Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
benzonatate (UNII: 5P4DHS6ENR) (benzonatate - UNII:5P4DHS6ENR)
Ascend Laboratories LLC
benzonatate
benzonatate 100 mg
ORAL
PRESCRIPTION DRUG
Benzonatate USP is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 100’s (NDC 67877-105-01), and 500’s (NDC 67877-105-05). Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted "128", available in bottles of 100 (NDC 67877-128-01) and 500's (NDC 67877-128-05). Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted "106", available in bottles of 100’s (NDC 67877-106-01) and 500’s (NDC 67877- 106-05). Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 Manufactured for Ascend Laboratories, LLC Montvale, NJ 07645 Rev 03/16 210082
Abbreviated New Drug Application
BENZONATATE - BENZONATATE CAPSULE ASCEND LABORATORIES LLC ---------- BENZONATATE CAPSULES, USP 100 MG, 150 MG AND 200 MG 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, 150 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 USP is indicated for the symptomatic relief of cough. CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds. WARNINGS 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 EFECTS 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. ACCIDENTAL INGESTION AND DEATH IN CHILDREN Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate 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 occ Прочитать полный документ