Benzonatate

Cardinal Health

BENZONATATE CAPSULES USP, 100 mg and 200 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• BENZONATATE DESCRIPTION:
• CLINICAL PHARMACOLOGY:
• BENZONATATE INDICATIONS AND USAGE:
• BENZONATATE CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS:
  • Information for Patients:
  • Usage in Pregnancy:
  • Nursing Mothers:
  • Carcinogenesis, Mutagenesis, Impairment of Fertility:
  • Pediatric Use:
• BENZONATATE ADVERSE REACTIONS:
• OVERDOSAGE:
• PRINCIPAL DISPLAY PANEL - Carton
• PRINCIPAL DISPLAY PANEL - Pouch
• PRINCIPAL DISPLAY PANEL - BAG

FULL PRESCRIBING INFORMATION

Rx only

DESCRIPTION:

Benzonatate, a non-narcotic oral antitussive agent, is 2,5,8,11,14,17,20, 23,26-nonaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7.

Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.

CLINICAL PHARMACOLOGY:

Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

INDICATIONS AND USAGE:

Benzonatate is indicated for the symptomatic relief of cough.

CONTRAINDICATIONS:

Hypersensitivity to benzonatate or related compounds.

WARNINGS:

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs.

PRECAUTIONS:

Benzonatate is chemically related to anesthetic agents of the paraaminobenzoic acid class (e.g., procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Information for Patients:

Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the capsules should be swallowed without chewing.

Usage in Pregnancy:

Pregnancy Category C.  Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate 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 benzonatate is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.

Pediatric Use:

Safety and effectiveness in children below the age of 10 have not been established.

ADVERSE REACTIONS:

Potential Adverse Reactions to benzonatate may include: Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Rare instances of deliberate or accidental overdose have resulted in death.

OVERDOSAGE:

Overdose may result in death.

The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms: If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.

Treatment: Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

Adults and children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times daily, as required. If necessary, up to 600 mg daily may be given.

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with “PA46”, available in bottles of 100’s and 500’s.

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in bottles of 30’s, 100’s and 500’s.

The capsules should be protected from light, moisture and humidity, and stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Dispense in a tight, light-resistant container as defined in USP/NF.

Manufactured by Banner Pharmacaps Inc., High Point, NC 27265

for PLIVA, Inc., Pomona, NY 10970

Dist. by Barr Laboratories, Inc., Pomona, NY 10970

Revised AUGUST 2007

B21-0883

BENZONATATE 100 mg capsules are available from Cardinal Health in unit dose

packages of 100.

100 mg Capsule NDC 55154-5750-4

Cardinal Health

Zanesville OH 43701

IU37360710509

PRINCIPAL DISPLAY PANEL - Carton

Benzonatate

Capsules, USP

100 mg

QTY 100

PRINCIPAL DISPLAY PANEL - Pouch

Benzonatate

Capsule, USP

100 mg

PRINCIPAL DISPLAY PANEL - BAG

Benzonatate Capsules, USP

100 mg

10 Softgels