Benzonatate

Mechanism-of-action class: Sodium-Potassium Exchanging ATPase Interactions.

• Benzonatate Capsule is indicated for the symptomatic relief of cough.ICD-10: R05.9

• Hypersensitivity to benzonatate or related compounds.contraindicated

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.

Hypersensitivity 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. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate Capsule in combination with other prescribed drugs. Accidental Ingestion and Death in Children Keep Benzonatate Capsules out of reach of children. Accidental ingestion of Benzonatate Capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).

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.

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.

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 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.

• Jan 29, 1993ANDAANDA081297Bionpharma
• Mar 30, 2007ANDAANDA040627Thepharmanetwork Llc
• Jun 8, 2007ANDAANDA040597Zydus Pharms Usa
• Jul 30, 2007ANDAANDA040682Heritage Pharms Labs
• Jul 30, 2015ANDAANDA091133Onesource Specialty
• Jul 31, 2015ANDAANDA202765Cspc-nbp Pharm
• Dec 19, 2018ANDAANDA206948Puracap Pharm Llc
• Feb 22, 2019ANDAANDA211518Ascent Pharms Inc

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Benzonatate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
  Unknown · Phase 1 · Interventional · 40 enrolled · CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  NCT03922373updated 2019-04-19
• A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms
  Unknown · Phase 3 · Interventional · 220 enrolled · CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  NCT03722914updated 2018-10-29
• Evaluation of the Effect of Benzonatate on QT Intervals Following Single Dose Administration of Benzonatate to Healthy Volunteers
  Completed · Phase 1 · Interventional · 68 enrolled · Pfizer
  NCT02207699updated 2014-08-04
• Benzonatate Dose Tolerance Study
  Completed · Phase 1 · Interventional · 9 enrolled · Pfizer
  NCT01690975updated 2012-09-24

Frequently asked questions

How does Benzonatate work?

Mechanism-of-action class: Sodium-Potassium Exchanging ATPase Interactions.

What is Benzonatate used for?

According to FDA labeling, Benzonatate carries indications including: Benzonatate Capsule is indicated for the symptomatic relief of cough.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Benzonatate?

Benzonatate is classified as Other cough suppressants, Non-narcotic Antitussive, Sodium-Potassium Exchanging ATPase Interactions, Decreased Tracheobronchial Stretch Receptor Activity.

What are the brand names for Benzonatate?

Benzonatate is marketed under brand names including Tessalon Perles.

What are the contraindications for Benzonatate?

Benzonatate labeling lists contraindications including: Hypersensitivity to benzonatate or related compounds.. Always consult the full prescribing information and a clinician.