benzocaine/dextromethorphan [Oropharyngeal]

Adult Dosing

Throat pain or irritation/Cough

2 lozenges PO q4 hrs PRN
Max: 12 lozenges/day

Pediatric Dosing

Throat pain or irritation/Cough

Children <6 yrs: Do not use
Children 6-11 yrs: 1 lozenge PO q4 hrs PRN; max: 6 lozenges/day
Children 12 yrs: 2 lozenges PO q4 hrs PRN; max: 12 lozenges/day

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Temporary relief of minor mouth irritation, pain due to canker sores, sore mouth and sore throat
Temporarily controls cough due to minor throat and bronchial irritation associated with the common cold

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Concomitant use of monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping MAOI therapy
Pediatric patients <6 yrs
History of hypersensitivity to local anesthetics namely butacaine, benzocaine, procaine, or other 'caine' anesthetics

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Do not exceed recommended dose
Discontinue therapy and consult a physician if sore throat becomes severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting
Discontinue use of benzocaine/dextromethorphan lozenges and consult a clinician if sore mouth symptoms do not improve in 7 days, swelling is noted, or if irritation/pain/redness persists or worsens
Stop therapy if cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache; further evaluate the patients as these could be signs of a serious condition

Cautions: Use cautiously in

Hepatic impairment
Thyroid disorder
Cardiovascular disease
Diabetes mellitus
CNS disease
Shock
Persistent or chronic cough
Cough with excessive phlegm
Debilitated patients
Geriatric population

Supplemental Patient Information

Instruct patients to inform their clinician if they are pregnant or breast feeding
Advise patients to keep the medication out of reach of children
Advise patients to seek medical help or contact a Poison Control Center, in case of medication overdose

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C (benzocaine), C (dextromethorphan)

Breastfeeding: No studies have been conducted on the excretion of dextromethorphan in milk or its effect on breastfed infants. However, this medication can be administered to infants as young as 1 month of age. It is unlikely that with usual maternal doses amounts in milk are as large as those given directly to infants or that breastfed infants would be harmed by the drug in breastmilk, especially in infants over 1 month of age. Avoid use of products with high alcohol content while nursing. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 December 2011). Manufacturer advises to consult a health professional.

Adverse Reactions ⬆ ⬇

CNS: Drowsiness, fatigue, dizziness
HEMA: Methemoglobinemia
LOCAL: Redness, irritation, swelling, pain
GI: Nausea, abdominal pain
MISC: Serotonin syndrome, abuse potential

Clinical Pharmacology ⬆ ⬇

Benzocaine

Local anesthetic; decreases neuronal membrane permeability to sodium ions by reversibly stabilizing the neuronal membrane, thereby blocking the initiation and conduction of nerve impulses
Minimal systemic absorption
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Dextromethorphan hydrobromide

Non-narcotic antitussive; suppresses cough by directly acting on cough center in the medulla
Rapid absorption
Metabolized by liver; CYP450: 2D6 substrate
Excreted in urine
Half-life: 11 hrs

Brands and Availability ⬆ ⬇