DERMACINRX PHN PAK (LIDOCAINE/EMOLLIENT COMBINATION NO.102)

Contraindicated



• Antabuse
• disulfiram

Severe



• None

Contraindicated



• Large open wound
• Methemoglobinemia

Severe



• Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
• Heart block
• Hemolytic anemia from PK and g6PD deficiencies
• Sepsis
• Shock

Contraindicated

None

Severe Precaution

Benzyl Alcohol (Topical, Otic)

No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.

• 1 Day – 29 Days
• No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.
• 1 Day – 179 Days
• No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Lidocaine (Top)

No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.

• 1 Day – 29 Days
• Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.
• 1 Day – 179 Days
• Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.

Management or Monitoring Precaution

Benzyl Alcohol (Topical, Otic)

No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.

• 30 Days – 179 Days
• No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.
• 180 Days – 13 Years
• No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Lidocaine (Top)

No safety and efficacy age < 6 months. There is a presumptive risk of gasping syndrome in neonates. This presumed risk is based on several 1982 case report series where premature neonates, receiving injections containing benzyl alcohol preservative, developed a frequently fatal "gasping syndrome" and metabolic acidosis. Plasma levels from 5% topical benzyl alcohol in children using short contact times (<30 minutes), were 37 fold lower than previously reported using injectable.

Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.

• 30 Days – 179 Days
• Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.
• 180 Days – 13 Years
• Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.