Carteolol (Carteolol Hydrochloride Ophthalmic) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carteolol hydrochloride did not produce carcinogenic effects at doses up to 40 mg/kg/day in two-year oral rat and mouse studies. Test of mutagenicity, including the Ames Test, recombinant (rec)-assay, in vivo cytogenetics and dominant lethal assay demonstrated no evidence for mutagenic potential. Fertility of male and female rats and male and female mice was unaffected by administration of carteolol hydrochloride dosages up to 150 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Carteolol hydrochloride increased resorptions and decreased fetal weights in rabbits and rats at maternally toxic doses approximately 1052 and 5264 times the maximum recommended human oral dose (10 mg/70 kg/day), respectively. A dose-related increase in wavy ribs was noted in the developing rat fetus when pregnant females received daily doses of approximately 212 times the maximum recommended human oral dose. No such effects were noted in pregnant mice subjected to up to 1052 times the maximum recommended human oral dose. There are no adequate and well-controlled studies in pregnant women. Carteolol Hydrochloride Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

OVERDOSAGE

No specific information on emergency treatment of overdosage in humans is available. Should accidental ocular overdosage occur, flush eye(s) with water or normal saline. The most common effects expected with overdosage of a beta-adrenergic blocking agent are bradycardia, bronchospasm, congestive heart failure and hypotension.

In case of ingestion, treatment with Carteolol Hydrochloride Ophthalmic Solution should be discontinued and gastric lavage considered. The patient should be closely observed and vital signs carefully monitored. The prolonged effects of carteolol must be considered when determining the duration of corrective therapy. On the basis of the pharmacologic profile, the following additional measures should be considered as appropriate:

Symptomatic Sinus Bradycardia or Heart Block

Administer atropine. If there is no response to vagal blockade, administer isoproterenol cautiously.

Bronchospasm

Administer a beta₂-stimulating agent such as isoproterenol and/or a theophylline derivative.

Congestive Heart Failure

Administer diuretics and digitalis glycosides as necessary.

Hypotension

Administer vasopressors such as intravenous dopamine, epinephrine or norepinephrine bitartrate.

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.