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Pronunciation:

(kar bi NOKS a meen)

U.S. Brand Names:

Carbihist; Carbinoxamine PD; Carboxine; Histex™ CT; Histex™ I/E; Histex™ PD; Histex™ PD-12; Palgic; Pediatex™; Pediatex™ 12

Synonyms:

Carbinoxamine Maleate; Carbinoxamine Tannate

Generic Available:

Yes: Liquid

Use:

Seasonal and perennial allergic rhinitis; urticaria

Pregnancy Risk Factor:

Pregnancy Implications:

Animal reproduction studies have not been conducted.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to carbinoxamine or any component of the formulation; use with or within 14 days of MAO inhibitor therapy

Warnings/Precautions:

Use caution with asthma, increased intraocular pressure, hypothyroidism, cardiovascular disease, hypertension, pyloroduodenal obstruction, symptomatic prostatic hyperplasia, or bladder neck obstruction. Causes sedation; caution must be used in performing tasks which require mental alertness (eg, operating machinery or driving). May cause paradoxical excitation in pediatric patients. Safety and efficacy have not been established in children <9 months of age.

Adverse Reactions:

Frequency not defined.

Central nervous system: Dizziness, excitability (children), headache, nervousness, sedation

Gastrointestinal: Anorexia, diarrhea, heartburn, nausea, vomiting, xerostomia

Neuromuscular & skeletal: Weakness

Ocular: Diplopia

Renal: Polyuria

Overdosage/Toxicology:

Symptoms in children may include ataxia, excitation, fever, flushing, hallucination, incoordination, and tremors; convulsions, coma or death may occur in severe cases. Symptoms in adults may include convulsions, drowsiness, excitation, fever, flushing, and postictal depression. Treatment should be symptomatic and supportive. Stomach should be evacuated (charcoal may be useful). Physostigmine may reverse anticholinergic symptoms.

Drug Interactions:

Barbiturates (and other CNS depressants): CNS depressant effects may be increased.

MAO inhibitors: Anticholinergic effects of the antihistamine may be increased and prolonged.

Tricyclic antidepressants: CNS depressant effects may be increased.

Stability:

Store at controlled room temperature of 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

Carbinoxamine competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract.

Pharmacodynamics/Kinetics:

Half-life elimination: 10-20 hours

Dosage:

Oral: Allergic rhinitis/urticaria:

Children:

1-3 months (Pediatex™): 0.4 mg (1.25 mL) every 4-6 hours

3-9 months:

Histex™ PD: 1 mg (1.25 mL) 4 times/day

Pediatex™: 0.9-1.3 mg (2.5-3.75 mL) every 4-6 hours

9-18 months:

Histex™ PD: 1-2 mg (1.25-2.5 mL) 4 times/day

Histex™ PD-12: 1.25 mL every 12 hours

Pediatex™: 1.3-1.75 mg (3.75-5 mL) every 4-6 hours

18 months to 6 years:

Histex™ PD, Palgic®: 2 mg (2.5 mL) 4 times/day

Histex™ PD-12: 2.5 mL every 12 hours

Pediatex™: 1.75 mg (5 mL) every 4-6 hours

2-6 years (Pediatex™ 12): 2.5-5 mL every 12 hours

6-12 years:

Histex™ CT: One-half tablet every 12 hours

Histex™ PD, Histex™ PD-12, Palgic®, Pediatex™: Refer to Adults dosing

Pediatex™ 12: 5-10 mL every 12 hours

12 years: Refer to Adults dosing

Adults:

Histex™ CT, Histex™ I/E: One capsule or tablet every 12 hours; maximum: 2 doses/24 hours

Histex™ PD, Palgic®: 4 mg (5 mL) 4 times/day

Histex™ PD-12: 5 mL every 12 hours

Pediatex™: 3.5 mg (10 mL) every 4-6 hours

Pediatex™ 12: 10-20 mL every 12 hours

Administration:

Shake suspension well before use. Histex™ CT tablets may be broken in half, but should not be crushed or chewed.

Additional Information:

Carbinoxamine tannate is ~40% carbinoxamine; carbinoxamine maleate is ~71% carbinoxamine

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause dizziness, nervousness, or sedation; may cause excitability in children

Mental Health: Effects on Psychiatric Treatment:

Contraindicated with or within 14 days of MAO inhibitor treatment; concurrent use with psychotropics may produce additive sedation

Dosage Forms:

Capsule, variable release (Histex™ I/E): Carbinoxamine maleate 2 mg [immediate release] and carbinoxamine maleate 8 mg [extended release]

Liquid, as maleate:

Carbihist: 4 mg/5 mL (120 mL) [cotton candy flavor]

Carbinoxamine PD: 4 mg/5 mL (480 mL) [bubble gum flavor]

Carboxine: 1.75 mg/5 mL (480 mL) [bubble gum flavor]

Histex™ PD: 4 mg/5 mL (480 mL) [alcohol free, dye free, sugar free; bubble gum flavor]

Pediatex™: 1.75 mg/5 mL (480 mL) [alcohol free, dye free, sugar free; cotton candy flavor]

Solution, as maleate (Palgic®): 4 mg/5 mL (120 mL, 480 mL) [bubble gum flavor]

Suspension, as tannate (Pediatex™ 12): Carbinoxamine 3.6 mg per 5 mL (480 mL) [contains sodium benzoate; candy apple flavor]

Suspension, variable release (Histex™ PD-12): Carbinoxamine maleate 2 mg [immediate release] and carbinoxamine tannate 6 mg [extended release] per 5 mL (120 mL, 480 mL) [alcohol free, dye free, sugar free; contains sodium benzoate; bubble gum flavor]

Tablet, as maleate [scored] (Palgic®): 4 mg

Tablet, timed release, as maleate (Histex™ CT): 8 mg

International Brand Names:

Allergefon® (FR); Histex® (AU); Histin® (TH); Omega® (AR); Sinumine® (TH)

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