benzonatate

RedPharm Drug Inc.

Benzoate Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• BENZONATATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• BENZONATATE INDICATIONS AND USAGE
• BENZONATATE CONTRAINDICATIONS
• PRECAUTIONS
• Information for patients:
• Usage in Pregnancy:
• Nursing Mothers:
• Carcinogenesis, mutagenesis, impairment of fertility:
• Pediatric Use:
• BENZONATATE ADVERSE REACTIONS
• OVERDOSAGE
• BENZONATATE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Package Label

FULL PRESCRIBING INFORMATION

BENZONATATE DESCRIPTION

CLINICAL PHARMACOLOGY

BENZONATATE INDICATIONS AND USAGE

BENZONATATE CONTRAINDICATIONS

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 para-aminobenzoic 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:

Usage in Pregnancy:

Nursing Mothers:

Carcinogenesis, mutagenesis, impairment of fertility:

Pediatric Use:

BENZONATATE 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.

BENZONATATE DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “106” on the other side, available in bottles of 30 (NDC 67296-0822-1)

Store at controlled room temperature 20º - 25ºC (68º - 77ºF) [See USP].

API-01, 5/07

Mfd by
Intergel Division of IVC Industries, Inc.
Irvington, NJ 07111

for
ASCEND LABORATORIES, LLC
MONTVALE, NJ 07645

Package Label