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Benzonatate Capsules | benzonatate [RedPharm Drug Inc.] | BioPortfolio

12:00 EST 27th January 2019 | BioPortfolio

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

Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D and C Yellow No. 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide.

Hypersensitivity to benzonatate or related compounds.

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.

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.

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.

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.

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

API-01, 5/07

Mfd byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111

Manufacturer

RedPharm Drug Inc.

Active Ingredients

Source

Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.

PubMed Articles [0 Results]

None

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