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Americaine

  • Generic Name: benzocaine
  • Brand Name: Americaine

side effects drug center americaine (benzocaine) drug

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

Drug Description

What is Americaine and how is it used?

Americaine is an over the counter medicine used to treat the symptoms of Bee Stings or other Insect Bites, minor burns, sunburn, mouth and gum irritation, sore throat, dental pain, boils, and premature ejaculation. Americaine may be used alone or with other medications.

Americaine belongs to a class of drugs called Anesthetics, Oropharyngeal; Anesthetics, Topical; Local Anesthetics, Esters.

It is not known if Americaine is safe and effective in children younger than 2 years of age.

What are the possible side effects of Americaine?

Americaine may cause serious side effects including:

  • headache,
  • tiredness,
  • confusion,
  • fast heartbeats,
  • lightheadedness,
  • shortness of breath,
  • pale, blue or gray appearance of your skin, lips or fingernails,
  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue or throat,
  • severe burning, stinging or sensitivity where the medicine is applied,
  • swelling,
  • warmth,
  • redness,
  • oozing,
  • blistering, and
  • signs of infection

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Americaine include:

  • mild stinging, burning, or itching where the medicine is applied,
  • skin tenderness or redness, and
  • dry white flakes where the medicine was applied

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Americaine. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

DESCRIPTION

AMERICAINE Anesthetic Lubricant contains benzocaine 20% with benzethonium chloride 0.1% as a preservative in a water soluble base of polyethylene glycol 300 and 3350.

Benzocaine, a local anesthetic, is chemically ethyl -aminobenzoate, C9H11NO2, with a molecular weight of 165.19. and has the following structual formula:

 

Indications & Dosage

INDICATIONS

AMERICAINE (benzocaine) Anesthetic Lubricant is indicated for general use as a lubricant and topical anesthetic on intratracheal catheters and pharyngeal and nasal airways to obtund the pharyngeal and tracheal reflexes; on nasogastric and endoscopic tubes; urinary catheters; laryngoscopes; proctoscopes; sigmoidoscopes and vaginal specula.

 

DOSAGE AND ADMINISTRATION

Apply evenly to exterior of tube or instrument prior to use.

 

HOW SUPPLIED

AMERICAINE Anesthetic Lubricant (benzocaine) is available in:

NDC 53014-376-16 28 g tube

NDC 53014-376-62 2.5 g unit dose foil packs, 144 per carton

Store at 15°-25°C (59°-77°F).

Celltech Pharmaceuticals, Inc.

Rochester, NY 14623 USA

® Ciba-Geigy Corporation, &Copy; 2001, Celltech Pharmaceuticals, Inc., R531 Rev. 7/01

 

Side Effects & Drug Interactions

SIDE EFFECTS

Contact dermatitis and/or hypersensitivity to benzocaine can cause burning, stinging, pruritus, tenderness, erythema, rash, urticaria and edema. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis. Intravenous methylene blue is the specific therapy for this condition.

 

DRUG INTERACTIONS

No information is available.

 

Warnings & Precautions

WARNINGS

No information is available.

PRECAUTIONS

General: Medication should be discontinued if sensitivity or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with AMERICAINE (benzocaine) Anesthetic Lubricant. It is also not known whether AMERICAINE (benzocaine) Anesthetic Lubricant can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AMERICAINE (benzocaine) Anesthetic Lubricant should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AMERICAINE (benzocaine) Anesthetic Lubricant is administered to a nursing woman.

Pediatric Use: Do not use in infants under 1 year of age.

 

Overdosage & Contraindications

OVERDOSE

No information is available.

 

CONTRAINDICATIONS

Known allergy or hypersensitivity to benzocaine.

 

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Benzocaine reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.

 

Medication Guide

PATIENT INFORMATION

Please refer to the PRECAUTIONS section.