Benzonatate

Description

DESCRIPTION Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink. structure formula

What Is Benzonatate Used For?

INDICATIONS AND USAGE Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

Dosage and Administration

DOSAGE AND ADMINISTRATION Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate capsules should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Potential Adverse Reactions to benzonatate capsules 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. Deliberate or accidental overdose has resulted in death, particularly in children. Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

Contraindications

CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds.

Pregnancy and Breastfeeding

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

Overdosage

OVERDOSAGE Intentional and unintentional overdose may result in death, particularly in children. 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 The signs and symptoms of overdose of benzonatate capsules have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. Treatment In case of overdose, seek medical attention immediately. 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.

How Supplied

HOW SUPPLIED Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC14” and are supplied as follows: NDC 42806-714-01 in bottle of 100 capsules NDC 42806-714-05 in bottle of 500 capsules Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with “PC15” and are supplied as follows: NDC 42806-715-01 in bottle of 100 capsules NDC 42806-715-05 in bottle of 500 capsules Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in tight (USP), child-resistant containers. Rx Only Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2018-00 PI-EBEN-00