Benzonatate Information
Benzonatate ()
Benzonatate () Description
Benzonatate () , a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl (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.
Benzonatate () 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.
Benzonatate () Indications And Usage
Benzonatate () is indicated for the symptomatic relief of cough.
Benzonatate () Contraindications
Hypersensitivity to Benzonatate () or related compounds.
Benzonatate () Precautions
Benzonatate () is chemically related to anesthetic agents of the para-amino-benzoic 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.
Swallow Benzonatate () Capsules whole. Do not break, chew, dissolve, cut, or crush Benzonatate () capsules. Release of Benzonatate () from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.
Keep Benzonatate () out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of Benzonatate () , skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of Benzonatate () at one time.
Benzonatate () Adverse Reactions
Potential Adverse Reactions to Benzonatate () may include:
Deliberate or accidental overdose has resulted in death, particularly in children.
Benzonatate () 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.
The signs and symptoms of overdose of Benzonatate () 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.
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.
Benzonatate () 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 are not to be broken, chewed, dissolved, cut or crushed.
Benzonatate () How Supplied
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 100’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
Distributed by:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Revised February 2011
Benzonatate () Principal Display Panel
Benzonatate ()
Capsules, USP
100 mg
PROTECT FROM LIGHT
Rx only
500 Soft Gelatin Capsules
TEVA
