CHLORPHENYLCAINE
-
phenylephrine hydrochloride,
antipyrine and
benzocaine liquid
Kylemore Pharmaceuticals, LLC
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Chlorphenylcaine Otic Drops
Chlorphenylcaine Otic Drops is an analgesic-decongestant ear drop. Phenylephrine HCl is a sympathomimetic amine with local vasoconstriction or decongestant action. It is chemically, (1) Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. (2) (—)-m-Hydroxy-α-[methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white crystals and is freely soluble in water and alcohol. Antipyrine is an analgesic with local anesthetic action. It is chemically 2, 3-dimethyl-1- phenyl-3-pyrazolin-5-one. Antipyrine appears as colorless crystals or white powder and is soluble in water and alcohol. Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate. It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.
Topical application of phenylephrine produces vasoconstriction mainly by a direct effect on α-adrenergic receptors. Phenylephrine, after absorption, is metabolized in the liver and the intestine by the enzyme monoamine oxidase (MAO). The type, route and rate of excretion of metabolites have not been defined. Like other local anesthetics, benzocaine acts by blocking nerve conduction first in autonomic, then in sensory and finally in motor nerve fibers. Its effect appears to be due to decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites. A vasoconstrictor, such as phenylephrine is added to decrease the rate of absorption and prolong the duration of action of the anesthetics. Antipyrine is believed to have analgesic and local anesthetic effects on the nerve endings. After absorption, it is slowly metabolized in the liver by oxidation and conjugated with glucuronic acid and is excreted in urine mainly in the conjugated form.
Chlorphenylcaine Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used concomitantly with systemic antibiotics as in the treatment of acute otitis media.
Chlorphenylcaine Otic Drops is contraindicated in patients sensitive to any of its ingredients. This medication should not be applied in the external auditory canal if there is a perforated eardrum or when this medication can reach the middle ear.
Overdosage is more likely to be associated with accidental or deliberate ingestion rather than cutaneous absorption. Call your local poison control center and/or your doctor if overdosage is suspected. Phenylephrine may cause hypertension, headache, vomiting and palpitations if absorbed. Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Antipyrine overdosage may cause giddiness, tremor, sweating and skin eruptions. Treatment is symptomatic. If ingestion of the contents of a bottle or more of this product is recent or food is present in the stomach, induction of emesis with ipecac syrup, gastric emptying and lavage and introduction of activated charcoal may be recommended.
Using the dropper, administer Chlorphenylcaine Otic Drops into the external ear canal until the canal is filled. Insert a cotton pledget (or absorbent dressing) into the opening of the ear after moistening with Chlorphenylcaine Otic Drops. Repeat every 2 to 4 hours, if necessary, until pain is relieved. Replace dropper in bottle without rinsing.
Store at 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Store in a tight, light-resistant container. [See USP.] Keep bottle tightly closed.
Chlorphenylcaine Otic Drops are supplied as a clear liquid in 15 mL vial, NDC 49769-377-15, and include a wrapped dropper.
Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09 377-10
Chlorphenylcaine Otic Drops labeling:
Chlorphenylcaine Otic Drops carton:
CHLORPHENYLCAINE
phenylephrine hydrochloride, antipyrine, benzocaine liquid |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 01/01/2010 | 03/16/2011 |
Labeler - Kylemore Pharmaceuticals, LLC (831892471) |