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Istalol

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Istalol

Istalol

Istalol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Istalol (timolol maleate) Ophthalmic Solution 0. 5% is a beta-blocker used to treat open-angle glaucoma and other causes of high pressure inside the eye. Common side effects include blurred vision, double vision, drooping eyelid, burning or stinging in your eye, headache, weakness, drowsiness, numbness, tingling, or cold feeling in your hands or feet, ringing in your ears, dry mouth, nausea, diarrhea, loss of appetite, upset stomach, skin rash or worsening psoriasis, insomnia, cough, or stuffy nose.

The starting dose is one drop of 0. 5 percent Istalol ophthalmic solution in the affected eye(s) once a day in the AM. Istalol may interact with clonidine, quinidine, reserpine, digitalis, acetazolamide, dichlorphenamide, methazolamide, oral timolol, other beta-blockers, calcium channel blockers, or antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Istalol should be used only if prescribed. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Istalol passes into breast milk and could harm a nursing baby. Consult your doctor before breastfeeding.

Our Istalol (timolol maleate) Ophthalmic Solution 0. 5% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Istalol in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • swelling or redness of your eyelids;
  • eye redness, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • depressed mood, confusion, hallucinations, unusual thoughts or behavior;
  • wheezing, gasping, or other breathing problems;
  • swelling, rapid weight gain;
  • chest pain, slow or uneven heart rate; or
  • feeling short of breath, even with mild exertion.

Less serious side effects may include:

  • blurred vision, double vision, drooping eyelid;
  • burning or stinging in your eye;
  • headache, weakness, drowsiness;
  • numbness, tingling, or cold feeling in your hands or feet;
  • ringing in your ears;
  • dry mouth;
  • nausea, diarrhea, loss of appetite, upset stomach;
  • skin rash or worsening psoriasis;
  • sleep problems (insomnia); or
  • cough, stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Istalol (Timolol Maleate Ophthalmic Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Istalol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

The most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with Istalol®. Additional reactions reported with Istalol® at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity. The following additional adverse reactions have been reported less frequently with ocular administration of this or other timolol maleate formulations.

Timolol (Ocular Administration)

Body as a whole: Asthenia/fatigue and chest pain; Cardiovascular: Bradycardia, arrhythmia, hypotension, 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 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 AND PRECAUTIONS); 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 WARNINGS AND PRECAUTIONS); Urogenital: Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease.

Postmarketing Experience

Oral Timolol/Oral Beta-blockers

The following additional adverse reactions 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.

Read the entire FDA prescribing information for Istalol (Timolol Maleate Ophthalmic Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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