WARNINGS
Deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).
Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.
PRECAUTIONS
General
As many other antihistamines, carbinoxamine maleate has an atropine-like action and, therefore, should be used with caution in patients with: increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension.
Antihistamines such as carbinoxamine maleate should not be used to treat lower respiratory tract symptoms, including asthma.
Information for Patients
Carbinoxamine maleate may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Drug Interactions
Monoamine oxidase inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
Carbinoxamine maleate has additive effects with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to determine the possible effects of carbinoxamine maleate on carcinogenesis, mutagenesis, and fertility.
Pregnancy
Pregnancy Category C
Animal reproductive studies have not been conducted with carbinoxamine maleate. It is also not known whether carbinoxamine maleate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Carbinoxamine maleate should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, use of carbinoxamine maleate is contraindicated in nursing mothers (see CONTRAINDICATIONS section).
Pediatric Use
Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).
Neonates have an increased susceptibility to anticholinergic side effects, such as CNS excitation, which may lead to convulsions.
Carbinoxamine maleate may diminish mental alertness in children. In the young child, particularly, they may produce excitation.
Geriatric Use
Carbixonaxime maleate is more likely to cause dizziness, sedation and hypotension in elderly patients (approximately 60 years or older). Sedating drugs may also cause confusion and over sedation in elderly. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic renal, or cardiac function, and of concomitant disease or other drug therapy.
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