Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
Rebel Distributors Corp
BENZONATATE
BENZONATATE 100 mg
ORAL
PRESCRIPTION DRUG
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. Hypersensitivity to benzonatate or related compounds.
Benzonatate Capsules, USP are available as: Soft gelatin capsules, 100 mg (oval, yellow) Imprint: A1.; bottle of 20 (NDC 42254-078-20) and bottle of 30 (42254-078-30 Store at 25°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Manufactured by: Swiss Caps AG Hausenstrasse 35 CH-9533, Kirchberg, Switzerland Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 09-2008 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
BENZONATATE- BENZONATATE CAPSULE, LIQUID FILLED REBEL DISTRIBUTORS CORP ---------- BENZONATATE CAPSULES, USP 100 MG AND 200 MG RX ONLY DESCRIPTION Benzonatate, a non-narcotic 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. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. 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 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. 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. 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 THE PATIENT Release of benzonatate from the capsule in th Leggi il documento completo