Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
benzonatate (UNII: 5P4DHS6ENR) (benzonatate - UNII:5P4DHS6ENR)
H.J. Harkins Company, Inc.
benzonatate
benzonatate 100 mg
ORAL
PRESCRIPTION DRUG
Benzonatate is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Safety and effectiveness in children below the age of 10 have not been established.
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “105” on the other side, available in bottles of 100’s (NDC 67877-105-01), 500’s (NDC 67877-105-05) and 1000’s (NDC 67877-105- 10). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “106” on the other side, available in bottles of 100’s (NDC 67877-106-01) and 500’s (NDC 67877-106-05). Store at controlled room temperature 20º - 25ºC (68º - 77ºF) [See USP]. 10/11 Mfd by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 for ASCEND LABORATORIES, LLC MONTVALE, NJ 07645 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444
Abbreviated New Drug Application
BENZONATATE - BENZONATATE CAPSULE H.J. HARKINS COMPANY, INC. ---------- 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 of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow # 10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide. 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. INDICATIONS AND USAGE Benzonatate is indicated for the symptomatic relief of cough. CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds. WARNINGS 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. PRECAUTIONS 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. INFORMATION FOR PATIENTS: Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Przeczytaj cały dokument