DESCRIPTION

Antipyrine and also Benzocaine Otic systems is an otic equipment containing Antipyrine, Benzocaine, Oxyquinoline Sulfate, and also Anhydrous Glycerin for use in the ear. The systems congeals in ~ 0°C (32°F), however returns to common consistency, unchanged, at room temperature.

You are watching: What is antipyrine and benzocaine otic

Antipyrine is one analgesic with regional anesthetic action, that is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. The energetic ingredient is represented by the structural formula:


*

Antipyrine occurs as colorless crystals or white powder, has actually a contempt bitter taste and is dissolve in water and alcohol.

Benzocaine is a neighborhood anesthetic. The is chemically ethyl p-aminobenzoate or Benzoic acid, 4-amino-, ethyl ester. The active ingredient is stood for by the structure formula:


*

It occurs as white crystals or white crystalline powder and is slightly dissolve in water and also soluble in organic solvents.

EACH mL CONTAINS:

Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.


CLINICAL PHARMACOLOGY

Antipyrine and Benzocaine Otic solution combines the hygroscopic property of anhydrous glycerin v the analgesic action of antipyrine and also benzocaine to relieve pressure, mitigate inflammation and congestion, and also to minimize pain and discomfort in acute otitis media.

Antipyrine and Benzocaine Otic equipment does no blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.


INDICATIONS and also USAGE

Acute Otitis media of miscellaneous etiologies

-prompt relief of pain and reduction that inflammation in the congestive and serous stages.

-adjuvant therapy during systemic antibiotic management for resolution of the infection.

Because of the near anatomical relationship of the eustachian pipe to the sleep cavity, otitis media is a regular problem, especially in children in who the tube is shorter, wider, and an ext horizontal 보다 in adults.

Removal of Cerumen

-facilitates the removed of too much or affected cerumen.


CONTRAINDICATIONS

The product is contraindicated in any person v hypersensitivity to any kind of of the components or substances regarded them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.


WARNINGS

FOR use IN ears ONLY-NOT FOR usage IN EYES

Discontinue promptly if sensitization or wake up occurs.


PRECAUTIONS

Information for Patients: stop contaminating the dropper with product from the ear, finger or various other source.


Pregnancy

Pregnancy: group C. Animal reproduction studies have not been performed with Antipyrine and also Benzocaine Otic Solution. It is additionally not well-known whether Antipyrine and Benzocaine Otic solution can reason fetal damage when administered to a pregnant mrs or can influence reproduction capacity. Antipyrine and Benzocaine Otic Solution should be offered to a pregnant woman only if plainly needed.


Nursing mothers

It is not recognized whether this drug is excreted in human milk. Because many drugs are excreted in person milk, caution have to be exercised when Antipyrine and also Benzocaine Otic equipment is administered to a education woman.


DOSAGE AND administration

Acute otitis media: Instill Antipyrine and Benzocaine Otic Solution, allow the solution to run along the wall surface of the ear canal until it is filled. Avoid emotional the ear with dropper. Then moisten a cotton pledget v Antipyrine and Benzocaine Otic Solution and insert into meatus. Repeat every one to two hours until pain and congestion room relieved.

Removal of Cerumen:

Before: Instill Antipyrine and also Benzocaine Otic systems three times day-to-day for two or 3 days to assist detach cerumen from wall surface of ear canal and also facilitate removal.

After: Antipyrine and Benzocaine Otic solution is advantageous for drying out the ear canal or relieving discomfort.

Before and after removal of cerumen, a cotton pledget moistened with Antipyrine and Benzocaine Otic Solution must be placed into the meatus adhering to instillation.


HOW offered

Antipyrine and also Benzocaine Otic equipment NDC 21695-216-15 is provided in a 15 mL light-resistant dropper-bottle through a screwtop party cap. Tamper obvious seal on bottle cap. Carry out not use if seal is broken.


Storage and Handling

Store at 20°-25°C (68°-77°F) . Safeguard from heat and also light. Defend from freezing.

Call your medical professional for clinical advice around side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See more: How Much Is A Pound Of Hundred Dollar Bills ? And 100 Lbs Of Ten Dollar Bills

Manufactured for:

Boca Pharmacal, Inc.

Coral Springs, FL 33065

www.bocapharmacal.com

1-800-354-8460

Rev. 04/09

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


*