Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
Bryant Ranch Prepack
BENZONATATE
BENZONATATE 100 mg
ORAL
PRESCRIPTION DRUG
BENZONATATE is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted with “PA46”, available in bottles of 100’s and 500’s. Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in bottles of 100’s. 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 by: BANNER PHARMACAPS INC.; High Point, NC 27265 Distributed by: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Revised February 2011
Abbreviated New Drug Application
BENZONATATE- BENZONATATE CAPSULE BRYANT RANCH PREPACK ---------- BENZONATATE CAPSULES USP, 100 MG AND 200 MG RX ONLY 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. INDICATIONS AND USAGE BENZONATATE is indicated for the symptomatic relief of cough. CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds. WARNINGS HYPERS ENS ITIVITY 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 in combination with other prescribed drugs. ACCIDENTAL INGESTION AND DEATH IN CHILDREN Keep BENZONATATE 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 occurs, seek medical attention immediately (see OVERDOSAGE). PRECAUTIONS B Lees het volledige document