Carbinoxamine Maleate

First generation antihistamine; an ethanolamine derivative.100 101

Acute Allergic Reactions

Amelioration of allergic reactions to blood or plasma.100 g

Adjunct to epinephrine and other standard measures for management of anaphylaxis after acute symptoms have been controlled.100 g

Allergic and Nonallergic Rhinitis

Symptomatic relief of seasonal (e.g., hay fever) or perennial (nonseasonal) allergic rhinitis or nonallergic (vasomotor) rhinitis.100 g

Allergic Conjunctivitis

Symptomatic relief of allergic conjunctivitis caused by foods or inhaled allergens.100 g

Allergic Skin Disorders

Symptomatic management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.100 g

Treatment of dermatographism.100 g

Regulations Governing Carbinoxamine-containing Preparations

Many unapproved carbinoxamine-containing preparations formerly on the US market contained inappropriate labeling that promoted unapproved uses (including management of congestion†, cough†, or the common cold†, and use in children <2† years of age), which posed serious health risks.101 102 (See Pediatric Use under Cautions and also see Preparations.)

Contraindications

• Children <2 years of age.100

• Women who are breast-feeding.100

• Patients receiving MAO inhibitor therapy.100

• Known hypersensitivity to carbinoxamine or any ingredient in the formulation.100

Warnings/Precautions

Warnings

Possible anticholinergic effects (e.g., dryness of mouth, nose, and throat; dysuria; urinary retention).b Use with extreme caution, if at all, in patients with angle-closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction.100 b

General Precautions

Use with caution in patients with increased IOP, hyperthyroidism, or cardiovascular disease (e.g., hypertension).100 b

Use of antihistamines generally not recommended in asthmatics who previously experienced a serious antihistamine-induced adverse bronchopulmonary effect. Do not use to treat lower respiratory symptoms, including asthma.100

Risk of drowsiness.100 b Caution when performing hazardous activities requiring mental alertness and motor coordination (e.g., driving a motor vehicle, operating machinery).100 b

Possible excitability (especially in children).100 (See Pediatric Use under Cautions.)

Concurrent use of other CNS depressants may have additive CNS depressant effects.100 b (See Interactions.)

Specific Populations

Category C.100 c

Discontinue nursing or the drug because of potential risk to nursing infants.100

Risk of diminished mental alertness in children.100

Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), particularly in young children.100 b

Safety and efficacy not established in children <2 years of age;101 death reported in such patients, although causal relationship to carbinoxamine not established.101 102 Use contraindicated in children <2 years of age.100

Possible increased risk of dizziness, sedation, and hypotension in patients ≥60 years of age.100 b Confusion or oversedation also may occur.100 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Sedation,100 g sleepiness,100 dizziness,100 disturbed coordination,100 epigastric distress,100 thickening of bronchial secretions.100

Specific Drugs and Laboratory Tests

• Risk of drowsiness; avoid alcohol and use caution when engaging in activities requiring mental alertness or motor coordination (e.g., operating machinery, driving a motor vehicle).100 b

• Importance of administering tablets or oral solution on an empty stomach with water.100

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.100

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100

• Importance of informing patients of other important precautionary information.100 (See Cautions.)