 0.5% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows:
  • NDC
  • Storage
  • Store at room temperature, 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Protect from freezing. Protect from light.
  • Because evaporation can occur through the unprotected polyethylene unit dose container and prolonged exposure to direct light can modify the product, the unit dose container should be kept in the protective foil overwrap and used within one month after the foil package has been opened.
  • Manufactured for:
  • Manufactured by:
  • u00a9Bausch & Lomb Incorporated
  • Rev. 02/17
  • 65NOT8556/B9390302
  • NDC
  • TIMOPTICin OCUDOSE
  • (TIMOLOL MALEATE OPHTHALMIC SOLUTION)
  • (DISPENSER)
  • 0.25%
  • Timolol Equivalent (Timolol Maleate 3.4 mg/mL)
  • 60 x 0.3 mL UNIT DOSES
  • FOR TOPICAL APPLICATION IN THE EYE
  • PRESERVATIVE-FREE STERILEOPHTHALMIC SOLUTION
  • BAUSCH + LOMB
  • NDC
  • Rx only
  • TIMOPTICin OCUDOSE
  • (TIMOLOL MALEATE OPHTHALMIC SOLUTION)
  • (DISPENSER)
  • 0.5%
  • Timolol Equivalent (Timolol Maleate 6.8 mg/mL)
  • 60 x 0.3 mL UNIT DOSES
  • FOR TOPICAL APPLICATION IN THE EYE
  • PRESERVATIVE-FREE STERILE
  • OPHTHALMIC SOLUTION
  • BAUSCH + LOMB

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