Timolol Maleate (Page 3 of 4)

Nursing Mothers

Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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 preexisting 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.

To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 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 14C 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%. The usual starting dose is one drop of timolol maleate ophthalmic solution 0.25% in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5% 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 timolol maleate ophthalmic solution 0.5% 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

Timolol maleate ophthalmic solution, USP is a clear, colorless solution.

Timolol maleate ophthalmic solution 0.25% timolol equivalent is supplied in a Natural LDPE bottle with a Natural LDPE controlled drop tip and a Yellow HDPE cap as follows:

NDC 70756-654-15 5 mL in a 5 mL capacity bottle

NDC 70756-655-30 10 mL in a 10 mL capacity bottle

Timolol maleate ophthalmic solution 0.5% timolol equivalent is supplied in a Natural LDPE bottle with a Natural LDPE controlled drop tip and a Yellow HDPE cap as follows:

NDC 70756-656-15 5 mL in a 5 mL capacity bottle

NDC 70756-657-30 10 mL in a 10 mL capacity bottle

Storage

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Protect from light. After opening, timolol maleate ophthalmic solution can be used until the expiration date on the bottle.

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Germany

Revised: May 2023, V-02

Instructions for Use

Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5%

(tim oh lol mal ee ate)

Read this Instructions for Use that comes with timolol maleate ophthalmic 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 solution:

  • Use timolol maleate ophthalmic solution exactly as your doctor tells you to use it. Your doctor will tell you how much timolol maleate ophthalmic 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 solution and your other eye medicines.
  • Do not touch your eye or areas around your eye with the tip of the timolol maleate ophthalmic 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 solution?

Step 1. Wash your hands.

Step 2. Turn your closed bottle of timolol maleate ophthalmic solution upside down (invert) and shake once.

Step 3. Remove the timolol maleate ophthalmic 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.

figure a
(click image for full-size original)

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.

figure b
(click image for full-size original)

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.

fugure c
(click image for full-size original)

Step 6. If your doctor has told you to use timolol maleate ophthalmic 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 solution bottle tip is made to give 1 drop at a time. Do not try to make the hole in the tip of your bottle bigger.
  • Do not wash the bottle tip.
  • After you have used all of your timolol maleate ophthalmic solution doses, there will be some timolol maleate ophthalmic solution left in the bottle. Do not try to remove the extra timolol maleate ophthalmic solution from the bottle. Throw it away.

How should I store timolol maleate ophthalmic solution?

  • Store timolol maleate ophthalmic solution at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position.
  • Do not freeze timolol maleate ophthalmic solution.
  • Keep timolol maleate ophthalmic solution out of light.

Keep timolol maleate ophthalmic solution and all medicines out of the reach of children.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about timolol maleate ophthalmic solution that is written for health professionals.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Rx only

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Germany

Revised: May 2023, V-02

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