Get your patient on Benzonatate - Benzonatate capsule (Benzonatate)
Benzonatate - Benzonatate capsule prescribing information
INDICATIONS AND USAGE
BENZONATATE is indicated for the symptomatic relief of cough.
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 should be swallowed whole. BENZONATATE Capsules are not to be broken, chewed, dissolved, cut or crushed.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
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.
Deliberate or accidental overdose has resulted in death, particularly in children.
To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DESCRIPTION
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 benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.
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.
HOW SUPPLIED
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with "PA46", available in bottles of 100's (NDC 69452-143-20) and 500's (NDC 69452-143-30).
Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with "PA83", available in bottles of 100's (NDC 69452-144-20) and 500's (NDC 69452-144-30).
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 for: Bionpharma Inc. Princeton, NJ 08540, USA Rev. 12/2022
