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Pronunciation:

(kar bi NOKS a meen & soo doe e FED rin)

U.S. Brand Names:

Andehist NR Drops; Carbaxefed RF; Carboxine-PSE; Hydro-Tussin™-CBX; Palgic®-D; Palgic®-DS; Pediatex™-D; Rondec® Drops; Rondec® Tablets; Rondec-TR®; Sildec

Synonyms:

Pseudoephedrine and Carbinoxamine

Generic Available:

Yes

Use:

Seasonal and perennial allergic rhinitis; vasomotor rhinitis

Pregnancy Risk Factor:

Pregnancy Implications:

Animal reproduction studies have not been conducted.

Lactation:

Enters breast milk/contraindicated

Contraindications:

Hypersensitivity to carbinoxamine, pseudoephedrine, or any component of the formulation; severe hypertension or coronary artery disease; MAO inhibitor therapy; GI or GU obstruction; peptic ulcer disease; narrow-angle glaucoma; avoid use in premature or term infants due to a possible association with SIDS; acute asthma attack

Warnings/Precautions:

Use caution with hypertension, ischemic heart disease, hyperthyroidism, increased intraocular pressure, diabetes mellitus, BPH, and patients >60 years of age. May cause decreased mental alertness; excitation in younger children; paradoxical reactions (manifested by hyperexcitability) in older children. The elderly may be more sensitive to anticholinergic and antihistamine effects and experience increased adverse effects. Use caution in atopic children. Safety and efficacy in children <1 month of age have not been established.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Arrhythmias, cardiovascular collapse, hypertension, pallor, tachycardia

Central nervous system: Anxiety, convulsions, CNS stimulation, dizziness, excitability (children; rare), fear, hallucinations, headache, insomnia, nervousness, restlessness, sedation

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

Neuromuscular skeletal: Tremors, weakness

Ocular: Diplopia

Renal: Dysuria, polyuria, urinary retention (with BPH)

Respiratory: Respiratory difficulty

Overdosage/Toxicology:

Symptoms of overdose include dry mouth, flushed skin, dilated pupils, and CNS depression. There is no specific treatment for antihistamine overdose. Clinical toxicity is due to blockade of cholinergic receptors. For anticholinergic overdose with severe life-threatening symptoms, physostigmine 1-2 mg I.V. slowly, may be given to reverse these effects.

Drug Interactions:

Antihypertensives: Antihypertensive effect may be decreased.

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

MAO inhibitors: Anticholinergic effects of the antihistamine may be increased and prolonged; sympathomimetic effect of the decongestant may be increased.

Tricyclic antidepressants: CNS depressant effect may be increased.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Stability:

Store at 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; pseudoephedrine, a sympathomimetic amine and isomer of ephedrine, acts as a decongestant in respiratory tract mucous membranes with less vasoconstrictor action than ephedrine in normotensive individuals

Dosage:

Oral:

Children:

Drops (Andehist NR, Carbaxefed RF, Rondec®, Sildec):

1-3 months: 0.25 mL 4 times/day

3-6 months: 0.5 mL 4 times/day

6-12 months: 0.75 mL 4 times/day

12-24 months: 1 mL 4 times/day

Liquid (Pediatex™-D):

1-3 months: 1.25 mL up to 4 times/day

3-6 months: 2.5 mL up to 4 times/day

6-9 months: 3.75 mL up to 4 times/day

9-18 months: 3.75-5 mL up to 4 times/day

18 months to 6 years: 5 mL 3-4 times/day

>6 years: Refer to Adults dosing

Syrup (Hydro-Tussin™-CBX, Palgic®-DS):

1-3 months: 1.25 mL up to 4 times/day

3-6 months: 2.5 mL up to 4 times/day

6-9 months: 3.75 mL up to 4 times/day

9-18 months: 3.75-5 mL up to 4 times/day

18 months to 6 years: 5 mL 3-4 times/day

>6 years: Refer to Adults dosing

Tablet (Rondec®): 6 years: Refer to Adults dosing

Tablet, timed release:

6-12 years (Palgic®-D): One-half tablet every 12 hours

12 years (Palgic®-D, Rondec-TR®): Refer to Adults dosing

Adults:

Liquid (Pediatex™-D): 10 mL 4 times/day

Syrup (Hydro-Tussin™-CBX, Palgic®-DS): 10 mL 4 times/day

Tablet (Rondec®): 1 tablet 4 times a day

Tablet, timed release (Palgic®-D, Rondec-TR®): 1 tablet every 12 hours

Administration:

Palgic®-D: Tablets may be broken in half; do not crush or chew

Rondec-TR®: Do not crush or chew

Patient Education:

Take as directed; do not exceed recommended dose. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience drowsiness, impaired coordination, blurred vision, or increased anxiety (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth or nausea (small, frequent meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report persistent dizziness, sedation, or agitation; respiratory difficulty or increased cough; changes in urinary pattern; muscle weakness; or lack of improvement or worsening or condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.

Nursing Implications:

Raise bed rails; institute safety measures; assist with ambulation

Dental Health: Effects on Dental Treatment:

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

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

Mental Health: Effects on Mental Status:

Drowsiness is common; may cause fatigue, nervousness, or dizziness; may rarely produce depression

Mental Health: Effects on Psychiatric Treatment:

Contraindicated with MAO inhibitors; concurrent use with sedating psychotropics or CNS depressants may produce additive adverse effects

Dosage Forms:

Liquid (Pediatex™-D): Carbinoxamine maleate 2 mg and pseudoephedrine hydrochloride 20 mg per 5 mL (480 mL) [alcohol free, dye free, sugar free; cotton candy flavor]

Solution, oral drops:

Andehist NR: Carbinoxamine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per mL (30 mL) [alcohol and sugar free; raspberry flavor]

Carbaxefed RF, Rondec®: Carbinoxamine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per mL (30 mL) [alcohol free; contains sodium benzoate; cherry flavor]

Sildec: Carbinoxamine maleate 1 mg and pseudoephedrine hydrochloride 15 mg per mL (30 mL) [raspberry flavor]

Solution: Carbinoxamine maleate 2 mg and pseudoephedrine hydrochloride 25 mg per 5 mL (480 mL)

Carboxine-PSE: Carbinoxamine maleate 2 mg and pseudoephedrine hydrochloride 20 mg per 5 mL (480 mL) [peach flavor]

Syrup: Carbinoxamine maleate 2 mg and pseudoephedrine hydrochloride 25 mg per 5 mL (480 mL)

Hydro-Tussin™-CBX, Palgic® DS: Carbinoxamine maleate 2 mg and pseudoephedrine hydrochloride 25 mg per 5 mL (480 mL) [alcohol, dye, and sugar free; strawberry/pineapple flavor]

Tablet (Rondec®): Carbinoxamine maleate 4 mg and pseudoephedrine hydrochloride 60 mg

Tablet, timed release:

Palgic®-D: Carbinoxamine maleate 8 mg and pseudoephedrine hydrochloride 80 mg [dye free]

Rondec-TR®: Carbinoxamine maleate 8 mg and pseudoephedrine hydrochloride 120 mg

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