Carteolol Hydrochloride Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 betaadrenergic 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).
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.
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.
In patients with non-allergic bronchospasm or with a history of non-allergic bronchospasm (e.g., chronic bronchitis, emphysema), carteolol should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.
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 been subject to protracted severe hypotension during anesthesia. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be appropriate.
If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSAGE).
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.
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 which might precipitate a thyroid storm.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Carteolol hydrochloride ophthalmic solution USP, 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.
There is currently no drug history available for this drug.
Carteolol Hydrochloride Ophthalmic Solution USP, 1%, is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. Carteolol hydrochloride is represented by the following structural formula:
C16H24N2O3•HCl Mol. Wt. 328.84
Chemical Name: (±)-5-[3-[(1, 1-dimethylethyl) amino]-2-hydroxypropoxy]-3, 4-dihydro-2(1H)-quinolinone monohydrochloride.
Each mL of sterile solution contains:
ACTIVE: Carteolol Hydrochloride 10 mg (1%), INACTIVES: Sodium Chloride, Monobasic and Dibasic Sodium Phosphate, Purified Water. PRESERVATIVE ADDED: Benzalkonium Chloride 0.005%. The product has a pH range of 6.2 - 7.2.