Timolol Maleate (Page 3 of 3)

ADVERSE REACTIONS

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, 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.

OVERDOSAGE

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 also 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.

DOSAGE AND ADMINISTRATION

Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be change to one drop of 0.5 percent solution in the affected eye(s) twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic 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 Solution.
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 percent 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. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)

HOW SUPPLIED

Sterile ophthalmic solution of timolol maleate is a clear, colorless solution.
Timolol maleate ophthalmic solution USP, 0.25% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap
NDC 67877-228-55 5 mL in a 5 mL bottle
NDC 67877-228-11 10 mL in a 10 mL bottle
NDC 67877-228-15 15 mL in a 15 mL bottle
Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap
NDC 67877-229-55 5 mL in a 5 mL bottle
NDC 67877-229-11 10 mL in a 10 mL bottle
NDC 67877-229-15 15 mL in 15 mL bottle

Storage
Store at 25° (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]
Protect from freezing. Protect from light.
Manufactured by:
FDC Limited
B-8, M.I.D.C. Waluj,
Dist. Aurangabad 431 136
Maharashtra State, India
Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645
Rx Only

InstructionsForUse(a)
(click image for full-size original)
InstructionsForUse(b)
(click image for full-size original)

InstructionsForUse(a)InstructionsForUse(b)

ASCEND
Laboratories, LLC
NDC 67877-229-55
Timolol
Maleate
STERILE OPHTHALMIC SOLUTION USP
0.5%
Timolol Equivalent
(Timolol Maleate 6.8 mg/mL)
For Topical
Application In The Eye
Rx Only
5 mL
Lot:
Exp:
Manufactured by: FDC Limited
At: B-8, M.I.D.C., Waluj
Dist. Aurangabad 431 136. India
Manufactured for: Ascend Laboratories, LLC
Montvale, NJ 07645
Each mL contains: Timolol maleate equivalent to 5mg timolol.
See accompanying Package Insert
Protect from freezing.
Protect from light.
Retain in carton until time of use.Mfg. Lic. No. 1032

0.5% 5mL Product Label
(click image for full-size original)
TIMOLOL MALEATE timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-229
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
BENZALKONIUM CHLORIDE 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-229-55 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 5 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (67877-229-55)
2 NDC:67877-229-11 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
2 10 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (67877-229-11)
3 NDC:67877-229-15 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
3 15 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (67877-229-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077259 03/09/2011
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
FDC Limited 862267994 manufacture (67877-229)

Revised: 12/2018 Ascend Laboratories, LLC

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