Carbinoxamine

DEA Class;  Rx

Common Brand Names; Arbinoxa, Carbihist, Carbinoxamine PD, Histex PD, Karbinal ER, Mintex PD, Palgic, Pediox, RyVent

Oral sedating antihistamine of the ethanolamine class
Used to relieve seasonal allergic rhinitis and to treat other allergic conditions
Deaths reported in very young children and infants; contraindicated for use in pediatric patients 2 years and younger

Varies in incidence & severity with the individual drug; also individual patients vary in susceptibility

Frequency Not Defined

• CNS depression
• Drowsiness
• Sedation ranging from mild drowsiness to deep sleep (most frequent)
• Dizziness
• Lassitude
• Disturbed coordination
• Muscular weakness
• Restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures is less common
• Epigastric distress
• Anorexia
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice is rare
• Tachycardia, palpitation ECG changes (eg, widened QRS)
• Arrhythmias (eg, extrasystole, heart block)
• Hypotension
• Hypertension
• Dizziness, sedation, and hypotension may occur in geriatric patients
• Dryness of mouth, nose, and throat
• Dysuria
• Urinary retention
• Impotence
• Vertigo
• Visual disturbances
• Blurred vision
• Diplopia; tinnitus
• Acute labyrinthitis
• Insomnia
• Tremors
• Nervousness
• Irritability
• Facial dyskinesia
• Tightness of the chest
• Thickening of bronchial secretions
• Wheezing
• Nasal stuffiness
• Sweating
• Chills
• Early menses
• Toxic psychosis
• Headache
• Faintness
• Paresthesia
• Agranulocytosis
• Hemolytic anemia
• Leukopenia
• Thrombocytopenia
• Pancytopenia

Deaths reported in children 2 years of age and younger treated with carbinoxamine-containing medications; therefore, contraindicated in children aged ≤2 years

May produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery;

Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of drug; avoid concurrent use of drug with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur

Drug has anticholinergic (atropine-like) properties and, therefore, should be used with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction

Drug contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in susceptible individuals; the overall prevalence of sulfite sensitivity in the general population is unknown and probably low; sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic individuals

Pregnancy

Published data over decades of use of antihistamines, including carbinoxamine, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; however, published data specifically evaluating risk of carbinoxamine were not found

No animal reproductive studies have been conducted

Lactation

Based on physical properties of carbinoxamine, it is likely is present in breast milk

Drowsiness and irritability in infants exposed antihistamines via breast milk have been reported

Postmarketing reports of death in children <2 years exposed to oral carbinoxamine

No data are available on effects on milk production

Not recommended to breastfeed during treatment

NOTE: Do not exceed recommended dosage limits for the specific product prescribed; the following are general guidelines.

Adults

32 mg/day PO for the 4 mg tablet, the oral solution, or the extended release oral solution; 24 mg/day PO for the 6 mg tablet.

Geriatric

32 mg/day PO for the 4 mg tablet, the oral solution, or the extended release oral solution; 24 mg/day PO for the 6 mg tablet.

Adolescents

32 mg/day PO for the 4 mg tablet, the oral solution, or the extended release oral solution; the 6 mg tablet is not recommended.

Children

6 years and older: 0.4 mg/kg/day or 24 mg/day PO for the oral solution or the extended release oral solution; 24 mg/day PO for the 4 mg tablet; the 6 mg tablet is not recommended.
3 to 6 years: 0.4 mg/kg/day or 16 mg/day PO for the oral solution or the extended release oral solution.
2 to 3 years: 0.4 mg/kg/day or 8 mg/day PO for the oral solution or the extended release oral solution.
Less than 2 years: Use is contraindicated.

Carbinoxamine 

Tablet

• 4mg

Oral solution

• 4mg/5mL

Oral suspension, extended-release (Karbinal ER)

• 4mg/5mL