Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 27 February 2017

Indication(s)

INDICATIONS AND USAGE 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.

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Advisory information

contraindications

CONTRAINDICATIONS Carteolol Hydrochloride Ophthalmic Solution, USP 1 % 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 hypersensitivity to any component of this product.

Adverse reactions

ADVERSE REACTIONS The following adverse reactions have been reported in clinical trials with Carteolol Hydrochloride Ophthalmic Solution, USP 1 %: 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 Hydrochloride Ophthalmic Solution, USP 1 % 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, USP 1 %: 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 beta1 and beta2 (nonselective) adrenergic receptor blocking agents: Body As a Whole: Headache Cardiovascular: Arrhythmia, syncope, heart block, cerebral vascular accident, cerebral ischemia, congestive heart failure, palpitation (see WARNINGS).

Digestive: Nausea Psychiatric: Depression Skin: Hypersensitivity, including localized and generalized rash Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure (see WARNINGS) Endocrine: Masked symptoms of hypoglycemia in insulin-dependent diabetics (see WARNINGS) Special Senses: Signs and symptoms of keratitis, blepharoptosis, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia, ptosis.

Other reactions associated with the oral use of nonselective adrenergic receptor blocking agents should be considered potential effects with ophthalmic use of these agents.

To report

SUSPECTED ADVERSE REACTIONS, contact

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION The usual dose is one drop of Carteolol Hydrochloride Ophthalmic Solution, USP 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.

Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk, although in animal studies carteolol has been shown to be excreted in breast milk. Caution should be exercised when Carteolol Hydrochloride Ophthalmic Solution, USP 1% is administered to nursing mothers.

Interactions

Drug Interactions Carteolol Hydrochloride Ophthalmic Solution, USP 1 % 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.

More information

Category Value
Authorisation number ANDA075546
Orphan designation No
Product NDC 24208-367
Date Last Revised 01-06-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 978573
Storage and handling Storage: Store between 15°-25°C (59°-77°F). Protect from light. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN
Marketing authorisation holder Bausch & Lomb Incorporated