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

• 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

• 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

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

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 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.

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

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

US Trade Name(s)

• Cepacol Sore Throat & Cough

US Availability

Cepacol Sore Throat & Cough (benzocaine/dextromethorphan)

• LOZENGES: 7.5 mg/5 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

ENT

Local Anesthetic/Antitussive; Combinations

Pulmonary

Local Anesthetic/Antitussive; Combinations