Carteolol Hydrochloride 10 mg/mL
Carteolol Hydrochloride · SOLUTION · Sandoz Inc
Carteolol Hydrochloride is a solution containing carteolol hydrochloride at 10 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Carteolol Hydrochloride
- Generic Name
- Carteolol Hydrochloride
- NDC Code (Product)
61314-238- Manufacturer
- Sandoz Inc
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA075476
- Marketing Start
- 01/05/2000
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.
Dosage & Administration
DOSAGE AND ADMINISTRATION The usual dose is one drop of Carteolol Hydrochloride Ophthalmic Solution 1% in the affected eye(s) twice a day. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine or dipivefrin, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.
Warnings
WARNINGS Carteolol has not been detected in plasma following ocular instillation. However, as with other topically applied ophthalmic preparations, Carteolol may be 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 with topical application of beta-adrenergic blocking agents (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: 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, Carteolol Hydrochloride should be discontinued. Non-Allergic Bronchospasm: In patients with non-allergic bronchospasm or …
Contraindications
CONTRAINDICATIONS Carteolol is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS ); sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure (see WARNINGS ); cardiogenic shock; or hypersensivity to any component of this product.
Drug Interactions
Drug Interactions Carteolol Hydrochloride Ophthalmic Solution should be used with caution in patients who are receiving a beta-adrenergic blocking agent orally, because of the potential for additive effects on systemic beta-blockade. Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride Ophthalmic Solution. Ocular: Transient eye irritation, burning, tearing, conjunctival hyperemia and edema occurred in about 1 of 4 patients. Ocular symptoms including blurred and cloudy vision, photophobia, decreased night vision, and ptosis and ocular signs including blepharoconjunctivitis, abnormal corneal staining, and corneal sensitivity occurred occasionally. Systemic: As is characteristic of nonselective adrenergic blocking agents, Carteolol may cause bradycardia and decreased blood pressure (See WARNINGS ). The following systemic events have occasionally been reported with the use of Carteolol Hydrochloride Ophthalmic Solution: cardiac arrhythmia, heart palpitation, dyspnea, asthenia, headache, dizziness, insomnia, sinusitis, and taste perversion. The following additional adverse reactions have been reported with ophthalmic use of beta 1 and beta 2 (nonselective) adrenergic receptor blocking agents: Body As a Whole: Headache Cardiovascular: Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation (s…
Frequently Asked Questions
What is Carteolol Hydrochloride used for?
Carteolol Hydrochloride contains Carteolol Hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Carteolol Hydrochloride a controlled substance?
Carteolol Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Carteolol Hydrochloride?
The generic name for Carteolol Hydrochloride is Carteolol Hydrochloride. There are no other listed brand versions of Carteolol Hydrochloride.
What is the NDC code for Carteolol Hydrochloride 10 mg/mL?
The NDC (National Drug Code) for Carteolol Hydrochloride 10 mg/mL is 61314-238, listed by Sandoz Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)