Istalol (Bausch & Lomb Incorporated): FDA Package Insert (2024)

ISTALOL- timolol maleate solution/ drops
Bausch & Lomb Incorporated

1 INDICATIONS AND USAGE

ISTALOL ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

2 DOSAGE AND ADMINISTRATION

One drop of ISTALOL should be administered in the affected eye(s) once a day in the morning (AM).

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

3 DOSAGE FORMS AND STRENGTHS

Ophthalmic solution containing 0.5% (5 mg/mL) of timolol (6.8 mg/mL of timolol maleate).

4 CONTRAINDICATIONS

4.1 Asthma, COPD

ISTALOL is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions( 5.1, 5.3)] .

4.2 Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock

ISTALOL is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock [see Warnings and Precautions (5.2)] .

4.3 Hypersensitivity Reactions

ISTALOL is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this product in the past.

5 WARNINGS AND PRECAUTIONS

5.1 Potentiation of Respiratory Reactions Including Asthma

ISTALOL contains timolol maleate; and although administered topically, it can be absorbed systemically. Therefore, 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 (4.1)].

5.2 Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of beta-adrenergic receptor blockade may precipitate more severe failure.

In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, ISTALOL should be discontinued [see Contraindications (4.2)].

5.3 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 ISTALOL is contraindicated] should, in general, not receive beta-blocking agents, including ISTALOL [see Contraindications (4.1)].

5.4 Increased Reactivity to Allergens

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

5.5 Potentiation of Muscle Weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

5.6 Masking of Hypoglycemic Symptoms in Patients with 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.

5.7 Masking of 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.

5.8 Contamination of Topical Ophthalmic Products After Use

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information (17)].

5.9 Impairment of Beta-adrenergically Mediated Reflexes During 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.

5.10 Angle-Closure Glaucoma

In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This may require constricting the pupil. Timolol maleate has little or no effect on the pupil. ISTALOL should not be used alone in the treatment of angle-closure glaucoma.

5.11 Cerebrovascular Insufficiency

Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with ISTALOL, alternative therapy should be considered.

5.12 Choroidal Detachment

Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g., timolol).

5.13 Contact Lens Use

ISTALOL contains benzalkonium chloride, an anti-microbial preservative which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following ISTALOL administration.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

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Istalol (Bausch & Lomb Incorporated): FDA Package Insert (2024)

FAQs

Is istalol the same as timolol? ›

Is Istalol the same as timolol? Istalol is a longer-acting, brand-name version of timolol maleate eye drops. It comes as a more concentrated strength, 0.5%, which contains about 5 mg of timolol per mL.

What are the ingredients in Istalol? ›

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)0.05 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
3 more rows

What is the generic name for timolol eye drops? ›

The generic form of Timoptic is called timolol. The generic form of Xalatan is called latanoprost. Brand-name medications usually cost more than generics.

What happens if I stop taking timolol eye drops? ›

Do not stop using timolol eye drops suddenly without talking to your doctor, as it may make your eye condition worse.

Is timolol discontinued? ›

TIMOPTIC (timolol maleate ophthalmic solution), 0.25 percent and 0.5 percent, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

What are the new eye drops for glaucoma? ›

Newer Eye Drop Medication

Rhopressa is prescribed for once-a-day use. In addition, a rho-kinase inhibitor/prostaglandin combination intraocular pressure (IOP) lowering eye drop, Rocklatan®, is also now available. The combination of netarsudil and latanoprost uses a dual mechanism of action to enhance IOP outflow.

How safe is timolol? ›

Timolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, weight gain, or trouble breathing.

Which timolol eye drops have no preservative? ›

Dorzolamide/Timolol 20 mg/ml + 5 mg/ml, Preservative-Free, Eye drops, solution in single-dose container should be used no longer than 15 days after first opening the sachet. Discard any unused single-dose containers after that time. Discard the opened single-dose container immediately after first use.

Is timolol recalled? ›

According to the August 21, 2024, US Food and Drug Administration (FDA) Enforcement Report, there is the potential for a spike from the product cap to be lodged in the container nozzle. The recall includes timolol maleate ophthalmic solution, 0.5%, sterile, in 5-mL bottles (NDC 64980-514-05), from lots 083H009 (Exp.

Who cannot take timolol? ›

Timolol is not suitable for some people. To make sure it's safe for you, tell your doctor before starting to take the medicine if you: have ever had an allergic reaction to timolol or any other medicine. have lung disease or asthma.

Does timolol cause weight gain? ›

Does timolol cause weight gain? Usually, timolol is not associated with weight gain and there is limited data to support this. However, in a few cases of heart failure, water retention could occur, leading to weight gain. Inform your doctor, in case you experience weight gain following timolol use.

Does timolol affect blood pressure? ›

TIMOLOL (TIM oh lol) treats high blood pressure. It may also be used to prevent further damage after a heart attack. It works by lowering your blood pressure and heart rate, making it easier for your heart to pump blood to the rest of your body. It can also be used to prevent migraine headaches.

Is timolol hard on kidneys? ›

Uses for timolol

This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure.

Is it better to put eye drops in the morning or at night? ›

Apply eye drops before you sleep

Nothing can be more irritating than waking up with dry eye symptoms. You may experience blurry vision, redness, and a gritty sensation in your eyes. These symptoms can happen when your eyelids don't entirely close while sleeping.

Does timolol cause hair loss? ›

Alopecia has been described following topical timolol use in a patient with glaucoma (33) . This manifested as tellogen effluvium, which remitted following drug discontinuation and pretreatment hair volume was restored in 14 months. ...

What is a substitute for timolol? ›

Timolol Alternatives Compared
TimololAimovig (erenumab)Emgality (galcanezumab)
More about TimololMore about Aimovig (erenumab)More about Emgality (galcanezumab)
Ratings & Reviews
41 more rows

What is the proprietary name for timolol? ›

Timolol
Clinical data
Trade namesBetimol, Blocadren, Istalol, Timoptic, others
AHFS/Drugs.comMaleate Monograph eent Monograph
MedlinePlusa684029
License dataUS DailyMed: Timolol
35 more rows

What is the generic name for latanoprost and timolol? ›

Latanoprost/timolol, sold under the brand name Xalacom, is a combination drug used for the treatment of glaucoma, consisting of latanoprost (increase uveoscleral outflow of aqueous humor) and timolol (a beta blocker decreasing the production of aqueous fluid).

What is another name for dorzolamide timolol? ›

Cosopt (dorzolamide / timolol) is available as both brand name and generic medications. It comes in a multi-dose bottle, as well as single-use, preservative-free vials.

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