Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Benzonatate capsules, USP are indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with PC14 and are supplied as follows: NDC 68071-5223-4 BOTTLES OF 4 NDC 68071-5223-6 BOTTLES OF 6 Dispense in tight (USP), child-resistant containers. Rx Only Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2018-00 PI-EBEN-00
Abbreviated New Drug Application
BENZONATATE- BENZONATATE CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- BENZONATATE CAPSULES, USP DESCRIPTION Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink. CLINICAL PHARMACOLOGY Benzonatate capsules act 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 capsules have no inhibitory effect on the respiratory center in recommended dosage. INDICATIONS AND USAGE Benzonatate capsules, USP are 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 EFFECTS Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking Benzonatate capsules 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 dea read_full_document